Physicians and patients are increasingly moving into telemedicine models of health care.
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.
For advice on properly structuring a telemedicine practice or business,consult an attorney experienced in telemedicine laws.
Our law office has attorneys with legal experience in FDA matters, including guiding clients involved in health care delivery, group medical and private medical practice, who are concerned about issues at the interface of federal and state law, concerned about medical board discipline or medical malpractice liability issues. We also review and draft informed consent forms and guide clients concerning a variety of health care law issues.
If you have legal questions concerning self-referral, kickbacks and fee-splitting or patient brokering in New York, California, Massachusetts, Washington DC, and other states, contact a lawyer who knows the rules.
Consult an experienced health care law attorney who knows complementary medicine and integrative medicine for legal advice pertaining to any project involving allied health or CAM professionals.
Healthcare & FDA attorney Michael H. Cohen is a thought leader in healthcare law & FDA law, pioneering legal strategies in healthcare. wellness, and lifestyle markets. As a corporate and transactional lawyer, FDA regulatory attorney who also handles healthcare litigation, healthcare mediation and healthcare arbitration, and international healthcare & wellness law speaker, Los Angeles / Bay Area healthcare & FDA lawyer Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek healthcare & FDA attorney Michael H. Cohen‘s legal savvy on all aspects of business law, healthcare law, and FDA law, including:
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