Ministry of Health introduces telemedicine rules with new ordinance

The Ministry of Health is finalizing the first comprehensive ordinance on remote medical assistance, establishing a regulatory framework for the implementation of telemedicine in Bulgaria, according to a statement from the ministry.

The normative act was developed in connection with amendments to the Medical Facilities Act and regulates the conditions for performing diagnostics, treatment, prevention, and patient monitoring through remote medical services.

The ordinance introduces a requirement that remote medical assistance be provided by medical facilities and healthcare professionals in compliance with all established standards and rules of good medical practice. Telemedicine will only be applied in cases where the same level of quality and safety as in-person treatment can be guaranteed.

The document explicitly lists activities that cannot be performed remotely. These include childbirth, certification of death, and other medical interventions that require mandatory physical contact with the patient.

Particular emphasis is placed on the protection of personal data and the security of health information. All telemedicine activities performed will be documented in the electronic health record through the National Health Information System, ensuring traceability and better coordination among medical professionals.

In drafting the ordinance, opinions from a wide range of stakeholders were taken into account, including medical professionals, healthcare facilities, professional and patient organizations, as well as representatives of the innovation sector. The public consultation process allowed the texts to be refined to achieve a balance between patient protection and the practical applicability of telemedicine.

The document is set to be published in the State Gazette. The Ministry emphasizes that this is a significant step toward the modernization of the healthcare system and better integration with European digital health policies. The new framework is expected to facilitate access to medical care and allow more patients to receive timely and quality care, regardless of their location.