Telemedicine or telehealth laws are providing a growing infrastructure of rules that healthcare practices and business can turn to when building out a model of healthcare beyond the brick-and-mortar practice.
Telemedicine Legal Issues
We counsel a myriad of telemedicine, e-health, mobile health, and digital health clients on legal and regulatory issues in telehealth – be it telemedicine, tele-psychiatry, tele-dermatology, or other areas of mobile or online healthcare.
The kinds of legal and regulatory issues we tackle include:
- Advice to telemedicine companies on legal safe harbors such as the provision of information and education only.
- Drafting Agreements between telehealth companies and hospitals, healthcare facilities, medical groups, and medical doctors or other healthcare practitioners.
- Compliance with fraud and abuse laws such as those prohibiting self-referral (Stark), kickbacks, and fee-splitting
- Licensing issues, including state-by-state telemedicine requirements (whether for diagnosis, treatment, or prescription)
- National telehealth professional standards and governmental regulations
- HIPAA and privacy and security issues
- FDA mobile medical app and medical device guidance
- FTC issues for mobile apps and online health programs
- Telehealth compliance with federal and state laws related to telemedicine
- Transactional issues, including contracts with telemedicine providers
- Other regulatory analysis and compliance advice
Legal Definitions of Telehealth
Telemedicine law is simply an extension of law governing medicine in general.
For example, on its webpage regarding telehealth, the Medical Board of California emphasizes the following:
- Physicians using telehealth technologies to provide care to patients located in California must be licensed in California.
- Physicians need not reside in California, as long as they have a valid, current California license.
- Physicians are held to the same standard of care, and retain the same responsibilities of providing informed consent, ensuring the privacy of medical information, and any other duties associated with practicing medicine regardless of whether they are practicing via telehealth or face-to-face, in-person visits.
- Information consultations between practitioners, telephone conversation, email or IM, or fax, are not telemedicine in California.
Every state has its own laws concerning telehealth practices. The general rule is that telehealth is governed both by the law of the state in which the physician is located (the “home state”) and, the law of the state in which the patient is located (the “remote state”).
In many (if not most) states—with some exceptions—the physician must be licensed in the Remote State as well as the Home State. Thus, it is not sufficient that the physician is licensed in California, if the patient is located in another state.
As well, some states may require that the physician—or a suitable licensed designee, such as (for example) an NP or PA—conduct an in-person exam of the patient. The requirement of a “good faith examination” (sometimes known as an “appropriate prior examination” is a second level of analysis—the first being, whether the physician is licensed in the Remote State or can fall within an applicable exemption.
Our Telemedicine and E-Health lawyers advise telemedicine and telehealth clients about legal rules applicable to their enterprises. Because telemedicine occurs nationally, this requires sensitivity to the nuances of laws in different states. Some states allow special telemedicine licenses while others simply prohibit telemedicine by requiring that physicians be licensed in-state to diagnosis or treat any patient in-state.
California’s Approach to Regulating Telemedicine
California regulates telemedicine by viewing the digital encounter as simply another vehicle in which medicine is practiced. To California regulatory authorities:
- Telemedicine is an extension of medicine: In California, telemedicine is seen as a tool in medical practice, not a separate form of medicine. There are no legal prohibitions to using technology in the practice of medicine, as long as the practice is done by a California licensed physician.
- Email or Phone is not Telemedicine: Under present definitions in California, telemedicine is not a telephone conversation, e-mail/instant messaging conversation, or fax; it typically involves the application of videoconferencing or store and forward technology to provide or support health care delivery.
- Standard of care is the Same: In California, the standard of care is the same whether the patient is seen in-person, through telemedicine or other methods of electronically enabled health care. Physicians need not reside in California, as long as they have a valid, current California license.
Standard of care issues figure prominently in telemedicine and we advise our clients on how to navigate these legal concerns.
We also advise on scope of practice for various health care providers and how applicable legal rules can shape a proposed telemedicine project.
We will draft contracts and guidelines for practice for the various players in a telemedicine project and advise our clients on relevant law.
Privacy and security (HIPAA) issues also arise in the telemedicine context. Telemedicine companies as well as healthcare professionals have a legal duty to safeguard protected health information (PHI)
Telehealth by Other Providers
State law governing telehealth normally is less developed than for other providers. For example, we have counseled on telehealth for providers including:
- Acupuncturists and licensed practitioners of Traditional Oriental Medicine
- Dieticians and Nutritionists
- Non-licensed, Health Coaches
The legal landscape varies by professions. Sometimes, where there are no explicit, written rules, laws governing telemedicine can provide powerful legal analogies to guide best practices. At other times, we will advise our clients if a particular business approach seems low-risk or high-risk.
For example, there is a lot of legal uncertainty around practice as a “health coach.” Medical doctors are also jumping onboard the “health coach” category and attempting to style their services as offerings as outside the medical domain, yet within the bounds of law. Our healthcare attorneys provide sensitive and nuanced information, tailored to the specific practitioner and business opportunity at hand.
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