Telemedicine Legal & Compliance
Guidance
Guidance
Telemedicine or telehealth laws are providing a growing infrastructure of rules that healthcare practices and businesses can turn to when building out a model of healthcare beyond the brick-and-mortar practice.
Telemedicine Law & 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, 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 matters, including contracts with telemedicine providers
- Website or Mobile App review, including Terms of Use (with telemedicine disclaimers) and Privacy Policy
- Other regulatory analysis and compliance advice
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.
Legal Definitions of Telehealth
Telemedicine law is simply an extension of the 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 conversations, email or IM, or fax, are not telemedicine in California.
Every state has its 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.
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 on using technology in the practice of medicine, as long as a California-licensed physician does the practice.
- 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 the 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)
Telemedecine by Other Providers
State law governing telehealth is normally less developed than for other providers. For example, we have counseled on telehealth for providers, including:
- Acupuncturists and licensed practitioners of Traditional Oriental Medicine
- Chiropractors
- Dentists
- Dietitians and Nutritionists
- Non-licensed Health Coaches
The legal landscape varies by profession. 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 the practice of being a “health coach.” Medical doctors are also jumping on board the “health coach” category and attempting to style their services as offerings 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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Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
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- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
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Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
