Rulebook on the Electronic Health Record, Personal Health Identification Number, and the Delivery of Data at the Patient’s Request (the “Rulebook”), was rendered on May 28, 2025, which establishes a unified method for collecting patient data and medical documentation via electronic means. The Rulebook will enter into practical application as of January 1, 2026.
What changes does the new Regulation bring:
- Establishment of a centralized registry of electronic medical documentation of patients, aimed at enhancing the efficiency of healthcare service delivery;
- Gradual input of data into the electronic health record (EHR): personal patient data, information on healthcare services provided and the patient’s medical condition, medical documentation – therapies, referrals, lab results, imaging, etc.;
- Appointment of an EHR Administrator – a person responsible for providing technical support for data exchange between healthcare institutions and the EHR system;
- A 24-hour deadline following the provision of a healthcare service or change in the patient’s medical condition for updating patient data in the EHR;
- Designated e-services for data exchange, requiring mandatory authentication prior to enabling access to patient data;
- For patients, access to EHR data is enabled via a web portal or mobile application managed by the competent ministry;
- The Rulebook provides for data protection measures and access controls to the EHR, and defines the authorized categories of persons permitted to access patient data;
- The competent ministry manages user accounts and access rights within the Republic Integrated Health Information System (RIHIS) which maintains records of authorized healthcare professionals and associates granted access to data from the EHR.
For additional information or consultations, the Tasić & Partners team is at your disposal.