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Dr who?

Dr who?

Remote medical services pose regulatory challenges

COVID-19 led to significant growth in the field of telemedicine. Áine McCarthy discusses the regulatory challenges of navigating the legal intricacies of telemedicine and remote medical services around the world.

Telemedicine offers many advantages over the traditional healthcare visit but, until recently, it was largely underutilised. On 11 March 2020, COVID-19 was declared a pandemic by the World Health Organisation, dramatically altering the way medicine is globally practised.

Dr who?

Dr who?

As quarantining and social distancing became the norm, the presence of patients in hospital emergency departments quickly became unsustainable, suddenly thrusting telemedicine into centre stage.

The EU Commission’s 2012 staff working document on the applicability of the existing EU legal framework to telemedicine services defines ‘telemedicine’ as the provision of healthcare services through the use of information or communication technology, in situations where the health professional and the patient are not in the same location.

One of the most relevant benefits of telemedicine during the (ongoing) pandemic is the increased safety of both patients and providers. By using virtual platforms, social-distancing measures can be easily enforced to reduce potentially infectious exposures.

Doctors without borders

There is a growing trend worldwide in the use of transnational telemedicine, whereby more doctors are seeking to serve patients across borders. The availability of cross-border telemedicine is particularly relevant for expatriates, permitting them to use a programme that connects them with virtual healthcare services in their home country if they experience a health-related issue during their stay abroad.

Cross-border telemedicine potentially makes quality expert care from specialists around the world available to patients who would not otherwise have access to such specialists for serious medical conditions. This is particularly important for high-risk populations that have difficulty accessing it due to distance or disability.

While it is widely accepted that the practice of medicine needs to be regulated globally, the practice of telemedicine often does not fit within the traditional areas of regulation applicable to the medical profession.

Crucially, even though some countries have begun to regulate the practice of telemedicine, such laws do not necessarily contemplate a scenario in which a foreign doctor, based outside the country where the patient is based, may provide remote services into that country.

As global regulation struggles to keep pace with developments in remote medical care, the regulations have become a blurry collection of laws from country to country, making it difficult to navigate the regulatory environment that applies to cross-border telemedicine.

Telemedicine regulations

The definition of ‘telemedicine’ varies tremendously in scope and breadth from country to country. Wikipedia sees it as a synonym for ‘telehealth’, which is described as the distribution of health-related services and information via electronic information and telecommunication technologies. In some countries, a much more limited term is used to describe telemedicine, and such services must involve steps such as diagnosis and monitoring.

In some countries, there is no definition and no specific legislation regarding telemedicine, and healthcare laws neither expressly regulate the activity nor contemplate a prohibition on the activity. However, this does not mean that telemedicine activities can proceed in such countries.

In such cases, the regulatory framework for rendering traditional healthcare services may nevertheless apply in ways that limit a foreign doctor’s services into the country, or that cause the doctor to be directly subject to the supervision of local medical regulatory boards.

For example, there is no legal permission for telemedicine in Austria, as the ‘iron principle of direct treatment’ (face-to-face) applies. The immediacy of the treatment is the core of the medical profession in Austria. Mere virtual treatment is, therefore, not permitted in Austria, with the exception of emergencies.

Occasionally, certain countries publish legislation or guidance solely to address telemedicine, but these laws often focus on in-country health professionals providing remote care to local patients.

Guidance in Ireland

Even though there is no specific legislation in Ireland, guidance issued by the Medical Council (the regulator of medical doctors in Ireland) may be relevant in this context. Current Medical Council guidelines set out basic rules on the provision of telemedicine services.

The key point is that telemedicine services can be provided in Ireland. The guidelines state that the provision of telemedicine services requires that a number of specific safeguards are in place, such as strong security measures and clear information policies, which would be challenging for every foreign doctor to adhere to.

In France, there are strict rules around telemedicine. Before the pandemic, to be eligible for coverage under the Assurance Maladie, the tele-consultation must be part of the ‘care pathway’, meaning that the user must have met the advising doctor once in the previous 12 months before the tele-consultation.

In Italy, while tele-advice is permitted, a doctor (not a nurse) should perform “any complex and specialised act of prevention, diagnosis, cure and therapy” – which implies that telemedicine involves an additional step of diagnosis and not mere tele-advice. The lack of clear and consistent definitions and rules represent a major challenge to providers designing a global remote-care model.

‘Telemedicine’ versus ‘tele-advice’

Members of the public are increasingly using the internet to research their health concerns. More than a third of adults in the US regularly use the internet to self-diagnose their ailments.

Private companies have, in recent years, launched their own symptom-checkers that, using computerised algorithms, ask users a series of questions about their symptoms or require users to input details about their symptoms themselves.

Symptom-checkers serve two main functions: to facilitate self-diagnosis; and to assist with triage. Following the use of the symptom-checker, the company will proceed to use the results of the checker with a triage function that informs patients whether they should seek care at all and, if so, where and with what urgency.

In some cases, this will be followed by tele-advice services that do not involve diagnosis or prescription-type services, which would, typically be provided by locally licensed doctors.

Due to the lack of a clear definition of telemedicine in most countries, there is a risk in certain countries that providers could engage in the unlicensed practice of ‘medicine’ – for example, by relaying a symptom-checker finding that is construed as the diagnosis of a user’s condition.

In addition, such software in use in the market is often categorised as a ‘medical device’ and must comply with medical-device regulation in various countries. However, the medical-device rules are not always clear when it comes to regulating new software that is distributed globally to users based in different countries under different global service and other contractual frameworks.

The practice of ‘medicine’

One of the most challenging aspects of cross-border telemedicine is how doctor-licensing rules apply when the doctor and patient are located in different countries. Globally, the residence of a patient typically dictates the applicable licensing and registration regime for direct doctor/patient encounters, and various local laws and guidance regulate whether a foreign doctor would be ‘practising medicine’ if rendering a medical diagnosis to a foreign patient.

For example, healthcare providers of telemedicine services to patients within Ireland must be registered with the Medical Council. The Medical Council guidance has no statutory effect, but derogations from the guidelines may constitute a breach of professional duty by the medical doctors.

Similarly, in Italy, while the practice of telemedicine is permitted, if the patient has his/her habitual residence in Italy and the doctor is located abroad, but directs its activities to Italy, Italian law applies. As a result of Italian law being applicable, any doctor engaged in the provision of such services must be admitted to practice in Italy.

Such rules again represent a situation that does not contemplate doctors who are not physically present in the country in which care is delivered, and this can be a major challenge to effectively render cross-border telemedicine in some countries.

North-American perspectives

US states require healthcare practitioners to be licensed prior to engaging in the practice of medicine, which most states define as the diagnosing or treating of a condition, and individuals engaged in such diagnosing or treating must be licensed by the applicable state’s professional regulatory body.

If a person engages in activities that a state considers the practice of ‘medicine’ without first obtaining such licensure, the person may be subject to adverse regulatory action for engaging in the unlicensed practice of the profession.

In Canada, the regulation of healthcare is the responsibility of each of the ten provinces and three territories and, accordingly, the definition of the practice of medicine and the registration process for doctors differ between provinces and territories across Canada.

One Canadian province takes the view that a doctor based outside the province need not have a licence 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. Exceeding the five-time limit triggers registration requirements and the local medical regulator’s disciplinary process and standards of practice.

Chinese medicine

In China, providing remote diagnosis normally constitutes the practice of medicine, and would be limited to locally licensed clinicians. Where a specific medical technique is regulated or considered a ‘controlled act’, the activity is often restricted to appropriately licensed professionals.

However, as is typical under Chinese law, the term ‘controlled act’ is not defined, and it is a matter of interpretation on a case-by-case basis, further increasing the risk of any doctor looking to provide cross-border telemedicine into that country.

Despite the existence of local rules to non-local doctors, it is often impractical for regulators to enforce disciplinary actions upon doctors located abroad. Nevertheless, doctors must be wary of consequences in their home country of violating another country’s rules and regulations, such as suspension of professional licences and negative press.

Data-privacy concerns

Given the current heavily regulated global landscape in the area of data privacy, a careful assessment of data-protection law is necessary in any form of cross-border telemedicine that involves collecting, processing, using, transferring, or storing patient personal data.

Several sources of privacy requirements may apply to such services, and the patient’s written consent is not necessarily sufficient to justify a cross-border 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.

For example, in the United Arab Emirates, federal law sets out that health information in the UAE may not be stored, processed, generated, or transferred outside the UAE, unless a decision is issued by the health authority in coordination with the ministry.

China imposes a regulatory regime in respect of network operators, including the imposition of data collection, processing, and localisation requirements. This means that ‘important data’ relating to medical treatment in China must be stored in China. Offshore transfer of personal data is only permissible if the entity in question passes a complex security assessment, formulated by the Cyberspace Administration of China.

It is clear that, by virtue of a healthcare provider holding such health data, this triggers compliance with administrative, technical, and physical safeguards that follow the data, including individual rights of access, correction of records, and retention requirements.

In a European context, General Data Protection Regulation principles will apply, and restrict the transfer of personal data to countries outside the European Economic Area, unless specified conditions are met.

Again, a frustrating paradoxical analysis often follows to determine whether and how, in practice, such laws operate to regulate foreign doctors who remotely provide advice or care to local patients. As the area of data protection becomes more heavily regulated globally, the practice of telemedicine will only become more complicated.

More than two years into the global pandemic, it is clear that cross-border telemedicine will continue to be more important than ever – but it seems that any standard-isation of international telemedicine law or practice standards is still a long way off. 

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Áine McCarthy is head of legal (international health) at Allianz Care and is a member of the Law Society’s In-House and Public Sector Committee. All views expressed in this article are her own, and do not represent the opinions of any entity whatsoever with which she has been, is now, or will be affiliated.