Key Legal Observations On The Draft Telemedicine Ordinance

The Ministry of Health has published for public consultation a draft Ordinance on the Provision of Medical Care from a Distance (Telemedicine).

The proposed act introduces a comprehensive legal framework for telemedicine in Bulgaria, defining the conditions, scope, and requirements for providing healthcare services without in-person contact between healthcare professionals and patients.

The draft Ordinance regulates:

• Conditions and procedures for providing remote medical care – It outlines how preventive, diagnostic, therapeutic, and rehabilitative services can be lawfully provided through electronic means. It specifies the categories of medical activities for which telemedicine is not permitted.
• Informed consent and information requirements – The Ordinance provides detailed rules for obtaining patients' informed consent through medical, information, and communication technologies, as well as the scope and form of information that must be given to patients before the service is provided.
• Data protection and information security – The regulation imposes strict obligations on healthcare providers to ensure the confidentiality, integrity, and security of personal and health data processed during remote consultations, in compliance with the Personal Data Protection Act and the Cybersecurity Act.
• Technical and organisational requirements – Healthcare establishments must use certified software and communication systems that meet EU standards (CE certification) and the national requirements on network and information security.
  Operational framework – Telemedicine services may be delivered by individual healthcare establishments or jointly through "Centers for Remote Medical Care," established under contractual arrangements between providers.
• Supervision and accountability – The Executive Agency "Medical Supervision" will oversee compliance with the Ordinance, and medical professionals remain personally responsible for the quality and safety of care provided remotely.
  The draft further clarifies that telemedicine may be used for both planned and emergency medical consultations, provided that patient safety and the quality of care are not compromised.

The adoption of this regulation marks an important step toward aligning Bulgaria's healthcare legislation with technological developments and European best practices in digital health.

We would raise the following points of concern that need the attention of the authority before the adoption of the Ordinance.

1. Voluntary establishment of Telemedicine Centres- Article 5(1) states that healthcare establishments may jointly provide telemedicine services through "Centres for Remote Medical Care." However, paragraph (2) of the same article creates ambiguity, suggesting that such centres must be established for cooperation or referrals to occur. The word "must" should be replaced with "may" to ensure patient referrals and cooperation without mandatory institutional structures.
2. It is required that the communication and computer equipment used by healthcare establishments for the provision of medical care from a distance must bear a CE mark, which is inappropriate for ICT services and general communication platforms, which are not subject to CE certification.

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