Legal and ethical considerations of informed consent.

BSTRACT: Obtaining informed consent for medical treatment, for participation in

medical research, and for participation in teaching exercises involving students and
residents is an ethical requirement that is partially reflected in legal doctrines and
requirements. As an ethical doctrine, informed consent is a process of communication
whereby a patient is enabled to make an informed and voluntary decision about
accepting or declining medical care. In this Committee Opinion, the American College of
Obstetricians and Gynecologists’ Committee on Ethics describes the history, ethical
basis, and purpose of informed consent and identifies special ethical questions pertinent
to the practice of obstetrics and gynecology. Two major elements in the ethical concept
of informed consent, comprehension (or understanding) and free consent, are reviewed.
Limits to informed consent are addressed

Informed consent is an ethical concept that has become integral to contemporary

medical ethics and medical practice. In recognition of the ethical importance of informed
consent, the Committee on Ethics of the American College of Obstetricians and
Gynecologists (ACOG) affirms the following eight statements:

1. Obtaining informed consent for medical treatment, for participation in medical

research, and for participation in teaching exercises involving students and residents is
an ethical requirement that is partially reflected in legal doctrines and requirements.
2. Seeking informed consent expresses respect for the patient as a person; it
particularly respects a patient’s moral right to bodily integrity, to self-determination
regarding sexuality and reproductive capacities, and to support of the patient’s freedom
to make decisions within caring relationships.
3. Informed consent not only ensures the protection of the patient against unwanted
medical treatment, but it also makes possible the patient’s active involvement in her
medical planning and care.
4. Communication is necessary if informed consent is to be realized, and physicians
can and should help to find ways to facilitate communication not only in individual
relations with patients but also in the structured context of medical care institutions.
5. Informed consent should be looked on as a process rather than a signature on a
form. This process includes a mutual sharing of information over time between the
clinician and the patient to facilitate the patient’s autonomy in the process of making
ongoing choices.
6. The ethical requirement to seek informed consent need not conflict with
physicians’ overall ethical obligation of beneficence; that is, physicians should make
every effort to incorporate a commitment to informed consent within a commitment to
provide medical benefit to patients and, thus, to respect them as whole and embodied
persons.
7. When informed consent by the patient is impossible, a surrogate decision maker
should be identified to represent the patient’s wishes or best interests. In emergency
situations, medical professionals may have to act according to their perceptions of the
best interests of the patient; in rare instances, they may have to forgo obtaining consent
because of some other overriding ethical obligation, such as protecting the public
health.
8. Because ethical requirements and legal requirements cannot be equated,
physicians also should acquaint themselves with federal and state legal requirements
for informed consent. Physicians also should be aware of the policies within their own
practices because these may vary from institution to institution.
The application of informed consent to contexts of obstetric and gynecologic practice
invites ongoing clarification of the meaning of these eight statements. What follows is an
effort to provide this.

The Ethical Meaning of Informed Consent

The ethical concept of “informed consent” contains two major elements: 1)
comprehension (or understanding) and 2) free consent. Both of these elements together
constitute an important part of a patient’s “self-determination” (the taking hold of her
own life and action, determining the meaning and the possibility of what she undergoes
as well as what she does). Both of these elements presuppose a patient’s capacity to
understand and to consent, a presupposition that will be examined later.

Comprehension (as an element in informed consent) includes the patient’s awareness

and understanding of her situation and possibilities. It implies that she has been given
adequate information about her diagnosis, prognosis, and alternative treatment choices,
including the option of no treatment. Moreover, this information should be provided in
language that is understandable to the particular patient, who may have linguistic or
cognitive limitations. Comprehension in this sense is necessary for freedom in
consenting.

Free consent is an intentional and voluntary choice that authorizes someone else to act
in certain ways. In the context of medicine, it is an act by which an individual freely
authorizes a medical intervention in her life, whether in the form of treatment or
participation in research or medical education. Consenting freely is incompatible with
being coerced or unwillingly pressured by forces beyond oneself. It involves the ability
to choose among options and to select a course other than what may be recommended.
It is important for physicians to be cognizant of their own beliefs and values during the
informed consent process. Physicians should have insight into how their opinions may
affect the way in which information is presented to patients and, as a result, influence
the patient’s decision to accept or decline a therapy. Different models of the physician–
patient relationship exist, and the degree to which a physician would share his or her
values and professional opinions with patients varies 
5. In many cases, the physician’s personal and professional values and clinical
experiences do, to some degree, influence the presentation and discussion of
therapeutic options with patients. Although not considered frank manipulation or
coercion, care should be taken that the physician’s perspectives do not unduly influence
a patient’s voluntary decision making.
Free consent, of course, admits of degrees, and its presence is not always verifiable in
concrete instances. If free consent is to be operative at all in the course of medical
treatment, it presupposes knowledge about and understanding of all the available
options.

Many thoughtful individuals have different beliefs about the actual achievement of
informed consent and about human freedom. Many philosophical disputes have raged
about what freedom is and whether it exists. These differences in underlying
philosophical perspectives do not, however, alter the general agreement about the need
for informed consent and about its basic ethical significance in the context of medical
practice and research. It is still important to try to clarify, however, who and what
informed consent serves and how it may be protected and fostered. This clarification
cannot be achieved without some consideration of its basis and goals and the concrete
contexts in which it must be realized.

The Ethical Basis and Purpose of Informed Consent

One of the important arguments for the ethical requirement of informed consent is an
argument from utility, or from the benefit that can come to patients when they actively
participate in decisions about their own medical care. The involvement of patients in
such decisions is good for their health—not only because it helps protect against
treatment that patients might consider harmful, but also because it often contributes
positively to their well-being. There are at least two presuppositions here: 1) patients
know something experientially about their own medical condition that can be helpful and
even necessary to the sound management of their medical care, and 2) wherever it is
possible, patients’ active role as primary guardian of their own health is more conducive
to their well-being than is a passive and submissive “sick role.” The positive benefits of
patient decision making are obvious, for example, in the treatment of alcohol abuse. But
the benefits of active participation in medical decisions are multifold for patients,
whether they are trying to maintain their general health, recover from illness, conceive
and give birth to healthy newborns, live responsible sexual lives, or accept the limits of
medical technology.

Utility, however, is not the only reason for protecting and promoting patient decision
making. Indeed, the most commonly accepted foundation for informed consent is the
principle of respect for persons. This principle expresses an ethical requirement to treat
persons as “ends in themselves” (that is, not to use them solely as means or
 instruments for someone else’s purposes and goals). This requirement is based on the
belief that all persons, as persons, have certain features or characteristics that
constitute the source of an inherent dignity, a worthiness and claim to be affirmed in
their own right. One of these features has come to be identified as personal autonomy—
a person’s capacity for self-determination (for self-governance and freedom of choice).
To be autonomous is to have the capacity to set one’s own agenda. Given this capacity
in persons, it is ordinarily an ethically unacceptable violation of who and what persons
are to manipulate or coerce their actions or to refuse their participation in important
decisions that affect their lives.

An important development in ethical theory in recent years is the widespread

recognition that autonomy is not the only characteristic of persons that is a basis for the
requirement of respect. Human beings are essentially social beings, relational in the
structure of their personalities, their needs, and their possibilities. As such, then, the
goal of human life and the content of human well- being cannot be adequately
understood only in terms of self-determination—especially if self-determination is
understood individualistically and if it results in human relationships that are primarily
adversarial. A sole or even central emphasis on narrow conceptions of patient
autonomy that presume a highly individualistic agent in the informed consent process in
the medical context risks replacing paternalism with a distanced and impersonal
relationship of strangers negotiating rights and duties. If persons are to be respected
and their well-being promoted, informed consent must be considered in the context of
individuals’ various relationships.

Patients approach medical decisions with a history of relationships, personal and social,
familial and institutional. They make decisions in the context of these relationships,
shared or not shared, as the situation allows. One such relationship is between patient
and physician (or often between patient and multiple professional caregivers).

The focus, then, for understanding both the basis and the content of informed consent
must shift to include the many facets of the physician–patient relationship. Informed
consent, from this point of view, is not an end, but a means. It is a means not only to the
responsible participation by patients in their own medical care but also to a relationship
between physician (or any medical caregiver) and patient. From this perspective, it is
possible to see the contradictions inherent in an approach to informed consent that
would, for example:

 Lead a physician (or anyone else) to say of a patient, “I consented the patient”

 Assume that informed consent is achieved simply by the signing of a document

 Consider informed consent primarily as a safeguard for physicians against

professional liability
This view of informed consent posits a dialogue between patient and health care
provider in support of respect for patient autonomy. A major objective of this view is to
prevent the practitioner from imposing treatments. It does not, however, require
practitioners to accede to patient requests for unproven or harmful treatment modalities.

Obstetrics and Gynecology: Special Ethical Concerns for

Informed Consent
The practice of obstetrics and gynecology has always faced special ethical questions in
the implementation of informed consent. How, for example, can the autonomy of
patients best be respected when serious decisions must be made in the challenging
situations of labor and delivery? What kinds of guidelines can physicians find for
respecting the autonomy of adolescents, when society acknowledges this autonomy by
and large only in the limited spheres of sexuality and reproduction? In the context of
genetic counseling, where being “non-directive” is the norm, is it ever appropriate to
recommend a specific course of action? How much information should be given to
patients about controversies surrounding specific treatments? How are beneficence
requirements (regarding the well-being of the patient) to be balanced with respect for
autonomy, especially in a field of medical practice where so many key decisions are
irreversible? These and many other questions continue to be important for fulfilling the
ethical requirement to seek informed consent.

Developments in the ethical doctrine of informed consent (regarding, for example, the
significance that relationships have for decision making) have helped to focus some of
the concerns that are particularly important in the practice of obstetrics and gynecology 
1. Where women’s health care needs are addressed, and especially where these needs
are related to women’s sexuality and reproductive capacities, the issues of patient
autonomy and its relational nature come to the forefront. Perspectives and insights for
interpreting these issues are now being articulated by women out of their experience—
that is, their experience specifically in the medical setting, but also more generally in
relation to their own bodies, in various patterns of relation with other individuals, and in
the larger societal and institutional contexts in which they live. These perspectives and
insights offer both a help and an ongoing challenge to professional self- understanding
and practice of obstetricians and gynecologists (whether they themselves are women or
men).
New models for the active participation of health care recipients have been created in
obstetrics and gynecology. Some of these developments are the result of arguments
that pregnancy and childbirth should not be thought of as diseases, although they bring
women importantly into relation with medical professionals and, in some cases, carry a
potential for morbidity or mortality. Even when women’s medical needs pointedly require
diagnosis and treatment, their concerns to hold together the values of both autonomy
and their relationships have been influential in shaping not only ethical theory but also
medical practice. Women themselves have questioned, for example, whether autonomy
can really be protected if it is addressed in a vacuum, apart from an individual’s
concrete roles and relationships. But women as well as men also have recognized the
ongoing importance of respect for autonomy, although they suggest it should be
reconceptualized as less individualistic and more “relational” 
9. They call for attention to the complexity of the relationships that are involved,
especially when sexuality and parenting are at issue in medical care, while upholding
the importance of bodily integrity and self-determination.
The difficulties that beset the full achievement of informed consent in the practice of
obstetrics and gynecology are not limited to individual and interpersonal factors. Both
health care providers and recipients of medical care within this specialty have
recognized the influence of such broad social problems as the historical imbalance of
power in gender relations and in the physician–patient relationship, the constraints on
individual choice posed by complex medical technology, and the intersection of gender
bias with race and class bias in the attitudes and actions of individuals and institutions.
None of these problems makes the achievement of informed consent impossible. But,
they point to the need to identify the conditions and limits, as well as the central
requirements, of the ethical application of this doctrine.

Ethical Applications of Informed Consent

Insofar as comprehension and voluntariness are the basic ethical elements in informed
consent, its efficacy and adequacy will depend on the fullness of their realization in
patients’ decisions. There are ways of assessing this and strategies for achieving
informed consent, even though it involves a process that is not subject to precise
measurement.

It is difficult to specify what consent consists of and requires because it is difficult to

describe a free decision in the abstract. Two things can be said about it in the context of
informed consent to a medical intervention, however, elaborating on the conceptual
elements identified previously in this Committee Opinion. The first is to describe what
consent is not, what it is freedom from. Informed consent includes freedom from
external coercion, manipulation, or infringement of bodily integrity. It is freedom from
being acted on by others when they have not taken account of and respected the
individual’s own preference and choice. This kind of freedom for a patient is not
incompatible with a physician’s giving reasons that favor one option over another.
Medical recommendations, when they are not coercive or deceptive, do not violate the
requirements of informed consent. For example, to try to convince a patient to take a
 medication that will improve her health is not to take away her freedom (assuming that
the methods of persuasion respect and address, rather than overwhelm, her freedom).

Second, although informed consent to a medical intervention may be an authorization of

someone else’s action toward one’s self, it is—more profoundly—an active participation
in decisions about the management of one’s medical care. It is (or can be), therefore,
not only a “permitting” but a “doing.” It can include decisions to make every effort toward
a cure of a disease; or when a cure is no longer a reasonable goal, to maintain
functional equilibrium; or, finally, to receive only supportive or palliative care. The variety
of choices that are possible to a patient ranges, for example, from surgery to medical
therapy, from diagnostic tests to menopausal hormone therapy, and from one form of
contraception to another. For women in the context of obstetrics and gynecology, the
choices may be positive determination of one kind of assisted reproduction or another
or one kind of preventive medicine or another—choices that are best described as
determinations of their own actions rather than passive “receiving” of care.

Consent in this sense requires not only external freedom and freedom from inner
compulsion, but also (as previously noted in this document) freedom from ignorance.
Hence, to be ethically valid, consent must be “informed.”

Consent is based on the disclosure of information and a sharing of interpretations of its

meaning by a medical professional. The accuracy of disclosure, insofar as it is possible,
is governed by the ethical requirement of truth-telling. The adequacy of disclosure has
been judged by various criteria, which may include the following:

1. The common practice of the profession

2. The reasonable needs and expectations of the ordinary individual who might be
making a particular decision

3. The unique needs of an individual patient faced with a given choice ‡

Although these criteria have been generated in the rulings of courts, the courts
themselves have not provided a unified voice as to which of these criteria should be
determinative. Trends in judicial decisions in most states were for a time primarily in the
direction of the “professional practice” criterion, requiring only the consistency of a
physician’s disclosure with the practice of disclosure by other physicians. Now the trend
in many states is more clearly toward the “reasonable person” criterion, holding the
medical profession to the standard of what is judged to be material to an ordinary
individual’s decision in the given medical situation. The criterion of the subjective needs
of the patient in question generally has been too difficult to implement in the legal arena,
but its ethical force is significant.
Health care providers should engage in some ethical discernment of their own as to
which criteria are most faithful to the needs and rightful claims of patients for disclosure.
All three criteria offer reminders of ethical accountability and guidelines for practice. All
three can help to illuminate what needs to be shared in the significant categories for
disclosure: diagnosis and description of the patient’s medical condition, description of
the proposed treatment and its nature and purpose, risks and possible complications
associated with the treatment, alternative treatments or the relative merits of no
treatment at all, and the probability of success of the treatment in comparison with
alternatives.

Listing categories of disclosure does not by itself include all the elements that are
important to adequacy of disclosure. Among other matters, the obligation to provide
adequate information to a patient implies an obligation for physicians to be current in
their own knowledge, for instance, about treatments and disease processes. As an aid
to physicians in communicating information to patients, ACOG makes available more
than 100 patient education pamphlets on a wide variety of subjects. When physicians
make informed consent possible for patients by giving them the knowledge they need
for choice, it should be clear to patients that their continued medical care by a given
physician is not contingent on their making the choice that the physician prefers
(assuming the limited justifiable exceptions to this that will be addressed later).

Those who are most concerned with problems of informed consent insist that central to
its achievement is communication—communication between physician and patient,
communication among the many medical professionals who are involved in the care of
the patient, and communication (where this is possible and appropriate) with the family
of the patient. Documentation in a formal process of informed consent can be a help to
necessary communication (depending on the methods and manner of its
implementation). The completion of a written consent document, whether required by
statute, regulation, policy, or case law, should never be a substitute for the
communication involved in disclosure, the conversation that leads to an informed and
voluntary consent or refusal 6 10.
To focus on the importance of communication for the implementation of an ethical
doctrine of informed consent is, then, to underline the fact that informed consent
involves a process. There is a process of communication that leads to initial consent (or
refusal to consent) and that can make possible appropriate ongoing decision making.

There are, of course, practical difficulties with ensuring the kind of communication
necessary for informed consent. Limitations of time in a clinical context, patterns of
authority uncritically maintained, underdeveloped professional communication skills,
limited English proficiency, “language barriers” between technical discourse and
ordinarily comprehensible expression, and situations of stress on all sides—all of these
frequently yield less than ideal circumstances for communication. Yet the ethical
requirement to obtain informed consent, no less than a requirement for good medical
care, extends to a requirement for reasonable communication. The conditions for
communication may be enhanced by creating institutional policies and structures that
make it more possible and effective.

Although understanding and voluntariness are basic elements of informed consent, they
admit of degrees. There will always be varying levels of understanding, varying degrees
of internal freedom. The very matters of disclosure may be characterized by
disagreement among professionals, uncertainty and fallibility in everyone’s judgments,
the results not only of scientific analysis but of medical insight and art. And the
capacities of patients for comprehension and consent are more or less acute, of greater
or lesser power, focused in weak or strong personal integration, and compromised or
not by pain, medication, disease, or social circumstance. Some limitations mitigate the
obligation to obtain informed consent, and some render it impossible. But any
compromise or relaxation of the full ethical obligation to obtain informed consent
requires specific ethical justification.

The Limits of Informed Consent

Because informed consent admits of degrees of implementation, there are limits to its
achievement. These are not only the limits of fallible knowledge or imperfect
communication. They are limitations in the capacity of patients for comprehension and
for choice. Assessment of patient capacity is itself a complex matter, subject to
mistakes and to bias. Hence, a great deal of attention has been given to criteria for
determining individual capacity (and the legally defined characteristic of “competence”)
and for just procedures for its evaluation
 8. When individuals are entirely incapacitated for informed consent, the principles of
respect for persons and beneficence require that the patient be protected. In these
situations, someone else must make decisions on behalf of the patient. A surrogate
decision maker should be identified to provide a “substituted judgment” (a decision
based on what the patient would have wanted, assuming some knowledge of what the
patient’s wishes would be); if the patient’s wishes are unknown, the surrogate makes a
decision according to the “best interests” of the patient. If the patient has previously
executed an advance directive, that document should guide the selection of a surrogate
decision maker or the specific decisions made by the surrogate or both, depending on
the nature of the advance directive.
The judgment that informed consent is impossible in some circumstances indicates a
kind of limit that is different from a partial actualization of consent or consent by an
appropriate surrogate. One way to acknowledge this is to say that there are limits to the
obligation to obtain informed consent at all. There are several exceptions to the strict
rule of informed consent.
First, impossibility of any achievement of informed consent suspends or limits the
ethical obligation. This is exemplified in emergency situations in which consent is
unattainable and in other situations when a patient is not at all competent or capable of
giving consent and an appropriate surrogate decision maker is not available. In the
practice of obstetrics and gynecology, as in any other specialty practice, there are
situations where decisions can be based only on what is judged to be in the best
interest of the patient—a judgment made, if possible, by a designated surrogate, legal
guardian, or family members together with medical professionals. Yet often when a
patient is not able to decide for herself (perhaps, for example, because of the amount of
medication needed to control pain), a substituted judgment or a judgment on the basis
of prior informed consent can be made with confidence if care has been taken
beforehand to learn the patient’s wishes. This signals the importance of early
communication so that what a patient would choose in a developing situation is known
—so that, indeed, it remains possible to respect the self-determination that informed
consent represents.

A second way in which the rule of informed consent may be suspended or limited is by
being overridden by another obligation. A number of other ethical obligations can, in
certain circumstances, override or set limits on the requirement to obtain informed
consent. For example, strong claims for the public good (specifically, public health) may
set limits to what a patient can refuse or choose. That is, although the rights of others
not to be harmed may sometimes take priority over an individual’s right to refuse a
medical procedure (as is the case in exceptional forms of mandatory medical testing
and reporting), scarcity of personnel and equipment may in some circumstances mean
that individual patients cannot have certain medical procedures “just for the choosing.”

In rare circumstances, what is known as therapeutic privilege can override an obligation

to disclose information and hence to obtain informed consent. Therapeutic privilege is
the limited privilege of a physician to withhold information from a patient in the belief that
this information about the patient’s medical condition and options will seriously harm the
patient. Concern for the patient’s well- being (the obligation of beneficence) thus comes
into conflict with respect for the patient’s autonomy 
11. This is a difficult notion to apply—great caution must be taken in any appeal to it—
and the rationale for withholding information should be carefully documented. The
concept of therapeutic privilege should not, for example, be used as a justification for
ignoring the needs and rights of adolescents (or adults) to participate in decisions about
their sexuality and their reproductive capacities. It is reasonable to argue that
therapeutic privilege is almost never a basis for permanently overriding the obligation to
seek informed consent. Ordinarily such overriding represents a temporary situation, one
that will later allow the kind of communication conducive to the restored freedom of the
patient.
Sometimes another exception to the rule of informed consent is thought to occur in the
rare situation when a patient effectively waives her right to give it. This can take the
form of refusing information necessary for an informed decision, or simply refusing
altogether to make any decision. However, the following two statements are reasons for
not considering this an exception of the same type as the other exceptions:
1. A waiver in such instances seems to be itself an exercise of choice, and its
acceptance can be part of respect for the patient’s autonomy.

2. Implicit in the ethical concept of informed consent is the goal of maximizing a

patient’s freedoms, which means that waivers should not be accepted complacently
without some concern for the causes of the patient’s desire not to participate in the
management of her care.

In any case, it should be noted that in states where written documentation of informed
consent is required, it may be necessary to meet this requirement in some legally
acceptable way.

Finally, limits intrinsic to the patient–physician relationship keep the requirement of

informed consent from ever being absolute. Physicians also are moral agents and, as
such, retain areas of free choice—as in the freedom in some circumstances not to
provide medical care that they deem either medically inappropriate or ethically
objectionable. It is unethical to prescribe, provide, or seek compensation for therapies
that are of no benefit to the patient 
12. Interpretations of medical need and usefulness in some circumstances also may
lead a physician to refuse to perform surgery or prescribe medication. The freedom not
to provide standard or potentially beneficial care to which one ethically objects is
sometimes called a right to “conscientious refusal,” although this right is limited 
13. Even in the context of justified conscientious refusal, physicians must provide the
patient with accurate and unbiased information about her medical options and make
appropriate referrals. In the mutuality of the patient–physician relationship, each one is
to be respected as a person and supported in her or his autonomous decisions insofar
as those decisions are not, in particular circumstances, overridden by other ethical
obligations. The existing imbalance of power in this relationship, however, is a reminder
to physicians of their greater obligation to ensure and facilitate the informed consent or
refusal of each patient. Differences in knowledge can and should be bridged through
efforts at communication of information; professional responsibilities to be honest and
uphold the primacy of patient welfare should be respected.
Acknowledging the limits of the ethical requirement to obtain informed consent, then,
clarifies but does not weaken the requirement as such. Hence, the Co mmittee on
Ethics reaffirms the eight statements that were presented at the beginning of this
Committee Opinion.
PATIENTS RIGHTS
1. Right to Appropriate Medical Care and Humane Treatment. - Every person has a right to health and medical care corresponding to his state of
health, without any discrimination and within the limits of the resources, manpowerand competence available for health and medical care at the
relevant time. The patient has the right to appropriate health and medical care of good quality. In the course of such, his human dignity, convictions,
integrity, individual needs and culture shall be respected. If any person cannot immediately be given treatment that is medically necessary he shall,
depending on his state of health, either be directed to wait for care, or be reffered or sent for treatment elsewhere, where the appropriate care can be
provided. If the patient has to wait for care, he shall be informed of the reason for the delay. Patients in emergency shall be extended immediate
medical care and treatment without any deposit, pledge, mortgage or any form of advance paymentfor treatment.

2. Right to Informed Consent. -  The patient has a right to a clear, truthful and  substantial  explanation,  in  a  manner  and  language 
understandable  to  the patient, of all proposed procedures, whether  diagnostic, preventive, curative, rehabilitative or therapeutic, wherein the person
who will perform the said procedure shall provide  his  name  and credentials  to  the  patient,  possibilities  of  any  risk  of mortality or serious side
effects, problems related to recuperation, and probability of success  and  reasonable  risks  involved:  Provided,   That  the  patient  will not  be
subjected  to any procedure without his written informed consent, except in the following cases:
a) in emergency cases, when the patient is at imminent risk of physical injury, decline Of death if treatment is withheld or postponed. In such cases,
the physician can perform any diagnostic or treatment procedure as good practice of medicine dictates without such consent;
b) when the health of the population is dependent on the adoption of a mass health program to control epidemic;
c) when the law makes it compulsory for everyone to submit a procedure;
d) When the patient is either a minor, or legally incompetent, in which case. a third party consent Is required;
e) when disclosure of material information to patient will jeopardize the success of treatment, in which case, third party disclosure and consent
shall be in order;
f) When the patient waives his right in writing
Informed consent shall be obtained from a patient concerned if he is of legal age and of sound mind. In case the patient is incapable of giving consent
and a third party   consent  is  required.  the  following  persons,  in  the  order  of  priority  stated hereunder, may give consent:

I. spouse;
II. son or daughter of legal age;
III. either parent;
IV. brother or sister of legal age, o
V. guardian

If a patient is a minor, consent shall be  ottained  from  his parents or legal guardian. If next of kin, parents or  legal guardians  refuse to give  consent 
to  a medical or surgical  proceoure  necessary to save the  life or limb of  a minor or a patient incapable of giving consent, courts, upon the petition of
the physician or any person interested in the welfare of the patient, in a summary proceeding, may issue an order giving consent.

3. Right to Privacy and Confidentiality.  -  The privacy of the patients must be assured at all stages of his treatment. The patient has the right   to be
free from unwarranted public exposure, except in the  foHowing cases: a) when his mental or physical condition is in controversy and the appropriate
court, in its discretion, order him to submit to a physical or mental examination by a physician; b) when the public health and safety so demand; and c)
when the patient waives this right in writing.

The patient has the right to demand that all information, communication  and records pertaining to his care be treated as confidential. Any health care
provider or practitioner involved in the treatment  of a patient and all those who have legitimate access to the patient's record is not authorized to
divulge any information to a third party  who  has  no concern  with  the  care  and  welfare  of  the  patient  without  his consent, except:  a) when  such
disclosure  will benefit public  health and  safety; b) when it is in the interest of justice and  upon the order of a competent court; and c) when the
patients  waives  in writing the confidential  nature of such  information; d) when  it is  needed  for  continued  medical  treatment  or  advancement  of 
medical science subject to de-identification  of patient and shared medical confidentiality  for those who have access to the information.

Informing the spouse or the family to the first degree of the patient's medical condition may be allowed; Provided That the patient of legal age shall
have the right to choose on whom to inform. In case the patient is not of legal age or is mentally incapacitated, such information shall be given to the  
parents, legal guardian  or his next of kin.

 4. Right to  Information. -  In the course  of his/her  treatment  and  hospital care, the patient or his/her legal guardian has a right to be informed of
the result of the evaluation  of the nature and extent of his/her disease,  any other additional  or further  contemplated   medical  treatment on surgical
procedure or procedures, including any other additional medicines to be administered and their generic counterpart including the possible
complications  and other pertinent facts, statistics or studies,  regarding  his/her  illness,  any  change  in the  plan  of  care  before  the change  is 
made,  the  person's  participation  in the  plan  of  care  and  necessary changes  before its implementation, the  extent to  which payment  maybe 
expected from Philhealth or any payor and any charges for which the patient maybe liable, the disciplines of health care practitioners who will fumish
the care and the frequency of services that are proposed to be furnished.

The patient or his legal guardian has the  right to examine and  be given an itemized bill of the hospital and medical services rendered in the facility or
by his/her physician and other health care providers, regardless  of the manner and source of payment.He is entitled to a thorough explanation of such
bill.

The  patient  or  hislher  legal guardian  has the  right to  be informed  by the physician or his/her delegate of hisJher continuing health care
requirements following discharge, including instructions about home medications, diet, physical activity and all other pertinent information to promote
health and well-being.

At the  end of  his/her confinement, the patient is entitled  to a brief, written summary  of the  course  of  his/her  illness which  shall  include  at least
the  history, physical examination, diagnosis, medications, surgical procedure, ancillary and laboratory procedures, and the plan of further treatment,
and which shall be provided by the attending physician. He/she is likewise entitled  to the explanation  of, and to view, the contents of medical record of
his/her confinement but with the presence of his/her  attending   physician  or  in  the  absence  of  the  attending  physician,  the hospital's
representative.  Notwithstanding that  he/she   may  not be able  to  settle  his accounts   by reason of  financial   incapacity, he/she is entitled  to
reproduction, at  his/her   expense,   the pertinent   part  or  parts  of the  medical   record  the  purpose   or  purposes   of  which   he shall  indicate  in
his/her  written  request  for  reproduction.   The  patient  shall likewise  be entitled  to  medical  certifICate, free  of  charge,  with  respect  to  his/her 
previous confinement.

5. The Right to Choose  Health  Care Provider  and Facility. -  The patient is free to choose the health care provider to serve   him as well as the
facility except when he is under the care of a service facility or when public health and safety so demands or when the patient expressly waives this
right in writing.

The patient has the right to discuss his condition with a consultant specialist, at the patient's   request and expense.  He also has the  right to seek  for a
second opinion and subsequent opinions, if appropriate, from another health care  provider/practitioner.

 6. Right to Self-Determination. - The  patient has the right to avail himself/herself of any recommended diagnostic and   treatment  procedures.Any
person of legal age and of sound mind may make an advance written directive for physicians to administer terminal care when he/she suffers from the
terminal phase of a terminal illness:  Provided That a) he is informed of the medical consequences of his choice; b) he releases those involved in his
care from any obligation relative to the consequences of his decision; c) his decision will not prejudice public health and safety.

7. Right to Religious  Belief. - The patient  has the  right to refuse medical treatment or procedures which may be contrary to his religious beliefs,
subject to the limitations described in the preceding subsection: Provided,  That such a right shall not be imposed by parents upon their children who
have not reached the legal age in a life threatening situation as determined by the attending physician or the medical director of the facility.

8. Right to Medical Records. - The patient is entitled to a summary of his medical history and condition.He has the right to view the contents   of his
medical records, except psychiatric notes and other incriminatory information obtained about third parties, with the attending physician explaining
contents thereof. At his expense and upon discharge of the patient, he may obtain from the health care institution a reproduction of the same record  
whether or not he has fully  settled  his financial obligation with the physician or institution concerned.

The health care  institution shall safeguard  the  confidentiality  of the medical records and to likewise ensure the integrity and authenticity of the
medical records and  shall  keep the same  within  a  reasonable time  as  may be determined  by the Department of Health.

The health care institution shall issue a medical certificate  to the patient upon request.Any other document that the patient may require for insurance
claims shall also be made available to him within forty-fIVe (45) days from request.

9. Right to Leave. - The patient has the right  to leave hospital or any other health care institution regardless of his physical   condition: Provided. That
a) he/she is informed  of the  medical consequences  of his/her decisionl  b) helshe  releases those involved in his/her care from any obligation relative
to the consequences of his decision; c) hislher decision will not prejudice public health and safety.

No patient shaD be  detained against hi$/her will in any health care institution on the  sole  basis  of  his failure to  fully  settle  his  financial 
obligations.  However, he/she shall only be allowed to leave the hospital provided appropriate arrangements have been made to settle the   unpaid 
bills: Provided.  further, That  unpaid  bills of patients shall be considered as loss income by the hospital and health care provider/practitioner   and shall
be  deducted from gross income as income loss only on that particular year.

10. Right to Refuse Participation In Medical Research. - The patient has the  right to be advised if the  health care provider  plans to  involve him in
medical research, including but not limited  to  human  experimentation which may be performed only with the written informed consent of the patient:
Provided, That, an institutional review board or ethical review board in accordance with the guidelines set in the Declaration of Helsinki be established
for research involving human experimentation:  Provided, further, That the Department of Health shall safeguard the continuing training  and 
education  of fUture health care provider/practitioner to ensure the development of the health care delivery in the country: Provided, fUfthermore, That
the patient involved in the human experimentation  shall be  made aware of the provisions of the Declaration of Helsinki and its respective guidelines.

11. RIght to Correspondence and to Receive Visitors. - The patient has the  right to  communicate  with  relatives and other  persons  and to receive
visitors subject to reasonable limits prescribed by the rules and regulations of the health care institution.

12. Right  to  Express Grievances. - The patient has the  right to  express complaints and grievances about the care and  services received  without
fear of discrimination or reprisal and to know about the disposition of such complaints.Such a system shall afford all parties concerned with the
opportunity to settle amicably all grievances.

13. RIght to be Informed of His Rights and Obligations as a Patient. - Every person has the right to be  informed of his rights and obligations as a
patient.The Department of Health,in coordination with heath  care  providers, professional and civic groups, the media, health insurance corporations,
people's organizations,local government  organizations,  shall launch and sustain a nationwide  information and  education  campaign  to  make 
known  to  people  their rights  as patients, as declared  in this Act  Such  rights  and obligations  of patients  shall  be posted in a bulletin board
conspicuously  placed in a health care institution.

It shall be the duty of health care institutions to inform of their rights as well as of the institution's rules and regulations that apply to the conduct of the
patient while in the care of such institution.

Republic Act 10173 – Data Privacy Act of 2012

What is the Data Privacy Act of 2012?
The National Privacy Commission (NPC), formed as a result of the Philippines’ Data Privacy Act of 2012 (Republic Act 10173), lays forth a set of requirements
designed to protect personal information in both government and private sector organizations. The regulation sets out a data privacy accountability and compliance
framework that covers a wide range of issues such as governance, data security, training, third party affiliations and breach notification. September 9, 2017 was the
Implementation of Rules and Regulation (IRR) deadline by which point organizations were to register their data processing systems with the NPC. The next
implementation phase’s deadline, during which organizations will need to show progress toward compliance, is set for March 8, 2018.

What does the Data Privacy Act of 2012 mean?

 The Data Privacy Act of 2012 requires organizations to appoint a Data Protection Officer (DPO), make their data processing transparent to their customers, and
maintain the confidentiality, integrity and availability of their data. ‘Security incidents’ as defined by the law do not require notification. However, should a data
breach occur and the following information applies, organizations will need to notify the NPC and customers. A breach will require notification if:
1. The breached information must be sensitive personal information, or information that could be used for identity fraud, and
2. There is a reasonable belief that unauthorized acquisition has occurred, and
3. The risk to the data subject is real, and
4. The potential harm is serious.

How to prepare your organization for the Data Privacy Act of 2012
Mitigating these 4 points will ensure that, even in the event of a data breach, organizations can reduce their notification obligations. The surest way to minimize your
notification obligations is to ensure that the breach of customer information does not result in risk to the data subject. Security controls, such as data
encryption and centralized key management, can keep customer data from external attacks not prevented by perimeter security, and from internal users capable of
abusing their privileged access.

How to apply robust data encryption and key management to protect your data
To address the Privacy Act’s compliance requirements, organizations may need to employ one or more encryption method in either their on-premises or cloud
environments, to protect the following:
 Servers, including via file encryption, application encryption, column-level database encryption, and full disk virtual machine encryption.
 Storage, including through network-attached storage and storage area network encryption.
 Media, through disk encryption.
 Networks, for example through high-speed network encryption.
Strong key management is necessary to protect encrypted data, so that in the event of a data breach the encrypted data is safe because the encryption keys are
secured.
Organizations will also need a way to verify the legitimacy of user identities and digital transactions, and to prove compliance. It is critical that the security controls
in place be demonstrable and auditable.
Gemalto offers the only complete data protection portfolio that works together to provide persistent protection and management of sensitive data, which can be
mapped to the Privacy Act’s framework.

 CHAPTER I – GENERAL PROVISIONS

o SECTION 1. Short Title.
o SECTION 2. Declaration of Policy.
o SECTION 3. Definition of Terms.
o SECTION 4. Scope.
o SECTION 5. Protection Afforded to Journalists and Their Sources.
o SECTION 6. Extraterritorial Application.
 CHAPTER II – THE NATIONAL PRIVACY COMMISSION
o SECTION 7. Functions of the National Privacy Commission.
o SECTION 8. Confidentiality.
o SECTION 9. Organizational Structure of the Commission.
o SECTION 10. The Secretariat.
 CHAPTER III – PROCESSING OF PERSONAL INFORMATION
o SECTION 11. General Data Privacy Principles.
o SECTION 12. Criteria for Lawful Processing of Personal Information.
o SECTION 13. Sensitive Personal Information and Privileged Information.
o SECTION 14. Subcontract of Personal Information.
o SECTION 15. Extension of Privileged Communication.
 CHAPTER IV – RIGHTS OF THE DATA SUBJECT
o SECTION 16. Rights of the Data Subject.
o SECTION 17. Transmissibility of Rights of the Data Subjects.
o SECTION 18. Right to Data Portability.
o SECTION 19. Non-Applicability.
 CHAPTER V – SECURITY OF PERSONAL INFORMATION
o SECTION 20. Security of Personal Information.
 CHAPTER VI – ACCOUNTABILITY FOR TRANSFER OF PERSONAL INFORMATION
o SECTION 21. Principle of Accountability.
 CHAPTER VII – SECURITY OF SENSITIVE PERSONAL INFORMATION IN GOVERNMENT
o SECTION 22. Responsibility of Heads of Agencies.
o SECTION 23. Requirements Relating to Access by Agency Personnel to Sensitive Personal
Information.
o SECTION 24. Applicability to Government Contractors.
 CHAPTER VIII – PENALTIES
o SECTION 25. Unauthorized Processing of Personal Information and Sensitive Personal
Information.
o SECTION 26. Accessing Personal Information and Sensitive Personal Information Due to
Negligence.
o SECTION 27. Improper Disposal of Personal Information and Sensitive Personal Information.
o SECTION 28. Processing of Personal Information and Sensitive Personal Information for
Unauthorized Purposes.
o SECTION 29. Unauthorized Access or Intentional Breach.
o SECTION 30. Concealment of Security Breaches Involving Sensitive Personal Information.
o SECTION 31. Malicious Disclosure.
o SECTION 32. Unauthorized Disclosure.
o SECTION 33. Combination or Series of Acts.
o SECTION 34. Extent of Liability.
o SECTION 35. Large-Scale.
o SECTION 36. Offense Committed by Public Officer.
o SECTION 37. Restitution.
 CHAPTER IX – MISCELLANEOUS PROVISIONS
o SECTION 38. Interpretation.
o SECTION 39. Implementing Rules and Regulations (IRR).
o SECTION 40. Reports and Information.
o SECTION 41. Appropriations Clause.
o SECTION 42. Transitory Provision.
o SECTION 43. Separability Clause.
o SECTION 44. Repealing Clause.
o SECTION 45. Effectivity Clause.