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...