Telemedicine: A European perspective - The Netherlands and Germany

Furthermore, European legal frameworks classify telemedicine as both a health service and an information service, leading to the simultaneous application of both regulatory frameworks.

In recent years, there has been a surge in legislative efforts at the EU level to establish telemedicine as a standard medical procedure, accessible to all European citizens and reimbursable under their respective national social security systems. Additionally, the e-Commerce Directive (Directive 2000/31/EC) comes into play, serving as the legal foundation for online services within the Internal Market. Its purpose is to eliminate barriers to cross-border online services in the EU and provide legal clarity to businesses and citizens, including those offering telemedicine services. Importantly, Directive 2011/83/EU on consumer rights also applies in this context.

The EU framework has been implemented differently across different member states.

In the Netherlands for example, there is no explicit legal framework exclusively dedicated to telemedicine. Nevertheless, several laws and regulations hold relevance in the context of telemedicine, including the Dutch legislative framework governing medical devices (comprising the Medical Device Act, Medical Devices Regulations, and Medical Devices Decree), legislation concerning data protection (GDPR), and the Dutch Medicines Act. Moreover, the Dutch Individual Health Care Professionals Act defines reserved actions that only specific groups of medical professionals are authorized to perform. Additional pertinent regulations encompass the Healthcare Quality, Complaints and Disputes Act, which outlines standards for the provision of high-quality care that healthcare providers must adhere to in every healthcare scenario.

Additionally, the Medical Treatment Contracts Act lays out comprehensive regulations governing treatment contracts forged between physicians and patients. This encompasses the entire spectrum of contract-related matters, including the establishment and termination of such agreements, ensuring informed consent, upholding confidentiality, safeguarding the rights of minors, and ensuring the proper delivery of healthcare services. Lastly, the Dutch Processing of Personal Data in Healthcare (Additional Provisions) Act plays a crucial role by instituting protective measures aimed at clients involved in electronic data exchange within the healthcare sector.

In Germany, there is specific legislation for telemedicine and services related since 2018. Prior to that, there was a strict ban on remote treatment of patients. Since then, several laws where introduced by the German government making treating patients without personal contact available in Germany. Such were, e.g. changes in the professional regulations for physicians, the e-health laws since 2016, the introduction of the Digital Care Act (Digitales-Versorgungs-Gesetz) and the Patient Data Protection Act (Patientendaten-Schutzgesetz) and others.

Overall, the existing framework provides for a strict regulatory environment for telemedicine. Apart from information obligations, consent requirements and medical requirements to the provided medical care additional formalities have to be observed. E.g. in form of authentication and digital identity checks. The tools used also need to adhere to legal requirements. E.g. video conferencing between the patient and his physician is only permitted with certified video providers, in closed rooms and on the condition that all people present are introduced. Medical prescriptions may only be issued if the physician is convinced of the patient’s condition or the clinical picture is known from previous treatments. In terms of issuing certificates of incapacity for work basically requires a personal examination except in cases the physician knows the patient already. In addition, the certificate is limited in time and therefore for longer periods, personal contact again is necessary.

Currently, in Germany, 30 percent of all medical treatments may be performed digitally via video. In general, digitisation in medicine is being promoted, e.g. by digitising doctors' letters, expanding secured messenger services in addition to teleconsultations/ telemonitoring and introducing the digital patient file, which is voluntary for the patient, but have to be offered by insurances.

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