The internet has forever changed the way health and medical services are provided. The last 10 years have seen a rapid expansion in telemedicine and telehealth services. In response many states have developed statutes to define and regulate telemedicine. For example, Vermont developed a statute (8 V.S.A. § 4100k ) requiring health insurance companies to cover and pay for telehealth services in the same manner as more traditional face-to-face provisions of health care.
The general definition of telemedicine is receiving/providing medical care remotely via the internet or telephone. The Vermont statute above defines telemedicine as:
“Telemedicine” means the delivery of health care services such as diagnosis, consultation, or treatment through the use of live interactive audio and video over a secure connection that complies with the requirements of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191. Telemedicine does not include the use of audio-only telephone, e-mail, or facsimile.”
This is a very different definition than the one proposed in 1996 by the Federation of State Medical Boards (“FSMB”) under the Model Telemedicine Act (“Model Act”). The Model Act defined telemedicine as “the practice of medicine across state lines.” The Model Act did not gain many adherents. But, interestingly enough, practicing medicine “across state lines” is the key legal issue with telemedicine.
In practice, telemedicine has existed for as long as the telephone has existed. Patients with a long-term relationship with a family doctor have likely experienced a “phone consultation.” You have a bad cough or something non-life-threatening; you call your doctor; he or she talks to you over the phone and prescribes a medication. Your doctor says something like: “Make an appointment and SEE me if your symptoms do not improve.” That is a form of telemedicine.
With the advent of the internet and internet-based video services like Skype, telemedicine has became even easier. Now with the omnipresence of mobile devices, each with a camera and video recorder, providing remote medical services is almost expected.
Telemedicine: Legal Practice Issues
Conceptually, telemedicine presents almost no legal issues other than potential malpractice issues for the healthcare provider. That is, telemedicine is basically a doctor meeting with a patient via electronic interface rather than face-to-face.
In practice however, telemedicine is being promoted via websites advertising a quick and easy method to obtain medical services and prescriptions. A good example is getRoman.com, a website dedicated to providing medicine for erectile dysfunction. See here. There are a maze of legal issues that have to be navigated for websites like this including:
- State laws with respect to who may provide medical services within the state
- State and federal laws with respect to prescribing medications — stricter standards
- Which state medical law is applicable? The medical laws of the doctor’s state or the patient’s state?
- Which state law and what body of law applies to the website?
- Licensure for the medical providers — related to the first issue
- Medical malpractice and standard of care issues — what is the standard of care for a virtual examination?
- Is the website providing “medical services” — legal difference between offering diagnosis and prescribing medications as opposed to simply providing conduit services, education and information
- Federal and state privacy, confidentiality and security — HIPAA, etc.
- FDA regulation of medical apps and medical devices — if healthcare is now delivered via mobile device, is that a “medical device” subject to FDA Class I regulation; what about programming in the app?
- Medicine ethics with respect to corporate structures, fee-splitting, and advertising
As can be seen, as a practical matter, the legal issues are numerous. If you are providing telemedicine services, you should consult with proven internet law attorneys who are on the cutting edge of technology and legal knowledge.
Using a Website Terms of Service Agreement to Solve Some of the Legal Issues
As telemedicine websites proliferate, some are attempting to use the website Terms of Service (“TOS”) Agreements to help solve some of the problems. One particularly bad problem is being criminally prosecuted for prescribing medications across state lines. For example, back in 2007, in the case of US v. Valdivieso Rodriguez, 532 F. Supp. 2d 316 (US Dist. Puerto Rico 2007), seven doctors were charged with 41 counts of having participated in a scheme to distribute drugs through the internet in violation of federal laws and the laws of Puerto Rico. The federal charges were brought pursuant to the Controlled Substance Act (“CSA”).
Under the laws of Puerto Rico, a doctor can only prescribe medications to residents of Puerto Rico. As such, when the doctors remotely prescribed medications — via the internet — to persons outside of Puerto Rico, according to the prosecutors, they were practicing medicine “outside the scope of professional practice … with whom they lacked a doctor-patient relationship” in violation of the CSA. The District Court upheld the charges as against various motions to dismiss.
The getRoman.com website attempts to avoid the Valdivieso issue via its TOS Agreement. See here. Its TOS Agreement specifically limits the availability of the internet service to California, Florida, Georgia, Kentucky, Illinois, New York, Nebraska, Michigan, Montana, Ohio, Pennsylvania, Virginia, Washington and Texas. The getRoman.com TOS then goes on to say that “[h]ealth care providers providing Services through the Site are licensed to practice in the states in which they treat patients.”
Whether that gets the doctors beyond the Valdivieso situation is fact-dependent. Can the medication be delivered to addresses outside of the covered state? Are Texas doctors interacting with Texas web-users? Will authorities really care since these are ED medications?
It will be interesting to see how the court deal with telemedicine websites and their various TOS Agreements. These websites are relatively new and our research did not uncover any cases yet reported dealing with TOS Agreements for websites like getRoman.com.
Telemedicine and TOS Agreements: Contact Revision Legal
If you would like more information about TOS Agreements or have other questions about business law, internet law, data breaches and other legal issues related to IP, contact the lawyers at Revision Legal. We can be reached by email or by calling us at 855-473-8474.4
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