THE WORLD MEDICAL ASSOCIATION, INC.
TITLE PROPOSED WMA STATEMENT ON THE ETHICAL
CONSIDERATIONS REGARDING HEALTH DATABASES
THE
WORLD MEDICAL ASSOCIATION, INC.
PROPOSED
WORLD MEDICAL ASSOCIATION STATEMENT ON
ETHICAL
CONSIDERATIONS REGARDING HEALTH DATABASES
1. The right to
privacy is fundamental in a free and democratic society. This right includes
each person’s right to determine with whom he/she will share personal health
information and to exercise control over the use and disclosure of, and access
to information collected about him or her whether as data or as part of human
tissue.
2. The right to
privacy and consent are at the essence of medical practice and essential to the
trust and integrity of the doctor-patient relationship. This reflects the
highly sensitive nature of personal health information and the circumstances of
vulnerability and trust under which it is collected. Only when all the relevant
personal health information is shared with the individual physician can a full
assessment of the individual patients needs be made and appropriate care and
treatment instituted.
3. These
principles have been incorporated in WMA statements since the WMA was founded
in 1947, in particular by:
3.1 The
Declaration of Geneva, adopted by the 2nd WMA General Assembly, held
in Geneva in September 1948, as last amended by the 46th General
Assembly, held in Stockholm in September 1994, requires the physician to
respect the secrets which are confided in him or her, even after the patient’s
death;
3.2 The
Declaration of Helsinki adopted by the 18th WMA General Assembly,
held in Helsinki in June 1964, states:
Section
1, paragraph 6: “The right of
the research subject to safeguard his or her integrity must always be
respected. Every precaution should be taken to respect the privacy of the
subject…”
Section
1, paragraph 9: “In any
research on human beings, each potential subject must be adequately informed of
the aims, methods, anticipated benefits and potential hazards of the study and
the discomfort it may entail. He or she should be informed that he or she is at
liberty to abstain from participation in the study and that he or she is free
to withdraw his or her consent to participation at any time. The physician
should then obtain the subject’s freely-given informed consent, preferably in
writing”.
4. The term
‘personal health information’ is defined for the purposes of this Statement as
including information about: an individual’s physical or mental health; any
medical or health services provided to the individual; any donation by the
individual of a body part or bodily tissue or substance, and any information
derived from an examination or analysis of that body part or bodily tissue or
substance; any sale of a medicinal drug, medical device or equipment pursuant
to a medical prescription; and any other information compiled in the course of
providing medical or health services to the individual or incidental to the
provision of such services. Also
included is registration information, such as a person’s social security or
personal health identification number, and any payment or billing information
of an obviously confidential nature. Tissue samples for research may be treated
as gifts to a custodian such as an institution subject to independent ethical
scrutiny if the sample is given with recorded explicit consent.
5. The
collection, use, access to and disclosure of personal health information
without consent violates the patients right to privacy and must only occur in
very limited circumstances such as emergency medical situations, in accordance with
legislation which meets the requirements of the principles outlined in this
statement or in response to a court decision or order. The principal purpose of
the collection of personal health information must be to benefit the patient
who confides or permits the information to be collected for a therapeutic
purpose and to enhance the continuing care of that person. The use of that
information for a secondary purpose such as education and research shall not be
pursued if such activities inhibit patients from confiding information for
their own health care needs, exploits their vulnerability or borrows on the
trust that patients invest in their physicians for their own benefit.
6. Progress in
medicine and in health care is contingent upon the conduct of health and
medical research, including retrospective epidemiological studies, which must
be based on information concerning the health of individuals, communities, and
societies. In many if not most cases, the information required for such studies
is of a non-identifying nature. There may be circumstances in which the coding
system used to anonymise the identity of the patient can be utilized to
identify a particular person or persons, for example, if there is a recognized
hazard to the health of an individual or a community. Biological samples carry
a unique identifier within them and with the rapid developments in DNA typing,
no sample can be truly anonymised.
7. Ethical
committee approval must be obtained for all new studies on biological samples
that were not planned at the time the sample was taken.
8. It is
recognized that non-identifying or de-identified information in the health
sphere does merit protection, not least since it is based, in many cases, on
information that has been compiled within the context of health and medical
care, and the individuals from whom it is derived have a legitimate interest in
it, even after it has been de-identified by a coding or other system.
9. Particular
safeguards may have to be introduced in the case of centralized national health
databases, especially when commercial interests are involved, for example, in
the collection of genetic information based on DNA samples. No individual or
institution should make a profit from allowing commercial access to the
information or samples they hold in guardianship for the individual patient.
PRINCIPLES
10. Right
to Privacy
Each
individual has the right to determine with whom his or her personal health
information is shared and to exercise control over that information even when
in anonymous form.
11. The
purpose of collecting personal health information
The
primary therapeutic purpose of collecting personal health information concerns
the initial reason for a patient consulting a physician and receiving care and
treatment with referral to other professional colleagues on a need-to-know
basis. The primary longitudinal purpose concerns the development of composite
information about a particular patient, in order to enhance ongoing care to
that person. When secondary purposes are involved, a distinction must be made
between purposes mandated in applicable legislation (national or sub-national)
and any other purposes (such as education or research). Non-consensual
collection of personal health information must occur only under strictly
regulated conditions and in very limited circumstances, when it is required or
permitted by national legislation or when it is ordered or decided by a court
of law.
12. Knowledge and specification of
purpose, collection, use, disclosure and access
In the
therapeutic context, health information is provided by or collected under the
patient’s presumption that it is necessary to meet his or her therapeutic
needs. The possibility that some or all of the health information may be
subsequently used, collected, disclosed, or accessed for other purposes, or
transmitted to a centralized database, must be made known to the patient by
reasonable means before it is confided or collected for primary purposes. It is
not acceptable to withhold such knowledge from the patient deliberately out of
concern that knowledge might inhibit him or her from providing important
information fully and truthfully.
13. Consent
The
patient’s ability to decide with whom he or she will share information is
crucial to the right of protection of privacy and the preservation of trust in
the therapeutic context. Only the patient’s consent to the collection, use, and
disclosure of, and access to, health information for the primary purpose can be
inferred, Except for non-consensual purposes of a very limited nature, any
other collection, use, disclosure, or access requires express consent. In some
jurisdictions, national legislation specifies who may give substituted consent
on behalf of minors, on behalf of adults who do not have the capacity to
consent for themselves, or on behalf of deceased persons.
14. Individual
access
Patients
have the right of access to their health information. In rare, limited
circumstances, health information may be withheld from a patient if there is
significant likelihood that disclosure would entail a substantial adverse
effect on the physical, mental or emotional health of the patient or
substantial harm to a third party. The health care provider must be in a
position to justify the denial of access.
15. Accurate
recording of information
Accurate
recording of information is important to protect the patient’s right of privacy
and in order to meet the purposes for which information is collected, used,
disclosed, and accessed.
16. Security
Security
safeguards must be in place in order to ensure that only authorized collection,
use, disclosure, and access occur. Such safeguards must also assure the
integrity of the available information.
17. Accountability
Accountability
is owed first and foremost to the patient. Health information custodians and
custodians of tissue samples must have in place policies and procedures that
recognise the principle of accountability and physicians’ and other health
professionals’ duty of confidentiality to their patients. Anyone a health
information custodian authorizes to have access to health information must be
capable of being held accountable for
his or her actions. In addition, health information custodians must designate a
qualified person responsible and accountable for monitoring and ensuring compliance
with these principles within the particular institution or establishment. In
cases of doubt and where time permits, reference to an independent locally
established ethical committee should be made by the custodians. In order to
promote accountability and discourage inappropriate access, there should be
audit systems in place, especially in electronic environments, to record who
has gained access to health information. Patients should be able to review this
record.
18. Transparency and openness
Policies,
practices and procedures relating to health information must be transparent so
that patients can clearly understand the extent and purpose of health
information collection, use, disclosure and access. These must be explicit
enough that the patients are adequately informed and able to acquire knowledge
germane to their confiding of information, and must also be open to scrutiny
and challenge.
RECOMMENDATIONS
19. It is
recommended that National Medical Associations cooperate with the relevant
health authorities, at the national and other appropriate administrative
levels, to formulate health information policies that conform to the above
principles. These policies should address and provide for the following with
respect to personal health information:
19.1
compliance with and giving effect to a code of
confidentiality;
19.2
protection of the security of health information;
19.3
ensuring the accuracy of recorded health information;
19.4
documentation of all purposes for which the health
information custodian and any custodian of tissue samples uses or discloses the
health information collected, including questions of access, format, consent;
19.5
documentation as to why, how and when the collected
health information may be linked to other information;
19.6
documentation as to what health information could be
made available to third parties;
19.7
allowing access only to authorized users in the
appropriate format and for the limited purposes for which authorization has
been granted;
19.8
identification of the person or persons who are
accountable for policies, procedures, and to whom complaints or enquiries can
be made;
19.9
receiving and responding to complaints or enquiries;
19.10
ensuring that the persons who collect, use, disclose
or access health information can be held accountable under an enforceable duty
to keep information secure;
19.11
ensuring that persons who work for or in health
institutions both public and private know and receive sufficient training about
the code of confidentiality and related institutional policies, procedures and
practices to ensure accountability;
19.12
the means of gaining access to one’s own health
information held by a health institution;
19.13
making available information that a particular
patient specifically requests or can reasonably be presumed to wish to know;
19.14
ensuring that patients have, or can be provided by
reasonable means, with knowledge about their health information and tissue
samples and that their consent is sought and obtained, as appropriate;
19.15
specification of the minimum and maximum retention
periods, and rules for the cession, transfer and destruction of health
information and tissue samples.
19.16
No individual or institution acting as a guardian
should make a profit from allowing commercial access to tissue sample
collections that have been given to the guardian as a gift;
19.17
Individuals and institutions involved in research
must have procedures for making patients aware that their information is used
for research and explain the reasons and safeguards. If patients object to
their information being passed to others, their objections must be respected;
19.18
The policies of health information custodians and the
custodians of tissue samples must be readily available to patients or their
legal representatives and should include information about practices and
procedures.
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19.9.2000
These
documents do not constitute official SAMA policy.
It is, however, the opinion of the legal department
and is provided without prejudice.