Deciphering International Telemedicine Regulations

Hogan Lovells

Hogan Lovells

As the world responds to COVID-19, physicians and patients increasingly turn to telemedicine solutions as a central facet of health care.

The rise of telemedicine should come as no surprise. Even with an average internet connection, telehealth services promise convenience, access to specialists, cost savings, and collaboration among heath care professionals. In the U.S., federal and state regulators are liberalizing telemedicine in response to COVID-19.

But outside the U.S., the regulatory framework can be difficult to decipher. Some countries have issued temporary permissive measures to allow for virtual medicine in response to COVID-19; others have allowed for "emergency" tele-consultation and remote second opinions. Yet these policies do not necessarily contemplate medical professionals who are not located in the same country as the patient.

As global regulation strains to keep pace with growing telemedicine demands, clinicians who seek to practice remotely across borders encounter a blurry legal patchwork from country to country. We offer some guideposts below.

Regulation of telemedicine and remote second opinions in the foreign country

Sometimes there is no specific regulator, especially where there is no specific law or legislation regarding telemedicine. However, this does not necessarily mean that telemedicine initiatives can proceed unencumbered. Traditional medical practice laws and physician codes of conduct may apply to all health care services — including remote services — depending on the specific telecare circumstances.

Telemedicine laws, where they do exist, do not necessarily contemplate physicians outside the country providing remote services into the country. Rather, these laws often focus on in-country health professionals providing remote care to local patients. A frustrating “square peg in a round hole” analysis often follows to determine whether and how, in practice, such laws operate to regulate foreign practitioners who remotely provide care to local patients.

Defining “practice of medicine” and “telemedicine”

Would doctors located in the United States be “practicing medicine” in China if they provide a remote medical diagnosis directly to a patient in China? What if the U.S. doctor and Chinese doctor are only consulting about potential treatment without patient interaction with the U.S. doctor?

Arrayed laws, practice guidelines and ethics rules inform whether a remote doctor would be “practicing medicine” in these circumstances, and the answer may differ from province to province within any given country.

In China, the Medical Practitioners Law generally refers to the “practice of medicine” as medical diagnosis, disease investigation, medical treatment and the issuance of corresponding medical documents by physicians. Rendering remote diagnoses normally constitutes practice of medicine in China and would be limited to locally licensed physicians and foreign physicians holding a Short-Term Foreign Practice License at approved hospitals. These requirements remain the same even under COVID-19 conditions. Physician-to-physician consultations, however, do not necessarily fall within the "practice of medicine" in China.

While some countries provide a legal definition of telemedicine, the definitions vary tremendously in scope and breadth. Various countries provide no “telemedicine” definition under applicable law. But the regulatory framework for rendering traditional health care services may nevertheless apply in ways that limit a foreign provider’s services into the country or that cause the provider to be directly subject to supervision and oversight of local medical regulatory boards.

Remote second opinions and doctor-to-doctor consultations internationally

Telemedicine regimes generally are more tolerant of cross-border remote second opinions and doctor-to-doctor (i.e., peer-to-peer) consultations where such communications and activities do not involve the remote doctor’s direct patient interaction, treatment and/or final diagnosis. Clinician-to-clinician e-consults are the only lawful option in various countries that effectively forbid direct-to-patient remote treatment from abroad on the basis that it constitutes practice of medicine that requires a local license.

Still, various medical codes of conduct around the world can be read to impose certain restrictions in relation to remote second opinion and peer-to-peer consultations. While these codes of conduct are not always legally binding, contravention of the code may render a medical practitioner liable to disciplinary proceedings. Navigating ethical and legal rules of the road can be daunting for physicians who wish to focus on remote second opinions and peer advice across borders.

Physician licensure/registration requirements for international telemedicine

The question of whether and how physician licensing rules apply when the doctor and patient are located in different countries is among the most challenging aspects of international telemedicine, not least because health care organizations can be penalized for employing a person to provide professional health services who meets the requirements to be licensed/registered and is not so registered in the applicable country.

Many non-U.S. jurisdictions expect U.S. physicians to have licensure in the non-U.S. jurisdiction insofar as the physician engages in live audio or video interaction with patients for direct treatment. The same physicians may be exempt from licensure where their cross-border activity is peer-to-peer only or does not involve final diagnosis, prescription, or psychiatric assessment.

Some regimes are more liberal. The United Kingdom generally takes the view that physicians located abroad may provide telemedicine services to patients in the U.K. if the physician is appropriately qualified, registered and regulated in the country in which they are based, and regulated to standards equivalent to those in the U.K.

Organizational licensure and marketing international telemedicine

Many hospitals are surprised to learn that they may need to be registered in the foreign jurisdiction as a “medical center” or “health services establishment” before their physicians can provide telemedicine services into that jurisdiction. But such registrations may be unavailable to organizations that do not maintain premises in the foreign location. Some jurisdictions may nevertheless allow such services to proceed on the basis of a contractual arrangement between a local hospital and foreign hospital.

Advertising telemedicine services across sovereign borders also can be a minefield. Several permissions and approvals in the foreign jurisdiction — including “legal presence” and commercial licensing — act as regulatory obstacles to large scale marketing. Where advertising is permitted, the use of titles such as “doctor” may be subject to specific restrictions, including disclosure that neither the organization nor its clinicians are licensed in the jurisdiction in which the advertisement appears.

Patient consent and data privacy in international telemedicine

Any form of cross-border telemedicine program that involves collecting, processing, using, transferring or storing patient personal data merits a careful assessment of data protection law.

Some countries prohibit health data from being transferred outside of the country unless the relevant health authority approves. Other countries have introduced restrictions on international transfers of personal health data whereby transfers require either data subject consent, an applicable exemption, or reliance on legal undertakings to ensure an adequate level of data protection. Privacy notices and parental consent (where the patient is a minor) also must be considered.

As the EU General Data Protection Regulation inspires similar laws across the world, the practice of international telemedicine will only become more complicated.

Looking forward

Many other challenging issues permeate international telemedicine programs. These include medical research, billing and reimbursement, liability and malpractice, e-commerce regulation, fraud and abuse, anti-corruption, and global tax compliance. While some jurisdictions are just beginning to consider regulating telemedicine, others are already in the process of updating existing rules in the wake of COVID-19.

Leveraging telemedicine to combat disease is crucial for COVID-19 and other pandemics. But any standardization of international telemedicine law is still a long way off, and providers seeking to serve patients and clinicians across borders will need to do some homework before engaging in remote medical practice.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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