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, psychology, 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.

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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.

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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:

Whether advising start-ups or established companies, Los Angeles / San Francisco / Bay Area healthcare & FDA attorney Michael H. Cohen brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges.  

The Michael H. Cohen Law Group counsels healthcare practices, entities, and companies, such as clinical laboratories, physicians, psychologists, chiropractors, acupuncturists, naturopaths, nurses, healers, medical spas, sleep centers, addiction treatment centers, surgery centers, anti-aging centers, integrative medicine clinics, anti-aging practices, mental and behavioral health counselors, medical service organizations, telemedicine and mobile (m-health) companies, online health ventures, stem cell and cord blood entities; and other health and wellness enterprises.

Healthcare and FDA lawyer Michael H. Cohen is admitted to practice in California, Massachusetts, New York, and Washington, D.C. Our clientele is national and international, and we also counsel healthcare and FDA clients in Los Angeles, San Diego, Ventura, San Francisco Bay Area, San Jose, Santa Barbara, Sacramento, San Bernadino, Alameda, Contra Costa County, and other California cities and counties.  

Contact our Los Angeles, Ventura County, & San Francisco Bay Area FDA & healthcare attorneys today if you need a telemedicine lawyer, concierge medicine lawyer, HIPAA lawyer, FDA lawyer or FDA regulatory consultant (dietary supplements, medical devices, cosmetics, OTC drugs), advertising compliance lawyer, healthcare mediator or arbitrator, concierge medicine attorney, management services organization attorney, or other specialized healthcare legal advice or FDA regulatory consulting.

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[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.”