Policy Tag: Confidentiality

Adopted by the 73rd WMA General Assembly, Berlin, Germany, October 2022

 

PREAMBLE

The interaction between the physicians and their relatives seeking medical care can be complex. Moreover, this possibility is highly conditioned by cultural aspects. Interaction can start with asking for simple advice, consultation for minor ailments, and general questions about healthcare and health promotion. This can escalate to seeking medical care and even surgery. Physicians are often their relatives’ first point of call for medical and emotional support. Physicians may be able to offer immediate care in cases of emergency and contribute to well-informed, evidence-based self-care. Other than in emergencies, offering general health information or for minor health problems, physicians should avoid treating those close to them.

The ethical principles governing the work of physicians are equally important and valid when treating relatives. Respect for autonomy may be compromised by lack of privacy, unintentional breaches of confidentiality, and failure to seek informed consent. The relationship with the physician might compromise the patient’s ability to make independent decisions.

Treating relatives may pose challenges in the following circumstances:

  • When objectivity is compromised and decisively affected by emotional factors, there could be a risk of either under- or over-treating relatives or of encountering problems that are beyond the physician’s expertise or abilities, which could cause serious harms.
  • When there are potential barriers to considering sensitive medical history and/or conducting an appropriate physical examination, which may result in incorrect medical diagnosis and treatment.
  • When the physician fails to fulfil requirements concerning patient clinical records, which may result in difficulties if the related patient needs follow-up treatment or when liability issues arise.
  • When a negative medical outcome could compromise the relationship between the physician and the related patient.
  • When the treatment is not in the best interest or against the will of the related patient.
  • When the physician risks providing relatives, perhaps unintentionally and unconsciously, with undue advantages.

 

RECOMMENDATIONS

1.Physicians should avoid routinely acting as a relative’s primary care physician or serving as the attending physician when treating a potentially life-threatening condition. Physicians may provide care to a relative in emergencies, for minor health problems or when there is no other qualified physician available.

2. Related patients may ask for a second opinion about another physician’s care. If a second opinion is shared, it should be consistent with these recommendations and fulfil the duties of physicians to colleagues. Care should be taken to only discuss the treatment, which is most appropriate and recommended, rather than any judgements about the other treating physician’s care and advice.

3. If a physician treats a relative, the physician should be mindful of the following:

  • Strict respect for medical ethics, the patient’s autonomy and consent, with special consideration for minors.
  • The physician has the duty to respect a patient’s right to confidentiality and should not share information with anyone else without a lawful basis, including other family members, with the exception of necessary clinical documentation when referring to other health care personnel.
  • If a relative indicates an intention to seek a second opinion about another physician’s care, that intention must be respected.
  • Consent for treatment must be given by the patient, including competent minors, and for that consent to be valid, it must be fully informed.
  • Depending on the nature of the relationship, taking a sensitive history and performing a physical examination may be emotionally difficult or uncomfortable for the patient or the physician. In such situations the physician and the patient should consider consulting another physician.
  • Clear and concise patient records must be maintained at all times.

4. If the physician cannot accommodate the recommendations above, the physician should avoid treating relatives.

5. While physicians are encouraged not to treat relatives except in certain circumstances, it is acknowledged that physicians are often approached by their relatives for medical advice or treatment, and their help is frequently beneficial and appreciated.

6. In all circumstances, physicians shall maintain the highest professional and ethical standards, in accordance with the Declaration of Geneva, the WMA International Code of Medical Ethics, and the WMA Declaration of Lisbon on the Rights of the Patient.

 

 

Adopted by the 58th WMA General Assembly, Copenhagen, Denmark, October 2007
amended by the 69th WMA General Assembly, Reykjavik, Iceland, October 2018
and rescinded and archived by the 73rd WMA General Assembly, Berlin, Germany, October 2022

DEFINITION

Telemedicine is the practice of medicine over a distance, in which interventions, diagnoses, therapeutic decisions, and subsequent treatment recommendations are based on patient data, documents and other information transmitted through telecommunication systems.

Telemedicine can take place between a physician and a patient or between two or more physicians including other healthcare professionals.

PREAMBLE 

  • The development and implementation of information and communication technology are creating new and different ways for of practicing medicine. Telemedicine is used for patients who cannot see an appropriate physician timeously because of inaccessibility due to distance, physical disability, employment, family commitments (including caring for others), patients’ cost and physician schedules. It has capacity to reach patients with limited access to medical assistance and have potential to improve health care.
  • Face-to-face consultation between physician and patient remains the gold standard of clinical care.
  • The delivery of telemedicine services must be consistent with in-person services and supported by evidence.
  • The principles of medical ethics that are mandatory for the profession must also be respected in the practice of telemedicine.

PRINCIPLES

Physicians must respect the following ethical guidelines when practicing telemedicine:

1. The patient-physician relationship should be based on a personal examination and sufficient knowledge of the patient’s medical history. Telemedicine should be employed primarily in situations in which a physician cannot be physically present within a safe and acceptable time period. It could also be used in management of chronic conditions or follow-up after initial treatment where it has been proven to be safe and effective.

2. The patient-physician relationship must be based on mutual trust and respect. It is therefore essential that the physician and patient be able to identify each other reliably when telemedicine is employed. In case of consultation between two or more professionals within or between different jurisdictions, the primary physician remains responsible for the care and coordination of the patient with the distant medical team.

3. The physician must aim to ensure that patient confidentiality, privacy and data integrity are not compromised. Data obtained during a telemedicine consultation must be secured to prevent unauthorized access and breaches of identifiable patient information through appropriate and up to date security measures in accordance with local legislation. Electronic transmission of information must also be safeguarded against unauthorized access.

4. Proper informed consent requires that all necessary information regarding the distinctive features of telemedicine visit be explained fully to patients including, but not limited to:

  • explaining how telemedicine works,
  • how to schedule appointments,
  • privacy concerns,
  • the possibility of technological failure including confidentiality breaches,
  • protocols for contact during virtual visits,
  • prescribing policies and coordinating care with other health professionals in a clear and understandable manner, without influencing the patient’s choices.

5. Physicians must be aware that certain telemedicine technologies could be unaffordable to patients and hence impede access. Inequitable access to telemedicine can further widen the health outcomes gap between the poor and the rich.

Autonomy and privacy of the Physician

6. A physician should not to participate in telemedicine if it violates the legal or ethical framework of the country.

7. Telemedicine can potentially infringe on the physician privacy due to 24/7 virtual availability. The physician needs to inform patients about availability and recommend services such as emergency when inaccessible.

8. The physician should exercise their professional autonomy in deciding whether a telemedicine versus face-to-face consultation is appropriate.

9. A physician should exercise autonomy and discretion in selecting the telemedicine platform to be used.

Responsibilities of the Physician

10. A physician whose advice is sought through the use of telemedicine should keep a detailed record of the advice he/she delivers as well as the information he/she received and on which the advice was based in order to ensure traceability.

11. If a decision is made to use telemedicine it is necessary to ensure that the users (patients and healthcare professionals) are able to use the necessary telecommunication system.

12. The physician must seek to ensure that the patient has understood the advice and treatment suggestions given and take steps in so far as possible to promote continuity of care.

13. The physician asking for another physician’s advice or second opinion remains responsible for treatment and other decisions and recommendations given to the patient.

14. The physician should be aware of and respect the special difficulties and uncertainties that may arise when he/she is in contact with the patient through means of tele-communication. A physician must be prepared to recommend direct patient-doctor contact when he/she believes it is in the patient’s best interests.

15. Physicians should only practise telemedicine in countries/jurisdictions where they are licenced to practise. Cross-jurisdiction consultations should only be allowed between two physicians.

16. Physicians should ensure that their medical indemnity cover include cover for telemedicine.

Quality of Care

17. Healthcare quality assessment measures must be used regularly to ensure patient security and the best possible diagnostic and treatment practices during telemedicine procedures. The delivery of telemedicine services must follow evidence-based practice guidelines to the degree they are available, to ensure patient safety, quality of care and positive health outcomes. Like all health care interventions, telemedicine must be tested for its effectiveness, efficiency, safety, feasibility and cost-effectiveness.

18. The possibilities and weaknesses of telemedicine in emergencies must be duly identified. If it is necessary to use telemedicine in an emergency situation, the advice and treatment suggestions are influenced by the severity of the patient´s medical condition and the competency of the persons who are with the patient. Entities that deliver telemedicine services must establish protocols for referrals for emergency services.

RECOMMENDATIONS

  1. Telemedicine should be appropriately adapted to local regulatory frameworks, which may include licencing of telemedicine platforms in the best interest of patients.
  2. Where appropriate the WMA and National Medical Associations should encourage the development of ethical norms, practice guidelines, national legislation and international agreements on subjects related to the practice of telemedicine, while protecting the patient-physician relationship, confidentiality, and quality of medical care.
  3. Telemedicine should not be viewed as equal to face-to-face healthcare and should not be introduced solely to cut costs or as a perverse incentive to over-service and increase earnings for physicians.
  4. Use of telemedicine requires the profession to explicitly identify and manage adverse consequences on collegial relationships and referral patterns.
  5. New technologies and styles of practice integration may require new guidelines and standards.
  6. Physicians should lobby for ethical telemedicine practices that are in the best interests of patients.

Adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002
and revised by the 67th WMA General Assembly, Taipei, Taiwan, October 2016

PREAMBLE

1.   The Declaration of Helsinki lays down ethical principles for medical research involving human subjects, including the importance of protecting the dignity, autonomy, privacy and confidentiality of research subjects, and obtaining informed consent for using identifiable human biological material and data.

2.   In health care provision, health information is gathered by physicians or other members of the medical team to record health care events and to aid physicians in the on-going care of their patient.

3.   This Declaration is intended to cover the collection, storage and use of identifiable data and biological material beyond the individual care of patients. In concordance with the Declaration of Helsinki, it provides additional ethical principles for their use in Health Databases and Biobanks.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

4.   A Health Database is a system for collecting, organizing and storing health information. A Biobank is a collection of biological material and associated data. Biological material refers to a sample obtained from an individual human being, living or deceased, which can provide biological information, including genetic information, about that individual. Health Databases and Biobanks are both collections on individuals and population, and both give rise to the similar concerns about dignity, autonomy, privacy, confidentiality and discrimination.

5.   Research using Health Databases and Biobanks can often significantly accelerate the improvement in the understanding of health, diseases, and the effectiveness, efficiency, safety and quality of preventive, diagnostic and therapeutic interventions. Health research represents a common good that is in the interest of individual patients, as well as the population and the society.

6.   Physicians must consider the ethical, legal and regulatory norms and standards for Health Database and Biobanks in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for individuals and population set forth in this Declaration.

When authorized by a national law adopted through a democratic process in respect of human rights, other procedures could be adopted to protect the dignity, autonomy and privacy of the individuals. Such procedures are only acceptable when strict rules on data protection are implemented.

7.   Consistent with the mandate of WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in using data or biological material in Health Databases and Biobanks to adopt these principles.

ETHICAL PRINCIPLES

8.   Research and other Health Databases and Biobanks related activities should contribute to the benefit of society, in particular public health objectives.

9.   Respecting the dignity, autonomy, privacy and confidentiality of individuals, physicians have specific obligations, both ethical and legal, as stewards protecting information provided by their patients. The rights to autonomy, privacy and confidentiality also entitle individuals to exercise control over the use of their personal data and biological material.

10. Confidentiality is essential for maintaining trust and integrity in Health Databases and Biobanks. Knowing that their privacy will be respected gives patients and donors the confidence to share sensitive personal data. Their privacy is protected by the duty of confidentiality of all who are involved in handling data and biological material.

11. The collection, storage and use of data and biological material from individuals capable of giving consent must be voluntary. If the data and biological material are collected for a given research project, the specific, free and informed consent of the participants must be obtained in accordance with the Declaration of Helsinki.

12. If the data or biological material are collected and stored in a Health Database or a Biobank for multiple and indefinite uses, consent is only valid if the concerned individuals have been adequately informed about:

  • The purpose of the Health Database or Biobank;
  • The risks and burdens associated with collection, storage and use of data and material;
  • The nature of the data or material to be collected;
  • The procedures for return of results including incidental findings;
  • The rules of access to the Health Database or Biobank;
  • How privacy is protected;
  • The governance arrangements as stipulated in paragraph 21;
  • That in case the data and material are made non-identifiable the individual may not be able to know what is done with their data/material and that they will not have the option of withdrawing their consent;
  • Their fundamental rights and safeguards established in this Declaration; and
  • When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to other institutions or third countries.

13. In addition to the requirements set forth in the Declaration of Helsinki, when persons who were not able to consent, whose data and biological materials have been stored for future research, attain or regain the capacity to consent, reasonable efforts should be made to seek the consent of those persons for continued storage and research use of their data and biological materials.

14. Individuals have the right to request for and be provided with information about their data and its use as well as to request corrections of mistakes or omissions. Health Databases and Biobanks should adopt adequate measures to inform the concerned individuals about their activities.

15. Individuals have the right, at any time and without reprisal, to alter their consent or to ask for their identifiable data to be withdrawn from the Health Database and their biological material to be withdrawn from a Biobank. This applies to future use of the data and biological materials.

16. In the event of a clearly identified, serious and immediate threat where anonymous data will not suffice, the requirements for consent may be waived to protect the health of the population. An independent ethics committee should confirm that each exceptional case is justifiable.

17. The interests and rights of the communities concerned, in particular when vulnerable, must be protected, especially in terms of benefit sharing.

18. Special considerations should be given to the possible exploitation of intellectual property. Protections for ownership of materials, rights and privileges must be considered and contractually defined before collecting and sharing the material. Intellectual property issues should be addressed in a policy, which covers the rights of all stakeholders and communicated in a transparent manner.

19. An independent ethics committee must approve the establishment of Health Databases and Biobanks used for research and other purposes. In addition the ethics committee must approve use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have to be taken to protect the donor. The committee must have the right to monitor on-going activities. Other ethical review mechanisms that are in accordance to par 6 can be established.

GOVERNANCE

20. In order to foster trustworthiness, Health Databases and Biobanks must be governed by internal and external mechanisms based on the following principles:

  • Protection of individuals: Governance should be designed so the rights of individuals prevail over the interests of other stakeholders and science;
  • Transparency: any relevant information on Health Databases and Biobanks must be made available to the public;
  • Participation and inclusion: Custodians of Health Databases and Biobanks must consult and engage with individuals and their communities.
  • Accountability: Custodians of Health Databases and Biobanks must be accessible and responsive to all stakeholders.

21. Governance arrangements must include the following elements:

  • The purpose of the Health Database or Biobank;
  • The nature of health data and biological material that will be contained in the Health Database or Biobank;
  • Arrangements for the length of time for which the data or material will be stored;
  • Arrangements for regulations of the disposal and destruction of data or material;
  • Arrangement for how the data and material will be documented and traceable in accordance with the consent of the concerned persons;
  • Arrangement for how the data and material will be dealt with in the event of change of ownership or closure;
  • Arrangement for obtaining appropriate consent or other legal basis for data or material collection;
  • Arrangements for protecting dignity, autonomy, privacy and preventing discrimination;
  • Criteria and procedures concerning the access to and the sharing of the health data or biological material including the systematic use of Material Transfer Agreement (MTA) when necessary;
  • The person or persons who are responsible for the governance;
  • The security measures to prevent unauthorized access or inappropriate sharing;
  • The procedures for re-contacting participants where relevant;
  • The procedures for receiving and addressing enquiries and complaints.

22. Those professionals contributing to or working with Health Databases and Biobanks must comply with the appropriate governance arrangements.

23. Health Databases and Biobanks must be operated under the responsibility of an appropriately qualified professional assuring compliance with this Declaration.

24. The WMA urges relevant authorities to formulate policies and law that protect health data and biological material on the basis of the principles set forth in this document.

Adopted by the 60th WMA General Assembly, New Delhi, India, October 2009
and revised by the 73rd WMA General Assembly, Berlin, Germany, October 2022

 

PREAMBLE

  1. Digital health is a broad term that refers to “the use of information and communication technologies in medicine and other health professions to manage illnesses and health risks and to promote wellness.” Digital health encompasses electronic health (eHealth) and developing areas such as the use of advanced computer sciences (including ‘big data’, bioinformatics and artificial intelligence). The term also includes telehealth, telemedicine, and mobile health (mHealth).
  2. The term “digital health” may be used interchangeably with “eHealth.” These terms also include within them: Telehealth” or “Telemedicine,” which both utilize information and communications technology to deliver healthcare services and information at a distance (large or small). They are used for remote clinical services, including real-time patient monitoring such as in critical care settings. Also, they serve for patient-physician consultation where access is limited due to physicians’/patients’ schedules or preferences, or patient limitations such as physical disability. Alternatively, they can be used for consultation between two or more physicians. The difference between the two terms is that “Telehealth” refers also to remote clinical and non-clinical services: preventive health support, research, training, and continuing medical education for health professionals.
  3. Technological developments and the increasing availability and affordability of mobile devices have led to an exponential increase in the number and variety of digital health services in use in both developed and developing countries. Simultaneously, this relatively new and rapidly evolving sector remains largely unregulated, which could have potential patient safety and ethical implications.
  4. The driving force behind digital health should be improving quality of care, patient safety and equity of access to services otherwise unavailable.
  5. Digital health differs from conventional health care in the medium used, its accessibility, and its effect on the patient-physician relationship, as well as on the traditional principles of patient care.
  6. The development and application of digital health has expanded access to health care and health education in both regular and emergency situations. At the same time, its effect on the patient-physician relationship, accountability, patient safety, multistakeholder interactions, privacy and data confidentiality, fair access, and other social and ethical principles should be taken into consideration. However, the scope and application of digital health, telemedicine or telehealth are context-dependent. Factors such as human resources for health, size of service area and level of healthcare facilities should also be taken into consideration.
  7. Physicians should be involved in the development and implementation of digital health solutions to be used in health care, in order to ensure they meet the needs of patients and health professionals.
  8. Consistent with the mandate of the WMA, this statement is addressed primarily to physicians and their role in the health care setting. The WMA encourages others who are involved in healthcare to develop and adhere to similar principles, as appropriate to their role in the healthcare system.

Physician autonomy

  1. Acceptable boundaries in the patient-physician relationship necessary for the provision of optimal care, should exist in digital as well as physical practice. The nearly continuous availability of digital health care has the potential to unduly interfere with a physician’s work-life balance due to theoretical 24/7 availability. The physician should inform patients about his or her availability and recommend services when he or she is not available.
  2. Physicians should exercise their professional autonomy in deciding whether digital health consultation is appropriate. This autonomy should consider the type of visit scheduled, the physician’s comfort with the medium, and the physician’s assessment, together with the patient, of the patient’s comfort level with this type of care.

Patient-physician relationship

  1. Face to face consultation should be the gold standard where a physical examination is required to establish a diagnosis, or where there is a wish on the part of the physician or patient to communicate in person as part of establishing a trusted physician-patient relationship. Face to face consultations may be preferable in some circumstances to take stock of non-verbal cues, and for consultations where there may be communication barriers or discussion of sensitive matters. Ideally, the patient-physician relationship in the context of digital health, should be based on a previously established relationship and sufficient knowledge of the patient’s medical history.
  2. However, in emergency and critical situations, or in settings where access to doctors is not available other than via telemedicine, delivery of care via telemedicine should be prioritized even when a prior patient-physician relationship was not established. Telemedicine can be employed when a physician cannot be physically present within a safe and acceptable period. It can also be used to manage patients remotely including self-management and for chronic conditions or follow-up after initial treatment, where it has been proven to be safe and effective.
  3. The physician providing telemedicine services should be familiar with the technology and/or should receive sufficient resources, training and orientation in effective digital communication. Additionally, the physician should strive to ensure that quality of communication during a digital health encounter is maximized. It is also important that the patient is comfortable using the technology employed. Any significant technical deficiencies should be noted in the documentation of the consultation and reported, if applicable.
  4. The patient-physician relationship is based on mutual trust and respect. Therefore, the physician and the patient must identify each other reliably when telemedicine is employed. However, it must be recognized that sometimes third parties or ‘surrogates’ such as a family member should become involved in the case of minors, the frail, the elderly, or in an emergency situation.
  5. The physician should give clear and explicit direction to the patient during the telemedicine encounter regarding who has ongoing responsibility for any required follow-up and ongoing health care.
  6. In a digital consultation between two or more professionals, the primary physician remains responsible for the patient’s care and coordination.  The primary physician remains responsible for protocols, conferencing, and medical record review in all settings and circumstances. Physicians providing consultation should be able to contact other health professionals and technicians, as well as patients, in a timely manner.

Informed consent

  1. Proper informed consent requires that the patient be informed of, have capacity for, and provide consent specific to the type of digital health being used. All necessary information regarding the distinctive features of digital health, in general, and telemedicine, in particular, must be explained fully to patients including, but not limited to: how telemedicine works, how to schedule appointments, privacy concerns, the possibility of technological failure, including confidentiality breaches; possible secondary use of data; protocols for contact during virtual visits, prescribing policies and coordinating care with other health professionals.  This information should be provided clearly and understandably without coercion or undue influence of the patient’s voluntary choices, while taking into account the patient’s perceived level of health literacy and other resource limitations specific to the type of digital health being used.

Quality of care

  1. The physician must ensure the standard of care delivered via digital health is at least equivalent to any other type of care given to the patient, considering the specific context, location and timing, and relative availability of face to face care. If the standard of care cannot be satisfied via digital technology, the physician should inform the patient and suggest an alternative form of healthcare delivery.
  2. The physician should have clear and transparent protocols for delivering digital health care such as clinical practice guidelines, whenever possible, to guide the delivery of care in the digital setting, recognizing that certain modifications may need to be made to accommodate specific circumstances. Changes to clinical practice guidelines for the digital setting should be approved by the appropriate governing and/or regulatory body or association. If the digital health solution is equipped with automated clinical practice support, this support must be strictly professionally based and not influenced by economic interests in any way.
  3. The physician providing digital services should follow all regulatory requirements and relevant protocols and procedures related to informed consent (verbal, written, and recorded); privacy and confidentiality; documentation; ownership of patient records; and appropriate video/telephone behaviors.
  4. The physician providing care by means of telehealth should keep a clear and detailed record of the advice delivered, the information on which the advice was based and the patient’s informed consent.
  5. The physician should be aware of and respect the particular challenges and uncertainties that may arise when in contact with the patient through telecommunication. The physician must be prepared to recommend direct patient-physician contact whenever possible if he/she believes it is in the patient’s best interests or will improve compliance.
  6. The possibilities and weaknesses of digital health in emergencies must be duly identified. If it is necessary to use telemedicine in an emergency, the advice and treatment suggestions will be influenced by the severity of the patient’s medical condition and the patient’s technological and health literacy. To ensure patient safety, entities that deliver telemedicine services should establish protocols for referrals in emergency situations.

Clinical Outcomes

  1. Entities providing digital health programs should monitor and continuously strive to improve the quality of services to achieve the best possible outcomes.
  2. Entities providing digital health programs should have a systematic protocol for collecting, evaluating, monitoring and reporting meaningful health care outcomes, safety data and clinical effectiveness. Quality indicators should be identified and utilized. Like all health care interventions, digital technology must be tested for its effectiveness, efficiency, safety, feasibility, and cost-effectiveness. Quality assurance and improvement data should be shared to improve its equitable use.
  3. Entities implementing digital health are urged to report unintended consequences to help improve patient safety and further the overall development of the field. Countries are encouraged to implement these guiding principles in their own legislation and regulation.

Equity of care

  1. Although digital health can provide greater access to distant and underserved populations, it may also exacerbate existing inequalities due to, among other things, age, race, socioeconomic status, cultural factors, or literacy issues. Physicians must be aware that certain digital technologies might be unavailable or unaffordable to patients, impeding access and further widening the health outcomes gaps.
  2. Digital technologies should be implemented and monitored carefully to avoid inequity of access to these technologies. Where appropriate, social or healthcare services should facilitate access to technologies as part of basic benefit packages while taking all necessary precautions to guarantee data security and privacy. Access to vital technologies should not be denied to anyone based on financial status or a lack of technical expertise.

Confidentiality and data security

  1. In order to ensure data confidentiality, officially recognized data protection measures must be used. Data obtained during a digital consultation must be secured to avoid unauthorized access and breaches of identifiable patient information through appropriate and up-to-date security and privacy measures. If data breaches do occur, the patient must be notified immediately in accordance with the law.
  2. Digital health technologies generally involve the measurement or manual input of medical, physiological, lifestyle, activity, and environmental data to fulfill their primary purpose. The large amount of data generated also may be used for research or other purposes to improve healthcare and disease prevention. However, secondary uses of personal mHealth data can result in misuse and abuse.
  3. Robust policies and safeguards to regulate and secure the collection, storage, protection, and processing of digital health users’ data, especially personal health data, must be implemented to assure valid informed consent and guarantee patients’ rights.
  4. If patients believe that their privacy rights have been violated, they may file a complaint with the covered entity’s Privacy Officer or data protection authorities, in accordance with local regulations.

Legal principles

  1. A clear legal framework must be drawn up to address potential liability arising from the use of digital technologies. Physicians should only practice telemedicine in countries/jurisdictions where they are licensed to practice and should adhere to the legal framework and regulations as defined by the country/jurisdiction where the physician originates care and the countries in which they practice. Physicians should ensure that their medical indemnity includes telemedicine and digital health coverage.
  2. Reimbursement models must be set up in consultation with national medical associations and healthcare providers to ensure that physicians receive appropriate reimbursement for providing digital health services.

Specific principles of mHealth technology

  1. Mobile health (mHealth) is a form of electronic health (eHealth) for which there is no fixed definition. It has been described as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other devices intended to be used in connection with mobile devices. It includes voice and short messaging services (SMS), applications (apps), and the use of the global positioning system (GPS).
  2. A clear distinction must be made between mHealth technologies used for lifestyle purposes and those that require physicians’ medical expertise and meet the definition of medical devices. The latter must be appropriately regulated, and users must be able to verify the source of medical information provided, as these applications could potentially recommend non-scientific or non-evidence-based treatments. The information provided must be comprehensive, clear, reliable, non-technical, and easily understood by laypeople.
  3. Concerted work must improve the interoperability, reliability, functionality, and safety of mHealth technologies, e.g., through the development of standards and certification schemes.
  4. Comprehensive and independent evaluations must be carried out regularly by competent authorities with appropriate medical expertise to assess the functionality, limitations, data integrity, security, and privacy of mHealth technologies. This information must be made publicly available.
  5. mHealth can only positively contribute to improvements in care if services are based on sound medical rationale. As evidence of clinical usefulness is developed, findings should be published in peer-reviewed journals and be reproducible.

 

RECOMMENDATIONS

  1. The WMA recognizes the value of digital health to supplement traditional ways of managing health and delivering healthcare. The driving force behind digital health should be improving quality of care and equity of access to services otherwise unavailable.
  2. The WMA emphasizes that the principles of medical ethics, as outlined in The Declaration of Geneva: The Physician’s Pledge and the International Code of Medical Ethics, must be respected in the practice of all forms of digital health.
  3. The WMA recommends that the training of digital health literacy and skills be included in medical education and continuing professional development.
  4. The WMA urges patients and physicians to be discerning in their use of digital health and to be mindful of potential risks and implications.
  5. The WMA recommends further research in digital health to assess safety, efficacy, cost-effectiveness, feasibility of implementation, and patient outcomes.
  6. The WMA recommends monitoring the risks of excessive or inappropriate use of digital health technologies and the potential psychological impact on patients and ensuring that the benefits of such technologies outweigh the risks.
  7. The WMA recommends special attention be given to patients’ disabilities (audio-visual or physical) and patients who are minors, when using digital healthcare.
  8. Where appropriate, National Medical Associations should encourage the development and update of ethical norms, practice guidelines, national legislation, and international agreements on digital health.
  9. The WMA recommends that other regulatory bodies, professional societies, organizations, institutions, and private industry, monitor the proper use of digital health technologies and share these findings widely.

 

 

 

Adopted by the 56th WMA General Assembly, Santiago, Chile, October 2005,
revised by the 60th WMA General Assembly, New Delhi, India, October 2009
and by the 70th WMA General Assembly, Tbilisi, Georgia, October 2019

 

PREAMBLE

Genetics contributes to the growing understanding of the causes, developments, classifications and treatments of diseases. The use of genetics is increasing, moving from the identification of monogenic diseases and use in cancer treatment towards predicting risks of multifactorial diseases and manipulation of individual genes. In these ways, the use of genetics does and increasingly will create great value at an individual as well as at a societal level. However, the use of genetic information about individuals also raises issues concerning confidentiality, privacy and the risk of psychological distress, stigmatization, and discrimination.

This declaration provides recommendations for the use of medical genetics that respects the ethical challenges that such use entails. It is primarily aimed at the use of genetics in the provision of health care. The collection, storage and use of genetic data beyond the individual care of patients should adhere to the principles put forward in the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks. The use of genetics in medical research involving human subjects, including research on identifiable human material and data, should adhere to the principles put forward in the WMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. The declaration should be updated in accordance with developments in the field of genetics.

Genetic information has characteristics that are ethically significant. Individually, these characteristics can also be found in other types of health care information. However, the combination of these characteristics makes genetic information particularly sensitive. This sensitivity – combined with the intense interest in genetic information from many different stakeholders – underscores the importance of respecting the fundamental principles of medical ethics, particularly the patient’s right to autonomy, confidentiality, privacy and benefit in relation to generating, storing, using or sharing genetic information.

Central among the ethically significant characteristics are:

  • Genetic information is identifying for an individual.
  • Genetic analysis can generate extensive and detailed information about an individual.
  • Genetic analysis may generate additional findings.
  • The full significance of the information generated by genetic analysis is not yet known.
  • Genetic information about an individual cannot be fully anonymized, and de-identified genetic information may be re-identified.
  • Genetic data contains information not only about the individual who has undergone testing, but also about individuals who are genetically related to the tested individual.
  • Genetic testing of one individual may entail that the physician asks for access to health care information about – or genetic testing of – genetically related persons (family members).

 

ETHICAL PRINCIPLES

Benefit

Genetic testing in the context of healthcare provision should primarily be done for the benefit of the patient being tested.

Relevance

Genetics test should not be wider in scope than what is relevant for the purpose of the test.

Informed consent

  1. Genetic testing should only be done with the informed consent of the individual or his/her legal guardian. Genetic testing for predisposition to disease should be performed on children only if there are clear clinical indications and being aware of the test results would be in the best interests of the child.
  2. The consent process must include providing the patient with understandable, accurate and adequate information about the following:
    • The purpose, nature and benefits of the test.
    • The risks, burdens and limitations of the test.
    • The nature and significance of the information to be generated by the test.
    • The procedures for return of results including additional findings and future discoveries.
    • The options for responding to the results, including possible treatments.
    • How, where, and for how long the test results, data and biological samples will be stored, and who can gain access to current and future results.
    • The possible secondary uses of the information generated by the test
    • The measures protecting confidentiality, privacy and autonomy, including data security measures
    • The procedures for managing results that have implications for genetically related persons
    • When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to third parties.

Additional findings (secondary and incidental findings)

  1. A genetic test may generate additional findings that are not related to the primary purpose of the test, also referred to as secondary or incidental findings. Procedures for handling such findings should be determined before the test, and information about these procedures should be communicated to the patient as part of the consent process.
  2. The principles for managing additional findings must include consideration for:
    • The patient’s preferences regarding the management of additional findings.
    • The significance of the additional findings for the patient’s health and other interests.
    • The significance of the findings for the health and other interests of persons who are genetically related to the patient.
    • The scientific validity of the additional findings.
    • The strengths of the evidence for the correlation between the additional findings and health related risks for the patient.
    • The degree to which the additional findings are actionable, medically or otherwise.

Genetic counselling

  1. Appropriate genetic counselling should always be offered when genetic tests or genetics-based treatments are offered or performed and for the interpretation of results. Counselling should enable the patient to make informed decisions according to their own values and interests. Counselling must not be biased by the personal values of the counsellor. The individual’s right not to be tested should be protected, and if the individual has been tested, there should be no obligation for the individual to act on the results of the test.
  2. Medical students and physicians should receive education and training in genetic counselling, particularly counselling related to pre-symptomatic diagnosis of disease.

Confidentiality

Like all medical records, information from genetic testing or genetic therapy must be kept strictly confidential and must not be revealed to third parties in identifiable form without the consent of the individual tested. Third parties, to whom results may in certain circumstances be released, are identified in paragraph 15.

Informing third parties

In the case of a test result that may have implications for third parties such as close relatives, the individual tested should be encouraged to discuss the results of the test with such third parties. In cases where not disclosing the results involves an expected harm that is serious and unavoidable except by disclosure, and clearly greater than the harm likely to result from disclosure, the physician may reveal necessary information to such third parties without the consent of the patient but should usually discuss this with the patient first. If the physician has access to an ethics committee, it is preferable to consult such a committee prior to revealing information to third parties.

Data protection

The collection, storage and use of genetic data requires the highest level of data protection.

Discrimination

No individual or group must be discriminated against in any way based on genetic makeup, including the fields of human rights, employment and insurance. This protection should apply to those individuals who have undergone genetic testing or genetic therapy as well as those individuals about whom genetic information can be inferred. Particular care should be taken to protect vulnerable individuals and groups. 

Cost of testing

The decision to include genetic analysis as part of medical care can introduce significant cost for the patient and the health care system. Therefore, such a decision should always be based on the expectation that the costs of the analysis are justified by the benefits for the patient.

Reliability and limitations

  1. The identification of disease-related genes has led to an increase in the number of available genetic tests, analyses and treatments. As the number, types and complexity of these increase, great care must be taken to ensure their reliability, accuracy and quality and to inform patients about their limitations.
  2. The benefit of a genetic test for an individual may depend on the availability of information about the relevant background population. Medical professionals should be aware of the scope and the limitations of genetic background data and health information stored in databases used in providing clinical genetic testing services.

Direct-to-consumer tests

If genetic tests are offered directly to consumers for medical purposes, they must meet the same technical, professional, legal and ethical standards as tests offered by certified laboratories and must be in accordance with the recommendations put forward in this statement. In particular, providers of direct-to-consumer tests must provide understandable, accurate and adequate information about the reliability and limitations of their services.

Clinical use of data from research

For research projects that involve genetic testing, and where the participant can be identified, the research participant must be informed about the possibility of findings that indicate a serious threat to the health of the participant. If there are such findings, the participant should be offered a referral to genetic counseling and appropriate medical intervention.

Gene therapy and editing

Gene therapy and editing represents a combination of techniques used to manipulate disease related genes. The use of these techniques should adhere to the following guidelines: 

  • The use of gene therapy and somatic genome editing should conform to standards of medical ethics and professional responsibility.
  • Patient autonomy should be respected, and informed consent should always be obtained. This informed consent process should include disclosure of the risks of gene therapy and editing, including the fact that the patient may have to undergo multiple rounds of gene therapy, the risk of an immune response, the potential problems arising from the use of viral vectors and off-target genome effects.
  • Gene therapy and editing should only be undertaken after a careful analysis of the risks and benefits involved and an evaluation of the perceived effectiveness of the therapy, as compared to the risks, side effects, availability and effectiveness of other treatments.
  • Gene editing of germline cells has scientifically unresolved risks and should not be clinically applied. This does not preclude testing gene editing or other similar research.

Cloning

Cloning includes both therapeutic cloning, namely the cloning of individual stem cells to produce a healthy copy of a diseased tissue or organ for transplant, and reproductive cloning, namely the cloning of an existing human to produce a genetic duplicate of that human. The WMA opposes reproductive cloning of humans.

Adopted by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
and revised by the 68th WMA General Assembly, Chicago, United States, October 2017

 

INTRODUCTION

1.      HIV/AIDS, a chronic manageable disease, is a global pandemic that has created unprecedented challenges for physicians and health infrastructures.

In addition to representing a staggering public health crisis, HIV/AIDS is also fundamentally a human rights issue.

Many factors drive the spread of the disease, such as poverty, homelessness, illiteracy, prostitution, human trafficking, drug (substance) abuse, stigma, discrimination and gender-based inequality.

These social, economic, legal and human rights factors affect not only the public health dimension of HIV/AIDS but also individual physicians/health workers and patients, their decisions and relationships.

Efforts to tackle the disease are also constrained by the lack of human and financial resources available in health care systems.

2.      Discrimination against HIV / AIDS patients by physicians is unacceptable and must be eliminated completely from the practice of medicine.

2.1    All persons with HIV/AIDS are entitled to adequate and timely support, treatment and care with compassion and respect for human dignity.

2.2    It is unethical for a physician to refuse to treat a patient whose condition is within his or her current realm of competence, solely because the patient is seropositive.

2.3    National Medical Associations should work with respective governments, patient groups and relevant national and international organizations to ensure that national health policies clearly and explicitly prohibit discrimination against people infected with or affected by HIV/AIDS, including vulnerable groups such as males having sex with males and transgender persons.

2.4    Woman and man having sex with same sex partners are at a higher risk of discrimination at all levels. National Medical organizations shall work with Government, Non-Governmental Organizations, and Community based organizations to remove the discrimination for these under-privileged disadvantaged groups.

 

APPROPRIATE / COMPETENT MEDICAL CARE

3.      Patients with HIV/AIDS must be provided with competent and appropriate medical care at all stages of the disease.

4.      A physician who is not able to provide the care and services required by patients with HIV/AIDS must make an appropriate timely referral to those physicians or facilities that are equipped to provide such services. Unless or until the referral can be accomplished, the physician must take care for the patient.

5.      All physicians should be able to timely suspect and identify common opportunistic infections such as tuberculosis, fungal infections in HIV-AIDs patients and also suspect HIV-AIDS in presence of these infections especially in high risk individuals like IV drug users.

They must timely counsel these patient about the nexus of these infections with HIV infection.

6.      Physicians and other appropriate professional bodies must ensure that patients have accurate information regarding transmission of HIV/AIDS and strategies to protect themselves against infection.

Proactive measures should be taken to ensure that all members of the population, particularly at-risk groups, are educated to this effect.

Public information and related strategies should recognise that everyone is at risk, and attempt to spell out methods of risk reduction.

7.      Physicians must effectively counsel all seropositive patients regarding responsible behaviour to prevent the spread of the infection to their partners and prevention of opportunistic infections.

8.      Physicians must recognize that many people still believe HIV/AIDS to be an automatic and immediate death sentence and therefore will not seek testing.

Physicians must ensure that patients have accurate information regarding the treatment options available to them.

Patients should understand the potential and need of starting early antiretroviral treatment (ART) to improve not only their medical condition but also the quality of their lives. The new strategy is test and treat strategy.

Effective ART can greatly extend the period that patients are able to lead healthy productive lives, functioning socially and in the workplace and maintaining their independence.

HIV/AIDS is now manageable chronic condition.

For ART country – specific WHO evidence based practice guidelines should be followed and promoted by all NMAs.

9.      Physicians should be aware that misinformation regarding the negative aspects of ART has created resistance toward treatment by patients in some areas. Where misinformation is being spread about ART, physicians and medical associations must make it an immediate priority to publicly challenge the source of the misinformation and to work with the HIV/AIDS community to counteract the negative effects of the misinformation.

10.    Physicians should encourage the involvement of support networks to assist patients in adhering to ART regimens. With the patient’s consent, counselling and training should be available to family members to assist them in providing care.

11.    Physicians must be aware of the discriminatory attitudes toward HIV/AIDS that are prevalent in society and local culture. Because physicians are the first, and sometimes the only, people who are informed of their patients’ HIV status, physicians should be able to counsel them about their basic social and legal rights and responsibilities or should refer them to counsellors who specialize in the rights of persons living with HIV/AIDS.

12.    Physicians should be aware of the current availability and prescribing guidelines for pre-exposure and post-exposure prophylaxis for any patient and health care providers who may have been exposed to HIV.

 

TESTING

13.    Mandatory testing for HIV must be required of donated blood and blood fractions collected for donation or to be used in the manufacture of blood products; organs and other tissues intended for transplantation; and semen or ova collected for assisted reproduction procedures.

Newer technologies which are more sensitive, specific, and reduce the window period of HIV detection, such as nuclear acid testing (NAT), should be encouraged for such screening.

14.    Mandatory HIV testing of an individual against his or her will is a violation of medical ethics and human rights.

15.    Physicians must clearly explain the purpose of an HIV test, the reasons it is recommended and the implications of a positive test result.

Before a test is administered, the physician should have an action plan in place in case of a positive test result. Informed consent must be obtained from the patient prior to testing.

16.    While certain groups are labeled “high risk”, anyone who has had unprotected sex should be considered at risk.

Physicians must become increasingly proactive about recommending testing to patients, based on a mutual understanding of the level of risk and the potential to benefit from testing. Pregnant women and her partner should routinely be offered testing for HIV, and those pregnant women found to be HIV positive should be offered immediate counseling and offered timely ART (at diagnosis) in order to prevent transmission of the virus to the fetus and treatment of the fetus if seropositive.

17.    Counselling and voluntary anonymous testing for HIV should be available to all persons who request it, along with adequate post-testing support mechanisms.

 

PROTECTION FROM HIV IN THE HEALTH CARE ENVIRONMENT

18.    Physicians and all health care workers have the right to a safe work environment. Especially in developing countries, the problem of occupational exposure to HIV has contributed to high attrition rates of the health labour force. In some cases, employees become infected with HIV, and in other cases fear of infection causes health care workers to leave their jobs voluntarily. Fear of infection among health workers can also lead to refusal to treat HIV/AIDS patients. Likewise, patients have the right to be protected to the greatest degree possible from transmission of HIV from health professionals and in health care institutions.

18.1  Proper infection control procedures and universal precautions consistent with the most current national or international standards, as appropriate, should be implemented in all health care facilities. This includes procedures for the use of preventive and timely bART for health professionals who have been exposed to HIV.

18.2  If the appropriate safeguards for protecting physicians or patients against infection are not in place, physicians and National Medical Associations should take action to correct the situation.

18.3  Physicians who are infected with HIV should not engage in any activity that creates a risk of transmission of the disease to others.

In the context of possible exposure to HIV, the activity in which the physician wishes to engage will be the determining factor.

There may be nationally agreed standards but if not a determination should be made by a suitable expert panel or committee of health workers.

18.4  In the provision of medical care, if a risk of transmission of an infectious disease from a physician to a patient exists, disclosure of that risk to patients is not enough; patients are entitled to expect that their physicians will not increase their exposure to the risk of contracting an infectious disease.

18.5  If no risk exists, disclosure of the physician’s medical condition to his or her patients will serve no rational purpose.

18.6  Physicians should be aware of current professional guidelines for post-exposure prophylaxis of health care workers in case of any accidental exposure to HIV.

 

PROTECTING PATIENT PRIVACY AND ISSUES RELATED TO NOTIFICATION

19.    Fear of stigma and discrimination is a driving force behind the spread of HIV/AIDS. The social and economic repercussions of being identified as infected can be devastating and can include violence, rejection by family and community members, loss of housing and loss of employment.

Normalizing the presence of HIV/AIDS in society through public education is the only way to reduce discriminatory attitudes and practices. Until that can be universally achieved, or a cure is developed, potentially infected individuals may refuse testing to avoid these consequences.

The result of individuals not knowing their HIV status is not only disastrous on a personal level in terms of not receiving treatment, but may also lead to high rates of avoidable transmission of the disease. Fear of unauthorized disclosure of information also provides a disincentive to participate in HIV/AIDS research and generally thwarts the efficacy of prevention programs. Lack of confidence in protection of personal medical information regarding HIV status is a threat to public health globally and a core factor in the continued spread of HIV/AIDS. At the same time, in certain circumstances, the right to privacy must be balanced with the right of partners (sexual and injection drug) of persons with HIV/AIDS to be informed of their potential infection. Failure to inform partners not only violates their rights but also leads to the health problems of avoidable transmission and delay in treatment.

20.    All standard ethical principles and duties related to confidentiality and protection of patients’ health information, as articulated in the WMA Declaration of Lisbon on the Rights of the Patient, apply equally in the context of HIV/AIDS. In addition, National Medical Associations and physicians should take note of the special circumstances and obligations (outlined below) associated with the treatment of HIV/AIDS patients.

20.1  National Medical Associations and physicians must, as a matter of priority, ensure that HIV/AIDS public education, prevention and counselling programs contain explicit information related to protection of patient information as a matter not only of medical ethics but of their human right to privacy.

20.2  Special safeguards are required when HIV/AIDS care involves a physically dispersed care team that includes home-based service providers, family members, counsellors, case workers or others who require medical information to provide comprehensive care and assist in adherence to treatment regimens. In addition to implementing protection mechanisms regarding transfer of information, ethics training regarding patient privacy should be given to all team members.

Many countries have specific legislation to protect the privacy of those who are HIV positive. Others may consider the same.

20.3  Physicians must make all efforts to convince HIV/AIDS patients to take action to notify all partners (sexual and/or injection drug) about their exposure and potential infection. Physicians must be competent to counsel patients about the options for notifying partners. 
These options should include:

20.3.1    Notification of the partner(s) by the patient. In this case, the patient should receive counselling regarding the information that must be provided to the partner and strategies for delivering it with sensitivity and in a manner that is easily understood. A timetable for notification should be established and the physician should follow-up with the patient to ensure that notification has occurred.

20.3.2    Notification of the partner(s) by a third party. In this case, the third party must make every effort to protect the identity of the patient.

20.4  When all strategies to convince the patient to take such action have been exhausted, and if the physician knows the identity of the patient’s partner(s), the physician is compelled, either by law or by moral obligation, to take action to notify the partner(s) of their potential infection. Depending on the system in place, the physician will either notify directly the person at risk or report the information to a designated authority responsible for notification.

Physicians must be aware of the laws and regulations in the jurisdiction in which they are practicing. In cases where a physician must disclose the information regarding exposure, the physician must:

20.4.1    inform the patient of his or her intentions,

20.4.2    to the extent possible, ensure that the identity of the patient is protected,

20.4.3    take the appropriate measures to protect the safety of the patient, especially in the case of a female patient vulnerable to domestic violence.

20.5  Regardless of whether it is the patient, the physician or a third party who undertakes notification, the person learning of his or her potential infection should be offered support and assistance in order to access testing and treatment.

20.6  National Medical Associations should develop guidelines to assist physicians in decision-making related to notification. These guidelines should help physicians understand the legal requirements and consequences of notification decisions as well as the medical, psychological, social and ethical considerations.

20.7  As per local and national laws and guidelines requiring the reporting of new HIV infections, sexually transmitted diseases, and opportunistic infections, physicians must protect the privacy and confidentiality of all patients and maintain the highest ethical standards.

20.8  National Medical Associations should work with governments to ensure that physicians who carry out their ethical obligation to notify individuals at risk, and who take precautions to protect the identity of their patient, are afforded adequate legal protection.

 

MEDICAL EDUCATION

21.    National Medical Associations should assist in ensuring that there is training and education of physicians in the most current prevention strategies and medical treatments available for all stages of HIV/AIDS and associated infections, including prevention and support.

22.    National Medical Associations should, when appropriate, collaborate with NGOs and community based organizations, insist upon, and when possible assist with, the education of physicians in the relevant psychological, legal, cultural and social dimensions of HIV/AIDS.

23.    National Medical Associations should fully support the efforts of physicians wishing to concentrate their expertise in HIV/AIDS care, even where HIV/AIDS is not recognized as an official specialty or sub-specialty within the medical education system.

24.    The WMA encourages its national medical associations to promote the inclusion of designated, comprehensive courses on HIV/AIDS in undergraduate and postgraduate medical education programs, as well as continuing medical education.

INTEGRATION of HIV/AIDS SERVICES with other STDs MANAGEMENT ACTIVITES

25.    The National Medical Associations should support governments to integrate HIV/AIDS preventive and curative services with other STD management activities in a comprehensive manner.

 

Adopted by the 45th World Medical Assembly, Budapest, Hungary, October 1993,
revised by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
and reaffirmed by the 203rd WMA Council Session, Buenos Aires, Argentina, April 2016 

 

PREAMBLE

Medical practitioners have an ethical duty and a professional responsibility to act in the best interests of their patients without regard to age, gender, sexual orientation, physical ability or disability, race, religion, culture, beliefs, political affiliation, financial means or nationality.

This duty includes advocating for patients, both as a group (such as advocating on public health issues) and as individuals.

Occasionally, this duty may conflict with a physician’s other legal, ethical and/or professional duties, creating social, professional and ethical dilemmas for the physician.

Potential conflicts with the physician’s obligation of advocacy on behalf of his or her patient may arise in a number of contexts:

  1. Conflict between the obligation of advocacy and confidentiality – A physician is ethically and often legally obligated to preserve in confidence a patient’s personal health information and any information conveyed to the physician by the patient in the course of his or her professional duties. This may conflict with the physician’s obligation to advocate for and protect patients where the patients may be incapable of doing so themselves.
  2. Conflict between the best interest of the patient and employer or insurer dictates – Often there exists potential for conflict between a physician’s duty to act in the best interest of his or her patients, and the dictates of the physician’s employer or the insurance body, whose decision may be shaped by economic or administrative factors unrelated to the patient’s health. Examples of such might be an insurer’s instructions to prescribe a specific drug only, where the physician believes a different drug would better suit a particular patient, or an insurer’s denial of coverage for treatment that a physician believes is necessary.
  3. Conflict between the best interests of the individual patient and society – Although the physician’s primary obligation is to his or her patient, the physician may, in certain circumstances, have responsibilities to a patient’s family and/or to society as well. This may arise in cases of conflict between the patient and his or her family, in the case of minor or incapacitated patients, or in the context of limited resources.
  4. Conflict between the patient’s wishes and the physician’s professional judgment or moral values – Patients are presumed to be the best arbiters of their best interests and, in general, a physician should advocate for and accede to the wishes of his or her patient. However, in certain instances such wishes may be contrary to the physician’s professional judgment or personal values.

RECOMMENDATION

  1. The duty of confidentiality must be paramount except in cases where the physician is legally or ethically obligated to disclose such information in order to protect the welfare of the individual patient, third parties or society. In such cases, the physician must make a reasonable effort to notify the patient of the obligation to breach confidentiality, and explain the reasons for doing so, unless this is clearly inadvisable (such as where telling the patient would exacerbate a threat). In certain cases, such as genetic or HIV testing, physicians should discuss with their patients, prior to performing the test, instances in which confidentiality might need to be breached.A physician should breach confidentiality in order to protect the individual patient only in cases of minor or incompetent patients (such as certain cases of child or elder abuse) and only where alternative measures are not available. In all other cases, confidentiality may be breached only with the specific consent of the patient or his/her legal representative or where necessary for the treatment of the patient, such as in consultations between medical practitioners.Whenever confidentiality must be breached, it should be done so only to the extent necessary and only to the relevant party or authority.
  2. In all cases where a physician’s obligation to his or her patient conflicts with the administrative dictates of the employer or the insurer, a physician must strive to change the decision of the employing/insuring body. His or her ultimate obligation must be to the patient.Mechanisms should be in place to protect physicians who wish to challenge decisions of employers/insurers without jeopardizing their jobs, and to resolve disagreements between medical professionals and administrators with regard to allocation of resources.Such mechanisms should be embodied in medical practitioners’ employment contracts. These employment contracts should acknowledge that medical practitioners’ ethical obligations override purely contractual obligations related to employment.
  3. A physician should be aware of and take into account economic and other factors before making a decision regarding treatment. Nonetheless, a physician has an obligation to advocate on behalf of his or her patient for access to the best available treatment.In all cases of conflict between a physician’s obligation to the individual patient and the obligation to the patient’s family or to society, the obligation to the individual patient should typically take precedence.
  4. Competent patients have the right to determine, on the basis of their needs, values and preferences, what constitutes for them the best course of treatment in any given situation.Unless it is an emergency situation, physicians should not be required to participate in any procedures that conflict with their personal values or professional judgment. In such non-emergency cases, the physician should explain to the patient his or her inability to carry out the patient’s wishes, and the patient should be referred to another physician, if required.