For the first time Bulgarian Law recognized the telemedicine as a valid and apparently important method for provision of medical/healthcare services. In fact, telemedicine is practiced nowadays even without being regulated, due to its role in increasing the access to healthcare services, improvement of medical cares; ensuring effectiveness of healthcare systems; technology integration; enhancing the flexibility of medical care services.
The amendments to the Healthcare Facilities Act of Bulgaria regarding telemedicine (remote medical care as outlined in Article 6b) introduce several important provisions:
Distance Medical Care
Medical establishments and specialists are now permitted to provide medical care remotely, encompassing diagnostic, curative, rehabilitative, and preventive activities.
Standards and Methods
Distance medical services must comply with existing medical standards and utilize scientifically validated methods. The use of secure medical, information, and communication technologies is mandated to protect personal and health information.
Risk Assessment
Remote medical assistance cannot be provided if it poses a risk to the patient’s life or health or if it may compromise the quality and safety of care.
Professional Responsibility
The decision to offer remote care is to be made on a case-by-case basis by the medical professional, who is responsible for ensuring the quality and safety of the service.
Informed Consent
Informed consent from the patient is required before providing distance medical care, which must cover various aspects, including the scope of services, risks, alternatives, and the patient’s right to withdraw from the process at any time; the name and specialty of the persons administering the telemedicine concerned, with clearly defined responsibilities and professional competence as well their to refuse or terminate the provision of medical care under certain conditions.
Patient Responsibilities
Patients are obligated to provide complete and accurate health information during telemedicine consultations and must facilitate timely access to their health data.
Right of Access
Medical professionals are granted access to patients’ electronic health records with the patient’s informed consent, adhering to specified regulations.
Regulatory Framework
The Minister of Health will establish regulations detailing the procedure for remote care provisions, the criteria for situations where remote assistance is not allowed, and the requirements for the technologies used in telemedicine.
These amendments aim to enhance the accessibility and availability of healthcare services and their economic efficiency while ensuring patient safety and data security.
The amendments shall enter into force as from 1st of April 2025.
