International Telemedicine: A Global Regulatory Challenge

As the world braces for public health emergencies such as coronavirus (COVID-19), leveraging telemedicine to combat disease is becoming crucial. Although the practice of medicine is regulated across the globe, the practice of telemedicine does not always fit within the traditional areas of law and regulation applicable to the medical profession. This article presents a sampling of regulatory challenges and lessons learned from navigating the legal thickets of international telemedicine and remote medical services around the world.

Health care providers increasingly reach across borders using technology to provide medical services directly to foreign patients and physicians. While international medical activity is nothing new for hospitals, universities, research institutions, and health care companies that have long been engaged in global health endeavors, modern telecommunication technology has forever changed the delivery model. Today, providing services to patients and physicians located halfway around the globe involves synchronous and asynchronous communication tools including electronic mail, interactive video, and smartphone apps that facilitate diagnosis, consultation, treatment, monitoring, and even medical research. Remote second opinions -- whereby a health care provider is asked by either a clinician or a patient to verify a diagnosis or treatment from a distance -- also have surged in the international medical sector.

The rapid growth of international telemedicine should come as no surprise. Even with an average internet connection, telehealth services promise convenience, broader access to specialists, cost savings, and collaborations among health care professionals who may be located in multiple countries. All this potentially leads to better health outcomes. And as the world braces for public health emergencies such as the outbreak of coronavirus (COVID-19), leveraging telemedicine to combat disease is crucial.

Although the practice of medicine is regulated across the globe, the practice of telemedicine does not always fit within the traditional areas of law and regulation applicable to the medical profession. And where countries do regulate telemedicine -- which is a growing trend -- such laws do not necessarily address the circumstances in which a foreign physician sitting outside the country may render remote services into the country. As more and more providers seek to serve patients and clinicians across borders, counsel is increasingly called upon to address difficult questions of foreign regulation, such as:

  • Are there specific foreign laws or regulations concerning real-time video visits with patients living abroad?
  • Would remote second opinions and doctor-to-doctor consultations be considered “practice of medicine” in the foreign country?
  • Can we lawfully market remote medical services into the foreign jurisdiction?
  • When can we receive identifiable patient data from the foreign jurisdiction as part of the telehealth care process?

As global regulation strains to keep pace with modern technology, the answers to these questions have become a blurry patchwork from country to country. But some themes have emerged as transnational telemedicine solutions grow in popularity. This article presents a sampling of regulatory challenges and lessons learned from navigating the legal thickets of telemedicine and remote medical services around the world.

1. Who regulates telemedicine and remote second opinions (RSOs) in the foreign country?

Sometimes the answer is “no one,” especially where there is no specific law or legislation regarding telemedicine. However, it would be a mistake to conclude that telemedicine initiatives can proceed unencumbered in such countries. For example, in Mexico, there are no specific laws on telemedicine and remote medical opinions, but the regulatory framework governing traditional medical practice and physician codes of conduct apply to all health care services – including remote services – depending on the specific telecare circumstances, under the authority of the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and the National Center for Technological Excellence in Health (Centro Nacional de Excelencia Tecnológica en Salud – CENETEC). This can present a “square peg in a round hole” situation where medical practice rules do not contemplate doctors who are not physically present in the country in which care is delivered. Such circumstances can be a major challenge to providers that aim to confidently design a remote care model.

Occasionally, a specific government agency operates solely to address telemedicine. For example, in the Kingdom of Saudi Arabia, the Saudi Telemedicine Unit of Excellence is supposed to lead, support, monitor and evaluate the implementation and development of telemedicine in Saudi Arabia, which is governed by specific telemedicine regulations issued in June 2018. Nevertheless, the existence of specific telemedicine law in any country can be deceptive because these laws do not necessarily contemplate physicians outside the country providing remote services from afar into the country. Rather, these laws often focus on in-country health professionals providing remote care to local patients. Again, 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 advice or care to local patients.

2. Defining the “practice of medicine” as relevant to international telemedicine and RSOs

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 patient’s local doctor is in the exam room at the same time? And what if the U.S. doctor and Chinese doctor are only consulting about a 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 Canada, for example, the regulation and delivery of health care is the responsibility of each of the ten provinces and three territories; accordingly, the definition and exact scope of the practice of medicine, and the registration or licensing process for physicians, differs between provinces and territories across Canada.

In China, the Medical Practitioners Law issued and amended by the State Council effective 27 August 2009 generally refers to the “practice of medicine” as medical diagnosis, disease investigation, medical treatment and the issuance of corresponding medical evidentiary documents by physicians for the adoption of appropriate plans for medical treatment, disease prevention and health care. (Medical diagnosis also includes mental health diagnosis.) Providing remote diagnosis -- i.e., rendering definitive diagnoses from afar -- normally constitutes practice of medicine in China and would be limited to locally licensed physicians and foreign physicians holding the Short-Term Foreign Practice License at approved hospitals; on the other hand, remote consultation services (i.e., physician-to-physician) do not necessarily fall within the “practice of medicine” in China. Many non-Chinese hospitals are looking closely at Sino-foreign joint venture medical institutions to more fully participate in direct-to-patient virtual care services in China.

Where a specific medical technique or procedure is regulated or considered a “controlled act,” often the activity is restricted to appropriately qualified, licensed, and registered professionals. The question becomes whether qualification, licensure, and registration in the physician’s home country alone is sufficient to deliver telecare across borders or to provide a second opinion, and whether special disclosures must be made to patients who are serviced by such non-local doctors.

3. The elusive definition of “telemedicine”

Wikipedia defines “telemedicine” as a synonym for “telehealth” -- which is described as the distribution of health-related services and information via electronic information and telecommunication technologies -- or sometimes as a more limited term to describe remote clinical services, such as diagnosis and monitoring. Some countries provide a legal definition of telemedicine that incorporates these concepts, but the definitions vary tremendously in scope and breadth. For example, the United Arab Emirates (UAE) is among the more definition-heavy jurisdictions; the UAE’s Federal Telehealth Regulations define various terms separately under the umbrella of “Remote Health Services”, which includes Remote Medical Monitoring, Remote Medical Intervention, Remote Diagnosis, Remote Medical Prescription, and Remote Medical Consultation. Each Emirate may further define terms like Telemedicine, Telemonitoring, and Teleconsultation in accordance with local standards and administrative decisions. Usually these terms are broad enough to include “audio only” and e-mail communications.

However, in many countries there is no “telemedicine” definition under applicable law, and health care laws neither expressly regulate the activity nor contemplate a limitation or prohibition on the activity. But the regulatory framework for rendering traditional health care services – general laws applicable to “medical practice” and/or “medical treatment” – 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.

4. RSO and doctor-to-doctor consultations internationally

Telemedicine regimes generally are more tolerant of cross-border RSOs 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. Asynchronous store-and-forward telemedicine services, such as for radiology, dermatology, and pathology service lines, may fall into this category. Clinician-to-clinician e-consults (or informal “curbside” consultations between physicians) are the only lawful option in various countries that effectively forbid direct-to-patient remote diagnosis/treatment from abroad on the basis that it constitutes practice of medicine that requires a local license which is inaccessible to non-local clinicians.

Still, various medical codes of conduct around the world can be read to impose certain restrictions in relation to RSO 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. Take for example a code of conduct that states that a doctor shall not (i) associate herself/himself with, or (ii) improperly delegate duties or functions in connection with the medical treatment of a patient to, a “non-qualified” person where “non-qualified person” is someone who is not registered as a medical practitioner in the country of the patient receiving services. Query whether this code (excerpted from one Asian jurisdiction) effectively precludes physician-to-physician consultation across borders because it delegates duties to a “non-qualified” person. Even if it does not, local codes may prohibit physician-to-physician consultation without consideration of specified factors, such as complexity of the medical advice, patient consent, and opportunity for follow-up.

Further, when a foreign doctor is called upon to express a view about a local medical practitioner’s decisions, local codes of conduct may compel the foreign doctor to swiftly report to local authorities concerns about the local medical practitioner’s competence or fitness to practice, which can be an awkward communication with health authorities. Individually these obligations are not hard to understand, but learning and navigating ethical and legal rules of the road for all the obligations can be daunting for physicians who wish to focus on secondary opinions and peer advice across borders.

5. 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 an international telemedicine program. Health care providers widely accept the obligation to practice medicine with a proper license, not only because it’s ethically required and in the best interest of the patient, but also because health care organizations can be criminally liable 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.

Around the world, a patient’s location typically determines the applicable licensing and registration regime for direct physician-patient encounters. Similar to the United States where providers generally must be licensed in the state in which the patient is receiving services (unless an exception applies), a significant number of non-U.S. jurisdictions would expect U.S. physicians to have licensure in the non-U.S. jurisdiction insofar as the U.S. physician engages in live audio or video interaction with patients for direct diagnosis and 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. For example, in Abu Dhabi and Dubai, prescribing medicine requires an in-person consultation, and this is understood to mean that the physician is in the same physical location as the patient and thereby practicing in UAE which requires licensure from the relevant Emirati regulatory authority.

Other regimes are more liberal. The highest medical regulatory authority in one western European country takes the view that physicians located abroad may provide telemedicine services directly to patients in the country so long as the physician is qualified and regulated in the country in which they are based. One Canadian province takes the view that a physician based outside the province need not have a license or registration with the province so long as the physician provides telemedicine services to patients in the province no more than five times per year, or in emergencies only; however, “telemedicine services” in that province are interpreted broadly to include RSOs, physician-to-physician consultations, and physician-to-patient consultations, and exceeding the five-time limit triggers registration requirements and the local medical regulator’s discipline process, standards of practice, code of ethics, code of conduct, and other health care policies.

The applicability of local rules and disciplinary processes to non-local physicians raises questions about the likelihood of enforcement. Even countries that prohibit the provision of telemedicine services by foreign physicians who are not locally licensed or registered encounter difficulty reaching individuals located outside the jurisdiction. Often it is impractical for medical regulators to enforce disciplinary actions, such as payment of fines, upon physicians located abroad due to resource constraints and other barriers. Nevertheless, clinicians must be wary of consequences in their home country of violating another country’s rules and regulations. Such consequences may include medical board investigations, risk of revocation or suspension of professional licenses, negative press, and disciplinary action by employers.

6. Organizational licensure and marketing international telemedicine

Many hospitals and medical institutions are surprised to learn that they may need to be qualified and registered in the foreign jurisdiction as a “medical center” or “health services establishment” before their physicians can properly provide telemedicine services into that jurisdiction. But such registrations may be unavailable to organizations that do not maintain a form of corporate structure or premises in the foreign location. Consequently, clinicians may not be able to provide international telemedicine services into a foreign country on behalf of their employer if the employer is not registered in the foreign jurisdiction. Some jurisdictions may nevertheless allow such services to proceed on the basis of a contractual arrangement between a local hospital and foreign hospital, such as a hospital-to-hospital agreement for clinical support services.

Advertising and marketing 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 a regulatory obstacle to large scale marketing. Where organizational advertising is permitted, the use of titles such as “Doctor” or variations or abbreviations thereof may be subject to specific restrictions, including disclosure that neither the organization nor its clinicians are licensed or qualified in the jurisdiction in which the advertisement appears. In practice, however, it can be difficult for authorities in one country to prohibit a foreign organization from marketing telemedicine and RSOs via the internet to patients located in that country, and enforcement has been uneven.

7. Patient consent and data privacy in international telemedicine

Any form of cross-border telemedicine program that involves monitoring, collecting, processing, using, transferring, or storing patient personal data merits a careful assessment of data protection law relative to the specific services and data in question. Several sources of privacy requirements may apply to global patient support services, and the patient’s written consent is not necessarily sufficient to justify a transnational transfer of personal health data. Some countries require health data to be processed and stored only inside the country of the patient receiving services, and such data may not be transferred outside of the country unless the relevant health authority issues special approval. 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.

Whether a telemedicine provider is prepared to become a custodian of a remote patient’s health information is worth special consideration. Providers have come to learn that holding such health data triggers compliance with administrative, technical, and physical safeguards that follow the data from the remote patient’s country, including individual rights of access, correction of records, storage limitations, and retention requirements. Where the provider implements new information systems involving health information, this may itself trigger reporting to the privacy regulator in the patient’s country.

Most providers are already familiar with EU General Data Protection Regulation (GDPR) principles that restrict the transfer of personal data to countries outside the European Economic Area (EEA) unless specified conditions are met. As GDPR inspires similar laws across the world, the practice of telemedicine will only become more complicated.

8. Medical research and international telemedicine

Innovative technologies have transformed the modern clinical research regime, and the technologies that underlie international telemedicine programs hold tremendous promise for subject recruitment, data capture, and research patient care. Issues related to subject enrollment, informed consent, data management, liability coverage, and privacy and security merit their own article as applied to research programs drawing on international telemedicine services. But to illustrate the foreign regulatory challenges in combining international research with telemedicine, consider the following case study:

A U.S. medical center proposes a telemonitoring program whereby research subjects in an African village carry a wearable device that automatically transmits to the U.S. hospital vital signs such as body temperature, blood pressure, heart rate, and respiratory rate. The remote technology reduces the need for patient visits to a clinic (which is many miles from the village), allows the U.S. research team to engage in real-time monitoring for research subject emergencies, and prompts immediate notification to in-country doctors when abnormalities are detected.

In this African jurisdiction, telemedicine is defined as physical and psychological diagnosis and treatment at a distance, including telemonitoring of patient vitals. Because the automatic data upload is considered an “encounter” with an identifiable patient and facilitates real-time medical decision-making by the U.S. research team for treatment purposes, the U.S. physicians are reasonably considered to be engaging in “medical practice” in the African country. Such medical practice requires professional licensure in that country. Moreover, the country considers the wearable device to be a medical device, given its intended use.

Changing the facts even slightly may spare the U.S. physicians from local licensure without affecting the study or patient safety. Principal investigators and others responsible for the design of research protocols would benefit from a basic orientation to such legal and regulatory issues, and compliance professionals may need substantial detail about the proposed international use of remote monitoring technology to appraise the impact of local law and regulation on the study.

Looking forward

Many other challenging issues permeate international telemedicine programs. These include:

  • Billing and reimbursement (e.g., whether and under what circumstances telehealth services can be billed and reimbursed by government and other third party payers)
  • Telehealth device regulation
  • Liability and malpractice
  • Clinical research regimes
  • Import/export, customs, and material transfer laws
  • E-commerce regulation
  • Intellectual property protection
  • Fraud and abuse
  • Anti-corruption
  • Global tax compliance

Transnational telemedicine will continue to proliferate as technology evolves and patients and physicians “go mobile.” While some jurisdictions are just beginning to consider telemedicine laws and regulations, others are already in the process of updating existing rules and guidance to address outstanding or unforeseen issues arising from the practice of telemedicine. As certain countries emerge as “telemedicine-friendly” jurisdictions, others will be inspired to follow suit. Any standardization of international telemedicine law, however, is likely still a long way off. But as the reach of health care broadens with technology and globalization, so does the risk of global pandemics, making telemedicine more important than ever.

 

Authored by William Ferreira and Adilene Rosales

 

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