Die Presse: telemedicine before the ECJ – the ruling

Authors: Thomas Riesz, Alexander Hiersche, Mathis Fister, Gisela Ernst and Dominique Korbel

The Life Sciences & Health Care Law practice group explains the landmark ruling of the ECJ in a guest contribution for the daily newspaper Die Presse. In addition, another article by the practice group on the topic “Artificial Intelligence in Medicine – Making Optimal Use of Innovation Potential Despite Regulation” was published.

As reported in our blog post in May, the ECJ addressed for the first time this year the question of what constitutes telemedicine and which legal framework applies to the provision of cross-border telemedicine.

The ruling in this landmark case (ECJ C-115/24), in which our law firm had the privilege to participate, was recently published and provides clarity on several key questions that have been debated across the EU in recent years.

What is telemedicine?

First, with regard to the question of what is to be understood as telemedicine in the context of Union law, the ECJ undertakes a grammatical, systematic, and teleological interpretation spanning several pages, taking into account multiple Union legal acts (the Patients’ Rights Directive [Directive 2011/24/EU], the E-Commerce Directive [Directive 2000/31/EC], and Directive 2015/1535/EU) as well as the Communication from the Commission on the benefit of telemedicine (COM[2008]689).

The Court first establishes that the term “telemedicine,” as mentioned in Article 3(d) of Directive 2011/24/EU, is an autonomous concept of Union law. According to the ECJ, the wording (“tele”) already indicates that the term refers only to medical services provided at a distance (para. 63).

Since telemedicine, in the context of the directive, constitutes an exception within the provision of healthcare services, the term must be interpreted narrowly (para. 65). Moreover, since, in the context of the directive, this concerns a form of “healthcare,” reference must be made to this term, which is defined in Article 3(a) of Directive 2011/24/EU as “health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices.”

In addition, it follows from the definition of “information society service” under Directive 2000/31/EC and Annex I of Directive 2015/1535/EU, which must also be taken into account, that telemedicine only exists if the healthcare provider and the patient are not present at the same location and the service is rendered by means of information and communication technologies.

Accordingly, telemedicine does not exist if the healthcare provider and patient are present at the same location at the same time.

Telemedicine in the sense of Union law is therefore cross-border healthcare that is provided at a distance via ICT, without the simultaneous physical presence of the healthcare provider and the patient.

Which legal framework applies?

Following this comprehensive delineation of the term telemedicine, the ECJ explains in its ruling that cross-border telemedicine services are subject to the provisions of the member state in which the healthcare provider is established (para. 102). This is referred to as the so-called country-of-origin principle.

Both directives provide that the country-of-origin principle applies to purely telemedical services. Accordingly, the legal provisions of the member state in which the healthcare provider is established are applicable.

However, it must be noted that the ECJ – contrary to the Advocate General’s opinion – assumes that telemedical elements are (virtually always) to be separated from physical treatment elements, even if both are part of a complex overall treatment. For services provided physically, the general rule of Article 3(d) of the Patients’ Rights Directive applies; the member state of treatment is the one on whose territory the service is actually provided, i.e., the member state of the patient’s stay. In complex cases, such as the one at issue where an interaction between physical and digital elements occurred, different legal regimes may apply to different components of the overall treatment.

What does this mean for telemedicine providers?

This is good news for anyone offering telemedicine services, as they do not have to deal with 27 different national regulatory frameworks when providing telemedicine across the EU, but only with the rules applicable in the member state in which they are based. Although a different line of reasoning could have been conceivable from a consumer protection perspective – since consumers cannot rely on the level of protection provided by their own member state and must expect that service providers may be subject to different, potentially less stringent regulations – the outcome is internal-market-friendly and aligns with the ECJ’s established case law.

The ruling also clarifies that providers may, in the sense of “forum shopping,” choose the member state for their establishment where the regulatory framework is favorable to their business model. If the provision of services is permitted in that member state, it may also be offered across borders throughout the EU. Other member states must tolerate this (principle of mutual recognition), even if, in the context of the current increase in telemedicine regulation, this leads member states to deliberately pursue more liberal regulatory approaches to gain a locational advantage. This represents, in particular, a significant encroachment on the competence of member states – enshrined in the treaties – to organize their health systems, in favor of the internal market.

What does this mean for patients?

For patients, this means, in addition to the aforementioned fact that they cannot rely on the level of protection provided by their member state of residence, that they themselves can influence, through the choice of provider, which regulations the service is subject to. This leads to a wider range of available services and can be of particular relevance for questions of liability.

In addition, the ECJ explicitly clarifies in the ruling that the cost reimbursement regime of Directive 2011/24/EU, which enables insured persons to apply for reimbursement of costs for cross-border healthcare, also applies to cross-border care provided via telemedicine. Thus, from the patients’ perspective too, clearer framework conditions arise for the passive freedom to provide services in the context of telemedicine.

However, the outlined situation, in which treatment consists of both physical and digital elements, entails additional risks and increases the complexity of assessing the applicable legal provisions, which in turn could lead to uncertainty.

Conclusion

With the judgment described above, the ECJ has made a groundbreaking contribution to greater legal certainty in the provision of telemedicine services. Even though it would have been desirable to see clarification of some of the issues raised in this case and discussed in more detail in the Advocate General’s Opinion, such as the divisibility or predominance of physical and digital treatment elements, the ruling represents a milestone for the further development of the digital internal market in the field of healthcare services.

Our members of the Life Sciences & Health Care Law practice group will be happy to provide information on all other legal provisions that must be observed in this complex field of activity, as well as on current developments.

Disclaimer

This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.