New legal issues will arise as the use of information and communication technologies in medicine proliferates. Cross-jurisdictional practice will be the primary cause, with issues arising because of different regulatory environments and the conflicting cultural and political values that may exist. Licensing, the right to reimbursement, and privacy concerns all have the potential to hinder the expansion of telehealth. Risk management and the availability of insurance in cross-jurisdictional practice are likely to become significant issues. The use of e-learning, which is becoming an integral component of health care, will raise issues of quality, ownership of content, and accreditation. Activities that are currently unregulated, such as the provision of health care information, will attract regulation in certain settings if consumers come to demand a level of quality and competency that is not being delivered by the information provider. Just as business has adapted to the existence of the Internet, telehealth can be expected to adapt to these strictly legal challenges.
”To our patients—For insurance reasons, the doctor will be treating you anonymously via teleconference from an undisclosed location.”
—Sign seen on doctor’s office wall
Telehealth is in its infancy, and not unexpectedly there are more questions than answers. That said, in a commercial context the law governing business has shown itself able to adapt in a short time to the existence of the Internet. Notwithstanding the uncertainty and the challenges that will arise, telehealth is likely to have the same experience in adapting to its legal challenges.
Distinguishing between the terms telehealth and telemedicine is a useful way to begin:
“Telehealth is the use of information and communication technology (ICT) to deliver health services, expertise and information over distance. It includes Internet or web-based ‘e-health’ and video-based applications, and can be delivered ‘real-time’ or through ‘store-and-forward’ mode. Telehealth is unique in having the capability to cross geographical, temporal, political, social and cultural barriers within the health sector... Telemedicine is often used interchangeably with telehealth, however the term telemedicine generally implies a physician mediated interaction with patients.”
These definitions are instructive because they point to (1) the interjurisdictional nature of information-technology-based health care and the problems raised by this, and (2) the need to be clear about what function is actually taking place when telehealth services are provided in order to assess the applicability of existing laws and regulations. The metaphors one uses to relate telehealth to current experience may well have a significant impact on how telehealth is viewed by the law.
It is accepted that physical interaction with patients by physicians and other licensed health care professionals will trigger both professional regulation and the potential for liability. It is not certain what degree of “electronic” interaction will be necessary to lead to a similar result.
When asserting their regulatory jurisdiction, the Canadian colleges of physicians rely on undefined statutory references as to what constitutes the practice of medicine. Clear definitions may be necessary to provide certainty in the context of telehealth.
Direct physician contact with patients (which is subject to regulation) can be distinguished from other largely unregulated telehealth activities such as the creation of an electronic health care record (although there are government-regulated standards in the USA with the Health Insurance Portability and Accountability Act, 1996), and the provision of general health and treatment-related information (which is not directed to a specific patient) through electronic media such as WebMD.com.
Three issues constitute potential barriers to the expansion of telehealth:
1. Licensure and the cross-jurisdictional regulation of practice and standards.
2. The right to reimbursement for services rendered.
3. Patients’ rights and attitudes with respect to privacy and personally identifiable electronic data.
As of 2002, 50% of American jurisdictions have addressed the issue of cross-border licensing. All have struggled with the concept of face-to-face treatment. There is no consensus in Canada about whether patient care takes place at the patient’s location or the health care provider’s location. In the absence of interjurisdictional agreement, the physical location of the patient at the time of the interaction is likely to remain a key factor in determining the applicability of local licensing and the standard of care required of the licensed professional. Until this is resolved, licensed health care providers will want to comply with the laws and regulations of all potentially interested jurisdictions.
To the extent that licensing is required, alternatives include consulting exceptions, endorsement where similar standards exist, mutual recognition, registration, limited licensure, and full licensure. The legal profession is responding to cross-jurisdictional practice in Canada in a way suggesting that a legal practice certificate will soon be more analogous to a driver’s licence than to a provincially restricted permit to practise. Some medical disciplines, such as psychiatry and emergency medicine, are more likely to be early adopters of telemedicine because tools such as videoconferencing provide a 21st-century alternative to face-to-face consultation. The manner in which these early adopters come to be regulated will be instructive.
Most telemedicine initiatives are currently being funded through academic research. Governments and HMOs have been slow to change existing tariffs, primarily because of cost. Physician entitlement to payment for telemedicine services is likely to remain an unresolved issue for some time.
In the past, privacy has usually been more of an institutional concern, and has included issues relating to the content and general security of the electronic medical record (EMR) and the impact of the Personal Information Protection and Electronic Documents Act. For example, among other things, the Act mandates standards relating to accuracy, security, and access, and imposes restrictions on the use of information unless for a stated purpose.
For individuals, however, personal privacy most often means the need to keep specific medical conditions private—most notably drug dependency, mental illness, and HIV status. Electronic storage of medical information (including the EMR) is analogous to long-term memory, and it is also conducive to the accumulation of information from unrelated sources. In their purest form, privacy rights include the right to have information “forgotten.” This principle is obviously incompatible with much of the health care information that might be kept.
In addition to federal and provincial privacy commissioners in Canada, there are many other governmental and nongovernmental agencies active in promoting personal privacy, such as the NGO TRUST.e.
Members of the public may well react negatively to telehealth as a result of privacy concerns until there is a history of secure storage and controlled access. The use of centralized facilities for patient interaction, such as videoconferencing suites, has suggested a heightened awareness on the part of patients for anonymity in their interactions with the health care system. Similarly, physicians may show some reticence about being recorded when providing patient care. Would, for example, the recording of a physician’s interaction with the patient form part of the EMR?
Other legal issues arising from the implementation of telehealth include:
• Quality of care, risk management, and the availability of insurance.
• Training, e-learning, and accreditation.
• Physician and other licensed health care provider web sites and the regulation of them.
• Health care commerce and the extent to which it needs to be regulated to ensure uniformity of quality.
Risk management in telemedicine suggests the need for protocols that establish the party primarily responsible for care. Having said that, existing protocols may be more than sufficient, provided they are the same in the jurisdictions involved in the particular telemedicine intervention. From an insurer’s perspective, this might translate into agreements allocating risk between participating health care providers. An alternative may be increased use of patient-consent forms and agreements between physicians with respect to allocating liability.
Differing standards of care in the jurisdictions involved could affect both the need for regulation and the extent of legal liability for negligence. The law generally sets the standard of care based on locale. Standards may vary from jurisdiction to jurisdiction, and there could be significant conflict between the standard in the patient’s jurisdiction and the jurisdiction of the licensed health care worker. One response may be the increased use of uniform practice guidelines.
It remains to be seen how insurance carriers will react to telemedicine. The continuing difficulty in obtaining errors-and-omissions coverage will only be exacerbated by the uncertainties of interjurisdictional practice. Caution suggests that physicians should confirm coverage with their insurance carriers.
Training is an integral component of the health care system. The scope of e-learning includes not only the training of health care providers but of patients themselves. Quality, ownership of content (including the right to use it), and accreditation issues may well arise.
Physicians and other licensed health care providers may feel compelled to increase their presence online for reasons of efficiency and in order to compete with other providers. Many jurisdictions have professional codes regulating physician advertising, which may need to be adapted in response to physicians’ online presence.
Traditionally unregulated activities may also come under scrutiny because of consumer demand. Telehealth commerce to date has been centred on information providers, online pharmacies, and alternative health care providers. To the extent that information technology facilitates the delivery and expansion of alternative health care, it is possible that governments may respond with an increase in regulation. Having said that, it appears that there is little willingness on the part of government and professional bodies to regulate services that merely provide information, as long as licensed health care workers are not involved. Ironically, this could lead to trained health care professionals being subject to more regulation than their untrained commercial “competitors.”
And last but not least, one can expect local authorities to become interested in determining how to tax telehealth services that are provided by a professional in one jurisdiction and delivered to patients in other jurisdictions.
Like the dinosaurs in the Jurassic Park films, which against all odds were able to procreate, telehealth will find a way. Its success will not be measured immediately, nor will it occur overnight. Until a clear scientific benefit and economic efficiencies can be demonstrated, the barriers to implementation will remain as they are today—theoretical.
1. US Department of Commerce/US Department of Health and Human Services. Telemedicine Report to Congress, 31 January 1997, www.ntia.doc.gov/reports/telemed/index.htm (accessed 2 May 2004).
2. Health Telematics Unit, University of Calgary. Glossary. http://www.fp.ucalgary.ca/telehealth/Glossary.htm (accessed 2 May 2004).
3. Smalley RE. Will a lawsuit a day keep the cyberdocs away? Rich J L & Tech 2001;7:29. http://law.richmond.edu/jolt/v7i3/article3.html (accessed 2 May 2004).
4. Office of the Privacy Commissioner of Canada. Privacy legislation. www.privcom.gc.ca/legislation/index_e.asp (accessed 2 May 2004).
5. TRUST.e web site. www.truste.org (accessed 2 May 2004).
6. TRUST.e applauds bankruptcy court decision regarding Toysmart.com. 17 August 2000. TRUST.e web site. www.truste.org/news/padvisories/users_toysmart_adv.html (accessed 2 May 2004).
7. Ho K, Karlinsky H, Bates J. Telehealth: Under-appreciated barriers to implementation. Panel discussion at: Telehealth 2002, 5th Annual Meeting of the Canadian Society of Telehealth, Vancouver, BC, 3–5 October 2002.
Gary W. Dunn, BA, LLB
Mr Dunn was called to the bar in British Columbia in 1975. Since then he has practised commercial law with an emphasis on technology-related and corporate matters, and has advised members of the medical profession and business on telehealth issues.
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