Is an online telemedicine or telehealth service legal?

Recently our law office has exploded with calls about the legal issues surrounding new online telemedicine or telehealth services.

Is an online telemedicine or telehealth service legal?

The answer, of course, it that it depends on the intersection of several areas of law.  These include:

  • licensing
  • malpractice liability
  • professional discipline
  • general liability principles
  • regulation of telemedicine and telehealth by state
  • ethical constraints in a given profession (such as medicine, pscyhology, psychiatry, or counseling)
  • insurance issues including insurance fraud, billing and coding, Medicare and Medicaid fraud and abuse, fee-splitting, kickback law and Stark, health care fraud, and so on
  • informed consent principles (legal and ethical)

The bottom line is that although most of the medical licensing statutes remain relatively unchanged since their passage in the late-nineteenth century, they control business use of modern technologies such as the Internet when it comes to health care practices.

There is fine line between merely giving information on the Internet regarding generic health care conditions, which is legally permissible, and giving information tailored to a specific patient, which can be considered "diagnosis" and "treatment" of a medical condition.

There is also a sliding scale between medical information and claims on one hand, and generic research, literature, and health advice on the other.

Many telemedicine providers obliterate the line and thus run afoul of current law and regulation, although regulators have not yet caught up and many fly under the radar.

Others are hoping for technology to push the boundaries of what is legally permissible.

There are several associations and organizations dedicated to telemedicine and telehealth, but getting free advice on legal issues can lead to taking a dangerous legal position and later facing lawsuits or criminal charges if that position is unsupportable.  It's sort of like deciding to wire your home based on reading a book about electricity and getting advice from a friend who is an electrician.  Not advisable.

                As well, there is often confusion about definitions such as “telemedicine” and “telehealth” and whether these terms variously refer to medical communications in-state or out-of-state. A changing regulatory landscape and conflicting advice from emerging professional or quasi-professional organizations complicates the picture. 

            Due to definitional confusion regarding legal issues raised by telemedicine, in 1996 the Federation of State Medical Boards (“FSMB”) promulgated a document known as A Model Act to Regulate the Practice of Medicine Across State Lines(the “Telemedicine Model Act”). The Telemedicine Model Act defines telemedicine as “the practice of medicine across state lines.” [1]  This includes “any medical act that occurs when the patient is physically located within the state and the physician is located outside the state” (emphasis added).[2]

            With respect to unlicensed medical practice, the Executive Summary of the Telemedicine Model Act states that:

Any contact that results in a written or documented medical opinion and that affects the diagnosis or treatment of a patient constitutes the practice of medicine. This is true whether the physician and patient are connected through telecommunications or whether patient data (such as X-rays, EKGs, or laboratory tests) are transported by courier services or in some other manner. When the practice of medicine occurs as defined by the Medical Practice Act of an individual state in which the patient is located, then such practice should be subject to regulation by the patient’s state medical board.

In other words, the contact will be regulated not only by the state in which the practitioner is located (the “Remote State”), but also by the state where the patient is located (the “Home State”).

            This is consistent with another document issued by the FSMB, Model Guidelines for the Appropriate Use of the Internet in Medical Practice (the “Internet Model Guidelines”). These state that “physicians who treat or prescribe through Internet websites are practicing medicine and must possess appropriate licensure in all jurisdictions where patients reside.”

            Essentially, in response to the problem of unlicensed medical practice across state lines, the Telemedicine Model Act calls for an abbreviated licensure process for out of-state physicians who wish to provide telemedicine services. Such licensure would subject the physician to the Medical Practice Act of the issuing state (i.e., the Remote State), including its disciplinary provisions, in addition to existing obligations under the Medical Practice of the Home State[3]. The special purpose license would only be required of physicians who “regularly or frequently” engage in the practice of medicine across state lines. According to the FSMB, each state medical board will define what constitutes the regular practice of such medicine.

            However, the Telemedicine Model Act provides one exception to the requirement for an abbreviated telemedicine license. The practice of medicine across state lines:

will not fall under the provisions of the model, if the practice occurs less than once a month, involves less than ten patients on an annual basis, or comprises less than one percent (1%) of the physician’s diagnostic or therapeutic practice. Importantly, it should be noted that physician-physician consultations, which occur from time to time and are traditional in the practice of medicine, would not be so regulated.

 

           The Model Act is not law, but a recommendation to states to implement legislation based on the model.Therefore, it is important to understand the in each Home State and well as Remote State in which the telemedicine provider has physicians and patients.

As suggested, many tele-medicine and tele-health or online providers of medical as well as mental health services are out of compliance with relevant telemedicine law and regulation.  They are simply pushing the envelope and hoping not to get caught; or, they may find their physicians and other health care providers are getting inquiries from local medical and other professional regulatory boards, and then it may be that the provider can simply drop the physician if the provider, but not the business, gets into legal trouble.

    There are important kickback, insurance coding and other issues, and it is important to consult an experienced telemedicine attorney for legal advice.

***

Our health care, business law, and alternative medicine law attorneys regularly consult and advise on telemedicine and other health care law and business legal matters involving online enterprises and emerging or established companies.  For legal advice concerning telemedicine and other health care practices, whether involving physicians, nurses, psychiatrists, psychologists, life coaches, fitness consultants, or CAM providers such as acupuncturists, nutritionists and dietitians, homeopaths, naturopathic physicians, hypnotherapists, energy healers, and others, contact our health care lawyers today.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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. Michael offers the Entrepreneur’s Legal Toolkit as a series of legal guides to businesses. The first legal e-book deals with Contract Essentials, giving legal tips every business needs to negotiate its legal agreements; the second addresses legal issues faced by multi-level marketing companies and individuals involved in multilevel marketing and direct sales; and the third one so far is a HIPAA Regulations and Privacy Manual at far less the cost than it would take for an attorney to prepare.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services

Read reviews of Michael’s work on the Complementary and Alternative Medicine Law Blog. And visit the Flat Rate Legal Services page for information on legal services offered at a flat rate or project fee (such as incorporation for entrepreneurs, review and drafting of business contracts, trademark, and health law services for CAM providers and others).

Michael’s clientele  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. 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. 

 

 

 

 

 

 

 


[1] The America Telemedicine Association (ATA) defines telemedicine as “the use of medical information exchanged from one site to another via electronic communications to improve patients' health status. According to the ATA, closely associated with telemedicine is the term "telehealth," which is often used to encompass a broader definition of remote healthcare that does not always involve clinical services. Videoconferencing, transmission of still images, e-health including patient portals, remote monitoring of vital signs, continuing medical education and nursing call centers are all considered part of telemedicine and telehealth.” The ATA includes in telemedicine services: specialist referral services; patient consultations; remote patient monitoring; medical education; and consumer medical and health information. For additional definitions and standards by a professional organization, see those promulgated by the Telemedicine Information Exchange.

[2] Where other practitioners are involved, some states refer to this as “tele-practice.”

[3] The Act would also subject the licensee to the “laws, rules and regulations governing the maintenance of patient medical records, including patient confidentiality requirements, regardless of the state where the medical records of any patient within the state are maintained.”

 

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