Policy Tag: Telemedicine

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and rescinded and archived by the 73rd WMA General Assembly, Berlin, Germany, October 2022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 44th World Medical Assembly Marbella, Spain, September 1992
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006

Modern medical technologies and therapies have led to the treatment and control (but not cure) of many potentially fatal illnesses. Such medical successes worldwide have, in turn, led to a rapidly growing population of chronically ill and disabled people of all ages. The problem facing the world health care community is how to best care for his chronically ill and disabled population (including the need to develop new technologies and social/medical organizations).

The goal of medical care in these cases is to control the disease processes and to help the patients maintain their independence and maximum level of function within their own homes and communities.

The scope of medical care includes not only diagnosis and medical treatment but also patient education in self-care and prolonged medical monitoring and supervision.

Patients must learn to perform a wide variety of medical tasks that have only been performed by trained medical personnel in the past. Such tasks can range from that of a diabetic patient who checks his/her blood glucose level 2-4 times a day and adjusts the insulin dose appropriately, to the patient with a pacemaker who learns to use the equipment to send a electrocardiographic rhythm strip over the telephone lines to the local physician’s office or to a distant monitoring center.

Telecommunication technology has made possible new ways for physicians to collect information and manage the medical needs of their patients from a distance. A wide range of medical information can now be transmitted via telephone including electrocardiograms, encephalograms, x-rays, photographs and medical documents of all kinds. Such information can be collected and sent from a patient’s home or physician’s office to a major medical center for interpretation and advice on treatment. The rapid exchange of medical information enables the patient to remain in his/her own home and community and receive the most comprehensive and up-to-date medical care.

The World Medical Association recognizes that “tele-medicine” will undoubtedly play an increasingly important role in the practice of medicine in the future.

Developing tele-surveillance systems need to address the following issues:

  • A central station needs to be able to receive and respond to calls coming from different bio-televigilance systems.
  • There is a need for an interactive system, such as an “interphone system” which allows for dialogue and intervention.
  • The tele-medicine network must establish a medical link from the patient’s home to the most sophisticated medical center. Implementation of tele-surveillance systems includes:
  1. The utilization of communications systems (telephone, television, satellites) for visual consultation and cooperation between doctors at a distance, and for connecting facilities in high quality medical establishments to:
    1. modest medical centers
    2. private homes
    3. convalescent clinics
    4. in those areas that are geographically isolated and distant, or that are not readily accessible in case of an emergency.
  2. Transmission of documents: electrocardiographs, encephalograms, photographs, radiographies, scanners, biological analysis, echograms, magnetic resonance imaging, and a history of the patient, etc.
    • description of symptoms
    • therapeutic and medico-surgical advice
  3. Assistance to homecare (tele-vigilance network): control in cardiology, obstetrics, renal dialysis, respiratory problems, serious physical disorders, etc.

The World Medical Association recognizes that in addition to the technological difficulties involved in developing and implementing tele-medicine systems, there are many ethical and legal issues raised by these new practices. Therefore, the World Medical Association recommends that physicians utilize the following guidelines as key elements in establishing an effective “tele-medicine” network/system.

  1. The physician must determine that the patient or family are competent and well-informed before initiating a tele-medicine system. Those systems that rely on the patient or the family to collect and send the data will not be effective if patients do not understand the significance of the tests and the importance of completing them. Patient compliance psychologically as well as physically is essential.
  2. There must be close collaboration and trust between the patient and the physician who is responsible for his/her medical care. The organizations providing “tele-medicine” services should respect the right of the patient to choose his/her personal doctor.
  3. Close collaboration between the patient’s personal physician and the staff at the “tele-medicine” center is essential to ensure humane, individualized, quality care.
  4. Confidentiality of all patients records must be ensured. There must be strict control of access to records, technological safeguards and heavy legal penalties for infringement.
  5. Control of the quality of the equipment used and the information sent is essential to ensure adequacy of care. Strict monitoring systems for calibration and maintenance of equipment are necessary for patient safety.

Adopted by the 51st World Medical Assembly Tel Aviv, Israel, October 1999
and rescinded at the WMA General Assembly, Pilanesberg, South Africa, 2006

PREAMBLE

Introduction

  1. For many years, physicians have used communications technology such as telephone and telefax to benefit their patients. New electronic information and communication techniques are constantly being developed which facilitate the exchange of information between physicians as well as between physicians and patients. Telemedicine is the practice of medicine, from a distance, in which interventions, diagnostic and treatment decisions and recommendations are based on clinical data, documents and other information transmitted through telecommunication systems.
  2. The use of telemedicine has many potential advantages, and is in increasing demand. Patients who would not otherwise have access to specialists, or occasionally even to basic care, can benefit greatly from this practice. For example, telemedicine enables the transmission of medical images for long distance evaluation by specialists in fields such as radiology, pathology, ophthalmology, cardiology, dermatology and orthopedics. This can greatly expedite specialist services while reducing the potential hazards and costs associated with the transportation of the patient and/or the diagnostic image. Communication systems such as videoconferencing and e-mail enable medical practitioners in many fields to consult with colleagues and with patients more frequently, and to keep excellent records of the consultations. Telesurgery, or electronic collaboration between telesurgical sites, enables less experienced surgeons to perform critical surgery with the guidance and assistance of expert surgeons. The continual development of technology is creating new systems of caring for patients which will widen the scope of benefits from telemedicine far beyond what it is currently. Furthermore, telemedicine provides greater access to medical education and research, particularly for students and medical practitioners in remote areas.
  3. The World Medical Association recognizes that, in addition to the positive consequences of telemedicine, there are many ethical and legal issues arising from these new practices. Notably, by eliminating a common site and face-to-face consultation, telemedicine disrupts some of the traditional principles which govern the physician-patient relationship. Therefore, there are certain ethical guidelines and principles that must be followed by physicians involved in telemedicine.
  4. Because this field of medicine is growing so rapidly, this Statement should be reviewed periodically to ensure that it addresses the most current and critical issues. Forms of telemedicine
  5. Physicians’ ability to use telemedicine depends on access to technology, and thus is not the same in all parts of the world. Without claiming to be exhaustive, the following list describes the most common uses of telemedicine in the world today :
    1. An interaction between a physician and a patient who is in a geographically isolated or hostile environment and has no access to a local physician. Sometimes referred to as tele-assistance, this form is generally restricted to very specific circumstances (e.g. emergencies).
    2. An interaction between a physician and a patient, in which medical information is transmitted electronically (blood pressure, electrocardiogram, etc) to the physician, so that the patient’s condition can be monitored regularly. Sometimes referred to as tele-monitoring, this is used most commonly for patients with chronic illnesses such as diabetes, hypertension, physical handicap, or high-risk pregnancy. In some cases, the patient or a family member can be trained to collect and transmit the necessary data. In other cases, a nurse, medical technician, or other specially qualified person must be involved in order to obtain reliable results.
    3. An interaction in which a patient seeks medical advice directly from a physician using any form of telecommunication, including the internet. This form is sometimes referred to as tele-consultation. On-line consultations, or tele-consultations, in which there is no pre-existing physician-patient relationships or clinical examinations, carry certain risks. Among these are uncertainty concerning reliability, confidentiality and security of information exchanged, as well as the identity and credentials of the physician.
    4. An interaction between two physicians: one physically present with the patient and another who is recognized as being particularly competent regarding a medical problem. Medical information is transmitted electronically to the consulting physician who must decide whether he or she can confidently offer advice based on the quality and quantity of data received.
  6. Regardless of the telemedicine system under which the physician is operating, the principles of medical ethics which are globally binding upon the medical profession must never be compromised.

    PRINCIPLES

    The physician-patient relationship

  7. Telemedicine must not adversely affect the individual physician-patient relationship. When used properly, telemedicine has the potential to enhance this relationship through increased opportunities to communicate and improved access by both parties. As in all fields of medicine, the physician-patient relationship must be based on mutual respect, the independence of judgement of the physician, autonomy of the patient and professional confidentiality. It is essential that the physician and the patient be able to reliably identify each other when telemedicine is employed.
  8. A major application of telemedicine is the situation in which the treating physician seeks another physician’s opinion or advice, at the request or with the permission of the patient. However, in some cases, the patient’s only contact with the physician is via telemedicine. Ideally, all patients seeking medical advice should have a face-to-face consultation with a physician, and telemedicine should be restricted to situations in which a physician cannot be physically present within a safe and acceptable time period.
  9. Where a direct telemedicine consultation is sought by the patient, it should ideally only take place when the physician has an existing professional relationship with the patient, or has adequate knowledge of the presenting problem, so that the physician will be able to exercise proper and justifiable clinical judgement. However, it must be recognized that many health services in which there are no pre-existing relationships (such as telephone counseling centers, and certain types of services in remote areas) are considered valuable services and generally work well within their appropriate frameworks.
  10. In an emergency situation involving telemedicine, a physician’s judgement may have to be based on less than complete information, but in such an instance the clinical urgency of the situation will be the determining factor in providing advice or treatment. In such an exceptional situation, the physician bears legal responsibility for his or her decisions.

    Accountability and Responsibilities of the Physician

  11. The physician must be free and fully independent to decide whether or not to use or recommend telemedicine procedures for his or her patient. A decision to use or reject telemedicine should be based solely on the best interests of the patient.
  12. When practicing telemedicine directly with the patient, the physician assumes responsibility for the case in question. This includes diagnosis, advice, treatment plans and direct medical interventions.
  13. The physician asking for another physician’s advice remains responsible for treatment and other decisions and recommendations given to the patient. However, the tele-expert is accountable to the attending physician for the quality of advice he or she provides, and should specify the conditions under which the advice is valid. He or she is obligated to decline participation if he or she lacks the knowledge, competence or sufficient patient information or data to provide a well-formed opinion.
  14. It is essential for a physician who does not have direct contact with the patient (such as a tele-expert, or a physician involved in a tele-monitoring situation) to be available to participate in follow-up procedures if necessary.
  15. Where non-physicians participate in telemedicine, for example by retrieving or transmitting data, for monitoring or for any other purpose, the physician must ensure that the training and competence of such allied health professionals is adequate to ensure the appropriate and ethical use of telemedicine.

    Role of the patient

  16. In some situations, the patient assumes responsibility for the collection and transmission of data to the physician, as in the case of tele-monitoring. It is the physician’s obligation to ensure that the patient has been properly trained in the necessary procedures, is physically capable, and fully understands the importance of his or her role in the process. The same principle should be applied to a family member or other caretaker assisting the patient in a telemedicine procedure.

    Patient Consent and Confidentiality

  17. Prevailing rules of patient consent and confidentiality also apply to telemedicine situations. Patient data and other information may be transmitted to a physician or other health professional, only on the request, or with the informed consent, of the patient, and to the extent approved by him or her. The data transmitted must be relevant to the problem in question. Because of the risks of information leakage inherent to some types of electronic communication, the physician has an active obligation to ensure that all established standards of security measures have been followed to protect the patient’s confidentiality.

    Quality of care and safety in Telemedicine

  18. A physician practicing telemedicine is responsible for the quality of care the patient receives., and must not opt for a telemedicine consultation unless he or she believes this to be the best option available. For this decision the physician should consider issues of quality, access and cost.
  19. Quality assessment measures should be used regularly to ensure the best possible diagnostic and treatment practices in the telemedicine situation. A physician should not practice telemedicine unless he or she is confident that the equipment necessary for the process is of sufficiently high quality, satisfactorily operational, and complies with recognized standards. Backup systems should be available in case of emergency. Routine controls and calibration procedures should be used to monitor the accuracy and quality of data collected and transmitted. For all telemedicine interactions there should be an established protocol that addresses issues regarding the appropriate actions to take if an equipment failure should occur or if a patient develops problems during a telemedicine situation.

    Quality of data and information

  20. The physician who practices medicine from a distance without seeing the patient must carefully evaluate the data and other information he or she has received. The physician can only give medical opinions, make medical decisions or give recommendations if the quality and quantity of data or other information received is sufficient and relevant to the case in question.

    Authorization and competence in practicing Telemedicine

  21. Telemedicine provides opportunities to enhance the effective use of medical human resources world-wide, and thus should be open to all physicians even across national borders.
  22. Physicians practicing telemedicine must be authorized to practice medicine in the country or state in which they are located, and should be competent in the field of medicine they are practicing. When practicing telemedicine directly with a patient located in another country or state, the physician must be authorized to practice in that state or country, or it should be an internationally approved service.

    Patient records

  23. All physicians practicing telemedicine must keep adequate patient records, and all aspects of each case must be properly documented. The method of patient identification should be recorded, as well as the quantity and quality of data and other information received. Findings, recommendations, and telemedicine services delivered should be adequately recorded., with every effort to ensure the durability and accuracy of the information stored.
  24. An expert whose advice is sought via telemedicine should also keep detailed records of the advice he or she delivers, as well as the data and other information on which it was based.
  25. Electronic methods of storing and transmitting patient information may be used only where sufficient measures have been taken to protect patient confidentiality and the security of the information registered or exchanged.

    Training in telemedicine

  26. Telemedicine is a promising field of medical practice, and training in this field should be part of both basic and continued medical education. Educational opportunities should be open to all physicians and allied health professionals interested in telemedicine.

    RECOMMENDATIONS

  27. The World Medical Association recommends that National Medical Associations:
    1. Adopt the World Medical Association Statement on Accountability, Responsibilities and Ethical Guidelines in the Practice of Telemedicine;
    2. Promote training and assessment programs for telemedicine techniques, regarding quality of care, the physician-patient relationship, and cost effectiveness;
    3. Develop and implement, together with the appropriate specialized organizations, practice guidelines which should be used as tools in the training of physicians and allied health professionals who might use telemedicine;
    4. Encourage the development of standard protocols, for national and international application, which address medical and legal issues such as physician registration and liability, and the legal status of electronic medical records; and
    5. Establish guidelines for the proper conduct of teleconsultations, which include the issues of commercialization and mass exploitation; and
  28. The WMA continues to monitor the practice of telemedicine in its various forms.

Adopted by the 66th WMA General Assembly, Moscow, Russia, October 2015
and rescinded and archived by the 73rd WMA General Assembly, Berlin, Germany, October 2022

PREAMBLE

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).

Sufficient policies and safeguards to regulate and secure the collection, storage, protection and processing of data of mHealth users, especially health data, must be implemented. Users of mHealth services must be informed about how their personal data is collected, stored, protected and processed and their consent must be obtained prior to any disclosure of data to third parties, e.g. researchers, governments or insurance companies.

The monitoring and evaluation of mHealth should be implemented carefully to avoid inequity of access to these technologies. Where appropriate, social or healthcare services should facilitate access to mHealth technologies as part of basic benefit packages, while taking all the required precautions to guarantee data security and privacy. Access to mHealth technologies should not be denied to anyone on the basis of financial status or a lack of technical expertise.

mHealth technologies cover a wide spectrum of functions. They may be used for:

  • Health promotional (lifestyle) purposes, such as apps into which users input their calorie intake or motion sensors which track exercise.
  • Services which require the medical expertise of physicians, such as SMS services providing advice to pregnant women or wearable sensors to monitor chronic conditions such as diabetes. mHealth technologies of this nature frequently meet the definition of a medical device and should be subject to risk-based oversight and regulation with all its implications.

mHealth may also be used to expedite the transfer of information between health professionals, e.g. providing physicians with free, cross network mobile phone access in resource poor settings.

Technological developments and the increasing prevalence and affordability of mobile devices have led to an exponential increase in the number and variety of mHealth services in use in both developed and developing countries. At the same time, this relatively new and rapidly evolving sector remains largely unregulated, a fact which could have potential patient safety implications.

mHealth has the potential to supplement and further develop existing healthcare services by leveraging the increasing prevalence of mobile devices to facilitate access to healthcare, improve patient self-management, enable electronic interactions between patients and their physicians and potentially reduce healthcare costs. There are significant regional and demographic variations in the potential use and benefits of mHealth. The use of certain mHealth services may be more appropriate in some settings than others.

mHealth technologies generally involve the measurement or manual input of medical, physiological, lifestyle, activity and environmental data in order to fulfil their primary purpose. The large amount of data generated in this way also offers huge scope for research into effective healthcare delivery and disease prevention. However, this secondary use of personal data also has great potential for misuse and abuse, of which many users of mHealth services are unaware.

The expansion of mHealth services has been largely market driven and many technologies have been developed in an uncoordinated, experimental fashion and without appropriate consideration of data protection and security or patient safety aspects. It is often impossible for users to know whether the information provided via mHealth stems from a reliable medical source. Major challenges faced by the mHealth market are the quality of mHealth technologies and whether their use ultimately helps patients or physicians achieve the intended purpose.

Comprehensive regulation and evaluation of the effectiveness, quality and cost effectiveness of mHealth technologies and services is currently lacking, which has implications for patient safety. These factors are crucial to the integration of mHealth services into regular healthcare provision.

RECOMMENDATIONS

The WMA recognises the potential of mHealth to supplement traditional ways of managing health and delivering healthcare. While mHealth may offer advantages to patients otherwise unable to access services from physicians, it is not universally appropriate, nor is it always an ideal form of diagnosis and treatment option. Where face-to-face treatment is available this is almost always advantageous to the patient.

The driving force behind mHealth must be the need to eliminate deficiencies in the provision of care or to improve the quality of care.

The WMA urges patients and physicians to be extremely discerning in their use of mHealth and to be mindful of potential risks and implications.

A clear distinction must be made between mHealth technologies used for lifestyle purposes and those which require the medical expertise of physicians and meet the definition of medical devices. The latter must be appropriately regulated and users must be able to verify the source of information provided. The information provided must be clear, reliable and non-technical, and therefore comprehensible to lay people.

Concerted work must go into improving the interoperability, reliability, functionality and safety of mHealth technologies, e.g. through the development of standards and certification schemes.

Comprehensive and independent evaluations must be carried out by competent authorities with appropriate medical expertise on a regular basis in order to assess the functionality, limitations, data integrity, security and privacy of mHealth technologies. This information must be made publicly available.

mHealth can only make a positive contribution towards 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.

Suitable reimbursement models must be set up in consultation with national medical associations and healthcare providers to ensure that physicians receive appropriate reimbursement for their involvement in mHealth activities

A clear legal framework must be drawn up to address the question of identifying potential liability arising from the use of mHealth technologies.

Physicians who use mHealth technologies to deliver healthcare services should heed the ethical guidelines set out in the WMA Statement on Guiding Principles for the Use of Telehealth for the Provision of Health Care.

It is important to take into account the risks of excessive or inappropriate use of mHealth technologies and the potential psychological impact this can have on patients.

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.