The Regulation of Telemedicine in Romania. Issues of Legal Limitations in Digital Medical Development

Ionuţ Vida-Simiti ()
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Ionuţ Vida-Simiti: University of Medicine and Pharmacy “Iuliu Haţieganu” Cluj-Napoca

A chapter in Sustainable and Resilient Businesses in the Global Economy, 2025, pp 309-321 from Springer

Abstract: Abstract In Romania, telemedicine was introduced by the amendments to Law no. 95/2006 by Government Emergency Ordinance no. 8/2018 and Government Emergency Ordinance no. 196/2020 with the implementing rules of Government Decision no. 1.133/2022. The present study analyses these regulations in the context of Romanian medical law as a whole, from which three significant problems emerge. First, the provision of medical assistance by telemedicine can only be done by health units accredited by the National Authority for Quality Management in Health Care through doctors specialized in the medical fields expressly and limitatively listed in Annex 1 of the GD. no. 1.133/2022. They may provide medical services by telemedicine only in compliance with Article 32 of the Code of Medical Ethics, which implies remote contact between doctor and patient assisted by another doctor, who in turn must be a specialist in a field listed in Annex 1 of GD. no. 1.133/2022 and employed at a health unit accredited for telemedicine services. Secondly, the fact that Article 4(2) of Annex 2 to Government Decision No 1.133/2022 instils the possibility that proof of obtaining the patient's consent for the provision of the medical service itself may be provided by the health establishment by any means whatsoever constitutes a breach of Article 660 of Law No 95/2006 and Article 13 of Law No 46/2003, which require that the patient's consent must be expressed in writing only. Thirdly, a significant aspect is the establishment of a specific form of liability for medical malpractice, since Government Decision No 1.133/2022 establishes the liability of the health unit for the medical service provided by telemedicine and, in this regard, expressly confers on health units the prerogative to assess the effectiveness of telemedicine medical services, depending on the diagnosis and pathological evolution of the patient, and, if the assessment is unfavorable, the patient will be indicated alternative ways of providing the medical service.

Keywords: Malpractice; Telemedicine; Patient consent; Confidentiality (search for similar items in EconPapers)
Date: 2025
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Persistent link: https://EconPapers.repec.org/RePEc:spr:prbchp:978-3-031-75883-6_19

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DOI: 10.1007/978-3-031-75883-6_19

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