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World Medical Association Statement on Accountability, Responsibilities and Ethical Guidelines in the Practice of Telemedicine |  |  |
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Adopted by the 51st World Medical Assembly
Tel Aviv, Israel, October 1999
A. PREAMBLEIntroduction §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: 5.1 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). 5.2 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. 5.3 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. 5.4 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.
B. PRINCIPLESThe 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.
C. RECOMMENDATIONS§27 The World Medical Association recommends that National Medical Associations: 27.1 Adopt the World Medical Association Statement on Accountability, Responsibilities and Ethical Guidelines in the Practice of Telemedicine; 27.2 Promote training and assessment programs for telemedicine techniques, regarding quality of care, the physician-patient relationship, and cost effectiveness; 27.3 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; 27.4 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 27.5 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.
