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EU Cross-border Telemedicine: A Partial Harmonisation of Product and Professional Liability?

Article written by Mrs Cristina Campiglio, PhD, Full Professor of International Law at the Department of Law of the University of Pavia, Italy

“Telemedicine” refers to the provision of healthcare services, using ICTs, in situations where the interested parties are not in the same location. It involves secure transmission of medical data and information, through text, sound, images or other forms needed for the prevention, diagnosis, treatment and follow-up of disease. As such, the concept of telemedicine encompasses both healthcare ‘professional-to-patient’ relationships as well as healthcare ‘provider-to-provider’ relationships. Thanks to telemedicine it is possible to provide healthcare services beyond traditional physical spaces, including national borders.

As involving a personalised and data-driven evaluation of the patient’s conditions, telemedicine services need complex regulatory choices that only partially overlap with those adopted for conventional healthcare services. Telemedicine services – that fall, as traditional healthcare services, within the scope of arts 56 and 57 TFEU – may indeed be characterized simultaneously as “healthcare service” pursuant to the Directive 2011/24/EU on the application of patients’ rights in the field of cross-border healthcare, as well as ‘information society service’ (ISS) within the meaning of the Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market.

In the case of cross-border telemedicine services, several key legal issues arise: licensing/registration of healthcare professionals performing telemedicine services; conditions for legitimate processing and protection of personal health data; respect for the patient’s self-determination; reimbursement of the services. The most problematic profile, though, is the patients’ clinical risk and the liability of healthcare professionals.

“Clinical risk” is a measure of the likelihood that patients may incur in adverse events in connection with the provided medical treatment. The occurrence of personal harm for patients may derive from defects or malfunctioning of the equipment used by professionals, from actions or omissions of healthcare professionals, or from structural/organizational deficiencies of healthcare facilities.

The occurrence of personal harm may of course trigger civil liability claims. To this effect, civil liability may be divided in “product” liability and “professional” liability depending on subject matter of the relevant dispute. Both types of civil liability claims may in turn involve several national legal systems.

To the extent that a dispute concerning product liability and/or health professionals’ liability in the context of telemedicine touches upon different legal orders, private international law issues come into play.

Private international law is generally understood as a discipline aimed at enabling the interoperability of diverse (unharmonised) legal orders. In recent years the EU legislator has undoubtedly presented itself as a particularly active player in harmonising the Member States’ substantive regimes on civil liability, e.g. with 2022 package of proposals aimed at adapting liability rules to the AI-based digital ecosystems. Yet, the path of deepening substantive harmonisation is deeply unlikely to result in complete EU-wide standardisation of national civil law regimes, primarily because of structural limitations of the EU legal order as a hybrid system based on the principle of conferral as well as on the coexistence of elements of supranationalism and national sovereignty. Given this background and despite their technically neutral approach, the general instruments of EU private international law have, for the time being, proved to be rather resilient and relatively fit for accommodating diverse legal orders in the digital age. Yet, their interaction with cross-border telemedicine services remains to some extent complex and uncertain, specifically in the light of the uncertain characterisation of medical liability. If the widespread deployment of eHealth is truly meant to be achieved within the EU, consistently with the position seminally expressed by the European Commission back in the 2010 Digital Agenda for Europe, private international law issues of eHealth should not be neglected. Rather, delivering sound guidance on how the general instruments of EU private international law are meant to govern cross-border eHealth services should remain a critical priority to achieve interoperability of eHealth in Europe to the benefit of EU citizens, the EU Member States’ healthcare sectors and medical research.