The Computer Based Patient Record An Essential Technology For Health Care Revised Edition PDF
The Computer Based Patient Record An Essential Technology For Health Care Revised Edition PDF
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i
THE COMPUTER-BASED
PATIENT RECORD
Revised Edition
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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 20418
NOTICE: The project that is the subject of this report was approved by the Governing Board of the
National Research Council, whose members are drawn from the councils of the National Academy
of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of
the committee responsible for the report were chosen for their special competences and with regard
for appropriate balance.
The committee report and the commentaries were reviewed by groups other than the authors
according to procedures approved by a Report Review Committee consisting of members of the
National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist
distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in
identifying issues of medical care, research, and education.
See page xv for a listing of the organizations that supported the original and revised reports.
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Study Staff
Original Edition
RICHARD S. DICK, Study Director
ELAINE B. STEEN, Staff Officer
EVANSON H. JOSEPH, Project Secretary
KARL D. YORDY, Director, Division of Health Care Services
KATHLEEN N. LOHR, Deputy Director, Division of Health Care Services
Revised Edition
MARILYN J. FIELD, Deputy Director, Division of Health Care Services
KARLA SAUNDERS, Administrative Assistant
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PREFACEREVISED EDITION
PrefaceRevised Edition
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PREFACEREVISED EDITION
vi
to offer AIDS sufferers in the way of treatment, neither did we use umbilical
cord blood for bone marrow transplantation. During these past few years
comprehensive government-led health care reform reached its pinacle, was
defeated, and market-driven changes in health care financing and delivery
permeated much of the country.
There have been equally significant changes in information technology.
Between 1991 and 1997, there was a 8-fold increase in power and capacity of
personal computers and comparable improvements in peripheral devices with
the result of making powerful workstations more affordable. The dramatic
strides in computer technology have been accompanied by the massive growth
of the Internet, as well as of local and regional networks that link communities,
schools, health care providers, and individuals to information resources around
the world.
Despite this milieu of rapid change, the vision outlined in this report by the
Committee on Improving the Patient Record remains remarkably on target, and
the case for CPRs is stronger today than it was 6 years ago. The demand for
timely, accurate health data continues to grow. The changing demographics of
the population are placing more demands on the information capabilities of
health care providers and systems. The increasing volume of data collected and
the continued growth of medical knowledge have created a dramatic need for
information technology appropriate for the task of sorting through all the
information available, assessing the strength of the evidence, and bringing it to
practitioners whenever they need it, particularly at the time they are making
care decisions. Further, the evolution of health care delivery organizations into
integrated delivery systems means that those organizations need a way of
managing their services. And, of course, citizens and other purchasers need
better tools for assessing the performance of health care providers as well as for
managing their own health care decisions.
Looking ahead, current trends in health care delivery, management, and
research will likely broaden the vision of CPRs in two areas: population-based
management of health through computer-based population records and citizenbased management of health through another variant of the CPR, the computerbased personal health record. First, CPRs will play an increasingly important
role in supplying data for computer-based population data bases. High-quality
data are essential to the management of care for individuals; however, such data
are equally critical for research, to support public health activities, and to track
the performance of health care providersboth individuals and institutions.
Second, as people continue to become more active consumers of health care and
assume greater responsibility for managing their own health, and as information
technology becomes available in more homes, individuals will increasingly use
elements of the CPR and CPR-related technology to search through the health
literature,
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PREFACEREVISED EDITION
vii
communicate with their health care professionals, access data on their health
care history, track the costs and value of the services they receive, diagnose
acute conditions, and manage chronic conditions. The emergence of personal
health information systemscustomer-based personal health recordsthat are
responsive to a variety of needs of individuals raises new opportunities for
systems developers to provide complicated information in an easily understood
format. Moreover, integrated delivery systems may increasingly view customerbased personal health record systems as a means of attracting new members,
streamlining communication with patients, and diagnosing and monitoring
patient conditions remotely and cost-effectively.
The demand for CPR systems has steadily increased since the release of
the first edition of this report. CPR innovatorsin the United States, Europe,
and elsewhereare proving not only that CPRs can meet users' needs, but also
that there are significant benefits to be gained from their use. Recent experience
has shown that access to data and information at the point of care and the ability
to analyze data for management and research purposes improve the quality and
reduce the costs of care. These capacities are critical for any health care provider
whether a group practice, hospital, or integrated delivery systemto function
successfully. Thus, CPRs are, and will continue to be, an essential technology
for health care.
Today there are several examples of quite robust hospital-based CPR
systems developed by individual institutions, and commercial systems have
moved toward achieving the 12 attributes of CPRs outlined in the original
report. Plenty of room remains, however, to combine the depth of systems
developed by institutions with easily modified, modular architecture, readily
available technology, and the use of national standards. Even as CPR systems
become increasingly robust, there is not, nor is there likely to be, a single CPR
product that meets all the needs of a provider organization. Thus, organizations
seeking CPRs face significant challenges in integrating various systems to
achieve the full functionality they need. Moreover, CPR diffusion goes far
beyond technology within an organization and relies at least as much on a
change in culture that requires motivated, educated leadership within institutions.
Until CPR use becomes the norm for all practitioners across all provider
settings as recommended in the original report, we will continue to lack the
tools needed to manage the quality and costs of health care, the scientific basis
for health care will continue to be undermined, and the dramatic transformation
of health care so urgently required will be impeded. Thus, a major challenge
facing us is to determine how to advance from where we are to where we need
to be with respect to the development and diffusion of CPRs. How can we take
full advantage of the lessons learned by the leaders in CPR development and
reduce the problems for future CPR users?
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PREFACEREVISED EDITION
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PREFACEREVISED EDITION
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PREFACEORIGINAL EDITION
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PrefaceOriginal Edition
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PREFACEORIGINAL EDITION
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PREFACEORIGINAL EDITION
xiii
and compromise as well, but we are fully convinced that the outcomes will be
well worth such an effort. What we believe will emerge will be a more caring,
more scientific, and, no less important, more cost-effective health care system.
We hope that this report will be a catalyst to encourage you to join with us to
address the opportunity at hand.
Finally, on a personal note, the enthusiasm, involvement, and support of
the many individuals and institutions acknowledged elsewhere in this report
were deeply appreciated.
Don E. Detmer, M.D.
Chair
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PREFACEORIGINAL EDITION
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xv
AcknowledgmentsRevised Edition
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ACKNOWLEDGMENTSREVISED EDITION
xvi
American Medical Record Association, Baxter Healthcare Corporation, BoozAllen and Hamilton, E. I. du Pont de Nemours and Company, Gerber Alley and
Company, the John A. Hartford Foundation, Hewlett-Packard Company, IBM
Corporation, Kaiser Foundation Hospitals, and Science Applications
International Corporation. In addition, the Health Care Financing
Administration (Contract No. 500-90-0041), the Department of Veterans
Affairs (Contract No. 101-C90014), and the Health Resources and Services
Administration provided financial support. Finally, the Agency for Health Care
Policy and Research (Contract No. 282-90-0018) provided funds for a
workshop that contributed to the deliberations of the study committee; the
former National Center for Health Services Research provided funds for
planning efforts before the study began (Grant No. 5909 HS055 2602).
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ACKNOWLEDGEMENTSORIGINAL EDITION
xvii
AcknowledgementsOriginal Edition
The committee would like to express its appreciation for the contributions
of many individuals and organizations to this project. In addition to the
subcommittee members listed in Appendix A, more than 200 individuals
representing organizations throughout the health care sector attended
subcommittee meetings or submitted written information, providing the
committee with a broad base of information from which to draw. Several
subcommittee members led work groups or prepared papers and presentations.
Subcommittee chairs and assistant chairs in particular devoted significant
amounts of time preparing for their meetings and writing reports of
subcommittee findings for use by the full study committee.
Several individuals prepared background papers that were most helpful to
the study committee and staff. In addition to Adele Waller (whose paper
appears in this volume), the committee acknowledges the contributions of Paul
Tang, Donald Lindberg and Betsy Humphreys, Margret Amatayakul and Mary
Joan Wogan, John Silva, and Orley Lindgren and Don Harper Mills. The
committee also expresses its gratitude to the participants of a workshop on
overcoming barriers to patient record development who provided the committee
with a sounding board for its ideas about an organizational framework to
accelerate such development.
This study would not have been possible without financial support from
many entities. Within the private sector, we acknowledge generous support
from the American Medical Record Association, Baxter Healthcare
Corporation, Booz-Allen and Hamilton, E. I. du Pont de Nemours and
Company, Gerber Alley and Company, the John A. Hartford Foundation,
Hewlett-Packard Company, IBM Corporation, Kaiser Foundation Hospitals,
and Science
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ACKNOWLEDGEMENTSORIGINAL EDITION
xviii
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CONTENTS
xix
Contents
COMMENTARIES
A PROGRESS REPORT ON COMPUTER-BASED PATIENT
RECORDS IN THE UNITED STATES
Paul C. Tang and W. Ed Hammond
A PROGRESS REPORT ON COMPUTER-BASED PATIENT
RECORDS IN EUROPE
Jan H. van Bemmel, Astrid M. van Ginneken, and Johan van der
Lei
21
ORIGINAL EDITION
SUMMARY
User Needs and System Requirements
Computer-Based Patient Record Technologies
Nontechnological Barriers
Recommendations
45
46
48
48
50
INTRODUCTION
The Study
Report Organization
The Patient Record
Information Management Challenges
Information Management Opportunities
Beyond Technology
Why Now?
52
53
56
56
63
68
69
69
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CONTENTS
xx
74
74
79
94
100
100
111
113
125
126
131
135
138
138
151
169
173
176
178
180
195
APPENDIXES
A
SUBCOMMITTEES
197
200
INDEX
225
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A PROGRESS REPORT ON COMPUTER-BASED PATIENT RECORDS IN THE UNITED
STATES
Commentary
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A PROGRESS REPORT ON COMPUTER-BASED PATIENT RECORDS IN THE UNITED
STATES
by discussions of health care costs and debate on effective ways to control them.
Although efforts at full-scale health care reform led by the federal
government gained momentum, peaked, and then disintegrated, market-driven
changes in health care delivery were already under way and steadily moving
forward. Managed care plans continue to gain increasing shares of the market
(Hoechst Marion Rousell, Inc., 1995). The need to examine and manage the
health needs of a population has dramatically increased the demand for
information systems that capture clinical data. The health care information
systems industry has shifted its attention from financial systems to clinical
systems, particularly CPR systems. Two core tenets of managed care that
impact the demand for CPR systems have been the central role of primary care
and the emergence of integrated delivery systems.
The Evolving Role of Primary Care
Managed care has redefined the primary care provider as the principal
provider of care and, in many instances, a gatekeeper for access to certain
diagnostic tests and specialty care. To efficiently carry out these roles, the
clinician needs ready access to both clinical and administrative data. At the
same time, guidelines are being promoted to reduce the variances among
clinical practices. When guidelines are integrated into a CPR system, they can
streamline the steps necessary to adhere to them and simultaneously document
that compliance. CPR systems that integrate clinical guidelines in the orderentry process have the best acceptance among providers (Sittig and Stead, 1994;
Sullivan and Mitchell, 1995; CPRI, 1996c, 1997). However, despite the
abundance of guidelines, few can be implemented in a computer as written
(Tierney et al., 1995). Software tools are needed to help author guidelines that
are internally consistent, include precise definitions of eligibility criteria, and
accommodate a variety of patient conditions.
One of the major goals of managed care is to provide more of the care
outside of the hospital. However, the impatient and the outpatient settings differ
substantially. There are differences in the temporal nature of information, the
responsibilities of each member of the health care team, the need for a
communications infrastructure to facilitate coordination of care, and other
logistical concerns which impact the detailed design of information systems.
Consequently, vendors of information system products for hospitals find that
there is a steep learning curve to understanding the information needs of
physicians in the ambulatory care setting. Deliberate analysis of the information
needs and work flow requirements in ambulatory care will help system
developers design information systems that increase the efficiency and
effectiveness of clinical practice throughout the continuum.
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A PROGRESS REPORT ON COMPUTER-BASED PATIENT RECORDS IN THE UNITED
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A PROGRESS REPORT ON COMPUTER-BASED PATIENT RECORDS IN THE UNITED
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desirable to examine two questions. First, to what extent have CPRs, as defined
by the study committee, been developed? Second, to what extent have the
available CPRs been adopted? Unfortunately, a comprehensive review of the
industry does not exist, and it would soon be out of date if it did. Alternatively,
one could rephrase the questions from the perspectives of providers and
vendors. From the perspective of system purchasers, do the CPR systems that
are available in the market meet the needs of health care institutions? And from
the perspective of vendors, is the market ready to buy CPR systems? Although
in neither case is the answer a resounding "yes," promising signs can be reported.
The CPR Market
One must be careful when describing a "CPR market" not to tether the
concept to a single, static idea whose incarnation can be purchased "off-theshelf." In some sense, it is precisely the static nature of the paper-based record
that has been such a great burden to the practice of medicine. Instead, a CPR
system is a constantly evolving concept whose value and function is expected to
grow with the constantly changing demands of the health care environment and
the improving technology upon which the system is built. The level of CPR
development activity has definitely increased significantly since 1991. The
number of commercial systems addressing various attributes of CPRs has
increased and most major health care information technology vendors now offer
CPR-related products. However, comprehensive information system products
that seamlessly integrate data and coordinate processes across the entire
continuum of health care services do not exist. Most health care information
system vendors, whether their products were formerly based in the impatient or
the outpatient side, are working to extend their products to cover the needs of
integrated delivery systems. Developers generally start from the data end of the
system and work toward the human side where the clinician interacts directly
with the system. Hence, one way to trace the evolving functionality is to look at
the transformation of data into information that clinicians use to make
decisions. Although the path is not necessarily sequential, five hallmarks of this
transformation are enumerated below:
1.
2.
3.
4.
5.
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where proximity between the health care team members and the patient was the
rule, the patient and care team in the outpatient setting meet more by
appointment than by clinical demand. Relying on paper-based mail is inefficient
and fallible. Clinicians need integrated communications support for effective
functioning of the multidisciplinary outpatient health care team (Tang et al.,
1996). A communications infrastructure that is linked to the shared patient
record facilitates overall coordination of care and timely response to changing
patient conditions.
Clinical Decision Support
Few, if any, commercial systems provide a high level of proactive decision
support. Drug interaction checking and simple abnormal laboratory-test result
alerts are available, but the richness of applying a broad range of knowledge to
influence physicians' orders is still under development (Johnson, 1994).
Only when both patient data and clinical knowledge reside in the system in
machine-understandable format can the system provide additional support to the
clinician making decisions. For example, encoded medical knowledge about the
meaning and significance of changing laboratory-test results would allow a
system to provide alerts, an active function, in addition to the passive data
retrieval function. Similarly, if the system could match the patient context with
relevant clinical guidelines, it could present ordering options consistent with the
appropriate guidelines. The clinician is responsible for the definitive decision,
but the system can actively provide options and explanations that improve the
clinician's efficiency and compliance with accepted guidelines of practice.
In summary, since the first edition, there has been a significant increase in
development efforts on CPR systems. We remain optimistic that the remaining
years of the decade-long challenge will deliver on the promises of computersupported decision making.
At the Fork
In 1991, the Committee on Improving the Patient Record reported that the
most advanced CPR systems were found in several academic medical centers or
teaching hospitals affiliated with universities as well as in the Department of
Veterans Affairs and the Department of Defense. Not surprisingly, today the
most advanced CPR systems implemented in the United States can be found in
the same places. Of the seven institutions that have been recognized as part of
the Computer-based Patient Record Institute Davies CPR Recognition Program
(described below), four are academic medical centers and one is the Department
of Veterans Affairs. One of the distinguishing factors of institutions that have
been recognized as having advanced CPRs is the clear organizational leadership
and commitment to CPR system implementation that helped make their efforts
successful (CPRI, 1995c, 1996c, 1997).
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A comic saying attributed to Yogi Berra states: "When you come to the
fork in the road, take it." In contrast to the early CPR system adopters, most
health care institutions are standing at the fork, trying to decide whether or not
to begin implementing a CPR system. Those who have made the decision to
invest in a CPR system are grappling with the complicated issue of how to do
so. Many organizations implement the CPR system in some, but not all areas.
Others implement a partial system and depend on a combination of paper and
electronic documentation. All adopters of CPR systems must address how to
integrate the components of the CPR and how to integrate the CPR with other
institutional information systems. The challenge of implementing such an
expansive, robust system is daunting, but the option of continuing to manage
the clinical and administrative data of an IDS on paper is increasingly becoming
a nonviable alternative.
Recent Activity to Advance CPRs in the United States
Against the backdrop of technical and nontechnical changes, interest in
and incentives to develop CPR systems have increased.
The National Library of Medicine (NLM) has been at the forefront in
stimulating research on the effective use of CPR systems and networked access
to shared data (Lindberg, 1995). NLM conducts intramural research that is
directly applicable to technological and infrastructural needs of CPR system
development and effectively uses its extramural research grants and contracts to
apply the results of academic research to health care. Through its HighPerformance Computing and Communications contracts, NLM has been a
leader in facilitating the use of information technology by health care
professionals of rural, urban, community, and statewide networks around the
country. NLM's extensive work on the Unified Medical Language System
(UMLS) has been a major contribution in the medical terminology arena. NLM
and the Agency for Health Care Policy Research (AHCPR) are sponsoring a
large-scale vocabulary test to assess the "extent to which a combination of
existing health-related classifications and vocabularies covers vocabulary
needed in information systems supporting health care, public health, and health
services research" (Humphreys et al., 1996). NLM is further extending the reach
of shared computer-based patient data and systems through its telemedicine
program.
Due to AHCPR's role in developing scientifically based clinical guidelines,
it has long recognized the importance of standard data definitions and capturing
clinical data in structured form. AHCPR has also played an active role in
facilitating standards development. Widespread use of CPR systems would not
only facilitate the collection of aggregate data in support of guidelines
development, but also make effective the dissemination and use of clinical
guidelines in clinical practice.
In addition to the efforts undertaken by NLM and AHCPR, other federal
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CPR does not exist. Without a clear understanding, users have a difficult time
selecting systems that will meet their needs and vendors have difficulty
supplying such systems. CPRI described a CPR as "electronically stored
information about an individual's lifetime health status and health care." It
replaces the paper medical record as the primary record of care, meeting all
clinical, legal, and administrative requirements. A CPR system provides
reminders and alerts, linkages with knowledge sources for decision support, and
data for outcomes research and improved management of health care delivery.
It is worth repeating a point made earlier that a CPR system is an evolving
concept that responds to the dynamic nature of the health care environment and
takes advantage of technological advances.
Beyond the first set of definitions, however, few details have been worked
out and agreed upon. For example, there is no common data model for the CPR,
no common set of data elements, no common vocabulary, and no common set
of scenarios that are supported. These requirements are fundamental if
developers are to create a person-centered CPR that links care across different
sites, specialties, and circumstances.
Many systems still follow the traditional organization and characteristics
of the paper-based system and have simply automated that system. Narrative
documentation, for example, is far more prevalent than structured text. Even
though most new CPRs support a multimedia record, new data forms have not
been smoothly integrated into the record, and little has been done to evaluate
their true worth. Finally, the concept of incorporating patient-derived
information (e.g., health status) as part of the patient record has not been
implemented to any significant degree.
Meeting User Needs
In order for clinicians to rely on data in the system, they must be the direct
users of the system. The emphasis on clinical data is a fundamental change from
the previous era of hospital information systems, where clerks were the main
users because the primary motivation was to capture charges and generate bills.
Analysis of the common questions concerning patient information that
physicians ask (e.g., what evidence supports the diagnosis, has a patient ever
had a specific test, and has there been any follow-up because of a particular
laboratory test result?) provides insight into the difficulties clinicians have had
finding the answers in the paper-based chart. Although current computer-based
tools installed in health care institutions can typically help clinicians retrieve
laboratory test results, they are not designed to answer many of the common
questions clinicians ask about patient data. CPR system developers will need to
address these needs to satisfy the new clinician users. The maker of the Swiss
Army Knife describes the key to inventions as follows: "Make it useful. Very
useful. Conveniently useful." Likewise, key to gaining clinician user
acceptance is providing efficient
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tools that help clinicians retrieve and understand data relevant to their decision
making tasks.
Clinicians also need answers to many questions regarding medical
knowledge (Covell et al., 1985). Diagnostic decision support tools are available
as stand-alone microcomputer programs (e.g., QMR, Illiad, DXplain) or are
available over the Internet (e.g., DXplain; Miller et al., 1986; Barnett et al.,
1987; Feldman and Barnett, 1991; Berner et al., 1996). However, their greatest
use would occur when proven diagnostic decision support tools are integrated
with CPR systems.
Among the more challenging issues confronting CPR system developers is
the issue of effective user-computer interfaces. Physicians must be the users of
the system, performing data entry (e.g., orders, progress notes) as well as
information retrieval, if they are to realize the benefits of interactive, on-line
decision support. Progress must be made in understanding the "cognitive
processes involved in human-computer interactions in order to design interfaces
that are more intuitive and more acceptable" (Tang and Patel, 1994). Cognitive
issues are also relevant to designing the presentation of clinical information in
ways that facilitate rapid assimilation and analysis. Ultimately, good solutions
to the human-computer interface will require changes not only in how the
system looks but also in how humans interact with the system. What
information the provider needs and what tasks the provider is performing will
influence what is presented as well as how it is presented. Templates that reflect
providers' work flows will aid them in using the system efficiently. Defaults
that represent common, desired selections, for example, not only improve
efficiency but also help increase compliance with practice-defined guidelines
(CPRI, 1996c, 1997).
Although user acceptance was a major barrier in the past, more and more
users are demanding that organizations implement computer-based means for
accessing and managing patient data. This is not to say that the cultural and
organizational challenges associated with major change are not substantial
barriers to overcome, but the users' awareness of the potential benefits will
become an increasing catalyst for change.
The change in users and uses has a dramatic impact on the applications
desired and the kinds of user interfaces required. The industry must now focus
on a completely different set of users and must define and address their
information needs. Proactive and informed user participation will be necessary
for implementations to succeed. The attention to clinical data and clinical users
described in this report is even more important today than it was 6 years ago.
Standards
Rather than existing as a monolithic system, contemporary health care
information systems are made up of multiple-component systems manufactured
by multiple vendors, owned by multiple entities. To share data, which is
required in
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17
Board of Directors must fund and support the implementation and use of
CPR systems as a business imperative. Often, chief executive officers must act
on personal conviction, existing evidence of benefits, and the desire to
capitalize on a strategic differentiatorthe value of data. In the new managed
care market, a CPR system is not only an essential tool for health professionals,
it is a business imperative. Time will tell whether investing in clinical systems
provides a strategic advantage or is a minimum requirement to "stay in the
game." Neither outcome favors continuing the status quo. It takes a combination
of leadership conviction, organizational fiscal strength, and medical informatics
and systems expertise to implement CPR systems effectively. Where such
leadership exists, CPR systems are more likely to be acquired and successfully
implemented.
CONCLUSION
A careful reading of The Computer-Based Patient Record by all
stakeholders in health care is still fruitful. We believe that the original vision
described by the IOM Committee on Improving the Patient Record was correct
and remains timely and essential to the success of the new health care delivery
system. Widespread use of CPRs would serve both private- and public-sector
objectives to transform health care delivery in the United States. Equally
important, early evidence indicates that the introduction and use of robust CPRs
will enhance the health of citizens and reduce the costs of care, and in so doing,
the use of CPRs will strengthen the nation's productivity.
Technological advances aside, progress toward CPRs as envisioned in this
report has been slower than anticipated. The IOM committee expressed its
strong belief that the early phase of CPRI's activities should be federally
initiated and funded. A major coordinated national effort with federal funding
and strong advisory support from the private sector is needed to accelerate the
pace of change in the United States. Health care is a public good and many of
the barriers to widespread implementation of CPR systems require national
mandates, policy changes, or, in some cases, new legislation. Leadership in
government and the private sector must be galvanized to make sweeping
changes where possible (e.g., a national UHI, confidentiality legislation) and to
instigate, motivate, and provide incentives to accelerate development of
solutions to other impediments (e.g., terminology standards).
Data are the currency of quality management and the endowment for
continuous quality improvement of patient care. Only by capturing primary
clinical data from health care providers in a way that they can be applied to
health care decisions for individuals and to policy decisions for populations can
the United States achieve its goal of providing high-quality, affordable health
care for all. A computer-based patient record is essential to accomplishing that
goal.
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ACKNOWLEDGMENTS
We are deeply indebted to Octo Barnett who refocused our attention on the
important points we were trying to communicate. The message is far stronger
because of his constructive comments. We thank Don Detmer and Elaine Steen
for their gracious invitation to contribute to this second edition.
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Tierney, W. M., M. E. Miller, and C. J. McDonald. 1990. The effect on test ordering of informing
physicians of the charges for outpatient diagnostic tests [see comments]. New England
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Tierney, W. M., M. E. Miller, J. M. Overhage, and C. J. McDonald. 1993. Physician inpatient order
writing on microcomputer workstations: Effects on resource utilization. Journal of the
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Tierney, W. M., J. M. Overhage, B. Y. Takesue, L. E. Harris, M. D. Murray , D. L. Vargo, and C. J.
McDonald. 1995. Computerizing guidelines to improve care and patient outcomes: The
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Commentary
Jan H. van Bemmel, Astrid M. van Ginneken, and Johan van der Lei
After more than two decades of pioneering efforts, in both the United
States and Europe, a new era in the use of computer-stored patient data has
clearly begun. The proliferation of inexpensive personal computers and
workstations, the development of more user-friendly interfaces, the
standardization of network technology, the original release of this report 6 years
ago, and the stimulation of health care telematics (i.e., network
communications) in Europe have contributed significantly to this growing
interest. Equally important, developers of systems have acquired much
experience since they first attempted to develop electronic patient records, and
their subsequent attempts have become more successful and gained momentum.
In this commentary we discuss some recent developments in computerbased patient records (CPRs) in Europe and review some CPR developments in
Europe that fall within the Framework Programs on Research and Development
of the European Union. Specifically, we review European developments in
CPRs for primary care, clinical care (i.e., hospital care), and shared care. We
also address the use of CPR data beyond patient care and two barriers to CPR
development: protection of patient confidentiality and standards development
for data.
THE CURRENT STATE OF CPRS IN EUROPE
Computer-based information systems are now abundant in a large
percentage of European hospitals as well as in primary care settings. Systems
support general tasks such as patient administration, scheduling, and billing, as
well as specific tasks such as in the clinical laboratory, radiology, or the
catheterization laboratory. Hospital information systems are primarily
administration oriented
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and seldom contain patient record data other than, for example, laboratory
results, drug prescriptions, or diagnostic codes. Some systems store patient data,
but none of them fully replaces the paper-based patient record. Many existing
systems are not connected or are only loosely interconnected in networks. CPRs
are being developed as part of a hospitalwide network (Degoulet et al., 1991;
Van Mulligen et al., 1994; Scherrer et al., 1995) or as stand-alone or
interconnected applications, such as in primary care (Westerhof et al., 1987;
Branger et al., 1992; van der Lei et al., 1993). Increasingly, systems are being
interconnected by electronic data interchange.
The field of hospital information systems in Europe consists, on the one
hand, of mainly homemade systems (e.g., Bakker, 1984; Scherrer et al., 1995)
sometimes supporting a group of hospitals and, on the other, of systems offered
by industry, mainly of U.S. origin. A wide variety of information systems are
operational on different platforms. Information systems in Europe reflect the
differences in health care organizations which arise from the different historical
developments, legislation, education, and languages among European countries.
Therefore, systems developed in one European country are rarely installed in
another country. This is also why the European hospital information system
industry, with few exceptions, is virtually absent from the global market.
The differences in health care structures of different European countries
might pose less of a problem for patient-centered approaches, such as CPRs. In
all countries, patient care itself is quite similar. Europe has succeeded early at
its attempts at CPR development and has since made considerable progress in
the use of CPRs, especially in the primary care setting (van der Lei et al.,
1991a; Millman et al., 1995). On the basis of these successes, several
collaborative projects were started in health care; these were financially
subsidized in part by the European Union (EU, 1994). Three developments
related to CPRs in Europe deserve attention: the use of CPRs in the primary
care setting, in hospitals, and for shared care (i.e., collaboration between care
providers). In addition, in the area of standardization in health care, the
European Union plays a pivotal role on a global scale as well (De Moor, 1993).
Network technology and communication (in Europe the latter is called
telematics) are now prominent developments in information technology and
have a large impact on health care (Branger et al., 1992; EU, 1994). By using
standard communication networks and standard software (De Moor, 1993), data
interchange between the four levels of health care delivery (i.e., the region, the
institution, the clinical department or outpatient clinic, and the individual
physician, nurse, or patient) is more efficient. A fully operational exchange of
patient data between systems, with proper authorization, is one of the present
challenges in European health care.
The data in CPRs are not begging to be used for electronic data exchange,
research, and shared care. The use of CPRs for purposes other than direct
patient care has been associated with several problems (van der Lei et al.,
1991a; Vlug
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and van der Lei, 1995). These limitations are, for instance, the lack of a
common terminology for patient data collection, or the use of different modes
for the CPR systems. As the knowledge gained from experience accumulates,
CPR developers learn important lessons, particularly the need to develop
structured patient records based on a clear conceptual model. If CPR systems
are not based on a conceptual model, and if the data in CPRs are not well
structured, it will not be possible to use CPR data for different goals, nor will it
be possible for such data to be exchanged between health care providers to
support shared care. Therefore, if CPR systems are to be used for these other
goals, care providers should realize that it is not sufficient that the systems
merely support their own practice or clinic, but they should take care that
patient data can be exchanged over the entire health care domain and be used,
for instance, to support clinical research, decision making, the assessment of the
quality of care, or management and planning.
A variety of CPR applications and projects have been completed or are
ongoing including those supported through Framework Programs on Research
and Development of the European Union. They concern computer-based
records for primary care, in hospitals, and for shared care, as well as the use of
data in CPRs for research, assessment of the quality of care, and decision
support. Other projects focus on what the Institute of Medicine (IOM)
Committee on Improving the Patient Record classified as barriers to CPR
development: privacy and confidentiality and standardization of terminologies
and data-exchange formats.
Several developments related to CPRs in Europe are discussed below,
including the status of CPRs in the primary care settings, in hospitals, and in
shared care (i.e., collaboration between care providers). The final sections
consider more specific uses of CPR data and remaining barriers to wider use of
the computer-based patient record.
CPR SYSTEMS IN PRIMARY CARE
In some European countries, especially The Netherlands (van der Lei et al.,
1993) and the United Kingdom (Millman et al., 1995), there has been a rapid
increase in the use of information systems by general practitioners (GPs) in
primary care (Figure 1). CPRs are incorporated into these information systems
and are quickly replacing existing paper-based records. The use of CPRs by
GPs in particular is rapidly increasing. At the beginning of 1996 it was
estimated that more than 90 percent of all GPs in The Netherlands and the
United Kingdom used information systems in their practices. About 50 percent
of Dutch GPs had implemented a CPR system for the support of patient care
and about 25 percent of GPs had a paperless office.
Similar figures apply to the United Kingdom (Millman et al., 1995). This
is directly related to the fact that in both the United Kingdom and The
Netherlands, GPs are the ''gatekeepers" in health care. Most GPs run a practice
by themselves or with a small number of colleagues. In contrast, specialists
work in large institutions
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The actual situation in The Netherlands offers a good example of both the
success and the potential use of CPRs (van der Lei et al., 1993). This can be
attributed to four factors: (1) the role of GPs, (2) physician training, (3) the
structure of health care, and (4) population-based care.
Role of GPs
From the outset, professional organizations of GPs have played an active
role in setting guidelines for information systems in general practice and in
assessing
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the systems available in the market. This active role was started in the early
1980s, when they identified the basic needs of GPs for using systems in their
practices and set the first broad guidelines for systems tailored specifically for
primary care. Furthermore, these organizations announced to industry that they
would recommend to their members that they use only those systems that would
meet their requirements. In this way, a de facto standard was established. Since
then, systems requirements are refined and extended every 2 to 3 years, and
vendors must submit their systems for reevaluation by professional
organizations. This iterative way of refining guidelines and assessing systems
gives potential buyers of systems a basis on which to judge the available
information systems. It also gives vendors clear-cut standards for their products.
During the last 15 years, the definition of standards started with requirements
for patient administration and evolved into standards for diagnostic coding (in
all systems the International Classification for Primary Care has been
implemented [Lamberts and Wood, 1987]), drug prescriptions (all systems use
the same national thesaurus for drugs), and the type of data to be contained in a
basic CPR and requirements for electronically interchanging patient data
between different systems in the primary care setting, that is, from one GP's
system to that of another.
Training
The success of information systems is largely determined by physicians'
expectations. Education at medical faculties of universities prepares physicians
in the use of computer-based information systems and patient records. Early on,
students get acquainted with how to use computers for the documentation of
patient data in CPRs. Professional organizations have also ensured that
postgraduate training of GPs conveys a realistic set of expectations. These
expectations must be realistic, because if they are too high they lead to
disillusionment, and if they are too low they may impede the introduction of
systems. The training emphasizes that the proper use of systems and CPRs
reduces administrative workload, increases the accuracy of billing (no
accountable patient data are lost), and enables the production of referral letters,
the use of electronic data interchange, and the tracking of certain categories of
patients.
Potential users should realize that, certainly at the beginning, investments
must be made. The investments must be expressed not only in financial terms
but also in time and personal efforts. For instance, for a typical practice of about
2,300 patients, it takes about 2 years for all patient data to be entered into the
system's CPR. This data transcription from paper to computer is most often
done at the time that patients come for a consultation, since the majority of
patients pay a visit to their GP once every 2 years. A GP who is just starting to
use a CPR system needs an extra 2 to 3 minutes during the consultation. The
GP's assistant enters data related to all administrative operations, such as patient
admission and patient scheduling, but the GP enters the patient care-related data
into the CPR.
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integrated with the generic CPR system ORCA2 (van Ginneken, 1996). Hermes
is also able to integrate with legacy systems by encapsulation.
The Helios workstation, similar to Hermes in many respects, also
integrates alphanumeric data (text), images, and biological signals. The Helios
platform is being used as one of the building blocks of a new generation of
hospital information systems. The Hermes approach, originally developed on a
Unix platform, has now migrated to a Windows NT/95 environment, forming
the basis for the European project I4C (van Bemmel et al., 1996), as explained
below.
Integrated CPRs
As an example of the introduction of a CPR in a clinical department, we
briefly describe the European project I4C (Integration and Communication for
the Continuity of Cardiac Care). Although I4C is intended to support
cardiology, it uses a generic CPR, ORCA, which is also applicable to other
departments. In this way, the CPR used in the I4C project can be used by many
other clinical departments (van Ginneken et al., 1995; van Ginnekin and Stam,
1995), because it contains a variety of patient data: patient history, physical
examination findings, laboratory test results, images, biological signals, and so
forth. Real-time data, such as from the catheterization laboratory, are also
intended to be incorporated into the CPR. Data are meant to be used by more
than one physician (e.g., the cardiologist often must coordinate his or her
treatment with that of other specialists in the hospital or with GPs in primary
care).
Figure 2 presents the CPR structure that forms the basis for the I4C
project, together with its branches to other systems in the hospital or elsewhere.
Patient record data, as well as images such as echocardiograms and coronary
angiograms, or signals such as ECGs or blood pressure curves are collected,
stored, and presented by using the workstation.
The I4C project in principle is intended to support cardiac care, from
prevention and treatment to follow-up and rehabilitation. This is accomplished
by: (a) consistently recording patient data in the CPR; (b) accessing diagnostic
and therapeutic information; (c) accessing patient data, images, and biological
signals wherever they are stored and irrespective of where the inquiry
originates; and (d) collecting well-defined reference sets of patient data.
2 ORCA (Open Record for patient CAre) is a generic CPR system in which the
knowledge model consists of a predefined vocabulary and knowledge about how the
terms of that vocabulary may be combined into meaningful expressions (van Ginneken,
1996). ORCA is used in the framework of different (European) projects (van Bemmel et
al., 1996). ORCA contains a powerful model for structuring a CPR and a knowledge
model for capturing patient data. Moreover, because it is generic, ORCA can be used for
different areas of health care and is user-adaptable. The relationships between the terms
in the knowledge model are semantically defined (van Ginneken et al., 1993, Moorman
et al., 1994), for instance, in an acyclic directed graph.
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Data are to be used not only for patient care, research, and education but
also for the assessment of the quality of care and for management and planning.
The fourth issue is similar to the data collection that resulted from the European
CSE3 project that preceded I4C (Willems et al., 1991). The project is carried out
by centers in The Netherlandswhich provides coordinationthe United
Kingdom, France, Germany, Italy, and Greece.
CPR Data Entry
For a CPR to have benefits, the data in that record need to be structured
and coded, at least to a certain degree. Obtaining structured and coded data,
however, has proved to be a significant hurdle. Physicians are accustomed to
paper records. How physicians use these records has been the subject of several
European projects (e.g., Nygren and Henriksson, 1992). From such
investigations it became apparent that physicians are far more likely to use
computers to consult the data in present patient records than to enter patient
data. This is not surprising: Data entry requires more effort from the physician
than browsing through the record. Some researchers have argued that direct
input by physicians will have to wait for radical improvements of the humanmachine interface, such as speech input. Experience in a number of countries
where GPs are particularly using CPRs (e.g., The Netherlands, the United
Kingdom, and Sweden) has shown, however, that physicians will accept the
limitations of the current human-machine interaction.
Views of CPR data for patient care, decision support, scientific data
analysis, or assessment of quality of care require patient data to be highly
structured and unambiguous. It is difficult to fulfill these requirements with
narrative (textual) data (e.g., Moorman et al., 1994). Ideally, therefore, patient
data should be acquired directly from the physician in a structured format and,
preferably, should also be entered by the physician. To accomplish this,
different approaches to data entry have received attention: form-driven data
entry, natural language processing, and structured data entry. The last two
methods are also the focus of several research projects in Europe (Nowlan and
Rector, 1991; Baud et al., 1992; Moorman et al., 1994).
Natural Language Processing
Natural language processing intends to automatically extract coded
medical data from free text. European research in this area has mainly been
done by Baud and colleagues in Geneva (1992). The basic advantage of natural
language processing is that physicians do not have to alter the way in which
they express their findings or document their decisions. Only when its
application domain is strictly
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Graphics and voice input may also serve to enhance the capabilities of
structured data entry.
CPR SYSTEMS FOR SHARED CARE
An environment in which patient record data can be electronically
interchanged regionally (Figure 3) is a necessary condition for a shared care
environment (Branger et al., 1992, 1994; Branger and Duisterhout, 1995). Local
and regional networks are increasingly used for the exchange of patient data
between health care institutions. They are also used for communication with,
for example, health insurance bodies, governmental organizations, libraries, and
research institutions. Orders and payments are exchanged by electronic data
interchange, databases are consulted remotely, and laboratory data or referral
letters are mailed electronically. Communication between specialists and GPs is
also increasingly taking place via telecommunication. In some instances
specialists and general practitioners communicate directly with a patient in the
patient's home, for example, patients with pacemakers, undergoing
hemodialysis, or receiving palliative care. For some purposes, remote medical
consultation (telemedicine) is also envisaged. Several regional shared-care
networks are under development in Europe within the Framework Programs for
Research and Development in health care telematics, as will be discussed
below. Such regional networks are a logical extension of networks within
hospitals.
With the existence of a computer-based shared care environment, new
applications for patient-centered care have arisen, such as:
1.
GPs are able to send a patient's data to the hospital to obtain results or
diagnostic advice instead of referring the patient.
2.
Patients' hospital stays are shorter and specialists may offer
teleconsultation services.
3. Outpatient clinics increasingly function as diagnostic screening and
ambulatory care centers. Patients are referred to these clinics only when
specific diagnostic tests or interventions must be performed.
4. Patient admission and scheduling are greatly facilitated, resulting in better
planning and decreased waiting times for examinations.
In the next two sections we provide two examples of European projects
involving the use of CPR data for shared care. The first describes the project
CoCo, concerning the coordination and continuity of health care (Bernstein and
Jensen, 1994). The second describes a project that deals with the exchange of
data in health care by smart cards, in this case, Diabcard (Schaefer and
Sembritzki, 1996).
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CoCo
The intention of the European project CoCo (Coordination and Continuity
in Health Care) is to establish large-scale interconnected regional health care
information networks, with the purpose of improving the coordination and
continuity of health care (Bernstein and Jensen, 1994; van Bemmel et al., 1996).
It uses available CPR-based systems and telecommunication infrastructures in
the participating countries, European EDIFACT4 standards, and electronic mail
techniques. The project will not interfere with regional regulations and will not
impose new rules on the users of the networks. A major effort is dedicated to
ensuring that the project will be implemented in a coordinated and standard
way. The practical guidelines and the experiences with the collaboration within
CoCo should also be usable for other applications in Europe. CoCo has two
goals:
1. Establishment of networks for the regional exchange of health care
information. Each region will establish running networks that will allow
for communication between all the major actors in health care: GPs,
laboratories, radiology departments, hospitals, pharmacies, regional and
national authorities, and social services and home care providers.
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2.
34
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5 Medical data can be categorized into permanent data (e.g., one's genetic profile) and
variable data (e.g., a blood pressure). The privacy aspect of permanent data is perhaps
the most crucial. Generally, these two types of data are used in different ways: variable
medical data (including alphanumeric data, biological signals, and pictures) are primarily
used for the diagnosis and treatment of transient diseases, whereas permanent data are
often strongly related to an individual's life and may possibly predict his or her future
health. The latter category is also of interest for one's next of kin: parents, brothers,
sisters, and children. Genetic data, for instance, do not change or age; they are valid for
an entire lifetime.
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(Treaty of Rome, 1954) and in European law (EU, 1995). Yet, it will be
difficult to totally prevent the improper use of data stored in CPRs.
Because modern health care often requires shared care instead of care by a
single physician only, the individual physician is no longer capable of
personally guaranteeing the privacy of a patient's data. For that reason, after
implementing regulations related to ensure the secrecy of patient data, modern
societies must ensure the right to privacy. This means that in the different
countries written regulations related to requests for personal data, including
patient data, are required. These regulations should be supervised by a privacy
committee and should contain descriptions of the purpose of the data
registration that is maintained. It also should describe when data can be
provided to third parties, and the right of all persons concerned to inspect, alter,
and destroy their own data. In principle, these regulations do not concern data
that have been made anonymous.
It is of utmost importance that in all (future) CPR systems proper measures
be taken to protect the privacy of patients and their data. This issue is also the
subject of discussions at the EU level, for example, in the standardization
committees established for health care informatics and telematics. Some of the
standardization activities related to CPRs are summarized in the following
section.
Standardization
As discussed above, it is essential that standards for the acquisition,
storage, and exchange of patient data be available. In health care this pertains to
both administrative data and patient data. On the basis of the experiences over
the past decade, a technical committee (TC 251 [De Moor and van Maele,
1996]) falling under CEN (Comit Europen de Normalisation, the ''European
Committee for Standardization") was established. This committee defines
preliminary standards and compiles reports on the standards to be introduced in
the different countries of the European Union (De Moor, 1993; De Moor and
van Maele, 1996). For instance, the ability to link systems via standard
interfaces is widely recognized as a necessity. Especially in Europe, where data
cross regional and national boundaries, agreement on how to exchange patient
data is urgent. Directly and indirectly, such standards will contribute to the
quality and efficiency of patient care.
From the long list of preliminary standards that have been or are being
elaborated by Technical Committee 251, a few examples specifically dealing
with data in CPRs are provided in the following sections (De Moor, 1996).
Electronic Health Care Record Architecture
Work on defining the basic architecture for data contained in an electronic
health care record has begun. Standardization is necessary if patient data are to
be exchanged between different health care professionals. It is also necessary so
that patients can travel or move from one region or country in Europe to
another. The
Copyright National Academy of Sciences. All rights reserved.
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architecture should enable physicians to use CPRs that are adapted to their own
requirements and should therefore support a variety of formats. The aim of this
standardization effort is not to specify the CPR system as such but to bring
structure to the data stored in such records.
Coding Systems for Drugs
Standardization of coding systems for drugs concerns prescribing drugs
and the effects of drugs on patients. A conceptual model for the correct labeling
of drugs is foreseen within Technical Committee 251. The standard covers the
identification of generic drug products as well as the drugs themselves. A
coding system itself, however, is not intended.
Syntax for Health Care Data Interchange
Electronic messages in health care can be coded in many different ways.
Therefore, consensus is required on the exchange formats for health care data
between different systems. This has many advantages, because the systems'
vendors can then handle the different data formats. The standard intends to
define and adopt syntaxes for this exchange of information.
Exchange of Medical Images and Related Data
The medical image exchange standard concerns the exchange of highvolume data such as images or similar data. The Technical Committee 251
standard has adopted the industrial DICOM6 3.0 standard for medical images,
enabling the possibility of standardized storage and global exchange of such
images, which is important for supporting, for example, teleradiology or similar
services.
User Identification
As open systems are gradually installed in hospitals and regional networks
become operational, it will be important to prevent patient data from being used
illegally. To ensure the proper use of patient data, it is necessary to positively
identify authorized users. Software systems should therefore make use of
automatic procedures for user identification, for example, by the use of
passwords and different technical measures. Smart cards are other means of
positive user identification (e.g., fingerprints or face recognition are possible
techniques that could be standardized and that may eventually replace the more
vulnerable passwords).
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CONCLUSION
Significant progress has been made in Europe toward the primary
recommendation of the IOM Committee on Improving the Patient Record's
report over the past 6 years. Several factors account for the success to date.
First, in those countries where CPRs are most prevalent, the health care delivery
system or structure relies on a gatekeeper model and emphasizes primary health
care and the health of the population. Thus, there is a recognized need for
individual and aggregate patient data and a willingness to invest at both macro(i.e., government) and microlevels (i.e., a practitioner) to make such data
available. Second, CPR development projects are ideal for the EU insofar as
they offer benefits both within and across countries and collaboration in their
development may well speed up visible success. The evidence of political
support and support by the medical professional organizations for CPRs sends a
strong message to system developers and users, as well as to the general public.
Third, the emerging focus on conceptual models that build upon rather
than are driven by the technology is a significant breakthrough in CPR
development and will likely result in systems that can be adopted throughout
Europe. Ultimately, this conceptual focus, which is also evident in the United
States, may increase the ability of generic CPR systems to be transported
globally. Fourth, collaboration between end-users and developers in system
specification is a critical element of a sound CPR development process, aiding
both the developers and users of the systems. Finally, the readiness of users
with realistic expectations eases the implementation and increases the
likelihood that CPRs will be used to their full potential. Thus, the education of
health professionals is an important strategy in speeding CPR diffusion.
Like in the United States, important challenges remain to be addressed for
CPR developers. First, continued support of CPR development efforts by supraregional and national organizations is absolutely essential. Second, the issues
surrounding the operational exchange of patient data must be fully explored and
addressed. Third, protecting the confidentiality of patient data in the
information age is a global issue that must be a priority in all countries and will
ultimately require greater collaboration among countries as the technologies
that support CPRs continue to evolve and are exploited in ways that we have
not yet identified. Fourth, flexible, user-adaptable generic models for the
generation of CPRs are needed to overcome the great variety in specialized
care, the differences in culture among various clinics, and particularly in
Europe, among countries.
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SUMMARY
45
Summary
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SUMMARY
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SUMMARY
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systems, links to bodies of medical knowledge, and other aids. This definition
encompasses a broader view of the patient record than is current today, moving
from the notion of a location or device for keeping track of patient care events
to a resource with much enhanced utility in patient care (including the ability to
provide an accurate longitudinal account of care), in management of the health
care system, and in extension of knowledge.
In the past, a patient record has served the basic function of storing patient
data for retrieval by users involved with providing patient care. Even this
classic function must be broader in the future, however, especially with respect
to the key feature of flexibility. Different health care professionals will require
different modes of record information retrieval and display. Today, both paper
and computer records are often cumbersome tools for these tasks. The record of
the future must be far more flexible, allowing its users to design and utilize
reporting formats tailored to their own special needs and to organize and display
data in various ways.
The patient record system of the future must provide other capabilities as
well, including links to administrative, bibliographic, clinical knowledge, and
research databases. To meet the needs of clinicians, CPR systems must be
linked to decision support systems; they must also support video or picture
graphics and must provide electronic mail capability within and between
provider settings.
Future CPR systems must offer enhanced communications capabilities to
meet emerging user needs. The systems must be able to transmit detailed
records reliably across substantial distances. Physician offices must be able to
communicate with local hospitals and national bibliographic resources. In
hospitals, all of the various departmental systems (e.g., finance, laboratory,
nursing, radiology) must be able to communicate with the patient record
system. In the larger health care environment, computer-based information
management systems must be able to communicate with providers, third-party
payers, and other health care entities, while at all times maintaining
confidentiality of the information.
If users are to derive maximum benefits from future patient record
systems, they must fulfill four conditions. First, users must have confidence in
the datawhich implies that the individual who collects data must be able to
enter them directly into the system and that the system must be able to reliably
integrate data from all sources and accurately retrieve them whenever
necessary. Second, they must use the record actively in the clinical process.
Third, they must understand that the record is a resource for use beyond direct
patient carefor example, to study the effectiveness and efficiency of clinical
processes, procedures, and technologies. Fourth, they must be proficient in the
use of future computer-based record systems (i.e., the systems described in this
report) and the tools that such systems provide (e.g., links to bibliographic
databases or clinical decision support systems).
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SUMMARY
48
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Many impediments to the CPR and to CPR systems arise from a lack of
awareness and understanding of their capabilities and benefits. The intellectual
understanding of what needs to be done, how to do it, and for whom to do it
that is, the demanding collection of insights required for designis a
continuing problem that must be addressed. (For example, when users are asked
what capabilities they would like to have available to them, they may have
difficulty imagining what CPR systems will be able to do in the future.) System
purchasers and users often lack adequate information about the benefits and
costs of the CPR. Developers and vendors require more specific information
about what users want from systems and what price providers would be willing
to pay for systems that meet their needs. Activities aimed at improving and
disseminating available information about CPR systemsfor instance, through
demonstration projects and education programsconstitute an important step
toward CPR implementation.
Other impediments arise from the lack of an infrastructure to support CPR
development and diffusion. Needed infrastructure components are standards for
communication of data (i.e., vocabulary control and data format standards);
laws and regulations that protect patient privacy but do not inhibit transfer of
information to legitimate users of data outside the clinical setting; experts
trained in the development and use of CPR systems; institutional, local,
regional, and national networks for transmitting CPR data; reimbursement
mechanisms that pay for the costs of producing improved patient care
information; and a management structure (i.e., an organization) for setting
priorities, garnering and allocating resources, and coordinating activities.
Consideration of the various barriers to CPR development, the interest and
resources of individuals and organizations able to effect change, and the
concerns of individuals who would be affected by implementation of CPRs
prompted the committee to identify eight critical activities that will help
advance CPR development: (1) identification and understanding of CPR design
requirements; (2) development of standards; (3) CPR and CPR systems research
and development; (4) demonstrations of effectiveness, costs, and benefits of
CPR systems; (5) reduction of legal constraints for CPR uses as well as
enhancement of legal protection for patients; (6) coordination of resources and
support for CPR development and diffusion; (7) coordination of information
and resources for secondary patient record databases; and (8) education and
training of developers and users.
Accomplishing these activities will require adequate funding and effective
organization. The committee reviewed organizational structures that could
provide the necessary framework for coordinating CPR activities and concluded
that no existing organization has the mandate and resources necessary to lead
the CPR effort. Thus, for reasons set forth more fully in Chapter 4, the
committee believes that a new organization is needed to
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SUMMARY
50
3.
4.
5.
6.
7.
RECOMMENDATIONS
The committee believes its recommendations (see Box 1) effectively
address the potential barriers to routine CPR use. The first recommendation
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SUMMARY
51
defines CPRs and CPR systems as the standard for future patient records; the
second proposes an organizational framework within which barriers to CPR
implementation can be systematically addressed and overcome. The remaining
recommendations focus on specific impediments: needed research and
development, promulgation of standards for CPR data and security, review of
legal constraints and remedies, distribution of costs for CPR systems, and
education of health care professionals.
The committee believes that the CPR can play an increasingly important
role in the health care environment. This role begins in the care process as the
CPR provides patient information when needed and supports clinical decision
making. It extends to management of care through the establishment of a
mechanism by which quality assurance procedures and clinical practice
guidelines are accessible to health care professionals at the time and site of
patient care. It also includes opportunities for reducing administrative costs and
frustrations associated with health care financing and for capturing
administrative data for internal and external review. Finally, the CPR's role
extends to capturing relevant, accurate data necessary for provider and
consumer education, technology assessment, health services research, and
related work concerning the appropriateness, effectiveness, and outcomes of
care.
The committee recognizes the considerable amount of work that remains to
be done and the practical limitations that must be overcome before CPRs
become the standard mode of documenting and communicating patient
information and before they are perceived and used as a vital resource for
improving patient care. The challenge of coordinating CPR development efforts
in the pluralistic health care environment is great. Resources are limited and
must be used wisely.
The committee is convinced that proper coordination and appropriate
resources will lead to achievement of the goal of widespread CPR utilization
within a decade. The desire to improve the quality of and access to patient data
is shared by patients, practitioners, administrators, third-party payers,
researchers, and policymakers throughout the nation. CPRs and CPR systems
can respond to health care's need for a "central nervous system" to manage the
complexities of modern medicinefrom patient care to public health to health
care policy. In short, the CPR is an essential technology for health care today
and in the future.
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INTRODUCTION
52
1
Introduction
1 The committee uses the term practitioners to refer to all health care professionals
who provide clinical services to patients. These professionals include, but are not limited
to, physicians, nurses, dentists, and therapists.
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INTRODUCTION
53
1991). First, automated patient records can improve health care delivery by
providing medical personnel with better data access, faster data retrieval, higher
quality data, and more versatility in data display. Automated patient records can
also support decision making and quality assurance activities and provide
clinical reminders to assist in patient care. Second, automated patient records
can enhance outcomes research programs by electronically capturing clinical
information for evaluation. Third, automated patient records can increase
hospital efficiency by reducing costs and improving staff productivity.
Several sources support these conclusions. The GAO reported that an
automated medical record system reduced hospital costs by $600 per patient in
a Department of Veterans Affairs hospital because of shorter hospital stays
(GAO, 1991). Reductions in the length of inpatient stays were also found in
other studies of computerized medical records and medical record summaries
(Rogers and Haring, 1979). Other investigators found enhanced care and
improved outcome of care for clinic patients (Rogers et al., 1982) and a
reduction in medication errors (Garrett et al., 1986).
The first step toward patient record improvement is a close examination of
the users of the patient record, the technologies available to create and maintain
it, and the barriers to enhancing it. To that end, the Institute of Medicine (IOM)
of the National Academy of Sciences undertook a study to recommend
improvements to patient records in response to expanding functional
requirements and technological advances. 2 This report is the product of the
multidisciplinary panel's 18-month study of how patient records can be
improved to meet the many and varied demands for patient information and to
enhance the quality of patient care and the effectiveness and efficiency of health
care delivery.
THE STUDY
The idea for this study originated in discussions between staff at the
National Institutes of Health (NIH) and IOM. The NIH staff were involved in
patient care, teaching, and research and were motivated by the need to make
patient records more useful for all of these purposes. The IOM
2 The IOM committee was originally named the Committee on Improving the Medical
Record in Response to Increasing Functional Requirements and Technological
Advances. The committee's first action was to change "medical" to "patient" in its name,
reflecting its consensus that the medical component of the record does not constitute the
total record. Thus, this report generally will refer to what are commonly called medical
records as "patient records.'' There are several instances, however, in which the
committee continues to refer to medical records rather than patient records. For example,
the committee's official charge relates to medical records, and the committee has not
undertaken to rename "medical record professionals."
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INTRODUCTION
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and Strategy and Implementation (see Appendix A). The subcommittees, each
with approximately 15 members, met at least twice and solicited information
from more than 70 advisers, including physicians (in both private practice and
academic medicine), nurses, dentists, medical record professionals, hospital
administrators, researchers, and congressional staff. Also among these advisers
were representatives of patient groups, computer software and hardware
vendors, third-party payers, government agencies, and professional
organizations. Each subcommittee prepared a report that was considered, along
with the results of a special workshop and several background papers, by the
full committee in its deliberations.
Definitions
During its work, the committee used the following specific definitions:
A patient record is the repository of information about a single patient.
This information is generated by health care professionals as a direct
result of interaction with a patient or with individuals who have
personal knowledge of the patient (or with both). Traditionally, patient
records have been paper and have been used to store patient care data.
A computer-based patient record (CPR) is an electronic patient record
that resides in a system specifically designed to support users by
providing accessibility to complete and accurate data, alerts,
reminders, clinical decision support systems,3 links to medical
knowledge, and other aids.
A primary patient record is used by health care professionals while
providing patient care services to review patient data or document their
own observations, actions, or instructions.
A secondary patient record is derived from the primary record and
contains selected data elements to aid nonclinical users (i.e., persons
not involved in direct patient care) in supporting, evaluating, or
advancing patient care.4 Patient care support refers to administration,
regulation, and
3 Shortliffe and colleagues define a clinical decision support system as "any computer
system designed to help health professionals make clinical decisions" (Shortliffe et al.,
1990:469). They identify three types of decision support functions: information
management, focusing of attention, and patient-specific consultation. Throughout this
report, clinical decision support systems refer to clinical consultation systems that use
population statistics or encode expert knowledge to assist practitioners in diagnosis or in
formulating treatment plans (Shortliffe et al., 1990).
4 The committee's distinction between primary and secondary patient records parallels,
but is not identical to, the approach used by Westin (1976). Westin identified three
"zones" through which information flows: (1) direct patient care, (2) supporting
activities, and (3) social uses of health data. This report does not address social uses of
patient care data that lie outside health care (e.g., law enforcement) and combines
supporting activities and health care social uses of patient data into one zone.
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have multiple patient recordsone for each health care provider they have
visited. Patient records have proliferated to the extent that some medical centers
in large metropolitan areas may now each have more than 4 million paper
patient records (Kurland and Molgaard, 1981). Although at any one time these
records are not all active, they must be stored for up to 25 years, depending on
state laws (Waller, in this volume). Moreover, a given patient may have more
than one record even within a particular institution.5
Patient records appear in a variety of formsfor example, as paper;
microfilm; a monitor strip; an optical disk; a computer card, tape, or disk; or a
combination of these (Amatayakul and Wogan, 1989). They are created and
used most frequently in health care provider settings such as physician or
dentist offices, hospitals, nursing homes, and public health clinics; but other
institutions such as correctional institutions, the armed forces, occupational
health programs of employers, and colleges and universities also maintain
patient health care records (Westin, 1976).6
For more than a century, the paper patient record has been the primary
vehicle for recording patient care information (Huffman, 1981). Yet recent
years have seen a trend toward automation of components of patient records
(e.g., clinical laboratory test results) or certain patient care functions (e.g.,
entering physician orders for hospitalized patients; Westin, 1976; Gardner and
Perry, 1989; Amatayakul and Sattler, 1990). Some hospitals, health
maintenance organizations, and physicians' offices now have prototype
elements of computer-based record systems .7 These facilities are still the
exception rather than the rule, however, and paper patient records, with their
sometimes overlooked strengths and frequently cited weaknesses, are still the
norm for most health care providers.
Strengths and Weaknesses of Paper Patient Records
The committee's literature review did not reveal any substantive
documentation of the strengths of paper patient records. This result may be
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INTRODUCTION
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explained in part by the facts that the value of maintaining patient records is
widely accepted in the health care community and that paper is the most widely
used record keeping form. Given the prevalence of paper patient records, the
committee noted that support by practitioners for this kind of record keeping
should not be underestimated. Time and resource constraints did not permit the
committee to survey user attitudes toward paper records; however, committee
members identified at least five strengths of such records from the perspective
of record users:
1.
2.
3.
4.
5.
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content; (2) format; (3) access, availability, and retrieval; and (4) linkages and
integration.
Problems with Patient Record Content
Patient record data are often missing, illegible, or inaccurate (Tufo and
Speidel, 1971; Zuckerman et al., 1975; Bentsen, 1976; Zimmerman, 1978; Fox
et al., 1979; Romm and Putnam, 1981; Gerbert and Hargreaves, 1986; Hsia et
al., 1988; Pories, 1990). Data can be missing for at least three reasons: (1)
questions were never asked, examinations were never performed, or tests were
never ordered; (2) the information was requested and provided, but either it was
not recorded by the clinician or delays occurred in placing the information in
the record; and (3) the information was requested and delivered but was
misplaced or lost. In addition, clinicians, patients, or equipment can all
introduce errors into patient records (Burnum, 1989).
Many studies have examined the quality of patient record content.
Table 1-1 presents the findings of several such investigations. The missing
information reported in the various studies often resulted in additional costs of
patient care. For example, an estimated 11 percent of laboratory tests in one
hospital were ordered to duplicate tests for which findings were unavailable to
the physician at the time of the patient visit (Tufo and Speidel, 1971).
Although for some records data are missing, in other cases certain data are
excessive or redundant (Zimmerman, 1978; Korpman and Lincoln, 1988). The
thickness and weight of the records of patients with chronic problems can be
imposing, if not daunting, and time constraints may prevent the user from
finding and using necessary information. (In one study of paper patient records,
the average weight of a clinic record was 1-1/2 pounds [Rogers et al., 1982].)
Other issues related to record content include failure to capture the rationale of
providers, lack of standardization of definitions of terminology, failure to
describe the patient experience, lack of patient-based generic health outcome
measures, and incomprehensibility for patients and their families.
Problems with Format
Several studies have pointed to patient record formats as a problem area
that at times impedes record use and effectiveness. The 1980 IOM study cited in
Table 1-1 found that the reliability of hospital discharge data depended on the
general organization, orderliness, and logic of the medical record. Zimmerman
(1978) conducted a survey of physicians who identified poor organization of
medical records as a deficiency that contributed
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to ineffective use. The format of the usual paper record does not lend itself
easily to dealing with multiple problems over a long period of time. For
example, Pories (1990) noted that the physical form of paper records (i.e.,
binders or charts) is often unmanageable; data are fragmented within the record
and not sorted for relevance. Fries (1974) showed that information could be
found four times faster in a structured flow sheet than in a traditional paper
medical record and that 10 percent of items in the traditional record could not
be found.
Traditionally, patient records are organized according to the sources and
chronology of data (Feinstein, 1970), although several alternative record
formats have been developed. For example, the problem-oriented medical
record (POMR) is assembled according to the patient's problems to support a
more organized approach to clinical problem solving and management
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Outpatient Records
Attention is frequently focused on patient records in hospitals rather than
in outpatient settings. (An inpatient record is used by many different individuals
during an episode of illness, so its weaknesses can appear quite pronounced.)
Yet outpatient records are greater in number, are scattered among individual
physician offices, and may exhibit even greater variance in quality than
inpatient records. There are no established standards or review organizations for
outpatient records as there are for inpatient records. As a result, outpatient
records often serve as files for ''correspondence and reports rather than as a well
organized chronology of health care" (Pories, 1990:49).
Ambulatory care records frequently contain poorly organized data, lack
documentation of key aspects of care, and exhibit inaccurate diagnostic coding
(IOM, 1990c). Health care researchers and clinicians who conduct retrospective
studies using such records are likely to identify at least four weaknesses: lack of
standardization in content and format, inaccessibility (except in some hospitals
or large health plans), incompleteness, and inaccuracies (Davies, 1990).
INFORMATION MANAGEMENT CHALLENGES
An Information-Intensive Industry
Providing high-quality health care services is an information-dependent
process. Indeed, the practice of medicine has been described as being
"dominated" by how well information is processed or reprocessed, retrieved,
and communicated (Barnett, 1990). An estimated 35 to 39 percent of total
hospital operating costs have been associated with patient and professional
communication activities (Richart, 1970). Physicians spend an estimated 38
percent (Mamlin and Baker, 1973) and nurses an estimated 50 percent
(Korpman and Lincoln, 1988) of their time writing up patient charts.
Information-processing activities associated with providing health services
to patients are extremely varied. Clinicians obtain and record information about
patients, consult with colleagues, read scientific literature, select diagnostic
procedures, interpret results of laboratory studies, devise strategies for patient
care, instruct allied health professionals, discuss care plans with patients and
families, and document the progress of patients. In addition, health care
practitioners must distill knowledge, interpret data, apply knowledge, and
manage the complexities of medical decision making (Haynes et al., 1989;
Greenes and Shortliffe, 1990). Thus, health care professionals routinely need
access to appropriate compilations of thorough, up-to-date knowledge and
advice to make prompt, informed decisions regarding
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patient care (Haynes et al., 1989; Saba et al., 1989; Greenes and Shortliffe,
1990). Furthermore, a wide range of information-processing tasks supports
patient care, including performing laboratory tests, processing medical imaging
data, capturing patient demographic information, filling prescription orders,
monitoring quality and appropriateness of services provided, and billing
(Martin, 1990).
An Information Explosion
For the past several years, health care practitioners have faced an explosion
in medical knowledge. For instance, MEDLINE9 now indexes approximately
360,000 new articles each year from those published in the biomedical literature
(National Institutes of Health, 1989). Scientific and technological advances that
have contributed to improving the health of the public have also resulted in
more complexity in medical practice; clinicians must track ever more numerous
diagnoses, procedures, diagnostic tests, clinical processes, devices, and drugs.
The increase in available technologies places an additional burden on
physicians: they must read and synthesize the literature and try to decide
whether and how new technologies should be applied (Brook, 1989). Often, a
gap occurs between the information physicians need and the information
available to them at the time of providing patient care. According to Covell and
colleagues (1985), an estimated 70 percent of physician information needs are
unmet during the patient visit.
In addition to more knowledge, there are more data for health care
professionals to manage. The volume and complexity of information per patient
have increased owing to a greater number of patient encounters (as patients live
longer and experience chronic disease), higher patient acuity of illness (both in
and out of hospitals), more kinds of clinical data elements arising from new
diagnostic technologies, and developments in the delivery system that result in
many patients receiving care at multiple sites. Concomitant with increases in
information, however, have been efforts to reduce unit costs of health care
provider institutions, which create pressures on health care professionals to be
more productive and to see more patients. This paradoxically reduces the time
and energy available for the functions associated with management and
communication of information. Health care professionals are thus placed in a
frustrating, difficult, and perhaps untenable position.
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10 Health care expenditures accounted for 7.3 percent of the nation's gross national
product (GNP) in 1970 (Levit et al., 1990). In 1989, health care spending amounted to
11.6 percent of GNP (U.S. Department of Health and Human Services, 1990).
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contain costs, payers have also increased their demands for data. Patient data
now are used for coverage decisions (e.g., preadmission review) as well as for
payment. Cost-containment approaches such as utilization management rely on
individual patient data for making short-term decisions; they also rely on
aggregated data to make judgments about the effectiveness of medical services
in the long-term (IOM, 1989). A recently developed hybrid of quality assurance
and cost containment"value purchasing"refers to the effort by purchasers,
providers, and consumers to promote "the idea of value or quality within the
context of cost" (IOM, 1990c:36). Value purchasing requires access to
information on both costs and outcomes of care.
The public health arena is also seeking more and better data. The 1988
IOM report on the future of public health recommended that a uniform national
data set be established to permit valid comparison of local, state, and national
health data to facilitate progress toward achieving national health objectives
(IOM, 1988). More recently, the U.S. Public Health Service identified public
health surveillance as a primary means of supporting the national disease
prevention objectives for the year 2000 (U.S. Public Health Service, 1990).
Data are needed to understand the health status of the U.S. population and to
develop, administer, and evaluate public health programs aimed at controlling
and preventing adverse health events. The Public Health Service report
specifically mentions data on (1) mortality, morbidity, and disability from acute
and chronic conditions; (2) injuries; (3) personal, environmental, and
occupational risk factors associated with illness and premature death; (4)
preventive and treatment services; and (5) costs.
The issues of quality, cost, effectiveness, and appropriateness largely
frame the questions that today's clinical and health services researchers pursue.
Efficacy and safety are no longer sufficient criteria for assessing a technology
whose purchasers also want to know (1) whether it is effective and safe outside
the controlled environment of clinical trials, (2) whether it is cost-effective, and
(3) whether it produces desired outcomes. "[L]ongitudinal observations of
natural variations in use and outcomes of economically and clinically important
medical technologies in different practice situations" are sought to support
utilization management (IOM, 1989:158).11
Late in 1989, the Omnibus Budget Reconciliation Act (P.L. 101239)
established the Agency for Health Care Policy and Research (AHCPR) to
enhance "the quality, appropriateness, and effectiveness of health care services,
and access to such services, through the establishment of a broad
11 One expert has suggested that "[w]hat is needed is a new kind of trial, one that
combines randomized prescription of approved drugs and hands-off follow-up with
recording of medical outcomes and determination of costs from routinely generated
computerized patient records" (Paterson, 1988:112).
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Third, patients and practitioners gradually are becoming accustomed to the use
of computers in virtually all facets of everyday life. Fourth, an aging and mobile
population results in more information to be managed and demands for
improved transferability or portability of that information. Finally, the
committee believes that those components of needed reform in health care that
require evaluation, consolidation of data, and improved communication will not
easily be achieved without reforms in the scope, use, and automation of the
patient record.
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INTRODUCTION
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THE COMPUTER-BASED PATIENT RECORD: MEETING HEALTH CARE NEEDS
74
2
The Computer-Based Patient Record:
Meeting Health Care Needs
In recent years, computerization of patient records has increased at a
moderate rate and this trend is likely to continue, particularly as technology
improves and becomes more affordable and as the demand for health care
information increases. If future patient records are merely automated versions
of most current records, however, an opportunity to improve a fundamental
resource for health care will have been lost. For example, in the patient record
of the future, the committee seeks the ability to access quickly a list of current
problems, a trail of clinical logic, the patient's health status, and the most recent
information about various treatment options for the patient's condition. Easy
access to and sound organization of data elements can be provided by
automation of patient records, but the availability of the data elements depends
on whether practitioners collect and record such data in the first place. Further,
access to bibliographic and knowledge databases will require new functions not
provided by traditional patient records.
Thus, the automation of patient record retrieval, maintenance, and use is
necessary, but not sufficient, for record improvement. Given existing and
emerging computer technologies and the evolving nature of health care, the
committee believes that the patient record can, must, and will develop to meet
the expanding needs of the health care field. This chapter identifies the
attributes of future patient records that are required to meet these needs,
discussing several of them in detail to highlight the scope and complexity of the
issues to be addressed.
DEFINING HEALTH CARE NEEDS
The quality of a patient record or a patient record system depends on its
ability to meet the needs and requirements of those who use it. As discussed
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THE COMPUTER-BASED PATIENT RECORD: MEETING HEALTH CARE NEEDS
75
below, those users include, but are not limited to, physicians and nurses
delivering care to patients. The committee followed three steps suggested by the
continuous quality improvement model to develop its vision of an improved
patient record and record system: (1) identify the customers; (2) understand
their requirements; and (3) translate those requirements into functional
characteristics of the system (Donabedian, 1966, 1988; Batalden and Buchanan,
1989; Berwick, 1989). 1
Patient Record Users
The committee broadly defined the users of patient records as those
individuals who enter, verify, correct, analyze, or obtain information from the
record, either directly or through an intermediary. All users of the patient record
ultimately support patient care. They differ, however, in how and why they use
the record.
Some users have daily contact with the record, others access the record
sporadically, and still others never actually handle the record but rely on data
derived from it. An exhaustive list of patient record users would essentially
parallel a list of the individuals and organizations associated directly or
indirectly with the provision of health care. Patient record users provide,
manage, review, or reimburse patient care services; conduct clinical or health
services research; educate health care professionals or patients; develop or
regulate health care technologies; accredit health care professionals or provider
institutions; and make health care policy decisions. All of these kinds of users
are ''customers" of the patient record, and their needs should be met by patient
record systems of the future.
Users are individuals, but they most commonly perform their functions on
behalf of institutions. Boxes 2-1A and 2-1B identify types of individuals and
organizations that rely on patient records or the data they contain. These lists
are illustrative rather than comprehensive and indicate the wide range of users
and settings in which patient records are employed.
The full array of patient record users and the respective needs of each were
too extensive for the committee to address fully. Therefore, it identified five
major categories of users that it considered the most significant and
representative. Specifically, the committee focused on practitioners (physicians,
1 As stated by Juran (1989), the remaining steps of the quality improvement process
are as follows: (4) design a system capable of supplying these functional characteristics;
(5) implement the design; (6) prove the value of the system; and (7) stabilize or further
improve the system, depending on the results of ongoing evaluation. Given the scope of
its charge, the committee stopped short of designing such a system; it did, however,
accomplish an intermediate step by determining the technological implications of the
functional requirements of future patient record systems (see Chapter 3).
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2 Setting priorities among patient record users risks giving the needs of some users too
little consideration or possibly omitting them entirely. Uncomfortable with this
compromise, the committee remained acutely aware that designers and implementers of
future patient record systems must attend to the needs of all parties, not just those
discussed in detail in this report.
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Primary uses of patient records are associated with the provision of patient
care, that is, with providing, consuming, managing, reviewing, supporting, and
charging and reimbursing patient care services. Secondary uses of patient
records are not considered necessary for a particular encounter between a
patient and a health care professional, but such uses influence
Employers
Insurers (federal, state, and
private)
Research
Disease registries
Health data organizations
Health care technology developers
and manufacturers (equipment
and device firms, pharmaceutical
firms, and computer hardware
and software vendors for patient
record systems)
Research centers
Education
Allied health professional schools
and programs
Schools of medicine
Schools of nursing
Schools of public health
Accreditation
Accreditation organizations
Institutional licensure agencies
Professional licensure agencies
Policymaking
Federal government agencies
Local government agencies
State government agencies
* Various hospital departments are one kind of institutional patient record user. A few
such users include the blood bank, diagnostic radiology, emergency medical services,
intensive care units, nutrition services, pharmacy, surgery, and social work.
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Education
Document health care professional experience
Prepare conferences and
presentations
Teach health care professions
students
Regulation
Serve as evidence in litigation
Foster postmarketing surveillance
Assess compliance with
standards of care
Accredit professionals and
hospitals
Compare health care organizations
Research
Develop new products
Conduct clinical research
Assess technology
Study patient outcomes
Study effectiveness and costeffectiveness of patient
care
Identify populations at risk
Develop registries and databases
Assess the cost-effectiveness of
record systems
Policy
Allocate resources
Conduct strategic planning
Monitor public health
Industry
Conduct research and develop
ment
Plan marketing strategy
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In compiling the list of user requirements, the committee noted two special
considerations. First, user needs can conflict with each othernot just among
groups (e.g., patients and practitioners need confidentiality, but claims payers
seek access to detailed clinical information), but also within a single user group
(e.g., doctors want access to information to be very fast, but they may also want
to be able to sort information according to complicated logical rules, which
slows response times). To the extent possible, the committee resolved such
conflicts by using sensible rules of priority. In
Intelligence
Decision support
Clinician reminders
Alarm systems capable of being
customized
Reporting Capabilities
Derived documents (e.g.,
insurance forms)
Easily customized output and
other user interfaces
Standard clinical reports (e.g.,
discharge summary)
Customized and ad hoc reports (e.g.,
specific evaluation queries)
Trend reports and graphics
Control and Access
Easy access for patients and their
advocates
Safeguards against violation of
confidentiality
Training and Implementation
Minimal training required for
system use
Graduated implementation
possible
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several cases, however, the conflicts remained nettlesome and are discussed in
Chapter 4 as particular challenges to future patient record development.
Second, at a technological frontier, customers may have difficulty
expressing or even imagining a need. This situation may well occur with the
computer-based patient record, which contains opportunities for functional
characteristics that most users would not think to request. The pioneering
designer must not only ask, "What do people want?" but also, "What would
people want if they knew what could be done for them?"
Patient Record Functions
The traditional function of patient records has been to store information
relevant to the care of a patient for subsequent retrieval. Patient record systems
should offer users at least two additional functions. First, records should be able
to guide the process of clinical problem solving. Second, records should support
clinicians with decision analysis, reminders, risk assessment, and other
"intelligent" features not available with paper records.
Storage
The attributes associated with the storage function are record access (i.e.,
availability, convenience, speed, and ease of use), quality, security, flexibility,
connectivity, and efficiency.
ACCESS First and foremost, users want to retrieve information easily when
and where they need it. Other features of a patient record system are essentially
irrelevant to users if they cannot gain access to the system, to the records in the
system, or to the data in the records.
Access can be described in terms of availability, convenience, reliability, 3
and ease of use. A patient record system should allow authorized clinical users
convenient access to any record 24 hours a day. This requirement implies an
adequate number of conveniently located terminals or work-stations, no system
downtime, no lost records or data, and access to the record by more than one
user at the same time. Nonclinical users typically require access to patient
record data at least during standard working hours.
Different users need different levels and kinds of information (see
Box 2-4). The ease with which users locate or retrieve needed data elements
depends largely on the record format. Current paper record formats tend to
segregate rather than integrate information; to facilitate communication of
3 System reliability refers to the constant availability of hardware and software needed
for work in the clinical setting.
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Several other capabilities are needed for optimal access. Users should be
able to display information at different levels of detail. Moreover, the system
should permit virtually every data item to be used as a key for retrieval and
should also enable users to access subsets of data. All users, regardless of their
level of computer expertise, should be able to enter most queries without the
intervention of a programmer; thus, an English-like retrieval language should be
part of the system.
Accessing information when needed includes more than finding an
available terminal; from the user's point of view, it means an adequate (i.e., fast)
system response time. Users want to perform their tasks at least as fast as they
currently perform them with paper records. Extremely rapid retrieval of
information, measured in fractions of a second, is an essential function for
primary users of the CPR. In addition, clinicians, who are accustomed to
writing or dictating their entries to patient records, want a comparable method
in the CPR system to add data to the record.
From the users' perspective, the difficulty involved in learning to use a
system also affects access. Thus, operation of patient record systems should
require only minimal training.4 Training for physicians in particular should be
short and easy, preferably occurring "on line" and at their convenience. Many
physicians are unwilling to devote large blocks of time to learning a new record
system, even if ultimately it might make their work easier. In addition, built-in,
displayable "help" documentation on system operation and the data elements
should be available to both clinical and nonclinical users.
The question of patient access to records is debated among practitioners. It
is likely, however, that the trend toward increasing patient access will continue.
Some providers consider it appropriate for patients to enter data (e.g., historical
medical information) into their records routinely. Recently, functional status
and preferences among various treatments have been identified as data that
could be recorded by patients to assist practitioners in developing care plans.
Some practitioners encourage patients to audit their records for accuracy
and completeness; they may also use the record for patient education. Indeed, as
patients become increasingly computer-literate, knowledge-seeking consumers
of health care services, the CPR may function as an important patient education
tool by offering patients access to resources such as MEDLINE.
4 This statement assumes that record users will receive adequate training in how to use
patient records and the other functions provided by patient record systems through
formal education (i.e., professional schools and continuing education). It also refers to
the requirement that users who work in more than one provider setting (e.g., physician
office and hospital) be able to learn multiple patient record systems easily.
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DATA QUALITY The notion of data quality has several attributes: legibility,
accuracy, completeness, and meaning. CPR systems eliminate the need for
handwriting and thus improve legibility. Accuracy of CPRs can be enhanced by
data entry screens and logical rules that flag or block inappropriate entries for
particular data fields. To the extent that CPRs reduce the need for an
intermediary to enter data (i.e., for transcription), a potential source of errors
(and cost) is removed. When errors do occur, for legal purposes the original
entry and the correction should both be preserved (Waller, in this volume). Data
accuracy also has implications for the security and reliability of CPR systems
insofar as the systems must ensure that data are not lost or unknowingly
corrupted.5
The completeness of patient records for subsequent users depends in part
on agreement among users about uniform core data elements. Without such
uniformity, what one patient record user views as complete data may be
considered incomplete by another. Data completeness implies that systems will
accommodate the currently expected range and complexity of clinical data and
that they will permit new data fields to be added and obsolete data fields to be
identified.6
For patient records to meet user needs, patient problems and the current
status of patient problems should be clearly noted in the record. In addition, it is
essential that the health care provider's rationale for clinical decisions be clearly
documented. Lack of a recorded rationale hinders the ability of subsequent
users of the record to make appropriate judgments regarding patient care,
quality assurance, utilization review, reimbursement, and research.
For purposes of health services research, patient health status is the single
most important data element that is usually missing from the patient records of
today. Formal, interpretable information on health status is a precondition both
to case mix or risk factor adjustment and to assessment of the outcomes of care.
The research community clearly wants health status information, collected in a
standard format, to be a routine part of the record of the future. Such records
should also document health risk factors (e.g., smoking).
Technology assessment, clinical investigation, and health services research
have been slowed by the lack of reliable, valid, standardized, consistently
5 The term corrupted is used to describe data that do not accurately represent the
information they are intended to reflect (e.g., data that have been transposed, scrambled,
or omitted).
6 After a period of time, certain data elements in a record or record system may no
longer be used to collect new information. Currently obsolete data elements are
nevertheless legitimate data elements in the old records, and they should be retained as
long as old records are retrieved and used.
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priori set of attributes is unique to the data, to the process operating on the data,
and to the data holder. Such attributes might include timeliness (e.g., every data
element is posted within five minutes of availability), completeness (e.g., a
certain set of data elements must be part of the record), and accuracy (e.g., there
are no spelling errors, every address has a zip code).
Data integrity in future patient records might be enhanced by including a
data validity field that would flag data that might not be correct. Data validity
would be an additional parameter against which integrity could be judged and
thereby controlled. Informing subsequent users that an entry might be incorrect
would allow them to discount or ignore the information.
FLEXIBILITY Users assign high priority to flexibility in records; they do not
want to be forced to use the record in a universally uniform or prescribed
manner. Thus, future CPR systems should permit customization of data entry
formats, reporting formats, and display formatsboth for and, in some cases,
by specific users. Patient record user needs are simply too many and too varied
for any one combination of input, reporting, or display options. Furthermore,
research has shown that the ability to customize computer interfaces according
to one's preferences and work habits increases user acceptance of computer
systems (Bikson et al., 1987).
Conventional formats should be designed and available as default modes,
but the users of the patient record of the future should find the record easy to
mold to their individual, local needs. Different formats for displaying
information on the screen or on paper should be available. The record should
also permit integration across disciplines and professional specialties and
provide different "views"8 of patient data for different users (see Box 2-4).
Flexibility is also required to meet the varied reporting needs of users,
particularly physician specialties. Doctors need record information available
both in easily accessible, standard reporting formats (such as letters, insurance
forms, school and camp certificates, etc.) and in formats they can easily
customize according to specialty and individual taste. Therefore, the CPR
system should contain a user-friendly report generator for physicians and others
who wish to design specialized reports for their own use.
CONNECTIVITY Connectivity denotes the potential of the record or record
system to establish links or to interact effectively with any sort of provider
8 The term view has a special use in computer science. A view is considered to be
perspective on a database. Different users of a database may have different uses for and
therefore different perspectives on the same database. For example, some users may
require data elements that are not of interest to other users. Alternatively, different users
may seek the same data elements presented in different formats (e.g., as a table or a
graph showing trends) or may want several data elements combined to create a new data
element.
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or database that may improve the care of the patient. Three different interfaces
are important in such interactions: the interface among records or record
systems of different provider institutions, the interface between the record and
other repositories or potential repositories of information that may be useful in
caring for the patient, and the interface between the record and a practitioner.
Linkages among the various clinical records pertaining to a single patient
are also important to users, who often want a longitudinal patient record
records from different times, providers, and sites of care that are linked to form
a lifelong view of a patient's health care experiences. Linkages are also needed
to transfer patient data from one care setting to another (e.g., from physician
office to hospital) to facilitate service coordination.
Linking the records of family members, or the records of individuals who
received a certain procedure in a particular facility, may prove useful for some
types of epidemiological analysis. The aggregation of patient data for largescale analysis, however, requires more complicated kinds of linkages.
Integration of relevant subsets of data across institutional boundaries is
especially important as researchers attempt to understand diseases and episodes
of illness independent of the particular institution or health care professional
with whom patients find themselves at a particular phase of their illness.
Patient record systems should also offer linkages to other databases and
other sources of information.9 Desirable linkages include databases that contain
scientific literature and bibliographic information, administrative information
(e.g., coverage for a particular elective procedure for a given insurance plan),
medical practice guidelines, insurance claims, and disease registries.
Connectivity makes several other demands on the system as well. To make
it simple for the practitioner to interact with the record, data entry must be
almost as easy as writing, and databases must be organized in such a way that
any terminal or microcomputer on the system can retrieve requested data. As
noted earlier, communication among practitioners depends on common data
dictionaries and clinical coding systems. To interface easily with a database or
registry requires a different sort of connectivity. Workstations must be designed
with telecommunications interfaces that allow the user to switch almost
instantly between the information in the record and its relevant counterpart in
the external knowledge base.
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of paper record features and behaviors that, upon reflection, have little or no
value to users. Examples of waste include information that is routinely collected
but never used; inflexible, redundant formats for recording data that result in
duplicative information (e.g., obsolescent manual medication files); and
retrospective quality assurance that could be replaced with online quality
assurance. Such features and behaviors add cost rather than quality to the record
system.
The committee did not specifically investigate the nature or scope of such
wasted effort in present-day records, but members shared the general
impression that it abounds. In developing the CPR, time would be well spent in
practical research to identify and remove these "non-value-added" steps,
features, and data elements, with the intent of producing a record that is leaner,
less complex, and more streamlined than that of today. This process is likely to
require changes in regulations or laws, and the committee urges that such
changes be analyzed, recommended, and adopted (see Chapter 5).
Guidance of Clinical Problem Solving
It has been suggested that a physician's thought process is formed in part
by his or her interaction with the patient record (Young, 1987). According to
Weed (1968), a properly formatted patient record can guide clinicians through
the process of clinical problem solving. It was this intention that led Weed to
design the problem-oriented medical record (POMR) (Weed, 1968; Margolis,
1979).12
Studies investigating the use of the problem-oriented format to record the
patient care process report three advantages over non-problem-oriented
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Practitioner Support
Given the volume and complexity of the information required to provide
patient care, users want the patient record to be more than a repository of data.
Computer-based record systems can support practitioners by providing at least
five kinds of tools that are not available with paper records. These tools include
mechanisms for focusing attention, for patient-specific consultation, for
information management, for data analysis, and for implementing quality
assurance and cost management policies.
Human cognition has measurable limitations, and as a result humans
"predictably overlook rare and uncommon events" (McDonald and Tierney,
1988:3435). Automated record systems can help practitioners recognize out-ofrange values or dangerous trends, remember needed actions, recall available
options, and make better clinical decisions. Human memory is imperfect,
especially when the task involves remembering a large set of items or recalling
the same items repeatedly. The computer can be relied on to remember large
numbers of items accurately and to check routinely whether the practitioner has
forgotten any standard items relevant to the diagnosis or treatment of a
particular problem. Some of these reminders may be critical, and they can be
linked to alarms (such as beep tones or messages) that warn the practitioner
before trouble occurs.13 (For example, an alarm might be triggered when two
incompatible drugs are prescribed together.)
CPR systems can also provide easy access to clinical decision support
systems that provide "custom-tailored assessments or advice based on sets of
patient-specific data" (Shortliffe et al., 1990: 469). Currently available patientspecific consultation systems suggest differential diagnoses, indicate additional
information that would help to narrow the range of etiologic possibilities,
suggest a single best explanation for a patient's symptoms, or provide advice on
therapy (Shortliffe et al., 1990).
CPR systems can support practitioners in the patient care setting by
providing easy access to knowledge and bibliographic databases. Such access
will free practitioners from relying on memory for infrequently used
information. Moreover, computer-based record systems can help educate
practitioners and keep them up-to-date on new developments by providing access
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COMPUTER-BASED PATIENT RECORD TECHNOLOGIES
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3
Computer-Based Patient Record
Technologies
User needs, both of individuals and of cohesive communities, are
paramount in the design and development of computer-based patient record
systems. Designers and vendors of CPR systems must understand such needs,
as well as how the systems will be used and what demands users will place on
the systems. The discussion of user requirements in Chapter 2 sets the stage for
explaining in this chapter the attributes of technologies required to create CPR
systems in the 1990s.
This chapter has three main goals: (1) to highlight technologies relevant to
CPR systems, (2) to convey what is possible with existing technologies, and (3)
to emphasize what will be required to build state-of-the-art CPR systems in the
1990s. The chapter also provides some insight into the current state of existing
clinical information systems that possess features crucial to the development of
state-of-the-art CPR systems. Finally, it discusses the technological barriers that
still must be overcome before CPR systems can become well established.
TECHNOLOGICAL BUILDING BLOCKS FOR CPR SYSTEMS
No clinical information system in 1990 is sufficiently comprehensive to
serve as a complete model for future CPR systems. That is, no operational
clinical information system in 1990 can manage the entire patient care record
with all its inherent complexities. A few existing clinical information systems
are beginning to approach the CPR system capabilities envisioned by the
committee. None of these is yet complete, but some might appropriately be
called today's CPR systems. Therefore, the committee sometimes
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refers to current CPR systems, meaning those clinical information systems that
are beginning to approximate the ideal CPR system envisioned by the
committee for the future (see Chapter 2).
The committee selected and reviewed nine technologies that are significant
for CPR systems. They include (1) databases and database management
systems, (2) workstations, (3) data acquisition and retrieval, (4) text processing,
(5) image processing and storage, (6) data-exchange and vocabulary standards,
(7) system communications and network infrastructure, (8) system reliability
and security, and (9) linkages to secondary databases. This section describes the
key attributes of these crucial technologies.
Databases and Database Management Systems
It is important to distinguish between the clinical datathat is, the
computer-based patient record, or CPRand the system that captures and
processes those datathat is, the CPR system. CPR functions relate to the
collection of data, such as patients' medical problems, diagnoses, treatments,
and other important patient information, including follow-up data and quality
measures. CPR system functions relate to storage capacity, response time,
reliability, security, and other similar attributes, but the system relies on the
collection of clinical data, the core CPR, to support virtually all of its activities.
Databases
The most desirable database model for CPR systems involves either (1) a
distributed database designthat is, a system with physically distributed
computers and databases but with logical central control of the entire record; or
(2) a centrally integrated physical database designthat is, a centrally located,
complete CPR within a single computer-stored database (see Figure 3-1);1 or
(3) some hybrid or mix of these two approaches. In any case, the key
requirements are central control and organizational integrity of the entire record
for each individual patient. Central control permits authorized persons using a
terminal located anywhere in the information system to access the entire
integrated patient record or any of its parts, regardless of the locations of any
other departmental subsystems where the various data items may have
originated. (Access is allowed only on the basis of parameters specific to
authorized users.)
1 The selection of the database management system that undergirds a CPR system is
critical to the performance and success of the system. Several publications during the
past decade have discussed this issue: Barnett et al. (1982); Pryor et al. (1983),
Wiederhold (1986), Kirby et al. (1987), McDonald et al. (1988), Whiting-O'Keefe et al.
(1988), Wilton and McCoy (1989), Canfield et al. (1990), Friedman et al. (1990), and
Hammond et al. (1990).
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different kinds of data, including text, graphics, images, numerical data, sound,
and full-motion video. To design a functionally integrated database system that
accommodates such diversity is a sizable technical challenge.
The CPR is so complex that no single database management system is
capable of optimally storing and retrieving the full range of patient data
(Hammond et al., 1990). As a result, CPR system developers have used a
variety of complementary DBMSs to address these complexities. This multipleDBMS approach is most common when the CPR system uses the distributed
database scenario; in that case, each subsystem often uses a different DBMS.
Because the CPR is distributed across many connected subsystems, each
subsystem will probably use a DBMS that is particularly suited to the kind of
data most frequently stored in that subsystem. The collection of appropriate
databases that results offers advantages of efficiency in manipulating and
storing the CPR complex data. Some CPR system developers have even created
their own proprietary database management systems, tailored to the CPR's
particular complexities.
The selection or creation of the DBMS that will support the CPR is among
the first and most crucial steps in developing a CPR system. Several database
management systems or architectures have evolved in recent years. Four
important ones developed by commercial vendors are hierarchical, relational,
text-oriented, and object-oriented databases. Each of these architectures has its
own particular strengths and weaknesses. Architects of current CPR systems
(both commercial and private) have mainly used hierarchical, relational, or textoriented models. Viable object-oriented database management systems have
been introduced only recently and are not yet in widespread use.
Workstations
Three general classes of workstations seem likely to prevail in future CPR
systems. First, "smart" terminals with data entry pointer/selector devices (e.g.,
mouse, touch-screen, light-pen, or voice) will be used for data input and
retrieval; they may also support "windowing" and medium-resolution imaging.
These terminals will use a graphical user interface (GUI) and communicate with
file servers, compute servers, and rule servers2 in a local area network
2 As computers have become smaller, more powerful, and more affordable, individual
computer systems have been dedicated to functions common to many applications and
users in a network. For example, data files may be stored in a computer dedicated to
serving the filing needs of network users, hence the name file server. Similarly, network
users executing computationally intensive applications (e.g., three-dimensional
reconstruction of images of an artery) require access to computers capable of serving
rapid computation needs, hence the name compute server. Another commonly needed
capability on a network is access to systems capable of rapidly executing rules for
decision support, hence the name rule server. As medical decision support systems
become more robust, rule servers will play an increasingly important role in health care
network.
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3 Greenes and Shortliffe (1990) define medical informatics as "the field that concerns
itself with the cognitive, information processing, and communication tasks of medical
practice, education, and research, including the information science and technology to
support these tasks."
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aggregation and dissemination of existing and future health care data mandate
the development of standards, both to exchange health care data and to
encourage more consistent medical vocabulary, especially in those portions of
the CPR containing natural language text. Developing such standards requires a
coordinated approach.
Efforts to develop data-exchange standards for components of the CPR
have only recently gained significant momentum in the United States. Because
so much is at stake in this sizable medical marketa market that remains
largely untapped from the vendors' point of viewstandards take on an even
more prominent role in fostering the evolution of the required technologies.
Currently, there are several related efforts to standardize and facilitate the
exchange of health data. HL 7 and Medix, as well as standards from the
American Society for Testing and Materials (ASTM), the American College of
Radiologists/National Electrical Manufacturers Association (ACR/NEMA), and
others are representative of the current movement to formulate data-exchange
standards.4
Several promising vocabulary developments are relevant to CPR systems.
These include a planned new edition of the Systematized Nomenclature of
Medicine (SNOMED); the Read Clinical Classification in Great Britain; the
ASTM Standard Guide for Nosologic Standards and Guides for Construction of
New Biomedical Nomenclature, which is now completed and ready for
distribution (ASTM, 1989); and the NLM's UMLS project. The overall goal of
UMLS is to help users retrieve relevant biomedical
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only to those with a need to know and to certify their identity before permitting
access. In addition, the CPR system must be capable of providing different
levels of data confidentiality as required for its various users. Audits of all
legitimate users of CPR systems must be conducted regularly to remind and
assure patients and staff that strict confidentiality is being maintained and
measured. Such periodic audits should help deter any attempts by staff to
breach confidentiality.
Members of the health care team who record patient data in the record are
responsible for such entries, but in a hospital or clinic, physicians typically still
have primary responsibility for ensuring the record's accuracy. As
documentation of health care shifts from paper to computer-based records,
practitioners will maintain their responsibility to document patient care, but the
data will reside within CPR systems. Legal, professional, and accrediting
standards must be revised to specify appropriate new roles and responsibilities
associated with the shift from the paper chart to the CPR.
In the aggregate, current CPR systems seem to use limited measures for
ensuring patient confidentiality. Most CPR systems do not approach the levels
of security or confidentiality that airlines or banks, for example, maintain to
protect their less sensitive information. Future CPR systems must implement
stricter measures to protect confidentiality (National Research Council, 1991).
Linkages to Secondary Databases
Many clinically relevant registries and databases have evolved in recent
years and are of particular interest to health care professionals as they attempt to
improve the quality of patient care. Increasingly, these collections of secondary
data will be extracted from primary data in CPRs in such a way as to protect the
confidentiality and identity of individual patients. Thus, patient records will
collect all data on all problems for a single patient; clinical research databases
will collect all data on one problem for many patients. For policymakers, the
secondary collection of relevant (nonconfidential) clinical information on large
populations of patients will support their development of policy strategies and
general assessments of quality and outcomes of care. Hundreds of databases are
available or are now evolving; some of these resources should be linked with
the CPR to provide clinical decision support when needed.
Some current CPR systems already offer linkages to knowledge and
research databases. Most CPR systems, however, lack this capacity, owing
primarily to the complexity and cost of developing such linkages. Health care
professionals are beginning to appreciate the support offered by timely access to
a diverse array of external information sources in providing care.
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NLM's GRATEFUL MED,5 for example, gives physicians in their offices ready
access to NLM's MEDLINE. For these purposes, it will be important to develop
easy-to-use linkages in real time so that feedback to the clinician occurs as part
of the decision making process.
EXPERIENCE WITH CPR SYSTEMS
Health care facilities have been using computers since the 1960s, but that
use has primarily focused on business and accounting functions of health care
(e.g., patient billing). Many have called these business systems for health care
environments either hospital information systems (HISs) or medical information
systems (MISs); they have been largely devoid of patient care data. The systems
of most interest to this report are clinical information systems, also sometimes
known as patient care management systems. Clinical information systems
consist of components related to clinical or direct care of patients (Blum, 1986),
regardless of the setting (ambulatory, inpatient, institution, or home).
In 1959, two pioneers in health care described a hypothetical health
computing system that might be able to address actual clinical problems
(Ledley and Lusted, 1960). Almost simultaneously, several other experts began
pioneering efforts using computing technologies in clinical settings. By the
mid-1960s, Spencer and Vallbona (1965:121) had concluded that at least six
areas of medical practice would be affected: "(1) medical diagnosis, (2) hospital
medical records, (3) laboratory analysis and functional testing, (4) patient
monitoring, (5) hospital communications, and (6) utilization of hospital services
and facilities." In 1965, Summerfield and Empey reported that at least 73
hospital and clinical information system projects and 28 projects for storage and
retrieval of medical documents and other clinically relevant information were
under way. Blum (1984:6) noted that progress through the 1960s was difficult
and slow and that "[s]uccesses in information processing during this phase were
limited. The Lockheed experience of the late 1960s resulted in the Technicon
MIS and a more sobering appraisal of the complexity of clinical information
systems."
These early experiences showed that clinical computing offered several
distinct challenges that would require significant time to address effectively. A
study of clinical systems between 1955 and 1973 by Giebink and
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Hurst (1975:xii) revealed that many of the systems planned or developed during
the 1960s were "extinctblunt testimony to the difficulties of implementing
computer-based information systems for health care delivery. Medical
computer applications which meet operational criteria are rare except for
routine business applications. Other than in developmental projects,
computerized medical records are abstracts of more complete records
maintained in hard copy form."
With the advent of less costly mini- and microcomputers, clinical
information system development flourished during the 1970s and 1980s. The
advances made during these years focused primarily on departmental systems
(known today as subsystems) for such areas as the clinical laboratory,
radiology, electrocardiology, and the pharmacy. One reason for this flurry of
development was that departmental systems were easier and less risky to
develop than comprehensive systems covering patient care management.
The 1970s and 1980s also saw the development of systems for clinical
decision support (Warner et al., 1972; Shortliffe, 1987). To perform their
sophisticated functions, these complex systems require that at least a subset of
the CPR be available as inputthat is, in machine-readable form. Once the use
of CPRs becomes more widespread and more and more patient data are
captured, these systems should become increasingly valuable to clinicians.
Virtually all of the current clinical information systems that might qualify
as CPR systems have evolved from a strong academic medical center's teaching
hospital or clinic records. Examples of this phenomenon include the COSTAR6
(Computer Stored Ambulatory Record; Barnett, 1984) system, which is used by
several institutions, including the Harvard Community Health Plan; a system
used by the Latter-Day Saints Hospital in Salt Lake City, Utah, known as
Health Evaluation through Logical Processing (HELP),7 which was developed
by faculty at the University of Utah (Warner et al., 1972; Pryor et al., 1983,
1984); the TMR (The Medical Record) system at Duke University Medical
Center (Stead and Hammond, 1988); and the THERESA system at Grady
Memorial Hospital, the primary teaching hospital for Emory University's
medical school (Walker, 1989).
With few exceptions, software developed in an academic setting is not
generally considered to be particularly robust or of an "industrial or commercial
grade"; consequently, some experts have been skeptical about the functionality
of these and other clinical information systems. Nevertheless, many of these
systems have proved their usefulness and viability in supporting the actual
delivery of health care in real-world settings. Attributes
6
7
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setting, however, the TMR system can provide a link to such imaging systems.
The TMR system can support a complete list of diagnoses and procedures,
as well as subjective and physical findings, laboratory data, and therapeutic
interventions. The system also allows multiple "views" of data. For example,
patient data may be viewed from any of several perspectivesfrom a problem,
time, task, or encounter orientation. 9 The look and feel of a particular TMR
system are controlled by a user-defined, object-oriented data dictionary that
separates the parameters, or variables, along which data are being collected
from the system features that manipulate those variables. Even users with no
programming expertise thus can tailor the TMR to their own needs.
Health Maintenance Organizations
Computer-Stored Ambulatory Record Systems
In 1968 the Laboratory of Computer Science at the Massachusetts General
Hospital implemented the COSTAR (Computer Stored Ambulatory Record)
system, which became one of the first systems capable of producing a computerbased patient record.10 COSTAR is a medical information management and
record system designed as a set of modules for which individual sites can
choose the portions of the system they wish to install. COSTAR supports
patient registration, scheduling of patient visits, storage and retrieval of clinical
information, and billing and accounts receivable (Barnett, 1984).
9 Patient records and the optimal formats for organizing and presenting their data have
been under discussion for more than 20 years (Weed, 1968). There are four major types
of approaches for organizing and presenting clinical data in a patient record. The
problem-oriented record links the patient's clinical data with his or her problems so that
all aspects of the care process are focused on resolving those problems. The timeoriented view of the patient's clinical data is more organizational than philosophical.
Entries in the record appear in chronological sequence, reflecting what was decided upon
and what was done at specific times. Task-oriented records emphasize the tasks
undertaken to care for the patient and present the patient's care organized in ways
specific to those who routinely perform certain sets of tasks. The encounter-oriented
record is an organized view of the patient's care processes structured by the encounters
of the patient (often over a long period of time). An encounter is defined as a hospital
stay or treatment for a single problem, regardless of how long the treatment may last
(sometimes years).
10 G. Octo Barnett, Harvard Medical School, provided the general description of
COSTAR. Where possible, reference is also made to published articles in peer-reviewed
journals. Stephen G. Schoenbaum, also affiliated with Harvard Medical School, provided
the explanation and description of the COSTAR system at the Harvard Community
Health Plan.
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their patients. THERESA is therefore one of the few clinical systems that have
successfully engaged clinicians in direct patient data entry. Grady also appears
to have successfully solved the problem of ensuring system access. Although it
has not installed expensive special fault-tolerant computer systems,12 for the last
seven years a distributed network of standard supermini-computers has
provided access to the system 99.95 percent of the time.
Health Evaluation Through Logical Processing
The Intermountain Health Care Corporation's Latter-Day Saints (LDS)
Hospital provides another example of the CPR system of today.13 The LDS
system, which has been under development for more than 25 years, is known as
HELP (Health Evaluation through Logical Processing; Pryor et al., 1983).
HELP's primary objective is to provide medical decision support, but it is also a
computer-based patient record system. Much of the input to HELP comes
directly from medical professionals entering data at terminals, but wherever
possible HELP utilizes automated input of the patient's clinical data. Although
LDS has conducted experiments using an automated patient history, currently
only minimal history and physical examination data are contained in the HELP
record. Consequently, at present, HELP maintains both a paper and a computerbased record for each patient.
Developers of HELP have consistently tried to focus on the use of patient
data in making decisions about care rather than on merely the storage and
communication of these data. To support its decision making goals, HELP
contains more than 100,000 rules and statistical processes pertaining to a broad
spectrum of health care; it uses these rules and processes to make decisions
(including diagnoses)just as a panel of experts might when presented with
similar data. The system makes decisions in both a background monitoring
mode and an interactive session with the health care
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14 Warner V. Slack and Charles Safran of the Center for Clinical Computing at
Harvard supplied the explanation and description of this system. Where possible, the
information was checked for consistency with published articles in peer-reviewed
journals.
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International Developments
DIOGENE, a system operating in the largest hospital in Geneva,
Switzerland, supports a nearly complete CPR and will soon support
communication of high-resolution images throughout the hospital complex. The
system's unique approach to clinical data capture (Scherrer et al., 1990) may
well offer a useful model that could be utilized in other health care organizations.
DIOGENE employs specially trained transcriptionists who can enter text
rapidly. A clinician who wants to enter narrative into the patient's computerbased record first identifies or displays the record on a computer terminal near
the point of care. He or she then places a call to an available transcriptionist on
a nearby telephone and begins dictating. As the dictation proceeds, the typed
narrative appears on the terminal display currently being used by the clinician.
At the completion of the dictation the clinician suggests any pertinent changes
and then approves the text, which becomes a permanent part of the computerbased patient record in DIOGENE.
Even at peak hours, a few specially trained transcriptionists can support all
practitioners' dictation. In the future, when clinical workstations can accept
direct voice input, transcriptionists will no longer be required.
The Exmouth Project
A large experimental study, known as the Exmouth Project, is being
conducted in Exeter, England. The experiment uses patient-carried "smart
cards"16 capable of storing critical portions of the complete patient record that
are essential in emergency as well as routine care situations. In Exeter, 98
percent of the pharmacies, 70 percent of general practitioners, and all hospitals
are able to read and use the credit card-sized patient Care Cards.
16 Smart cards are electronic devices (usually encased in plastic) that resemble a credit
card one might carry in a wallet. To date, these cards are more popular in Europe than
elsewhere and are used in a variety of applications, from banking and financial
transactions to medical applications. They contain electronic circuitry capable of storing
limited amounts of information crucial to the specific application for which the card is
intended. For example, in a health care application, a patient's card might ideally contain
such things as demographic information, payer information, allergy history, blood type,
personal and family history, environmental and other risk factors, a photograph of the
patient, a record of the last 10 vital sign readings (perhaps revealing trends such as
hypertension), current medications, recent but former medications, discharge summaries
from the last three hospitalizations, and other information that might prove vital in
providing health care, especially in an emergency situation. Similar to drivers' licenses
the card would be carried at all times. When the patient appeared for care or in an
emergency situation, the card could be made available to all members of the health care
team.
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for cases in which myocardial infarctions actually occurred, and the package
quite accurately suggested the possibility of that diagnosis, as well as other
potentially devastating illnesses that apparently had not been seriously
considered.
Chart Checker's benefits are so well demonstrated that in certain instances
it has led to an across-the-board 20 percent reduction in malpractice insurance
premiums for physicians. In Massachusetts, for example, this reduction in
premiums (amounting to $2,400 or more per physician) became effective in
July 1990 for all emergency room physicians who regularly use Chart Checker
(Blau, 1990). This software is representative of many clinical decision support
systems that can be expected to evolve in the near future. Such tools cannot be
used by health care professionals, however, until clinical data are captured in
machine-readable form. In short, the CPR must come first.
Problem-Knowledge Coupler
The problem-knowledge coupler (PKC) is another personal computerbased system designed to assist clinicians in organizing patient data in a variety
of care settings (Weed, in press). Weed's system permits the clinician to build a
computer-based, problem-oriented patient record; it also uses medical
knowledge derived from the literature to provide the clinician with timely
suggestions and information specific to the symptoms or problems of the
current patient to guide and assist the clinician's decision making. Thus, the
PKC presents a nearly complete list of potential causes of a patient's reported
problems. Only a few topics in medicine have been covered so far, however,
because many couplers have yet to be written.
The PKC is designed to provide practitioners with information they need
from the literature when they need it. At the moment, the system supplies
references to highly relevant, targeted articles that have been searched
beforehand and are directly associated with the patient's problems. Some of the
system's architects have proposed that a ready link to MEDLINE at the NLM is
the solution to answering clinicians' questions near the time of the patient
encounter. Currently, however, that notion may be unrealistic because the time
required to formulate and perform an adequate bibliographic search is measured
in minutes, not seconds.
Medical Logic Modules
Decision support systems for health care have been successfully
demonstrated in recent years, but they too lack a common standard for
representing the knowledge they contain, thus limiting exchanges of their
contents (Pryor et al., 1984; Miller et al., 1986). As special medical knowledge
databases
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are developed at different institutions, the ability to share these databases will
become important. Anticipating this need, the Center for Medical Informatics at
the Columbia Presbyterian Medical Center has been exploring and testing the
development of the Arden syntax for medical logic modules (Hripcsak et al.,
1990). The Arden syntax is designed to facilitate the sharing of medical
knowledge and is especially well suited for the transfer of medical knowledge
bases among disparate medical decision support systems.
Clinical data derived from operational CPR systems will contribute
significantly to the body of medical knowledge used by future medical decision
support systems. Indeed, it is highly probable that CPR systems may realize
their full impact only when used in conjunction with medical decision support
systems. Similarly, medical decision support systems are likely to mature only
when medical knowledge can be readily transferred between systems.
Therefore, indirectly, the Arden syntax may be crucial to the rate of CPR
system deployment.
CLINICIAN INTERACTION AND RESISTANCE
Perhaps the single greatest challenge that has consistently confronted every
clinical system developer is to engage clinicians in direct data entry. Clinical
systems have used many different strategies to solve this problem; they range
from eliminating the need for clinician input to mandating direct data entry by
clinicians.
The LDS Hospital in Salt Lake City, Utah, is a good example of an
innovative approach to circumvent resistance to clinician data entry. As
discussed earlier in this chapter, the hospital's HELP system directly captures
clinical data (from the laboratory, intensive care units, and other departments)
virtually without human intervention wherever possible; it uses specially
designed data-capture devices attached to conventional medical instruments that
convert analog to digital information. Today, most vendors of such medical
instruments and devices provide computer-ready output capabilities as standard
equipment or as options.
Other systems require data to be typed by clinicians or by some
intermediary. Yet the bulk of the patient record is still unstructured text, such as
the patient history, the discharge summary, and physical examination findings;
this text must be entered into the clinical system either by dictation, which must
be transcribed in some timely manner, or by automated speech-recognition
systems. Another alternative is for the information to be typed manually into the
system. Many system developers have attempted to use typed input, but this
approach has generally failed because busy clinicians reject it. The next section
discusses possible technical support to overcome clinician resistance to
interacting with CPR systems.
Finding appropriate mechanisms to encourage direct clinician input remains
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Second, systems should be speaker independent; that is, the system should be
able to recognize words spoken by any individual who might speak without first
''training" the system to recognize the words spoken by that individual. Third,
systems for general medicine require large vocabularies; some domains and
subdomains, for example, may require vocabularies in excess of 30,000 words
or meaningful phrases. As vocabularies expand, both the costs and error rates
generally become intolerable. Emerging voice-recognition technology is likely
to ease the inputting of clinical data in future CPR systems, but the successful
experiences discussed earlier with such systems as HELP, THERESA, and
DIOGENE confirm the existence of currently available alternative approaches
to capturing crucial clinical data (including text) in the CPR.
Text Processing
Assuming that text can be conveniently entered into the clinical system
through voice-recognition technology or other means, the problem then
becomes one of effectively analyzing in an automated way the content and
meaning of the textual data. The raw material for epidemiological analysis and
for effectiveness and outcomes studies is primarily text from patient records,
which must be converted to coded data. For accurate comparisons, patient
record data must be correctly transformed into precise, unambiguous codes that
represent specific characteristic processes.
Text processing is generally considered to be a complex operation; its
application to the data in the CPR, with its special and diverse vocabularies,
further complicates the challenge of implementing it as a system capability.
Often, the more experienced the practitioner, the more succinct or abbreviated
the notes in the record. The notes thus may consist of abbreviations, acronyms,
and mnemonics, which could be difficult to interpret, even by other health care
professionals. Although text processors have improved markedly in recent
years, they can approach but never exceed the quality of written or dictated
information. Therefore, the quality of patient records can be improved only
through more disciplined approaches to consistent vocabulary in the record.
Although technology (voice-input or menu-driven input systems) can artificially
impose more consistent terminology, practitioners should be encouraged as a
rule to avoid idiosyncratic terminology and to use more formal, well-defined
vocabularies. Additional technological research is needed in this area, as well as
studies of incentives for behavioral change, before CPR systems can reach their
full potential.
Confidentiality and Security
Among the important priorities for the 1990s is the further development
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issues may also pertain to others engaged in providing health care. For example,
all members of the health care team deserve the same level of protection against
unauthorized access or abuse of information in the CPR that applies to the
patient.
One important method for ensuring confidentiality, and data and program
integrity, is to allow access to the CPR system only to those with a need to
know and then to certify positively their identity before granting access.
Fortunately, the problem of implementing measures to ensure confidentiality
and privacy is not unique to medicine. Confidentiality issues are important in
several areas outside health care such as finance and banking, libraries, and
communications, and these sectors may offer approaches that could be tailored
to the needs of health care users. For example, future CPR systems must be
capable of providing different levels of data confidentiality as required by their
users. Psychiatric data are a case in point: they must be available only to the
patient's psychiatrist. In addition, some sensitive data for drug abuse,
alcoholism, and similarly sensitive diagnoses must be protected by legal and
professional rules and regulations.
Health Data-Exchange Standards
Progress toward developing acceptable standards for transferring an entire
CPR has been slow, primarily because standards development has been largely
ad hoc. Still, although such progress is meager in comparison to what is needed,
it appears impressive when one considers that it has been accomplished
virtually without government funding and without substantial industry-wide
commitment. Nevertheless, the lack of funding for and coordination of
standards development for CPRs can constitute a major barrier to CPR
development, testing, and deployment. What is perhaps of even greater concern,
given the current limited support for standards development, is the potential
long-term negative impact of premature standards development. Without
substantially better coordination and greater funding relatively soon, standards
may evolve that may later prove to be inadequate, and neither as well conceived
nor as robust as the standards needed to support a broad array of future CPR
applications.
Before an actual exchange of clinical data can take place, agreement must
be reached on what is being transferred. Many vendors and government
agencies have independently developed their own internal clinical data
dictionaries. These dictionaries differ in terms of the actual data elements
included, naming conventions, definitions, and relationships among data
elements. No attempt has yet been made to create a composite clinical data
dictionary (CCDD) using input provided by these and other groups interested in
the CPR (Figure 3-3). For example, the federal government alone has at least
three distinct clinical data dictionaries (namely, those of DoD, the VA, and the
Health Care
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out the actual data transfers. For example, one potential template might be
HCFA's Uniform Clinical Data Set (UCDS), a collection of approximately
1,600 data elements (Krakauer, 1990). Over time, many other relevant data sets
for varied purposes are likely to be generated using subsets from the universe of
data elements defined in the CCDD. For example, emergency room (ER)
physicians might designate a small set of clinical data elements from the CCDD
(such a subset could be the ER template) that are required to facilitate
appropriate care in an emergency setting. This template could then be used to
formulate an appropriate health data-exchange standard to perform the actual
transfer of patient data between disparate CPR systems.
The diversity of patient record data is likely to continue as a number of
different vendors and mix of institutions, service bureaus, reimbursement
agencies, and governmental agencies increase their use of clinical data. It is
essential, therefore, that development and promotion of standards for data
representation and data exchange be major priorities. Without such standards, it
will be impossible to support the necessary exchange of CPR data among the
different interested organizations and institutions.
SUMMARY
Although progress has been steady over the past two decades in
developing complete CPR systems, and although several powerful clinical
information systems have become operational in recent years, as yet not one is
capable of supporting the complete CPR. Most of the former technological
barriers to developing CPR systems have now or are about to disappear, and no
technological breakthroughs are needed to implement CPR systems.
Nevertheless, further maturation of a few emerging technologies, such as voiceinput or voice-recognition and text-processing systems, would facilitate the
development of state-of-the-art CPR systems in the 1990s.
Many different standards must be developed, tested, and deployed before
the CPR can realize its full potential. Standards to facilitate the exchange of
health care data are needed now so that clinical data may be aggregated and
analyzed to support improved decision making. When clinical data from CPR
systems are pooled in regional and national databases and made available
through networks, they will constitute a vast information resource on which to
base health care policy, clinical studies of effectiveness and appropriateness,
and equitable reimbursement policies.
Standards are also needed for the development of more secure CPR
systems. All of this effort should focus on ensuring the integrity of the clinical
data in the CPR and on patient confidentiality. Confidentiality of health data in
CPR systems is crucial to the success of these systems. Further, confidentiality
must be maintained not only for the patient but for all health care professionals
and especially for members of the health care team.
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136
computer-based patient record and the data that should be captured in it. Vendor
responses suggested that the industry viewed direct data entry as desirable, but
they also reflected industry pessimism about whether physicians and nurses
could be convinced to actually enter data (although three vendors stated that
they had implemented systems in which direct data entry by practitioners was
occurring). Other impediments to the immediate implementation of CPRs
today, as opposed to in the future, included the cost of the system, general
resistance to change within the health care industry, the need for data sharing
among many different kinds of systems (including departmental systems), and
the lack of a good decision support system.
Vendors showed more agreement in their view of the forces that could
propel the medical record environment into the computer age. Most cited the
increasingly broad range of medical record users, which mandates a patient
record with expanded access. Strong consensus emerged regarding the CPR as a
tool with the potential to benefit every aspect of the health care environment.
Vendors also voiced some skepticism, however, that the CPR could receive the
broad-based, organization-wide support required for its implementation and use
in a hospital.
According to the vendor responses, technologies commonly believed to be
5 to 10 years distant are, in fact, already being employed in workable CPR
systems. Three vendors claimed that they had implemented a full-scale
electronic medical record in a hospital environment: one in a facility of
unspecified size, the second in a hospital of 176 beds, and the third in a large,
urban teaching hospital of more than 900 beds. Two of these vendors offered
decision support systems, one of which was described as a powerful reportwriting system and the other as an actual interactive decision support system.
The survey responses also indicated that direct data entry by patient care
practitioners was feasible, resistance to change notwithstanding, provided the
CPR system was user-friendly and was perceived as improving quality and
reducing costs for the hospital, clinic, or practice. Taken together, the survey
responses appeared to suggest that the environment is right for the
implementation of CPRs in hospitalsthat is, if enough of the system's
beneficiaries can be convinced that such a comprehensive system justifies the
difficulties of implementation.
SURVEY FINDINGS
FINDING 1. Close reading of the responses generates some skepticism
about whether all of the named products meet the requirements of a
comprehensive CPR system. This may be the case in part because too few of
the necessary patient record components have been automated.
FINDING 2. The majority of the systems noted in the survey operate in
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4
The Road to CPR Implementation
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2 Some experts believe hospitals must have 200 or more operating beds to make
optimal use of hospital information systems. According to the GAO report (1988), nearly
70 percent of community hospitals have fewer than 200 operating beds.
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The CPR market may also be uncertain because computer applications are
generally not well understood by health care practitioners (Anderson and Jay,
1987). This lack of understanding limits the demand for such products and, as a
result, reduces commercial interest in developing new products. Few sources
exist to help practitioners learn what a computer technology can do for them,
and there is little likelihood such help will be forthcoming in the near future,
given the costs associated with producing such resources.
Barriers to Diffusion
Technological diffusion has been analyzed in greater depth than
technological development. Rogers (1987) presents five characteristics of a
technology that influence its adoption:
relative advantage over existing technologies (the degree to which an
innovation is perceived as better than the practice it supersedes);
compatibility (the degree to which an innovation is perceived to be
consistent with values, experiences, and needs of potential adopters, as
well as with the structure of adopting organizations);
complexity (the degree to which an innovation is perceived as difficult
to understand and use);
feasibility3 (the degree to which one can experiment with an innovation
on a limited basis); and
observability (the degree to which the results of an innovation are
observable to others).
Other factors also affect CPR adoption and use, including the environment
of the health care system; leadership; user behavior, education, and training;
costs; social and legal issues; and network needs. Major concerns in these areas
are briefly noted below.
Environment of the Health Care System
The U.S. health care system has been characterized as comprising
"thousands of relatively autonomous units, centering on large hospitals, which
are themselves made up of relatively autonomous divisions and departments"
(Lindberg, 1979:215). Maintaining CPRs, however, "imposes requirements for
greater coordination among separate ancillary services, particularly with regard
to terminology" (McDonald and Tierney, 1988:3438).
3 Rogers (1987) uses the term trialability to reflect the degree to which an innovation
can be experimented with on a limited basis.
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Some individuals in the health care community are skeptical that computer
systems can be designed to meet user performance and functional requirements.
They may also doubt that a CPR system will improve an institution's ability to
manage its information. Previous negative experiences with computer systems
or inaccurate data generated by a system may cause some providers to actively
resist the acquisition and implementation of CPRs. Whether or not an individual
clinician is skeptical about a CPR system, using it will require behavioral
changes. Thus, as noted earlier, some natural resistance to the CPR is to be
expected.
Individual institutions will need educational programs to support these
changes. Educational curricula for health care professionals must also be
modified to reflect the role of the CPR in the provision of health care services.
Who will develop, implement, and pay for such materials (e.g., vendors or
professional groups) is an area of considerable uncertainty.
CPR implementation requires experts who can support CPR users, but at
present only a relatively small number of individuals have the necessary
expertise in medical informatics (Clepper, 1991). More people must be
encouraged to enter this field and a variety of educational and training
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time, whereas the automated system provided access to 100 percent of the
records requested. Quantification of the access benefit reduced the difference in
costs between the two systems (Koster et al., 1987).
This cost analysis illustrates another major difficulty faced by health care
provider institutions deciding on acquisition of a CPR system. Decisions about
whether to acquire technology are based in part on information about the
benefits of the technology; once again, data on CPR system benefits are sparse.
Few recent studies have analyzed actual costs and benefits. The studies that
have been conducted address MISs rather than CPR systems; they also focus on
projected rather than actual experience or include only those benefits that can be
measured in terms of dollars and exclude such benefits as improved quality of
care or reduced waiting time for patients.
The costs of acquiring and operating CPRs and CPR systems will be borne
primarily by practitioners and health care provider institutions. Yet the benefits
of these systems will accrue to patients, practitioners, health care provider
institutions, third-party payers, researchers, policymakers, and the public. These
cumulative benefits of CPR systems should exceed the benefits individual
practitioners and health care providers might be expected to gain. As such, CPR
systems in certain respects represent a public good.
Given today's strict budget constraints, health care provider institutions
(including physicians' offices) must choose among alternative technologies
when allocating resources. Compared with a CPR system, other technologies
could offer greater monetary benefits to an individual institution, albeit lower
combined or social (public good) benefits. When this situation prevails,
provider institutions have fewer incentives to invest in CPRs and CPR systems.
Nonclinical data users (e.g., third-party payers and researchers) could also
incur costs from CPR implementation. They may need to modify existing
systems or acquire new ones to be compatible with CPR standards; they may
also need to revise procedures for handling computer-based data and develop
training programs for personnel.
The cost of CPR technology, like the cost of computer technology in
general, may well decrease over time. Moreover, CPRs may reduce the costs of
care enough to offset the expense of acquiring and operating CPR systems,
although this remains to be proved. The committee was quite concerned about
the immediate barriers to CPR implementation raised by potentially substantial
costs for full acquisition, installation, and operation of CPR systems across the
nation; it was also concerned about the distribution of these costs.
Consequently, it formulated a specific recommendation to address these
matters, which is presented in Chapter 5.
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5 Westin's 1976 study of the impact on citizen rights of computers in the health care
field found that ''most cases of actual harm involving individuals were still arising from
manual records" and concluded that the main problem with the use of computer-based
patient records involved "potential harmthe creation of health data systems that many
health professionals, citizen groups, and individuals directly affected by such systems
consider to be threats to basic rights" (Westin, 1976:xvi, emphasis in original). As noted
by Lindberg (1970), however, the public and its elected legislators must have their
anxieties allayed about potential misuses of data.
Some observers have suggested that computer-based patient record systems will offer
greater confidentiality for patient information because they can limit the information that
various users can see. For example, administrative or financial personnel could be
prevented from seeing sensitive diagnostic or treatment data. Further, CPR systems
could provide an audit trail listing those personnel who accessed a particular record
(Hard, 1990).
As discussed in Chapter 3, however, existing security technology frequently has been
not applied to current CPR systems. Moreover, a recent National Research Council
(NRC) study on computer system security concerns concluded that several trends
reflected a growing potential for system abuse. Among these trends are the proliferation
of networking and embedded systems, the widespread use of databases containing
personal information, and the widespread ability to use and abuse computers (NRC,
1991).
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6 There has also been some discussion about the potential for practitioners to be found
negligent if they do not use clinical decision support systems once the systems become
widely available in the future (Willick, 1986; Metzger, 1988).
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understanding of the strengths and limitations of CPRs and CPR systems and to
offer substantial support or opposition to CPR activities.
Provider Institutions
Health care provider institutions are likely to be interested in CPR systems
in response to concerns about quality and costs and to internal and external
demands for information. By purchasing a CPR system, provider institutions
can influence CPR development and implementation in three ways. First, such
action signals the market that demand for CPR systems exists. Second, it
directly affects the staff who must use the system. Third, it can help to create an
understanding on the part of both providers and patients that such systems are
the emerging standard of practice.
Third-party Payers
Third-party payers include both insurers and employers. For insurers, CPR
systems offer an opportunity to streamline operations. To realize the gains in
efficiency and productivity offered by CPR systems, however, insurers may
have to incur short-term costs to make their systems compatible with CPR
formats. Long-term improvements in efficiency may also be realized; for
instance, redundant data entry can be eliminated through electronic claims
submission and payment.
Insurers have a major stake in improving the knowledge base for quality
and cost management (e.g., clinical practice guidelines and utilization
management), as well as for coverage and reimbursement decisions (e.g.,
technology assessment and outcomes research). As change agents, insurers
could offer incentivesfor example, faster payment of claims when they are
submitted in electronic form. Alternatively, because third-party payers should
value improved data, they could increase reimbursement rates to reflect the
costs of implementing and operating CPR systems.
Employers are likely to be interested in CPRs as a means of improving the
quality and reducing the costs of care received by their employees and related
beneficiaries. Groups such as the U.S. Chamber of Commerce, the Washington
Business Group on Health, and regional health care business coalitions have
devoted considerable resources to finding ways to manage the utilization and
cost of health care services, which are ultimately reflected in the health care
insurance premiums employers pay. The potential for CPRs to improve
information management at the micro (patient) and macro (population) levels is
likely to be of interest to employers. Health care business coalitions, chambers
of commerce, and major employers could all contribute to CPR development
and implementation efforts by financially supporting research and pilot
demonstrations and by developing relationships
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with insurers and health care provider institutions that use or support CPR
systems.
Federal Government
EXECUTIVE AGENCIES Federal agencies have varying degrees of interest in
and authority to influence CPR development and implementation. Certain
agencies can provide substantial funding for research and development; others
may be able to finance the acquisition of CPR technology. Federal agencies can
support standards development through funding or regulatory mandate. For
instance, they can direct major federal providers of health care to use CPR
equipment that meets certain standards, or they can require the use of CPR
technology for hospital accreditation or Medicare participation. The remainder
of this section outlines the change agent and stakeholder roles of selected
federal departments and agencies.
Within the Department of Health and Human Services (DHHS), the Public
Health Service agencies10 would benefit greatly from efficient access to
complete, accurate patient care data; therefore, their interest in CPRs is likely to
be high. For example, the Agency for Health Care Policy and Research
(AHCPR) is charged to develop uniform definitions of data to be collected and
used in describing a patient's clinical and functional status; it also supports the
development of common reporting formats and linkages for such data and of
standards to ensure data security, confidentiality, accuracy, and maintenance
(U.S. Congress, 1989). These activities support or would be supported by CPR
implementation.
The research institutes of the National Institutes of Health (NIH) are
viewed as stakeholders who would benefit from improved patient data. Within
NIH, the National Library of Medicine (NLM) is in a strong position to support
CPR development directly through its medical informatics program and its
work on the Uniform Medical Language System (UMLS). Further, MEDLINE,
HEALTH, and other on-line databases of the NLM's MEDLARS (Medical
Literature and Retrieval Systems) are valuable resources for health care
professionals that could be made available through CPR workstations.
The Centers for Disease Control (CDC) and the FDA could each benefit
from the implementation of CPR systems in two ways. First, CPR
implementation would likely improve patient data for epidemiological research.
10 These agencies include the Agency for Health Care Policy and Research, the
Centers for Disease Control (including the National Center for Health Statistics), the
Food and Drug Administration, the Health Resources and Services Administration, the
Indian Health Service, and the National Institutes of Health (including the National
Library of Medicine).
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11 HRSA uses two main types of funding. The majority of support is awarded to state
health agencies through MCH block grants that are intended to enable states to ensure
access to maternal and child health services for low-income individuals and individuals
who live in areas of limited health resources. The purposes to which these funds can be
put are quite broadranging from reducing infant mortality and the incidence of
preventable diseases to improving the rates of use of diagnostic and therapeutic services.
Most of the remainder of MCH appropriations is disbursed through awards called
special projects of regional and national significance (SPRANS). These programs can
involve MCH research, training, and projects related to genetic disease testing and
counseling and to diagnosis and treatment of hemophilia. More recently, amendments to
Title V of the Social Security Act have directed that some funds be used specifically for
newborn screening and for child health demonstration projects.
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Data Set (UCDS), to improve the efficiency of the Medicare peer review
organizations (PROs; Krakauer, 1990). At present, the UCDS must be
abstracted manually from hospital charts of Medicare patients; CPR systems
would improve the efficiency of collecting these necessary data.
The HCFA Bureau of Program Operations engages in three activities that
would benefit from widespread CPR technology. First, the bureau is trying to
promote submission of claims by electronic media. Second, it is developing a
so-called Common Working File, in which all claims for all kinds of services
will be located and accessible upon inquiry. Third, it is seeking to develop a
capability for real-time cooperation with PROs that will allow on-line
authorization of services.
The Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508)
provides for the development of prospective and retrospective drug utilization
review (DUR) programs by states participating in Medicaid. 12 The act also
includes provisions to conduct demonstration projects to evaluate the efficiency
and cost-effectiveness of prospective DURs in patient counseling and reducing
costs. Such demonstration projects, which would be overseen by HCFA, are
likely to address issues of interest to CPR developers and could support CPR
development efforts.
As noted in Chapter 3, the Departments of Defense (DoD) and Veterans
Affairs (VA) have installed integrated medical information systems in
numerous hospitals (GAO, 1988) and are actively engaged in developing and
implementing components of a CPR. Widespread use of CPR systems can be
expected to benefit both departments by expanding the availability of
technology to meet patient care, research, and education needs. For example,
with the CPR, the VA can improve its ability to coordinate health care services
provided to veterans in both VA and non-VA settings. The
12 Drug utilization review (DUR) is a formal program for comparing data on drug use
against explicit, prospective standards and, as necessary, introducing remedial strategies
to achieve some desired end. Three primary objectives of DUR are (1) improving quality
of care, (2) conserving drug funding resources and controlling individual expenditures,
and (3) maintaining program integrity (i.e., controlling fraud and benefit abuse).
Retrospective DUR is a systematic process that involves selection, review, analysis, and
interpretation of drug use data that are collected and analyzed after events occur.
Retrospective DUR is used to identify drug utilization trends that warrant further
education of practitioners and patients; it also highlights areas of system abuse that might
call for more extensive peer-level review and provides mechanisms for evaluation and
modification of program criteria and standards. Prospective DUR refers to systems that
are designed to influence drug prescribing, dispensing, or use in a real-time environment.
Implementation of such a system requires that a health care professional with patient
care responsibilities have sufficiently detailed information regarding a patient's medical
condition, drug use profile, and history to make an informed decision regarding new or
renewed drug use (Norris, 1991).
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13 More recent evidence of Congress's interest in the quality of health care appears in
the form of H.R. 1565, which was introduced in the House of Representatives on March
21, 1991. This bill is intended to increase access to health care and to affordable health
insurance, as well as to improve health care quality and contain costs.
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States
State governments face issues similar to those of the federal government in
that they devote significant percentages of their budgets to health care and are
concerned about health care quality, cost, and access for their citizens. States
have also been fertile grounds for progressive policymaking and legislation.
They have played important roles in developing regional databases to monitor
quality, manage costs, and assess clinical effectiveness.14 State governments,
cabinet-level health officers, and groups such as the National Conference of
State Legislators, Council of State Governments, Association of State and
Territorial Health Officials, and National Association of Health Data
Organizations could provide a regional perspective in national CPR efforts. In
addition, states would be likely candidates for pilot regional studies or
experimental prototypes.
Universities and Professional Schools
CPR systems offer several advantages to universities. For example,
universities whose professional schools (i.e., schools of medicine, nursing, and
dentistry) are involved in clinical research can benefit from the improved data
likely to be available for analysis. Furthermore, CPR systems may give the
schools a means of disseminating their results for application in clinical
practice. (These benefits are likely to accrue to independent research centers as
well.)
The interest of health professions schools in CPRs may be mixed,
however. On the one hand, faculty members' concerns about threats to their
expertise and professional roles might prompt negative reactions to the CPR.
On the other hand, individuals in academic or research settings might be
14 The following descriptions are examples of the types of state activities already in
progress (National Association of Health Data Organizations, 1988).
In 1977 New York established the Statewide Planning and Research Cooperative
System (SPARCS), a public-private effort that provides a unified data system to gather
information throughout the state regarding all hospital stays. SPARCS is a major
management tool for assisting hospitals, agencies, and other organizations with decision
making regarding the financing, planning, and monitoring of inpatient hospital services.
In 1985 the General Assembly of Colorado established the Colorado Health Data
Commission to collect, analyze, and disseminate data as a way to encourage competition
and informed decision making.
In 1986 the Pennsylvania Health Care Cost Containment Council was established
through an act that mandates health care utilization and cost data collection and
dissemination. Its central purpose is to increase purchaser and consumer knowledge of
health care costs and quality.
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more innovative and more receptive to change than health care professionals in
other types of settings.
Through the training of health care professionals (including continuing
education), professional schools can both shape attitudes toward and provide
the skills for using CPRs. Moreover, to the extent that professional schools
influence the agenda of researchers (by providing space and support), they can
foster the development of CPR systems. Some schools also now serve as
centers of medical informatics training and of continuing research in medical
informatics.
The NLM supports 11 institutions in efforts to develop prototypes of an
Integrated Academic Information Management System (IAIMS). The objective
of these projects is to ''develop the institutional information infrastructure that
permits individuals to access information they need for their clinical or research
work from any computer terminal wherever and whenever it is needed" (NAS,
1989). These projects may become models for linking the many departments of
academic health and medical centers, including other departments in parent
universities (e.g., economics, law, sociology) that have a role to play in clinical
and health services research. IAIMS sites may also provide an infrastructure on
which to base selected pilot CPR demonstration projects.
Standard-setting Organizations
Two kinds of standard-setting organizations are potential CPR change
agents. The first is those groups that are developing standards for health care
information systems, primarily in the areas of communication protocols and the
characteristics of information collection and use. Among these organizations are
the Institute of Electrical and Electronics Engineers (IEEE), the American
Society for Testing Materials (ASTM), and the International Standards
Organization (ISO). The second kind of standard-setting group comprises
various health care accreditation organizations, such as the Joint Commission
on Accreditation of Healthcare Organizations, the National Committee on
Quality Assurance, and the National League of Nursing. Their role may be to
foster CPR development, acquisition, and use by setting standards for
accreditation that are most effectively met through CPR systems.
Vendors
CPR system vendors are likely to support development if the projected
demand for CPR technology seems sufficient to recoup investment and
marketing costs. As discussed earlier, however, vendors are uncertain about the
willingness of health care providers to purchase CPR systems. Users or
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other change agents (such as Congress) may need to provide incentives for a
greater or more certain CPR market before vendors can be expected to invest
major sums for research, development, or marketing.
Activities and Resources Critical to CPR Development
In light of the various barriers to CPR development, the interest and
resources of change agents, and the concerns of stakeholders, the committee
identified eight critical activities that will help to advance CPR development:
(1) identification and understanding of CPR design requirements; (2)
development of standards; (3) CPR and CPR systems research and
development; (4) demonstrations of effectiveness, costs, and benefits of CPR
systems; (5) reduction of legal constraints for CPR uses as well as enhancement
of legal protection for patients; (6) coordination of resources and support for
CPR development and diffusion; (7) coordination of information and resources
for secondary patient record databases; and (8) education and training of
developers and users.
Dedicated resources and improved organization must be provided to
accomplish these activities. Resources can take the form of funding, expertise,
and equipment. Without adequate funding, however, the other kinds of
resources are unlikely to be available. Funding is required to support standard
setting, research, demonstrations, review of legal issues, information
coordination, education, and a user-developer forum.
Potential sources of funding include federal and state governments,
vendors of CPR systems, and private foundations. The committee believes that
funding for CPR development should be a governmental priority because the
CPR is essential to achieving a variety of ends desired by government (e.g.,
improved patient care and research). The budget deficits faced by federal and
state governments, however, may make the infusion of significant new funds
difficult. CPR vendors may be willing to contribute some funds but probably
not enough to support all needed activities. Vendors may be more likely to
contribute when uncertainty regarding the market for CPR systems has been
reduced. Foundations and other groups in the private sector that support healthrelated research and educational activities may also be an important, indeed,
necessary source of funding; again, however, the sums available from this
source will not be sufficient to support the entire task envisioned by the
committee. Purchasers of systems are unlikely to provide funding for
development efforts. They may be willing, however, to contribute in-kind
support, for instance, through their participation in demonstration projects.
Substantial levels of resources are already devoted to CPR system
development, and this suggests that a major effort should be made to avoid
duplication of effort and to build on expertise that has already been developed.
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15 Nonfederal hospitals in the United States spend more than $5 billion per year on
computing-related products and services (Booz-Allen and Hamilton, 1990).
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The
advantages
and
Federal Agency
There are several advantages to a federally based CPR development effort.
In general, a federal initiative associated with an existing agency has implied
authority and power, as well as lower start-up and operating costs than would be
incurred for a newly created, freestanding organization. Moreover,
congressional support is likely to be stronger if the CPR effort is closely linked
to federal efforts that are already under way. In addition, staff would not need to
spend time raising funds as would be necessary for a private sector effort.
A federal agency would have less independence than a private sector
organization, however, and would face possible limitations from bureaucratic
policies and procedures. Thus, greater potential for innovation might exist in the
private sector. Another disadvantage to locating leadership for CPR
development within the federal government is the potential for health care
providers to see such efforts as too closely aligned with government and
therefore open to excessive regulation and intrusiveness. Finally, such an
approach must rely on receiving a mandate and funding, which could make startup time for federal efforts longer than for a private organization.
Within DHHS, several agencies might be considered. First, the Office of
the Assistant Secretary for Planning and Evaluation (ASPE) might be able to
bridge the gaps among various agencies and programs in DHHS. It would be
unlikely, however, to gather the resources and expertise required to mount an
effort of the magnitude envisioned by this report.
AHCPR has functions quite consistent with the objectives of the leadership
entity proposed by the committee, although these functions are not its primary
responsibilities. Currently, AHCPR does not have the resources to undertake a
CPR implementation project, but if such funding were forthcoming it could,
over time, assume a more significant role. One drawback, however, is that such
an effort might be seen as possibly undermining the agency's main mission
that is, support of health services, outcomes, and effectiveness research and the
development of clinical practice guidelines.
HCFA has a substantial interest in the CPR for both operational and
quality improvement reasons. Although HCFA would be a key beneficiary of
widespread CPR implementation and hence likely to want to provide
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critical resources, it may not be the ideal agency to champion patient record
development. If HCFA were to lead the CPR effort, health care providers might
not be able to separate it from HCFA's other activities, particularly regulation of
the Medicare program, cost containment, and related efforts. Providers might
resist the CPR development initiative because of a perception that it was
intended as a cost-containment mechanism rather than as a way to improve
health care delivery.
The Departments of Defense (DoD) and Veterans Affairs (VA) are both
making significant investments in comprehensive medical information
systems.17 As a result, they have a great deal of expertise in designing and
implementing such systems. These departments do not seem likely candidates
for leading a CPR initiative, however, because of their restricted populations
and other non-health care responsibilities. In short, no existing federal
organization simultaneously has the mandate, mission, credibility, and
resources to take on this responsibility.
Private Sector Sponsorship
The committee also considered a private sector, not-for-profit membership
organization, similar to the Joint Commission on the Accreditation of
Healthcare Organizations, to lead the CPR development effort. A decided
advantage to a purely private approach is that the conversion to computer-based
records would become something championed by, rather than imposed on, these
organizations and their constituents. The active involvement of such
organizations might prompt them to provide core funding, and the efforts to
secure funding from others might then be more effective. In addition, staff
recruitment for a private organization would be facilitated by the broad-based
support the organization would receive from national health care groups.
This strategy has its limitations, however. Most important is that such an
organization would lack the power and authority implicit in a governmental
entity. Further, federal funding could be difficult to obtain unless key agencies
played a major role in the organization's activities.
Public-Private Commission or Consortium
In theory, a public-private organization would offer the advantage of
involving and being able to draw on funding and personnel resources from
17 DoD is acquiring the Composite Health Care System for installation in its 167
hospitals and nearly 600 clinics. The costs for full deployment of this system are
expected to be $1.6 billion. The VA is installing the Decentralized Hospital Computer
System to support its 172 hospitals and 358 outpatient facilities. The VA estimates that
this system as currently defined will cost $925 million (GAO, 1988, 1990).
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both sectors. Furthermore, because the problems with patient records affect both
public and private organizations, acceptance of a solution would be more likely
if both sectors were involved in the decision making process.
The drawbacks of a public-private entity should not be underestimated,
however. Managing the diverse interests that would be represented in such an
organization presents a major challenge. Certain federal agencies already have
charters that would overlap the charge to such an organization. In addition, a
purely private sector organization might offer more entrepreneurial agility than
a hybrid group. Perhaps the biggest drawback of a public-private organization is
the inherent instability of such an approach. Lacking a federal mandate and
given the less-than-immediate contribution to the profitability of private sector
participants concerned with CPR development, a public-private organization
may not command sufficient resources and attention to address effectively the
barriers to CPRs and CPR systems.
Preferred Approach
The committee recognizes that the federal sector has considerable
resources (including authority and knowledge) to influence CPR development.
For example, HCFA can establish reimbursement mechanisms that reward
providers who submit insurance claims generated by CPR systems. AHCPR is
expressly mandated to improve patient data for research. The VA and DoD
have gained considerable experience in CPR development and implementation.
NLM has made significant contributions to the management of medical
knowledge for practitioners.
Nevertheless, several factors militate against a purely federal approach.
First, the resources, potential change agents, and stakeholders that must be
coordinated or engaged in CPR development are present in both the public and
private sectors. Thus, a structure is needed that can draw from both sectors.
Second, the committee believes that routine use of the CPR can be achieved
most efficiently through a collaborative process that develops consensus on key
issues (e.g., data and security standards, the minimum content of CPR systems)
yet allows flexibility at the local level to foster innovation in the development
and use of CPRs.
Third, the committee believes that patient care should be the primary focus
of CPR development and implementation. Practitioner use of CPR systems
requires that the systems meet practitioner needs, and only if practitioners are
willing to use CPR systems to capture data and to secure assistance in clinical
decision making can the benefits of CPRs for moderating costs and conducting
research be realized. It is essential that practitioners view the CPR as a valuable
resource for improving patient care. Thus, CPR efforts must involve health care
providers as well as federal agencies.
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THE ROAD TO CPR IMPLEMENTATION
169
acquisition, and use by setting standards for accreditation that are most
effectively met through CPR systems.
In their training of health care professionals (including continuing
education), professional schools could both shape attitudes toward and
provide the skills for using CPRs. They could also foster the
development of CPR systems to the extent that the agenda of
researchers is influenced by the schools' provision of space and support.
Researchers could study the costs and benefits of CPR systems, at both
micro and macro levels, including the impact of CPR systems on the
quality and costs of care.
State agencies, hospital associations, and local professional groups
could establish working groups to develop a common understanding
and vision of how CPRs could support their health care environment
and to identify the elements of local and regional infrastructure needed
to support future CPRs. Working groups could study the relationships
among referring physicians and among other providers to understand
their entire system of health care. They could also define needed data
elements, educate local health care professionals on health care
information management issues, and monitor progress in the
development of standards for security and data exchange.
SUMMARY
In addition to technological advances, successful implementation of CPR
systems requires elimination of the barriers to development and diffusion. It
also requires that the concerns of stakeholders be addressed and that potential
change agents be engaged.
Many impediments to the CPR arise from a lack of awareness and
understanding of CPRs and their capabilities. System purchasers and users lack
adequate information about the benefits and costs of CPRs. In particular,
developers and vendors require more specific information about what users
want from systems and what price providers would be willing to pay for
systems that meet their needs. Activities aimed at improving (e.g.,
demonstration projects) and disseminating (e.g., education programs) available
information about CPR systems constitute an important step for CPR
implementation.
Other impediments arise from the lack of an infrastructure to support CPR
development and diffusion. Such an infrastructure comprises standards for
communication of data (i.e., vocabulary control and data format standards);
laws and regulations that protect patient privacy but do not inhibit transfer of
information to legitimate users of data outside the clinical setting; experts
trained in the development and use of CPR systems; institutional, local,
regional, and national networks for transmitting CPR data; reimbursement
mechanisms that pay for the costs of producing improved
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THE ROAD TO CPR IMPLEMENTATION
171
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Automated Patient Record. Paper prepared for the Institute of
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APPENDIX: MATERNAL AND CHILD HEALTH CARE AND COMPUTER-BASED
PATIENT RECORDS
173
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PATIENT RECORDS
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PATIENT RECORDS
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IMPROVING PATIENT RECORDS: CONCLUSIONS AND RECOMMENDATIONS
176
5
Improving Patient Records: Conclusions
and Recommendations
Computer-based patient records and the systems in which they function are
becoming an essential technology for health care in part because the
information management challenges faced by health care professionals are
increasing daily. Technological progress makes it possible for CPRs and CPR
systems to provide total, cost-effective access to more complete, accurate
patient care data and to offer improved performance and enhanced functions
that can be used to meet those information management challenges. CPRs can
play an important role in improving the quality of patient care and strengthening
the scientific basis of clinical practice; they can also contribute to the
management and moderation of health care costs.
The Institute of Medicine (IOM) study committee believes that the time is
right for a major initiative to make CPRs a standard technology in health care
within a decade. Achieving this goal within 10 years will require a nationwide
effort and a great deal of work. More research and development are needed in
several critical areas to ensure that systems meet the needs of patients,
practitioners, administrators, third-party payers, researchers, and policymakers.
For example, the need to protect patient privacy must be balanced by the need
for timely access to data at multiple sites. Systems must offer both considerable
flexibility for users and standards required for data transfer and exchange.
CPR implementation will necessitate both organizational and behavioral
changes. Organizationally, it will require substantial coordination across the
many elements of the pluralistic U.S. health care system. Behaviorally, it will
demand that users develop new skills to use CPR systems and to change their
documentation behaviors.
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3.
4.
5.
6.
7.
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current patient records will perpetuate their deficiencies and will not be
sufficient to satisfy emerging user demands. If future patient records are to be
an asset in patient care, they must offer broader functions than those provided
by the record systems of today.
The future patient record will be a computer-based, multimedia record
capable of including free text, high-resolution images, sound (e.g.,
auscultations), full-motion video, and elaborate coding schemes. CPR systems
will offer access (availability, convenience, speed, reliability, and ease of use),
quality, security, flexibility, connectivity, and efficiency. In addition, future
patient records will provide new functions through links to other databases and
decision support tools.
No contemporary clinical information systems are sufficiently
comprehensive to be considered full CPR systems. Several existing systems,
however, offer prototypes of components of CPR systems.
The committee considers nine technological capabilities to be essential to
CPR systems: (1) databases and database management systems, (2) workstations, (3) data acquisition and retrieval, (4) text processing, (5) image
processing and storage, (6) data-exchange and vocabulary standards, (7) system
communications and network infrastructure, (8) system reliability and security,
and (9) linkages to secondary databases.
No new technological breakthroughs are needed to develop robust CPR
systems, but some emerging technologies are crucial. Low-cost yet powerful
clinical workstations and improved human interface technologies are needed.
Voice-recognition systems, high-capacity networks (e.g., fiberoptic), and openarchitecture systems will be required to achieve broad adoption of CPR
systems. Emerging clipboard-sized computers that accept input through a handheld stylus may also prove to be a critical development. In addition, CPR
diffusion requires development of standards for health care data and greater
emphasis on protecting the integrity and confidentiality of CPR data.
Technology is not the only potentially limiting factor in advancing CPR
systems; informational, organizational, and behavioral barriers must also be
addressed. Barriers to CPR development include development costs and lack of
consensus on CPR content. CPR diffusion is adversely affected by the
disaggregated health care environment, the complex characteristics of CPR
technology, unpredictable user behavior, the high costs of acquiring CPR
systems, a lack of adequate networks for transmitting data, a lack of leadership
for resolving CPR issues, a lack of training for CPR developers and users, and a
variety of legal and social issues.
The committee developed a plan for advancing the development and
implementation of CPRs and CPR systems that identifies a broad group of
stakeholders who would be affected (both positively and negatively) by CPR
system implementation. It also identifies a group of organizations
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The CPR contains a problem list that clearly delineates the patient's
clinical problems and the current status of each (e.g., the primary illness is
worsening, stable, or improving).
2. The CPR encourages and supports the systematic measurement and
recording of the patient's health status and functional level to promote
more precise and routine assessment of the outcomes of patient care.
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3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
181
The CPR states the logical basis for all diagnoses or conclusions as a
means of documenting the clinical rationale for decisions about the
management of the patient's care. (This documentation should enhance
use of a scientific approach in clinical practice and assist the evolution of
a firmer foundation for clinical knowledge.)
The CPR can be linked with other clinical records of a patientfrom
various settings and time periodsto provide a longitudinal (i.e., lifelong)
record of events that may have influenced a person's health.
The CPR system addresses patient data confidentiality comprehensively
in particular, ensuring that the CPR is accessible only to authorized
individuals. (Although absolute confidentiality cannot be guaranteed in
any system, every possible practical and cost-effective measure should be
taken to secure CPRs and CPR systems from unauthorized access or
abuse.)
The CPR is accessible for use in a timely way at any and all times by
authorized individuals involved in direct patient care. Simultaneous and
remote access to the CPR is possible.
The CPR system allows selective retrieval and formatting of information
by users. It can present custom-tailored "views" of the same information.
The CPR system can be linked to both local and remote knowledge,
literature, bibliographic, or administrative databases and systems
(including those containing clinical practice guidelines or clinical decision
support capabilities) so that such information is readily available to assist
practitioners in decision making.
The CPR can assist and, in some instances, guide the process of clinical
problem solving by providing clinicians with decision analysis tools,
clinical reminders, prognostic risk assessment, and other clinical aids.
The CPR supports structured data collection and stores information using
a defined vocabulary. It adequately supports direct data entry by
practitioners.
The CPR can help individual practitioners and health care provider
institutions manage and evaluate the quality and costs of care.
The CPR is sufficiently flexible and expandable to support not only
today's basic information needs but also the evolving needs of each
clinical specialty and subspecialty.
The committee believes that the CPR can be well established within a
decade in the majority of offices of physicians, dentists, and other health care
professionals and in clinics, hospitals, and multifacility provider institutions.
Achieving such widespread use in only 10 years is an ambitious goal, but it can
be accomplished if two conditions are met. First, a concentrated effortwith
appropriate leadership, resources, coordination, and incentivesmust be
mounted. Second, CPR systems must be affordable and at least minimally
acceptable to users.
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1 The name Computer-based Patient Record Institute is descriptive and not intended to
limit the concept of the organization or its potential responsibility for related
infrastructural issues (such as a national biomedical communications network).
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184
a plan would establish priorities for CPR development within and among
activities (e.g., define where data standards are most needed or where they
could be applied most quickly). By defining and coordinating the roles of key
change agents, the CPR can help focus attention on the most important tasks
and avoid redundancy of effort. Moreover, by tracking and reporting concrete
progress toward CPR development, the CPRI can help maintain and perhaps
continue to increase interest in and resources for CPR development. It is
essential that the CPRI and all organizations and individuals associated with
CPR development build on existing efforts. For example, CPRI can work with
the Agency for Health Care Policy and Research (AHCPR) to identify needed
progress for existing databases so that secondary user needs can be better met
during the transition to CPRs.
The committee, for several reasons, concluded that in the long run an
independent public-private organization would be the optimal structure for the
CPRI. No one federal agency would have the prestige, funding, or personnel to
pursue a complete CPR agenda successfully; in addition, suspicion or
skepticism on the part of the private sector (both the business and the health
care communities) regarding a purely governmental effort would be difficult to
overcome. The committee emphasizes that if the CPRI is to be successful, it
must represent all patient record users, particularly practitioners.
A purely private sector effort also has little likelihood of success: past
history shows that private sector CPR development has been fragmented,
unique to particular institutions, and generally underfunded. Indeed, the base of
funding in the private sector is not sufficiently solid to support a new
organization at this time. In addition, it is unlikely that private sector activities
can overcome intentional and unintentional governmental barriers, such as the
myriad state laws and regulations that hamper progress in this area.
Furthermore, certain government agencies (notably the Departments of Defense
and Veterans Affairs) have made more progress in this area than the private
sector, and that work should be incorporated into any national effort.
Ultimately, the committee concluded that a federally initiated and funded
approach would be most appropriate for inaugurating the necessary activities.
The goal of such an interim effort would be to turn over, within five years, CPR
coordination efforts to a public-private organization supported by its members.
The committee thus recommends a two-phase strategy for the establishment of
the CPRI. In the first phase, the secretary of the Department of Health and
Human Services should establish an office or program to organize specific
activities aimed at reducing the barriers to computer-based patient record
development. In the second phase, the CPRI should be established as a publicprivate organization dedicated to coordinating the many activities needed to
facilitate widespread use of the CPR.
The main goals of the initial federal program should be to respond to
immediate needs to advance CPR efforts and to lay the groundwork for the
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importance to the CPR: they are necessary for transmitting complete or partial
patient records, and they are essential to the aggregation of information from
many sources, either for longitudinal records of individual patients or for
databases of secondary records to be used for research or epidemiological
purposes. Significant efforts are under way to support standards development
for CPR data dictionaries, uniform coding, vocabulary, and data formatting.
More needs to be accomplished, however, before the CPR can be shared across
institutions or even by different clinical information systems within institutions.
CONTENT STANDARDS Two main kinds of standards must be developed for the
content of CPRs. The first requirement is a minimum data set that applies to all
CPRs; the second is content standards for specific kinds of CPR records (e.g.,
hospital, dentist office). The lack of either of these kinds of standards will
impede effective use of CPR data by clinical and nonclinical users because
record content will continue to vary among practitioners and provider
institutions. A further requirement is to establish a specific meaning for data
elements; that is, data elements should be used to collect the same piece of
information in all record systems. Efforts by various federal agencies (e.g.,
HCFA, DoD, VA) and health data standards groups to develop clinical data
dictionaries should be coordinated to ensure a reasonable level of consistency
and compatibility. The committee suggests that the CPRI foster efforts to
establish a composite clinical data dictionary that would enable users to
translate data from different systems to equivalent meanings.
DATA-EXCHANGE STANDARDS It is likely that patient record data will continue
to be diverse because they are produced using a variety of technologies from
different vendors and by a complex mix of institutions, service bureaus,
reimbursement agencies, and government agencies. A major priority should be
to develop and promote standards for data representation and data exchange.
Without such standards, it will be impossible to support the necessary exchange
of patient medical, financial, and administrative information among the
different interested organizations and institutions.
In 1991, no nationally or internationally recognized format standard exists
for transferring a complete patient record between disparate clinical information
systems. At present, only one health data format standard (Medix, from the
Institute of Electronic and Electrical Engineers) even has the objective of
transferring the entire patient record, and it is not yet operational. Therefore, the
CPRI should coordinate efforts to develop, test, and demonstrate a health data
format standard capable of transmitting all or any portion of the CPR between
different clinical systems. The committee urges that special care be taken to
include input from and coordination with international
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standards efforts (especially those in Europe) to ensure that the format standard
complies with the International Standards Organization's Open Systems
Interconnect.
CLINICAL VOCABULARY STANDARDS Effective retrieval and use of health care
information in the CPR depend in large part on the consistency with which a
CPR content names and describes clinical findings, clinical problems,
procedures, and treatments. The development and widespread dissemination of
the content and techniques of effective vocabulary control of high-priority data
elements are major intellectual, technical, and organizational challenges.
Standardized vocabulary efforts such as the Unified Medical Language
Systems (UMLS) of the National Library of Medicine (NLM) are needed to
establish a common vocabulary base for clinical systems. The committee
believes that funding for development of standards for clinical vocabulary
systems should be expanded and, because of the technical difficulties involved,
sustained for at least a decade. The committee urges that the NLM be granted
increased funding over the same period to refine the UMLS further, particularly
the vocabulary involved in patient care and access to clinical knowledge bases.
The NLM is the appropriate organization to educate the health care community
concerning UMLS and other clinical vocabulary activities, and it is well
positioned to do so effectively. The CPRI could work closely with the NLM to
ensure efficient, nonredundant efforts in this area.
Security Standards
PATIENT DATA CONFIDENTIALITY Among the highest priorities in the coming
decade will be the enhancement and application of methods to ensure the
privacy and confidentiality of patient data in the CPR. Much of the technology
to make the CPR more secure already exists, but for greatest effectiveness these
technologies must be better deployed or embedded in CPR systems.
Today, no standards define the limits and scope of privacy and
confidentiality for sensitive data in clinical information or CPR systems. Thus,
the committee suggests that the CPRI coordinate development of such standards
for health care, which will include minimal procedures with which systems
must comply to ensure privacy and confidentiality in CPR systems. The
institute should also address similar issues for computer systems containing
secondary records (derived from data in the CPR) and establish standards for
these systems as well. In particular, standards are needed to address the limits
and procedures for removing (or scrambling) patient and provider identifiers in
secondary records.
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DATA AND SYSTEM SECURITY Standards are needed to ensure the integrity of
the data in CPR systems. The committee suggests that the CPRI actively
participate in developing such standards and that it coordinate and cooperate
with the FDA and the Information Security Foundation proposed in the
National Research Council's 1991 report, Computers at Risk: Safe Computing in
the Information Age (published by the National Academy Press). Considerable
attention was focused in the late 1980s on broad security measures for computer
systems; now, the special requirements of the CPR need to be articulated and
infused into the deliberations about these evolving industry standards. The
committee therefore recommends that the CPRI coordinate efforts with
organizations that are already active in establishing standards for secure systems
and for the transmission of sensitive data over standard communications
networks.
Networking Support
The information-intensive nature of health care mandates a strong
emphasis on communication and transmission of information to many different
organizations in diverse places. Electronic mail, file transfer, and image
communication will become increasingly important support services, not only
within a given hospital or health care institution but also across cities and states,
and nationwide. Strong federal support will be critical for providing networking
opportunities for health care information transfer at all organizational levels.
Current federal initiatives to develop high-performance national computer
networks largely address the key relevant issues (enhanced transmission speeds,
logistics of routing, standards for connectivity, and transmission protocols). The
overall focus to date, however, has been on communications support for the
research community; recognition of the role of such networks in supporting the
clinical enterprise in general and the CPR in particular has been limited. To
remedy this inadequacy, the CPRI should become an active participant in
discussions by the Federal Networking Council regarding the National Research
and Education Network.
Cost-Benefit Analysis
In view of the substantial direct costs of CPR development and
implementation, issues of cost-effectiveness are important from both
institutional and societal perspectives. It is not reasonable to imagine wholesale
investment in and development of CPRs and CPR systems without some
reliable sense of what will be gained, and at what cost. Given study time and
staffing constraints, the committee did not systematically inquire into evidence
regarding the cost-effectiveness of CPRs or conduct a cost-benefit
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outcomes of care, and they can do so more efficiently than with a paper-based
patient record system. In addition, those organizations whose responsibilities
include the accreditation, regulation, and improvement of health care can, with
appropriate safeguards, accumulate and analyze the data they need using the
CPR rather than the paper record.
Quality of care has taken on greater salience in recent years, and public
and private programs of quality assurance and continuous quality improvement
have multiplied. Many of these rely (or intend to rely) on information residing
in computer databases, including administrative or insurance claims files. At
present, these kinds of databases are rather primitive foundations for reliable
quality assurance efforts, and they have at best sparse information on important
aspects of the processes and outcomes of care. Moreover, emerging efforts to
develop uniform clinical data sets based on information in paper records are
hampered by various drawbacks in using those records (e.g., long manual
abstraction times).
Thus, CPRs and CPR systems offer great promise for furthering the
nation's movement toward improving the quality of health care. Many
questions, however, remain to be investigated. These include definition of
minimum clinical data sets for different types and settings of care, development
of appropriate real-time clinical reminders and alerts, and mechanisms for
applying the statistical tools and methods of modern continuous quality
improvement approaches. Although other public and private sector agencies and
organizations will undoubtedly take primary responsibility for R&D in this
area, the CPRI should be empowered to work directly with those groups to
support these activities.
Structure and Format of the Patient Record
The technological capabilities of CPR systems offer new possibilities for
improved design of patient record structure and format. To use these
capabilities most effectively, the committee believes the relationship between
the structure of patient records and the quality of patient care should be
explored further. For example, specific elements of patient records that
contribute to patient care outcomes need to be identified for incorporation into
CPR systems.
The committee declined to endorse a particular patient record format at
this time; rather, it strongly urges rigorous evaluation of the value of various
attributes of different patient record structures.
RECOMMENDATION 4. The CPRI should promulgate uniform
national standards for data and security to facilitate implementation of the
CPR and its secondary databases.
As discussed earlier, major financial and organizational support is needed
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to promote the development of uniform national standards for data and security.
Once agreed upon, these standards must be incorporated into the design and use
of CPR systems; they must also be continually reviewed and revised to keep up
with technological advances.
Mechanisms must be developed to communicate standards to the parties
affected by them. For example, system developers and vendors should be
notified when uniform national standards have been established so they can
design systems with up-to-date features. System purchasers, for their part, must
be educated about the value of these voluntary standards to ensure that they will
buy systems that offer features that meet the standards. System users (e.g.,
clinicians) who may be one step removed from purchase decisions also need to
be educated about standards so they can demand such features in the systems
that are acquired by their institutions. Furthermore, institutions should adopt
and enforce organizational policies and procedures that support standard
security practices. The CPRI is an appropriate body to develop mechanisms for
endorsing and communicating health care standards to affected parties.
RECOMMENDATION 5. The CPRI should review federal and state
laws and regulations for the purpose of proposing and promulgating model
legislation and regulations to facilitate implementation and dissemination
of the CPR and its secondary databases and to streamline the CPR and
CPR systems.
The committee identified at least four ways in which legal issues affect
CPR development and use. First, the inconsistency of licensure lawsfor
instance, for hospitals across the statescan impede development and diffusion
of new systems. Second, regulations can force inefficiencies on record keeping
(e.g., redundant collection of data). Third, laws concerning ownership,
responsibility, and control of patient records and data may be ambiguous or
inconsistent, or both, and thus hinder the electronic transfer of CPR data.
Fourth, laws protecting confidentiality of computer-based patient data need to
be strengthened to address concerns about patient privacy.
The committee concluded that a comprehensive review of pertinent laws
and regulations, especially state laws and regulations, is needed to remove
potential legal barriers and to ensure adequate protection of patient privacy.
Following this review, guidelines should be developed and disseminated to
appropriate audiences. The committee noted that the Uniform Health-Care
Information Act should be included in this review and that efforts should focus
on why it has not been widely adopted. The committee also determined that the
review process should include an assessment of and recommendations
regarding penalties for violation of the privacy of patients or providers through
unauthorized access or misuse of patient data in the CPR or other patient records.
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The committee assigns high priority to these legal and regulatory issues
because they pose major obstacles for steady progress toward the CPR and may
take a long time to resolve. For this reason, the committee suggests that the
CPRI convene a panel of experts to conduct such a review and prepare a report,
including guidelines for state and congressional consideration. The committee
also suggests that the CPRI disseminate the findings of the report through
educational conferences and other means.
RECOMMENDATION 6. The costs of CPR systems should be shared
by those who benefit from them. Specifically, the full costs of implementing
and operating CPRs and CPR systems should be factored into
reimbursement levels or payment schedules of both public and private
sector third-party payers. In addition, users of secondary databases should
support the costs of creating such databases.
The committee believes that capturing complete and accurate clinical data
is an essential element of the patient care process; it sees the CPR as an
essential tool for improving and evaluating the quality of patient care and for
decreasing its costs. Short-run benefits of CPRs and CPR systems should
include (1) improved patient care resulting from increased availability of patient
data, medical knowledge, and clinical aids (e.g., decision support); (2) increased
productivity of health care professionals from improved access to patient data
and reduction of redundant data recording; and (3) reduction in administrative
costs. Long-run benefits should include the ability to increase and improve
medical knowledge through research using patient data derived CPR systems.
As discussed in Chapter 4, the current distribution of costs and benefits of
CPR systems may not provide adequate investment incentives for health care
provider institutions. To overcome this problem, the committee believes that a
better understanding of the costs and benefits of CPR systems (as discussed
earlier in this chapter) and some sharing of CPR costs will be needed. Cost
sharing would encourage health providers to invest in CPR systems and thus
move the nation toward an optimal level of CPR system use. Further, the
existence of cost-sharing mechanisms would send a signal to CPR developers
regarding the strength of the CPR market and should increase the willingness of
developers to invest in additional R&D.
The costs associated with CPR systems go beyond one-time procurement
expenses, entailing expenditures for installation, training, maintenance, and
other activities that must be planned for and appropriately budgeted. The
committee therefore suggests that reimbursement mechanisms address three
kinds of CPR system costs for all health care providers: (1) costs associated
with procurement or leasing, (2) costs associated with installation and
implementation (including training), and (3) costs associated with operation and
maintenance.
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The CPRI should take the lead in coordinating efforts to develop and
implement reimbursement mechanisms that incorporate the costs of CPR
systems. This process, which will require collaboration with representatives of
practitioners, health care provider institutions, business, third-party payers,
Congress, and federal and state government agencies (especially HCFA), could
explore several CPR reimbursement mechanisms: incentives for data that are
provided in electronic form, enhanced capital pass-through for CPR system
acquisition, recognition of the costs of CPR operation in reimbursement rates,
or a combination of the above. The committee urges organizations concerned
with developing reimbursement levels or schedules (e.g., the Health Insurance
Association of America, the Physician Payment Review Commission, the
Prospective Payment Assessment Commission, and individual third-party
payers) to make the establishment of acceptable CPR reimbursement
mechanisms a high priority in the early 1990s.
CPR systems will greatly facilitate the creation of secondary databases for
claims payment, health care policy, and clinical research by eliminating the
need for manual data abstraction from records. In some cases, these databases
can be constructed at a cost lower than that associated with current patient
record systems; in other cases, desirable databases simply would not have been
possible with current record systems. (The ability to select, retrieve, and
aggregate desired data from CPRs will be of particular benefit to researchers.)
Thus, users of such secondary databases should support the costs of data
capture, processing, storage, and retrieval by CPR systems. The CPRI should
develop an equitable plan to divide some of the costs of CPR systems that
contribute to secondary databases among all such database users.
RECOMMENDATION 7. The committee recommends that health
care professional schools and organizations enhance their educational
programs for students and practitioners in the use of computers, CPRs,
and CPR systems for patient care, education, and research.
An essential requirement for optimal functioning of CPR systems is
efficient user operation of computers, CPRs, and CPR systems, including
associated decision support, bibliographic retrieval, and other clinical aids.
Because students and practitioners alike have educational needs in these areas,
health care professional schools, programs, societies, and organizations all have
a role to play in CPR education.
Such training will require curriculum modification, development of
continuing postgraduate education programs, and preparation of faculty. In
addition to formal training, professional schools, programs, societies, and
organizations can reinforce computer skills by using computers to conduct
routine business. (For example, professional societies could administer
licensing examinations by computer.) The CPRI should facilitate this evolution
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196
of standards for CPR data and security, review of legal constraints and
remedies, distribution of costs for CPR systems, and education of health care
professionals.
The committee recognizes that considerable work must be accomplished
and practical difficulties resolved before CPRs become the standard mode of
documenting and communicating patient information and before they are
perceived and used as a vital resource for improving patient care. The challenge
of coordinating CPR development efforts in the pluralistic health care
environment is great. Resources are limited and must be used wisely. Further,
achieving maximum benefit from CPR systems will require that they be linked
to an information infrastructure (i.e., network) that allows patient data, medical
knowledge, and other information to be transmitted and accessed when and
where needed, subject to appropriate security and confidentiality measures.
The committee is convinced that with proper coordination and appropriate
resources the goal of widespread CPR utilization within a decade can be
achieved. The desire to improve the quality of and access to patient data is
shared by patients, practitioners, administrators, third-party payers, researchers,
and policymakers across the nation. CPRs and CPR systems can respond
effectively to the health care system's need for a ''central nervous system" to
manage the complexities of modern medicine. The CPR, in short, is an essential
technology for health care.
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APPENDIX A
197
Appendix A
Subcommittees
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APPENDIX A
198
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APPENDIX A
199
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APPENDIX B
200
Appendix B
Legal Aspects of Computer-based Patient
Records and Record Systems
Adele A. Waller
Computer-based patient records and record systems may bring into play
laws of many kinds. For example, system hardware may be patented and system
software copyrighted. If a computer-based patient record system fails and the
failure results in harm to a patient, tort liability can result to the vendor or to the
provider using the system, or to both. Tort liability can also arise if a system is
not protected from unauthorized access and breaches of patient confidence
result or records are destroyed or altered. A computer hacker gaining
unauthorized access to a computerized patient record system faces possible
criminal liability. Various privacy laws limit permitted disclosure or
redisclosure of information stored in computer-based patient record systems.
Other laws must also be taken into account. Licensure laws applicable to
health care providers, as well as reimbursement and insurance laws, all impinge
on computer-based patient records, as do public health laws that require
reporting of vital statistics and of various injuries and diseases. Contract law
and the Uniform Commercial Code come into play in contracts for computerbased record systems. The availability of specific performance as a remedy for
a vendor's breach of contract is a question that
The author is an attorney in the Health Law Department of the law firm of Gardner,
Carton & Douglas, in Chicago. She gratefully acknowledges the assistance of her
colleagues Deborah K. Fulton and Bernadette M. Broccolo with the computer science
and computer law aspects of this paper.
Copyright National Academy of Sciences. All rights reserved.
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APPENDIX B
201
1 State licensure requirements have lagged far behind the development of technology
and have been criticized for so lagging for 20 years or more. See, e.g., Eric W. Springer,
Automated Medical Records and the Law (Pittsburgh, Pa.: Health Law Center, 1971).
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APPENDIX B
202
2 410 Ind. Admin. Code 15-1-9(1) (1988); Mo. Code of State Regulations, 19 C.S.R.
30-20-.021(3)(D) (1990); Oreg. Admin. Rule 333-505-050 (1989); Neb. Regulations
and Standards for Hospitals 003.04 (1979); Pa. Rules and Regulations for Hospitals
115.25 (1987). In the regulations of these states, however, there is little reflection of
any systematic examination of the special problems and challenges posed by automated
patient records. Even Oregon, which of all the states has most systematically amended its
regulations to be consistent with automated records systems, has done little more than
adapt regulations from the era of paper records to permit automated patient records.
3 22 Calif. Admin. Code 70751; Conn. Pub. Health Code, ch. 4, 19-13-03(d); 77 Ill.
Admin. Code 250.1510 (1990); Lic. Stds. for Hospitals, N.J.A.C. 8:43G:-15.2; R.I.
Rules and Regulations for Licensing of Hospitals 25.0 (1989); S.D. Admin. Rules
44:04:09:04 (1989); Tex. Hospital Licensing Stds. 1-22-1.4 (1985); Utah Admin.
Code R432-100-7.405 (1989); Rules and Regulations for the Lic. of Hospitals in
Virginia 208.0 (1982); Wisc. Admin. Code, ch. HSS 124 Hospitals, 124.14 (1988).
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APPENDIX B
203
patient records used by hospitals under a cloud.4 Other state laws and
regulations appear to permit some forms of automation but not others, or the use
of automation for some but not all medical record functions.5
Oklahoma requires that all orders and medications be written in ink, a
requirement that is incompatible with a fully automated medical record system.
Oklahoma also prohibits substituting a signature stamp for the physician's
signature, apparently requiring handwritten authentication of medical records,
with the exception of records of diagnostic examinations, for which computer
signatures are authorized.6 South Carolina also requires orders to be "written in
ink and signed," but permits use of a signature stamp with appropriate controls.7
Iowa requires medical records to be "written" and "signed" by the attending
physician.8 North Carolina requires that records be "written'' for all patients
admitted to a hospital.9 If a medical record must be signed in ink, the paper
recordeven if it is generated on a computerbecomes the original record,
and many of the efficiencies of automated storage and retrieval of records
cannot be realized. Other states restrict permissible medical record storage
media to the original or microfilm. 10 Such a restriction is incompatible with
storage of records on
4 See, e.g., the rules of states that, as of the time research was completed for this paper,
still required that clinical reports or clinical information be filed in or with the medical
record or that records of both inpatient and outpatient treatment be filed in one folder:
Ariz. Rules, Regulations and Standards for the Licensing and Regulation of Health Care
Institutions R9-10-221 (1982); Rules, Regulations and Min. Stds. for Hospitals in
Idaho, IDAPA 16.02.1360.10.a; Regulations for the Licensure of General and Specialty
Hospitals in the State of Maine, ch. XII (1972); Min. Stds. for Operation of Miss.
Hospitals 1704.4 (1990); N.Mex. Regulations Governing General and Special Hospitals
700.B.4.f (1989); Lic. Rules for General Hospitals in North Dakota, N.D.A.C.
33-07-01-16.6.a (1990); Lic. Stds. for Hospitals and Related Institutions in the State of
Oklahoma 13.5-A (1989); 64 W. Va. Legisl. Rules 10.3 (1987); Wisc. Admin. Code,
ch. HSS 124 Hospitals, 124.14 (1988).
5 See, e.g., Mo. Code of State Regulations, 19 C.S.R. 30-20.021(3)(D) (1990); Utah
Admin. Code R432-100-7.406 (1989); Hospital Rules and Regulations, Wash. Admin.
Code. 248-18-440 (1989).
6 Licensure Standards for Hospitals and Related Institutions, State of Oklahoma 13.1B(4) and 13.9-D (1989).
7 S.C. Standards for Licensing Hospitals and Institutional General Infirmaries 601.6
(1990).
8 Iowa Admin. Code 641.51.5 (1988).
9 Rules and Statutes Applying to the Licensing of Hospitals in North Carolina,
Subchapter 3c, .1400 (1988). See also 77 III. Admin. Code 250.350(a), which
requires that all orders for medication and treatment be written except in emergencies.
On the basis of this requirement, the Illinois Department of Public Health strongly
discourages fully computerized medical records in hospitals.
10 See, e.g., Colo. General Hospitals, ch. IV, 4.2 (1982); Conn. Pub. Health Code, ch.
4, 19-13-03(d) (1989); 410 Ind. Admin. Code 15-1-9(2)(b)(1) (1988); Regulations for
the Licensure
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APPENDIX B
204
computer disks, magnetic tape, or optical disksthat is, unless the records were
both originally created and authenticated by computer and are permanently
retained on the original medium (which may be difficult or infeasible,
depending on the medium's durability).
A serious legal barrier to full realization of the potential of computer-based
patient records is the confusion and lack of clarity in some states' standards
when they are applied to computer-based medical records.
It is not always clear whether regulations requiring that records be kept in
ink or "type" (or in ink or "typewritten") permit creation of medical records
electronically or with the use of lasers, although a provision permitting
authentication of records by computer key, such as that found in Colorado's
rules, implies that patient records may be created on a computer.11 Similarly, it
is unclear whether a requirement that medical records be recorded in ink,
typewritten, or recorded electronically permits recording by lasers on optical
disks.12
The regulations of some states require that medical records be "signed" but
are silent on whether the substitution of a computer key or code for a
physician's signature is permitted.13 This silence cannot be interpreted as
of General and Specialty Hospitals in the State of Maine, ch. XII (1972); Min. Stds.
for Operation of Miss. Hospitals 1702 (1990); Mo. Code of State Regulations, 19
C.S.R. 30-20.021(3)(D) (1990); Operational Rules and Regulations for Health
Facilities, Nev. Admin. Code 449.379 (1988); N.Mex. Regulations Governing General
and Special Hospitals 700.B.1.b (1989); S.C. Standards for Licensing Hospitals and
Institutional General Infirmaries 601.6 (1990); Tenn. Hospitals Rules and Regulations
1200-8-4-.03(f) (1986); Wisc. Admin. Code, ch. HSS 124 Hospitals, 124.14 (1988).
Tennessee has recently amended its statute to permit storage of medical records on "nonerasable optical and electronic imaging technology." See Tenn. Code Ann. 68-11-306
(b) (1991).
11 See, e.g., Rules of Alabama State Bd. of Hlth., Div. of Lic. and Cert., Hospitals,
420-5-7.07(f) (1988); Rules and Regulations for Hospitals and Related Institutions in
Arkansas 0601(C) (1988); Colo. General Hospitals, ch.IV, 4.4 (1982); Tenn. Hospitals
Rules and Regulations 1200-8-4-.03 (1986); Vermont Lic. Stds. for the Construction,
Maintenance and Operations of Hospitals 3-946 (1954); 64 W. Va. Legisl. Rules 10.3
(1987).
12 Mo. Code of State Regulations, 19 C.S.R. 30-20.021(3)(D) (1990).
13 See, e.g., Ariz. Rules, Regulations and Standards for the Lic. and Regulation of
Health Care Institutions R9-10-221 (1982); Conn. Pub. Health Code, ch. 4, 19-13-03
(d) (1989); Ga. Rules and Regulations for Hospitals 290-5-6-.11 (1977); Rules,
Regulations and Min. Stds. for Hospitals in Idaho, IDAPA 16.02.1360.13; Iowa Admin.
Code 641.51.5 (1988); Ky. 902 KAR 20:016 (1989); Min. Stds. for Operation of Miss.
Hospitals 1704.4 (1990); Nev. Operational Rules and Regulations for Health Facilities
449.379; N.Mex. Regulations Governing General and Special Hospitals 700; Lic.
Rules for General Hospitals in North Dakota, N.D.A.C. 33-07-01-16.9 (1990); Lic.
Stds. for Hospitals and Related Institutions in the State of Oklahoma 13.5-A (1989);
S.C. Standards for Licensing Hospitals and Institutional General Infirmaries 601
(1990); Tenn. Hospitals Rules and Regulations 1200-8-4-.03 (1986); Vermont Lic.
Stds. for the Construction, Maintenance and Operations of Hospitals 3-946 (1954); 64
W. Va. Legisl. Rules 10.3 (1987); Wisc. Admin. Code, ch. HSS 124 Hospitals, 124.14
(1988); Wy. Stds., Rules and Regulations for Hospitals and Related Facilities 7 (1979).
Copyright National Academy of Sciences. All rights reserved.
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APPENDIX B
205
14
See, e.g., N.J. Lic. Stds. for Hospitals, N.J.A.C. 8:43G-15.2(d)(1) (1990).
Rules and Regulations for Hospitals and Related Institutions in Arkansas 0601(V)
(1988); Conn. Pub. Health Code, ch. 4, 19-13-03(d)(6) (1989); 410 Ind. Admin. Code
15-1-9(2) (1988); Iowa Admin. Code 641.51.5(1) (1988); Ky. 902 K.A.R. 20:016
(1989); Regulations for the Licensure of General and Specialty Hospitals in the State of
Maine, ch. XII (1972); Min. Stds. for Operation of Miss. Hospitals 1701.4 (1990); N.J.
Lic. Stds. for Hospitals, N.J.A.C. 8:43G-15.2(h) (1990); N.Mex. Regulations Governing
General and Special Hospitals 700.B.1.b (1989); Rules and Statutes Applying to the
Licensing of Hospitals in North Carolina, Subchapter 3c, .1403(d) (1988); Licensure
Standards for Hospitals and Related Institutions, State of Oklahoma 13.2-C (1989); Pa.
Rules and Regulations for Hospitals 115.28 (1987); S.C. Standards for Licensing
Hospitals and Institutional General Infirmaries 601.4 (1990); Tenn. Hospitals Rules and
Regulations 1200-8-4-.03(b)(1) (1986); 64 W. Va. Legisl. Rules 10.3.1(a) (1987);
Wisc. Admin. Code, ch. HSS 124 Hospitals, 124.14(2) (1988).
16 410 Ind. Admin. Code 15-1-9 (1988).
15
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APPENDIX B
206
even more than hospital licensure laws and regulations, they may be keyed to a
paper record.
For example, Illinois' long-term care facility licensure regulations require
that (1) resident records be written in ink or typed and (2) all physician orders,
plans of treatment, Medicare and Medicaid certifications and recertification
statements, and similar documents have the original written signature of the
physician. Use of a rubber stamp signature, with or without initials, is not
permitted. In addition, resident records must contain a "physician's order sheet,"
a "medication sheet," and "treatment sheets," implying that a manual record
must be maintained.17
State licensure requirements for nonhospital institutional providers exhibit
the same lack of national uniformity in standards for patient records exhibited
by state hospital licensure requirements. In addition, similar concerns regarding
obsolete and ambiguous laws and regulations arise in state licensure
requirements for institutional providers other than hospitals.
State laws and regulations applicable to physicians, nurses, and other
individuals licensed to provide health care typically contain an express or
implied obligation of confidentiality with respect to patient confidences and, in
some statutes or regulations, with respect to patient records. Willful or negligent
breaches of confidentiality may constitute grounds for professional discipline.18
The canons of ethics of a profession may be incorporated into a state's
licensure requirements, usually by a provision in a licensing act that makes
"unprofessional conduct" grounds for professional discipline. 19 The 1989
publication Current Opinions of the Council on Ethical and Judicial Affairs of
the American Medical Association contains detailed guidelines on computerized
patient databases.20 These may be impliedly incorporated into the statutes and
regulations governing licensure of physicians in some states.
Medicare Regulations
To participate in the Medicare program, a provider must meet the
applicable Medicare conditions of participation. The conditions of participation
for hospitals include requirements for medical records but do not include
17
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APPENDIX B
207
any express restriction on permissible media for creating and storing medical
records.21 Medical records may be authenticated by signature, written initials, or
computer entry.22 Thus, the conditions of a hospital's participation in the
Medicare program pose no barrier to the use of computer-based patient records.
The Medicare conditions of participation for long-term care facilities do
not expressly restrict the media for creation and storage of the records.23
However, they require each individual who completes a portion of the
assessment to "sign" the assessment.24 In addition, these conditions of
participation require that, at each visit to a resident, the physician supervising
the resident's medical care must "write, sign and date progress notes" and "sign
all orders." 25 It is not clear whether these conditions of participation permit a
fully automated record because it is not clear whether authentication by
computer code or key provides the required signature and whether a progress
note made on a computer fulfills the requirement that a physician must write the
note.26
The Health Care Financing Administration (HCFA) permits physician
certifications of medical necessity to be executed by computer or transmitted to
a hospital by facsimile machines. A provider seeking permission for its
physicians to attest to medical necessity on a computer or by facsimile must be
able to demonstrate to its intermediary that its system contains adequate
safeguards of accuracy and confidentiality and meets certain other standards.27
21
42 C.F.R. 482.24.
C.F.R. 482.24(c)(1)(ii).
23 42 C.F.R. 483.75(n).
24 42 C.F.R. 483.20(c)(2).
25 42 C.F.R. 483.40(b).
26 Apparently, the Health Care Financing Administration (HCFA) believes that these
conditions of participation would permit a fully automated record because HCFA is
discussing with nursing home operators the possibility of requiring that nursing homes
computerize resident assessment records to comply with the provision of the Omnibus
Budget Reconciliation Act of 1987 requiring maintenance of a uniform, minimum data
set on residents' conditions. See Paula Eubanks, "Homes Doubt They Can Computerize
per HCFA's Request," Hospitals 64, no. 23 (1990):56.
27 See the HCFA Medicare Hospital Manual Transmittal No. 567 (July 1989). The
provider's request must explain (1) the provider's physician identification system, (2)
system safeguards to ensure confidentiality, (3) how data are displayed for physician
review before electronic attestation, (4) how physician identity is determined upon
certification and stored in the provider's system, (5) how the system records a systemgenerated date and time of entry at the point of attestation, (6) system backup procedures
for prolonged downtime, and (7) how the physician verifies that attestations executed
through the system have been correctly recorded. HCFA permits use of physician access
systems that employ an alphanumeric identifier or biometric identification of physicians.
22
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APPENDIX B
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28 See, e.g., the following regulations, which incorporate JCAHO standards for
medical records into state hospital licensure requirements: N.H. Code of Admin. Rules,
Part He-P802 (1986); R.I. Rules and Regulations for Licensing of Hospitals 25.7; Rules
and Regs. for the Licensure of Hospitals in Virginia 208.5 (1982).
29 42 U.S.C. 1395bb.
30 Joint Commission on Accreditation of Healthcare Organizations, "Medical Record
Services (MR)," Accreditation Manual for Hospitals (Chicago: 1990).
31 5 U.S.C. 552a.
32 The threats to patient privacy posed by increased use of computers for health
records were detailed by Alan F. Westin in Computers, Health Records and Citizen
Rights (Washington, D.C: U.S. Government Printing Office, 1976).
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APPENDIX B
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from peer review bodies, third-party payers (both governmental and nongovernmental), outside billing and computer services, and government, but
from employers, insurers, and others who use health care information for nonhealth care purposes.
When information from patient records is disclosed by a provider
whether with or without the patient's consentit is extremely difficult to
control redisclosure of the information effectively, even though confidentiality
agreements and notices are still advisable. Furthermore, when patient records
are computerized, they can easily be transmitted across state lines, limiting the
ability of any one state to protect the privacy of its citizens.
To the extent that patients and providers are aware that computer-based
patient records increase the threat to patient privacy, they may be unwilling to
provide or record complete information in the patient record, particularly with
regard to sensitive matters, such as abortions, AIDS (acquired immune
deficiency syndrome), psychiatric problems, and drug or alcohol abuse. Thus,
the lack of adequate, uniform, national protection of patient privacy with
respect to patient records may hinder full development of computer-based
patient record systems.
The Uniform Health-Care Information Act skillfully addresses issues of
confidentiality and release of patient information.33 Only Montana, however,
has enacted this act into law.34
Right of Access to Health Records
Most states expressly allow a patient or a patient's authorized
representative to inspect and copy the patient's hospital records.35 Rights of
access to health records maintained by physicians and other individual health
care providers may not always be clear.
Before records become available, the person seeking access typically must
request such access in writing from the provider and pay reasonable clerical
costs. A few states grant patients the right to review their hospital records only
after discharge.36
Many states permit providers to refuse to grant a patient's request for
disclosure where psychiatric records are involved and where release of the
information would be detrimental to the patient's mental health or general
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APPENDIX B
210
37 See, e.g., Fla. Stat. Ann. 395.017(1); Okla. Stat. Ann., ch. 76, 19A; Cal. Health &
Safety Code Ann. 1795.14(b); Colo. Rev. Stat. 25-1-801; Hawaii Rev. Stat. Ann.
622-57; Maine Rev. Stat. Ann. 1711; Minn. Stat. Ann. 144.335.
38 See, e.g., Cal. Health & Safety Code Ann. 1795.12(c) and (e).
39 See, e.g., Cal. Health & Safety Code Ann. 1795.20(a); Minn. Stat. Ann 144.335.
40 See, e.g., Cannell v. Medical and Surgical Clinic, 21 Ill. App. 3d 383, 315 N.E. 2d
278 (1974); Matter of Weiss, 208 Misc. 1010, 147 N.Y.S. 2d 455 (N.Y. Spec. Term.
1955); Hutchins v. Texas Rehab. Comm., 544 S.W. 2d 802 (Tex. Civ. Ct. App. 1976).
41 9 Uniform Laws Ann., Part 1 (West 1988), p. 475.
42 M.C.A. 50-16-501, et seq.
43 The NAIC model act is a good beginning but does not go far enough in protecting
individuals whose health records are disclosed to insurance companies. One Kansas
court, for example, found that transmission of health information concerning the plaintiff
to the Medical Information Bureau did not invade the plaintiff's privacy (Senogles v.
Security Benefit Life Insurance Co., 217 Kan. 438, 536 P. 2d 1358 [1975]). The Medical
Information Bureau is a nonprofit association formed to conduct a confidential exchange
of information between its more than 700 insurance company members, which pool
information on underwriting decisions and the health status of individual insureds.
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APPENDIX B
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47 See, e.g., Rule 801(c), Federal Rules of Evidence, and Rule 801(c), Uniform Rules
of Evidence.
48 See, e.g., Rule 802, Federal Rules of Evidence, and Rule 802, Uniform Rules of
Evidence.
49 See, e.g., Rule 803(6), Federal Rules of Evidence, and Rule 803(6), Uniform Rules
of Evidence.
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50 Rule 803(4), Federal Rules of Evidence. This exception to the hearsay rule is known
as the medical records exception.
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51
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APPENDIX B
215
record systems an even more tempting target than paper records. As the medical
information included in patient records becomes more sophisticated (e.g.,
genetic information), this temptation will only increase.
Mass disclosure of patient information could result in catastrophic liability
for a provider; it could also result in licensure sanctions or statutory penalties.
Theories under which providers may be held liable for breaches of
confidentiality include both statutory and common-law theories. Common-law
theories under which providers may be held liable for breaches of
confidentiality include invasion of privacy, betrayal of professional secrets,
breach of contract, slander, and negligent or intentional infliction of emotional
distress. Statutes such as the federal statute concerning confidentiality of drug
and alcohol abuse patient records provide penalties for breaches.
Security mechanisms and procedures can provide some level of protection
to computer-based patient records against unauthorized access by users both
inside and outside a provider organization. Yet even the most sophisticated
security measures will not provide fail-safe protection of patient records,
particularly in decentralized systems. In fact, one of the biggest threats to the
security of computer-based patient records comes from the trend toward
networked systems. Security measures that are both adequate and affordable
and that do not interfere with efficient patient care currently do not exist for
such systems.
A computer-based patient record system should include a security system
that, as far as is practicable, permits only authorized users to access patient
records and permits authorized users to access only those portions of the records
that are relevant to their particular functions. The system should also ensure that
access to each record is tracked by the system and monitored as a deterrent to
unauthorized review of records. Access to sensitive records or portions of
records should be sharply limited; this kind of access should also be tracked by
the system and carefully monitored by the provider. Such records include HIVantibody test results, records of drug and alcohol abuse patients, psychiatric
records, and records of celebrity patients. With AIDS patients, the main and
more easily accessible portion of the record can include a notation to use body
fluid precautions without identifying the patient as having AIDS, hepatitis, or
some other disease transmissible by body fluids. HIV-antibody test results can
either be omitted from the automated system or stored in a restricted portion of
the record. To the extent that sensitive records are not stored on the system,
however, the advantages of a totally automated system cannot be realized.
A provider with a computer-based patient record system that uses
passwords, access codes, and key cards should have and strictly enforce policies
against disclosing or sharing such means of access. Alternatively, a provider
could use a system that identifies users biometrically through voice-prints,
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APPENDIX B
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APPENDIX B
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APPENDIX B
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In addition to its potential for hindering patient care, which may result in
negligence liability, excessive patient record system downtime may also create
regulatory violations or JCAHO accreditation deficiencies. The following
precautions can help protect against inaccessibility of computer-based patient
records:
1.
2.
3.
4.
5.
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APPENDIX B
219
Accuracy Issues
Errors in computer-based patient records can result from faulty software or
equipment or from human error. A patient record system should be free from
significant errors in computer hardware and software. Laboratory equipment
and other machines providing input to a computer-based patient record system
should also be free from such errors.
Mechanisms for minimizing human error, such as reviews of input for
accuracy, are also advisable. When corrections are made, they should be logged
on the system as suggested in the previous section concerning evidentiary
issues. If clinical observations are recorded using bar coding or other
programmed codes, there should be a mechanism in place for visual
confirmation or other verification of the codes entered into the computer.
Selected Legal Issues in Computer Contracting
Leases and acquisitions of computers may involve some or all of the
following: hardware, operating, and application software licenses; installation,
testing, and implementation services; and postinstallation maintenance and
support services for both operating and application software and equipment.
Use of multiple agreements to address these interrelated components of
computer system acquisitions creates the risk of conflict among the agreements
and may confuse even more the issues of what law applies to these agreements.
Unless multiple agreements cannot be avoided (e.g., different vendors for the
hardware/operating software and application software), a single agreement is
preferable.
Because of the hybrid nature of contracts for computer systems, it is not
always clear what law governs issues of contract interpretation, the rights of the
parties, procedures for resolving disputes, and so forth. If a court characterizes a
transaction as a sale of goods, the Uniform Commercial Code will apply.
However, computer system acquisitions involve both goods and services and
often involve licenses rather than sales of software (to which the Uniform
Commercial Code may or may not apply).
An inaccurate product definition in a contract for a computer-based patient
record system or a product definition that is not sufficiently detailed can result
in delivery of a system that does not function properly as a patient record
system or in a contract that does not require the vendor to deliver a system that
has certain important features or the capability to perform crucial patient record
functions.
It is common for system vendors to "puff" the capabilities of their products
in their marketing materials and in their proposals to health care providers or to
promise software or features that are still on the vendor's drawing board.
Although some contracting strategies help to minimize
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APPENDIX B
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APPENDIX B
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APPENDIX B
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APPENDIX B
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INDEX
225
Index
A
Academic research, 8, 112, 114, 150, 159
Access issues, 62, 67, 74, 80, 81-83, 136,
179, 181
computer technology and, 4, 68, 101
insurers, 80, 209, 210
knowledge resources, 7
legal right to, 14, 83, 209-210, 214-216,
217-218
patient records, 6-7, 63
software source code, 220
system redundancy, fault tolerance, 118,
119
system response, 83, 106, 120, 126,
145-146, 220
see also Confidentiality
Accreditation, 65, 75, 77, 110, 149, 160,
168-169, 208, 214, 217, 218
Accredited Standards Committee, 13
Accuracy issues, 95, 110, 127, 207, 219
see also Errors and error analysis
Acute disorders and care, 66, 123-124, 131
Administrative functions, 46, 47, 51, 65, 89,
93, 95, 121, 181, 195
access to, 7, 21-22
billing, 64, 78, 106, 120
costs, 46, 51, 68, 98, 193
standards, 13
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INDEX
226
C
Case studies
hospital information systems, 119-120
maternal and child health care, 173-175
Centers for Disease Control, 155-156, 185
Change agents, 151-161, 163, 166,
168-169, 183, 184
Chart Checker, 123-124
Chronic diseases, general, 46, 64, 66
Clinical practice guidelines, 2, 9, 51, 67, 98,
164, 181, 190
Clinical processes and systems, 47, 48, 56,
66-67, 85, 100-101, 121-126
decision support/problem solving, 7, 51,
53, 55, 61-62, 63-64, 68-69, 74, 81,
84, 90-93, 95, 105, 112, 117,
124-125, 136, 149, 181, 223
department-level information systems,
112, 113, 136
historical perspectives, 111-113
knowledge-based system, 74, 88, 92, 95,
105, 110, 119, 124-125, 181
laboratory tests, 64, 116, 123
linkages, 6, 88
Classification, see Standards: data exchange
and vocabulary
Coding standards for data elements, 13-14,
25, 39
Common Object Request Broker Architecture, 31
Composite Health Care System, 121
Computer-based Patient Record Institute,
10, 14, 50, 167, 168, 177 , 182,
183-185, 187, 188, 189, 191-195
Davies CPR Recognition Program, 8, 16
Computer-Stored Ambulatory System
Record Systems (COSTAR), 112,
115-117
Computers at Risk: Safe Computing in the
Information Age, 189
Confidentiality, 46, 47, 48, 67, 82, 80,
86-87, 95, 147-148, 153, 169, 181,
188, 192, 200, 207, 208-209,
214-216, 221-222
contract provisions, 221
design for, 14-15, 40, 139
European systems, 37-38
future systems, 94
individual practitioners' patient records,
57, 67
insurer access and, 80, 209, 210
Internet and, 4
pharmacy records, 57
privacy defined, 67
secondary databases, 110
standards, 13, 40, 131, 188
state law, 147-148, 208-209
technological aspects, 110, 126, 127-129
Communications infrastructure, 7-8
see also Networks;
Telecommunications
Connectivity, see Linkage and integration
Content issues, 59, 60-61, 80
definition of, 163, 183
outpatient records, 63
standards, 63, 140, 187
tables of, in computerized records, 82
Contracts, 200-201, 219-221
Coordination, see Organizational factors
Coordination and Continuity in Health Care
(CoCo) project, 32, 33-34
COSTAR, 112, 115-117
Cost factors, 46, 49, 53, 58, 66, 68, 89, 93,
153, 154, 158, 161, 169-170, 178,
179, 181, 182, 186, 189-190
administrative, 46, 51, 68, 98, 193
clerical, 123, 141
computing technology, 7, 15-16, 69-70,
105-106, 112, 126, 127, 136 , 137,
141, 146
containment issues, 1-2, 15-16, 26, 35
data entry, 7, 84, 89, 126
demonstration projects, 157
design and development aspects, 15, 139,
140-142, 164
diffusion of technology, 145-146
hospital systems, 53, 63, 64, 137, 141
insurers, 65-66, 145, 154, 194
malpractice insurance, 124
maternal and child health care program, 156
medical information systems, 141, 146
per patient, 53, 145
secondary databases, 50, 110, 177, 193
sharing, 50, 51, 165-168, 177, 183,
193-194, 196
standards, 146
technological innovations, general, 69-70,
105-106, 112, 126, 127, 136, 137,
141, 146
voice recognition, 127
Council on Ethical and Judicial Affairs of
the American Medical Association , 206
Court cases, see Litigation
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INDEX
227
D
Database management systems, 101,
103-104, 179
specific, 111-125
Databases, 50, 101-103, 148, 150, 179
AMA guidelines, 206
bibliographic, 47, 69, 74, 92-93, 95, 119,
124, 181
federal role, 67
linkage of, 49, 69, 88, 89, 95, 105,
106-107, 110-111, 124;
see also Networks
prescription drug, 36-37
problem-oriented medical record, 91
query languages, 106, 117
secondary, 49, 50, 55-56, 69, 74, 95,
77-78, 98, 110-111, 124, 161 , 163,
177, 179, 181, 182, 183, 191-193
specific, 111-125
see also Knowledge-based systems
Data entry, 117-118, 122, 125-126, 136,
137, 186
approaches, 29-32
cost factors, 84, 89, 126
errors, 84, 89, 105
physician orders, 2, 7, 25, 29-32, 126,
145, 168, 186
transcription, 25
voice recognition, 29, 106, 126-127, 131,
179, 186
Data quality, 84-86
Data retrieval, 47, 48, 53, 105-106, 111,
179, 181
Data storage, general, 81-90, 111
Decentralized Hospital Computer Program,
120-121
Decision support and problem solving, 51,
53, 55, 61-62, 63-64, 68 -69, 74, 81,
84, 90-93, 95, 105, 112, 117,
124-125, 136, 149, 181, 223
alerts, 8
knowledge-based systems, 12, 14, 74, 88,
92, 95, 105, 110, 119, 124 -125, 181
status in U.S., 8, 12, 14
Defense Advanced Research Projects
Agency (DARPA), 150
Definitional issues, 55-56, 90, 95, 163, 183
change agents versus stakeholders, 151, 184
computer-based patient record, 9, 10-11,
13, 55, 95, 135-136, 139
contract law, 219
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INDEX
228
F
Federal government, 50, 65, 66-67,
120-121, 155-158, 161, 164-168,
173-175, 184-185
Computer-based Patient Record Institute,
8, 10, 14, 50, 167, 168, 177, 182,
183-185, 187, 188, 189, 191-195
cooperation with public sector, 131,
165-168, 182, 184, 185
funding, 50, 155, 164-168, 184-185
interagency coordination, general, 175,
184, 185
national information system, 9-10, 50,
95-98, 166-168, 169, 173, 174, 177,
182-185, 189
organizational role, general, 66-67, 175,
184, 185
research, 67, 155, 164-165, 174, 175
standards, 66, 67, 129-131, 155, 161
see also Laws, specific federal
Federal Networking Council, 150, 189
Federal Privacy Act, 208
Financial factors, 46, 49, 51, 65, 82, 98,
119-120
federal role, 65, 66-67
see also Billing;
Cost factors;
Funding;
Insurance and insurers, health
Flexibility, 87, 113, 137, 179, 181
Flow sheets, 61
Food and Drug Administration, 148-149,
185, 189
Format issues, records, 59, 61-62, 80,
90-91, 115
European, 38-39
outpatient records, 63
problem-oriented, 61-62, 90-91, 93, 115,
117, 124
standards, 12-14, 23, 38-39, 63, 140, 186,
191
tables of contents/indexes, 82
Foundations, 161, 163, 185, 189
Framework Programs on Research and
Development of the European Union ,
21, 23
France, 29, 36
Funding, 49, 50, 143, 155, 161, 165, 174,
177, 179, 182, 184-185
federal, 50, 155, 164-168, 184-185
hospital systems, 141
standards development, 129
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INDEX
229
G
General Accounting Office, 52-53, 141,
167-168
General practitioners, 23-26, 33
Germany, 34
Government role, see Federal government;
State governments;
and specific departments and agencies
Graphics, 32, 47, 93, 95, 104, 105-106,
150, 179
picture archiving and communication system, 27
windowing, 117, 137
see also Images and image processing
Group practices, 114-115
194
H
Harvard Community Health Plan, 112,
115-117
Harvard Medical School, 119
HEALTH, 155
Health Care Financing Administration, 65,
129-130, 131, 156-157, 164-165,
166, 175, 185, 207
Health care system, structure of, 1-5, 22, 26,
142-143, 179
Health Evaluation through Logical Processing (HELP), 112, 118-119, 125, 127
Health maintenance organizations, 115-117
Health Plan Employer Data and Information
Set (HEDIS), 3
Health Resources and Services Administration, 156, 173-174, 175, 185
Hearsay, evidence, 212-214
High-Performance Computing Act, 150
High-Performance Computing and Communications contracts, 9
Historical perspectives, 48, 52, 56-57,
111-113
committee study, 53-55
COSTAR, 112, 115-117
hospital systems, 111, 141
networks, 150
THERESA, 112, 117-118
HL 51 standards, 108
Hospital systems, 82, 89, 111, 117-121, 136
costs, 53, 63, 64, 137, 141
defined, 56
department-level information systems,
112, 113, 136
European, 26-32
historical perspectives, 111, 141
licensure laws, 147, 201-205, 217
15-16
Integrated Services Digital Network, 109
Intellectual property, 220
Intelligence, 49, 80, 81
artificial intelligence, 201, 223
see also Knowledge-based systems
Intermountain Health Care Corporation, 118
International Classification for Primary
Care, 25
International programs and activities, 21-40,
122-123, 139, 187-188
Internet, 4, 12, 150
see also World Wide Web
Intranet, 5
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INDEX
230
J
Joint Commission on Accreditation of
Healthcare Organizations, 65, 160,
165, 208, 214, 217, 218
K
Knowledge-based systems, 28, 31-32, 74,
88, 92, 95, 105, 110, 119, 124-125, 181
Knowledge resources, access to, 7
L
Laboratory tests, 64, 116, 123
Laws, specific federal
Federal Privacy Act, 208
High-Performance Computing Act, 150
Insurance Portability and Accountability
Act of 1996, 13, 14
Omnibus Budget Reconciliation Act,
66-67, 157
Social Security Act, 173, 174
Uniform Health-Care Information Act,
192, 210, 222
Leadership issues, 8, 14, 16-17
Legacy systems, 27, 31
Legal issues, 49, 142, 147-149, 161, 182,
183, 192-193, 200-223
contracts, 200-201, 219-221
evidentiary, 211-214
licensure laws, 147, 192, 200, 201-206,
220, 221-222
information access, right to, 83, 209-210,
214-216, 217-218;
see also Confidentiality
intellectual property, 14, 220
malpractice, 124, 144
ownership of data, 14, 147, 192, 211, 220
systems defect liability, 149, 200
vendors, 149, 200-201, 202, 219-221
viruses, computer, 217, 222
see also Laws, specific federal;
Litigation;
Regulations
Legislation, 90
model, 50, 192-193, 210, 221-222
see also Laws, specific federal
Licensure laws, 147, 192, 200, 201-206, 220
national, 221-222
Linkage and integration, 47, 62, 80, 87-89,
95, 181
16
Malpractice, 124, 144
Managed care, 2, 7, 26
Management of care, general, 65, 78, 93, 94;
see also Administrative functions
Maternal and child health care program,
156, 173-175
Medicaid, 157, 174, 206
Medical information systems, 111
access to, 7
costs, 141, 146
defined, 56
Medical Logic Modules, 124-125
The Medical Record (TMR), 114-115
Medicare, 156-157, 158, 165
peer review, 65, 157
regulations, 206-208, 214, 217
Medix, standards, 108
MEDLARS, 155
MEDLINE, 124, 155
MILNET, 150
Modular design, 116, 120-121, 124-125
Multimedia records, 11
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INDEX
231
N
National Aeronautics and Space Administration, 150
National Association of Insurance Commissioners, 210
National Committee for Quality Assurance, 3
National Committee on Vital and Health
Statistics, 14
National Conference of Commissioners on
Uniform State Laws, 148
National Electrical Manufacturers Association, 108
National Institute of Standards and Testing,
10
National Institutes of Health, 53, 155
National Library of Medicine, 9, 13, 124,
155, 160, 166
National Research and Education Network,
150-151, 189
National Research Council, 54
National Science Foundation, 150
Natural language processing, 29-31
Netherlands, The, 23-24, 26, 29, 36, 37
Networks, 5, 49, 51, 68, 95, 109, 150, 186,
189
design for, 139
diffusion of innovations, 142, 149-151
electronic mail, 47, 119, 150, 189
European, 22-23, 26-27, 32
national information systems, 9, 50,
95-98, 150-151, 163, 166-168, 169,
173, 174, 177, 182-185, 189
security, 4, 88, 96, 148, 216
for shared care, 32-34, 38
standards, data exchange and vocabulary,
5, 9, 12-14, 27, 39, 48, 50, 51, 85-86,
96, 106, 107-109, 116, 126, 127,
129-131, 140, 149-151, 155, 163,
168, 169, 174, 175, 177, 179, 181,
183, 186-188, 191-192, 196
Nurses, chart writing, time spent, 63
O
Office of Technology Assessment, 141
Omnibus Budget Reconciliation Act, 66-67,
157
ORCA, 28
Organizational factors, 49-50, 51, 52,
162-168, 176, 179-180, 182-183
accreditation, 65, 75, 77, 110, 149, 160,
168-169, 208, 214, 217, 218
168-169
see also Administrative functions;
Format issues, records;
Linkage and integration;
Management of care, general
Outcomes reporting requirements, 3
Outpatient records, 63, 112, 141
COSTAR, 112, 115-117
summary time-oriented record, 62
Ownership issues, 147, 192, 211, 220
P
PaperChase, 119
Paper records, 57-63, 81, 84, 90, 178
Patient record, general, 56-57
defined, 55, 95, 135-136, 139
paper, 57-63, 81, 84, 90, 178
patient-derived information, 11
transcription, 25
users and uses, 29, 34-35, 75-78
Patients, general, 153-154
access to information, legal right, 83,
209-210, 214-216, 217-218
cost per, 53, 145
as data users, 65, 83
education, 75, 83
see also Confidentiality
Peer review, 65, 157
personal computers, 123, 124
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INDEX
232
186
personal computer system, England, 123
time factors, 63, 83
Physicians' Desk Reference, 119
Policy development, 77, 79, 82
politics, 46, 48-49, 195
public opinion, 153, 195
Population-based care, 26
Population dynamics, see Demographic factors
Poverty, 156
maternal and child health care, 156,
173-175
Medicaid, 157, 174, 206
Primary care, CPR in, 2, 23-26
Primary patient record, general, 77, 78
defined, 55
Privacy, see Confidentiality
Private sector, 50, 79, 129, 165-166, 168,
177
cooperation with public sector, 50, 131
165-168, 177, 182, 184, 185
employers, 154-155
foundations, 161, 163, 185, 189
information system vendors, 100,
135-137, 149, 160-161, 162, 169,
185, 200-201, 202, 219-221
see also Insurance and insurers, health;
Professional associations and societies
Problem-knowledge coupler, 124
Problem-oriented medical record (POMR),
61-62, 90-91, 93, 115, 117 , 124
Problem solving, see Decision support and
problem solving
Productivity
health professionals, 46, 68, 94, 193
insurers and, 154
Professional associations and societies, 50,
65, 143, 153, 168, 179 -181, 194, 210
AMA, 67, 206
JCAHO, 65, 160, 165, 208, 214, 217, 218
176-196
Redundancy, fault tolerance, 118, 119
Registered Record Administrators (RRAs),
195
Regulations, 50, 79, 90, 147-149, 177,
192-193, 204-205
clinical reporting requirements, 3
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INDEX
233
221-222
accreditation, 65, 75, 77, 110, 149, 160,
208, 214, 217, 218
clinical practice guidelines, 51, 67, 98,
164, 181, 190
confidentiality, 131, 188
content, general, 63, 84-86, 140, 186, 187
221-222
standards, 204
Statistical analysis, 93, 95, 118
Summary time-oriented record, 62
Surgery, 121
Systematized Nomenclature of Medicine, 108
T
Task-oriented medical records, 115, 117
Technicon, 120
Technological innovations, 46, 48, 68, 74,
81, 94, 100-132, 135-137, 138
advances, 3-6
barriers, general, 10-17, 126-131
computer processing power, 3
confidentiality and, 110, 126, 127-129
costs, 69-70, 105-106, 112, 126, 127,
136, 137, 141, 146
see also Design and development;
Diffusion, innovations;
Research
Telecommunications, 109
electronic mail, 47, 119, 150, 189
European, 22
reliability, 95
workstation linkages, 88
see also Networks
Text processing, 106-107, 108, 126, 127,
131, 179
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INDEX
234
V
Vendors, 100, 160-161, 162, 169, 185
legal issues, 149, 200-201, 202, 219-221
survey of, 135-137
Veterans Administration, see Department of
Veterans Affairs
Viruses, computer, 217, 222
Vocabulary control, 9, 11, 13-14, 25, 31,
39, 48, 50, 51, 85-86, 96, 106,
107-109, 116, 126, 127, 129-131,
140, 149-151, 155, 163, 168, 169,
174, 175, 177, 179, 181, 183,
186-188, 191-192, 196
Voice recognition, 29, 32, 106, 126-127,
131, 179, 186
W
Windowing, 117, 137
Windows NT/95 environment, 28
Word processing, see Text processing
Workstations, 26-28, 88, 104-105, 179
World Wide Web, 4-5
122-123
Universities, 159-160
academic research, 112, 114, 150, 159
University of California at Los Angeles, 4
UNIX, 28, 137
U.S. CPR systems, status
advances, 3-4, 9-10
barriers/challenges, 10-17
implementation, 8-9
market, 6-8
practice environment, 1-5
Users, 46-47, 58, 65, 70, 74-93, 143-145,
181
authentication/identification, 14, 39
computer interface with, general, 4-5, 7,
11-12, 29, 87, 88, 126-127, 179
diffusion of innovations, 142, 143-145
needs, general, 46-47, 76-93
multiple, 65
patients as, 65, 83
projections, 94-98
see also Access issues;
Change agents;
Stakeholders
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