Telehealth – Licensing, mHealth, Online Prescriptions, and Informed Consent

The telehealth landscape is continually changing. Our experienced healthcare lawyers are continually working to understand the new rules and regulations that apply at both the federal and state levels. These updates include the compliance issues for telehealth across state lines, FDA and FTC oversight of telehealth devices, the requirements for online consultations, and the need to obtain an informed consent from a patient for telehealth services.

Cross-State licensing and telehealth services

In theory, telehealth can expand medical services and consultations nationwide. A doctor in California can talk to a patient in Florida while consulting with a specialist in New York, By law though, physicians can generally only give advice to patients who reside in states where the physician is licensed to practice.

Generally, the place where the patient is located is considered the “original site” and the “place of service.” The distant site healthcare providers must then be in compliance with the licensing rules and regulations of that “place of service” site – even if the distant provider doesn’t reside in the same state. Every state has its own medical licensing requirements. Some states do allow physicians to provide cross-border (cross-state) medical services in limited situations. Other states ban cross-border medical services completely.

Many advocates of telehealth services state that these licensing prohibitions are the among the largest challenges to using telehealth. Physicians may be able to obtain licensing in other states – but it is often an expensive and time consuming process.

Current cross-state licensure barrier legislation and actions

Some of the attempts to ease the telehealth licensing restrictions include:

• Federal legislation. Some federal legislation has been introduced to try to address the problem of cross-state licensing for telehealth providers. For example, legislation proposals try to re-define the “place of service” from the originating site (site of the patient) to the distant site (site of provider delivering care).” This change would be very helpful because the provider would then only need to be licensed in the state the provider physically resides in – and the provider could advise patients throughout the country. So far, this legislation, has not been enacted.
• The Veterans Administration. In 2017, the Department of Veterans Affairs published a final rule expanding “preempting state licensing requirements” to distribute VA providers more evenly. The final rule provides that VA health care providers “may provide telehealth services, within their scope of practice to VA beneficiaries, irrespective of the State or location within a State where the health care provider or the beneficiary is physically located.” The rule doesn’t cover VA contractors.
• COVID-19 Related Licensing Exception. Due to the coronavirus pandemic, some states have announced licensing waivers or exceptions – to provide more care at safer distances. Some of the waivers are due to executive orders that cover many different types of healthcare providers. Other waivers only apply to specific professionals such as doctors and psychologists. The current status of these COVID-19 licensing exceptions and telehealth-specific licensing waivers can be viewed on this website of the Federation of State Medical Boards Health. Health providers should also check the professional boards in the state where the patient resides to determine which waivers apply and what requirements must be met.
• Interstate compacts. Some professions have initiated interstate licensing compacts to make it easier to practice in different states. “For a state to participate in a compact, the state would need to enact standard legislative language that sets out the ground rules for the Compact. There are currently six compacts that CCHP is tracking:”
  • Nurse Licensure Compact (NLC): This compact permits nurses “to practice in both their home state and other states which have signed on to the compact.”
  • Interstate Medical Licensure Compact: This compact helps expedite the licensing of physicians in other states.
  • The Physical Therapy Compact: “Under the Compact, a physical therapist or physical therapist assistant needs to obtain a “Compact Privilege” (the authorization to work in a Compact member state other than the PT or PTA’s home state) in each member state.”
  • The Psychology Interjurisdictional Compact (PSYPACT): This compact helps psychologists practice in other states that are part of the compact.
  • The Recognition of EMS Personnel Licensure Interstate CompAct (REPLICA): This compact “extends a privilege for EMS personnel to practice on a short-term, intermittent basis in another member state under certain circumstances.”
  • Audiology and Speech-Language Pathology Interstate Compact (ASLP-IC): This compact authorizes “both telehealth and in-person practice across state lines in ASLP-IC states for audiologists and speech-language pathologists.”

Each compact has different rules and requirements.

The FTC is reviewing whether cross-state licensing prohibitions are “anti-competitive.”

mHealth Laws and Regulations

The Center for Connected Health Policy (California) also reviewed current legislation and rules regarding mobile health, also known as mHealth. mHealth includes such technology as:

• Smart phones
• Portable monitoring sensors which sent data to the health providers
• Dedicated software apps downloaded onto devices

There are new policies and regulations being enacted/created for these devices on a regular basis including regulations by

• Food and Drug Administration (FDA)
• The Federal Trade Commission (FTC)
• The Federal Communication Commission (FCC)

FDA oversight

FDA regulates equipment or software intended for use in the diagnosis or treatment of a disease or other condition. FDA authority over regulating medical apps is authorized by the Food and Drug Administration Safety and Innovation Act in 2012.

In particular, if the mHealth product is classified as a medical device, “FDA requires registration and listing, premarket notification and/or approval, good manufacturing practices, and post-market surveillance.” FDA regulations also apply to the software the telehealth systems use.

In February 2014, FDA provided guidelines for mobile medical app manufacturers and others. These guidelines state there would be FDA discretion regarding mobile medical apps that pose a low risk to patients’ safety. The guidelines also state that FDA “would practice enforcement discretion on medical device data systems (MDDS) devices.”

“MDDS is a device that is intended to transfer, store, convert or display medical device data without controlling or altering the functions or parameters of any connected medical devices.” MDSS includes electrical hardware, modems, software, interfaces, and communication portals.

The definition of MDDS “does not include devices intended to be used in connection with active patient monitoring.”

FTC

The Federal Trade Commission (FTC) is the federal agency that fights for consumers by helping to ensure claims are not misleading or false and that acts are fair and not deceptive. The FTC’s role with mHealth is to focus on claims by device (hardware) and app (software) makers about the effectiveness of their products. The FTC “also has jurisdiction over health data breaches when the entities involved are not HIPAA-covered entities.”

The FTC works closely with both FDA and the FTC – on many matters.

FCC

The Federal Communications Commission (FCC) regulates devices that utilize ”electromagnetic spectrum, or broadcast devices.” Regulating a device as a communication device is not the same as regulating a device as a medical device. Since, there may be some overlap though, the FCC and FDA entered into a Memorandum of Understanding, in which the agencies agreed to work with each other when necessary.

“In 2012, the FCC approved its mobile body area network (MBAN), which allocates an electromagnetic spectrum for personal medical devices.” This spectrum:

“Would be used to form a personal wireless network, within which data from numerous body sensors could be aggregated and transmitted in real time. This dedicated spectrum would allow for faster and more reliable transmission of information from patient monitoring devices to practitioner.”

Because development in this field is proceeding quickly and the number of applications is expanding, a number of legal and ethical questions are being raised about privacy protection.

“With the vast amount of individual health data being generated by remote monitoring and mHealth devices, determining what are actionable health data, who monitors the data, and where it gets stored are challenges that we will need to address as the field evolves.”

Using online technology for prescriptions

The CCHP (California) defines online prescribing/internet prescribing – as when a provider prescribes a drug for a patient through an online interaction.

“E-Prescribing is the act of a provider sending a prescription electronically to a pharmacy, such as through an EHR, and should not be confused with online or internet prescribing.”

One of the concerns with online prescribing is whether the patient-health provider relationship is “solely” established through an online encounter. Before prescriptions can be written, there should be a patient-provider relationship – generally established through an in-person visit. Typically, a patient treats with a physician in-person but after the initial prescription, new orders of the drugs are easier if the orders are made through an online encounter – though a phone call could also suffice.

The concern with interactions which are completely online is whether the provider is able to make an informed enough decision on behalf of the patient – i.e., is there enough information about the patient’s health status and history (and is there “confirmation that the patient is accurately representing himself or herself).”

Some states specifically prohibit patient-provider relationships based solely on internet interactions.

Prescribing through the Internet

In 2008, a federal law, the Ryan Haight Online Pharmacy Consumer Protection Ac, was enacted. The law prohibits dispensing controlled substances through the Internet unless there’s a “valid prescription.” To be valid, a prescription needs to be issued for a “legitimate medical purpose in the usual course of professional practice, meaning that, with limited exceptions, a doctor must conduct at least one medical evaluation of the patient in person or via telemedicine.”

The Haight Act essentially defines telemedicine as practitioner/patient communications through telecommunication – provided the patient “is being treated by, and physically located in, a hospital or clinic” or “while the patient is being treated by, and in the physical presence of, a practitioner.”

The Drug Enforcement Agency how the power to enforce the Ryan Haight Act of 2008.

State laws and online prescriptions

States are also wrestling with whether an online consultation is enough to establish a doctor/patient relationship. Generally, until there’s a valid doctor/patient or health provider/patient relationship, online prescriptions are not permitted at the state level. States have different positions on whether the doctor/health provider must give the patient an in-person physical examination before writing a prescription.

Informed Consent

According to CCHP (California), Medicare doesn’t require an informed consent before a telehealth consultation takes place – though must states do require informed consent – as part of their Medicaid program or their state oversight of medical professionals.

Generally, informed consult for telehealth means:

• Explaining what telehealth is
• Explaining the benefits and risks of telehealth
• Explaining the security concerns

Normally, informed consent requires a written form and/or “oral acknowledgement that is noted in the patient’s record.” The informed consent requirement will vary depending on the medical profession. Some states require informed consent for just the first telehealth consultation while other states require informed consult for every telehealth consult.

Doctors and IT developers understand the advantages of telehealth. The need for telehealth will likely continue to expand even after the pandemic. Telehealth helps many patients get better quality care. The states and federal government understand the advantages of telehealth too. Still, there are many concerns about telehealth that physicians and companies need to understand to use telehealth properly and so developers can develop the correct hardware and apps. Failure to meet compliance issues can result in FDA and FTC warning letters, state actions, actions by medical boards, and other consequences.

Medical practitioners and telehealth developers should contact Cohen Healthcare Law Group, PC for legal advice about FDA, FTC, FCC, federal, state, and medical board compliance requirements. Our experienced healthcare attorneys advice both physician practices and healthcare businesses on their current compliance issues.