CYIL vol. 14 (2023)

PETR ŠUSTEK CYIL 14 (2023) jurisdictions. 19 There are many variables in these approaches, including the questions of whether there are special rules for telemedical health services, and whether these services can be provided by a provider that does not have the patient in “physical” care. One of the most permissive stances is held by Sweden . Telemedical services are subjected to the same legal regulation as health care based on physical visits, i.e., several different statutes 20 and regulations. Providers of digital health services are not obliged to admit the patient in their physical facility before or after the provision of a telemedical service. In their care for the patient, they are allowed to operate fully in the digital arena, having access to patient’s medical records and being able to cooperate with other subjects providing health care. They can also provide their services on the whole territory of Sweden, no matter how physically far away from the patient. In the United Kingdom , there is no specific legal regulation for telemedicine as providers follow guidelines issued by the General Medical Council. 21 The National Health Service (NHS) has several telemedicine projects, including a national advice telephone line and a website with the same aim. 22 Nevertheless, providers of online medical services need a special certification. Reimbursement mechanisms have not yet been made entirely available. In Israel , telemedicine is specifically regulated in the form of a guideline embodied in the General Director Circular No. 6/2019 on Standards for Provision of Telemedicine Services from 26 June 2019. The providers who wish to engage in telemedical services need to undergo special training dedicated to telemedicine. Before the remote service is provided in the particular case, the provider must prepare a dossier containing relevant information (such as the description of the service and its compatibility with the used technological devices, its alternatives, risks and benefits, as well as safety measures). The dossier might be demanded by the Ministry of Health for review. Every telemedical service must have an appointed professional manager in charge of it, who needs to have the same certification as the health professionals performing the service. Legal liability does not in principle differ from any other health services. In Germany , telemedicine is primarily addressed by a non-binding document issued by the federal German Medical Association. 23 The position taken in this document is nevertheless adopted by many state medical associations in their internal regulations which are binding for physicians. 24 According to these documents, physical care is considered to be the standard 19 The following outlines of regulation of telemedicine in Sweden, the United Kingdom, and Israel are, for a large part, based on the document Telemedicine. Legal Framework in Europe & Israel. July 2021. Biolegis. European Life Sciences Lawyers. (8 September 2021.) accessed 27 August 2023. 20 The most important of which is the Healthcare Act – Hälso- och sjukvårdslagen (2017:30) . 21 See Good Medical Practice 2024. General Medical Council. (22 August 2023.) accessed 27 August 2023. 22 See for example the overview of NHS remote monitoring plans in: Supporting care with remote monitoring. NHS England. accessed 28 August 2023. 23 See the following notice of the German Medical Association: Hinweise und Erläuterung zu § 7 Abs. 4 MBO-Ä – Behandlung im persönlichen Kontakt und Fernbehandlung. [Notes and Explanations to Section 7(4) of the MBO-Ä – Model Professional Regulations for Physicians – Treatment in Personal Contact and Remote Treatment.] Bundesärztekammer. [German Medical Association.] (22 March 2019.) 24 See for example the relevant documents of state medical associations in Bavaria, North Rhine-Westphalia, or Saxony: Berufsordnung für die Ärzte Bayerns. Bayerisches Ärzteblatt. (2018, No. 12), p. 694 and following

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