CAMLAW: Complementary and Alternative Medicine Law Blog : Complementary, Alternative, & Integrative Medicine Law, Regulation, Ethics & Policy (Alternative and Complementary Medicine, Medical Spa Information, Holistic Health Attorney, and Legal Resources)

Witness this recent report of telemedicine use via mobile phone:

The night before his fourth birthday, Rohan Giare of Rockville rolled off his bed and gashed the bridge of his nose. Rohan's dad, not knowing whether he should focus on getting the bleeding to stop or go immediately to the emergency room, snapped pictures of the cut with his BlackBerry and sent them to his doctor friend, Neal Sikka.

"I just gave [Sikka] a ring," Vishal Giare said, "and got initial input on how serious it might be."

Sikka, an emergency physician at George Washington University, looked at the photos and recommended a trip to the hospital.

Sikka has gotten comfortable using his camera phone to make informal diagnoses for friends and family since he became a doctor in 1999. And as he embraced cellphone culture, Sikka said, he wondered if he could confidently and consistently make diagnoses if regular patients sent him injury snapshots.

In May, Sikka began a six-month study examining how accurately emergency doctors and physician assistants at GWU Hospital could diagnose wounds from patient-generated cellphone images. According to Sikka, it is the largest "mobile health" study looking at acute wound care.

"Mobile health" does not mean a clinic on wheels. It is an emerging field within telemedicine that comprises all aspects of care generated from or available on a portable mobile device such as a cellphone.

Doctors already use traditional forms of telemedicine -- teleconferencing and videoconferencing -- but Sikka said "mHealth" goes further, eliminating the need for scheduling conference rooms and reserving equipment.

MHealth could especially benefit patients living in isolated areas and those who don't want to spend the time, money and energy waiting for evaluation of a superficial injury, Sikka added.

Snapping photos on injuries on a phone and getting advice to head for emergency care are one thing; using telemedicine to substitute for a medical visit, another.  Many states require a face to face encounter as part of the standard of care.

Recently, our attorneys advised a client regarding telemedicine:

At minimum, your question involves three distinct issues:

1. Do ND’s have the scope of practice authority within a given state to prescribe to patients, and if so, under what parameters?

2. Does such prescription authority, to the extent available, include HCG—what are the risks, particularly with respect to investigation either by the relevant state regulatory board, given the controversies surrounding: (i) the efficacy of HCG vs. placebo; (ii) use of HCG in weight loss clinics; (iii) standard of care for treatment of obesity?

3. Can the proposed prescription be given without a face-to-face encounter by the ND (i.e., via Skype or otherwise)?

Obviously neither we nor any attorney can guarantee that X number of states exist where all the answers will magically align to help you move forward. What we can do is carefully research a number of states, which we will identify based on our extensive collective experience (which includes multi-state surveys of telemedicine law, laws governing HCG, laws governing ND scope of practice, and other issues), and explore whether you can find states where legal rules more closely align with your intended business model.

                Please note that the email you forwarded to us from your former attorney only addresses the issue of Internet prescribing, and does not in our minds answer the three key questions identified above. As well, your business model in existing states does raise legal concerns, including these:

·         HCG is, as noted, controversial and has led to enforcement activity by the California and other state medical boards. Attorney experience here is particularly valuable as enforcement priorities can be gleaned by practice experience and not through research of findable law.

·         In many states, tele-consults by non-MD’s (i.e., here, ND’s) are not covered by telemedicine statutes, which usually deal strictly with medical encounters by licensed physicians. 

·         California treats HCG as a controlled substance requiring a prescription; and appears to require that ND’s prescribe only in accordance with standardized procedures or protocols developed by the ND with his or her supervising MD or DO.

·         Telemedicine is often thought of as justified by the need to reach patients in rural locations where few physicians are available, whereas here the model appears to be framed as designed to enhance provider convenience, since patients are physically seen in a clinic and specialty providers are consulted via the Web. This potentially could raise regulatory red flags, and require more careful structuring of the business model to ensure that potential legal safeguards are in place. On a broader scale, proper informed consents and documentation for your clinics and tele-presence, steps to ensure patients privacy and confidentiality, agreements with providers and clinics, and other matters would require proper creative consideration and/or review. 

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Michael H. Cohen is an attorney providing business legal advice to green entrepreneurs and companies, and health care law advice to businesses and physicians, acupuncturists, naturopaths, homeopaths and others in the holistic health, wellness, and green industries.

As a founding attorney of the Global Vision Law Group, he represents businesses poised for vertical lift, whose leaders are conscious, intuitive, and committed to shaping a better world. Michael also advises medical spas and integrative medicine clinics, physicians, chiropractors, naturopathic physicians, massage therapists, energy healers, nutritionists and herbalists, dietary supplement and cosmetics companies, and businesses with bio-energy and other technologies and medical devices. The website also offers the Entrepreneur’s Legal Toolkit as a series of legal guides to businesses.

Read reviews of Mr. Cohen's work on the Complementary Complementary and Alternative Medicine Law Blog. And visit the Legal Services page for information on legal services where a  flat rate or project fee can be discussed (such as incorporation for entrepreneurs, review and drafting of business contracts, trademark, and health law services for CAM providers and others).

Clients through the Global Vision Law Group includes businesses not only in California, New York, Maryland, Massachusetts, Washington, D.C., and other U.S. states, but also abroad.  Our firm also provides special expertise to attorneys and law firms whose clients are involved in wellness industry projects or who require guidance regarding fee-splitting, Stark, anti-kickback, medical board discipline, and other health law and regulatory compliance issues.

To speak with a lawyer about health care law issues pertaining to complementary and alternative medicine, or to consult a business lawyer about laws and legal issues for entrepreneurs and new enterprises that are seeking legal advice, contact the Global Vision Law Group today.