The proposed amendments, together with the Law on Data Management and Digital Health, aim to modernize the system while strengthening patient data protection and standardizing healthcare records.
Key developments include the establishment of the Digital Health Agency and the Integrated Health Information System (IHIS), which will enable standardized processing, exchange, and secure access to health data across all healthcare institutions. The reforms introduce mandatory digital health records, telemedicine capabilities, and comprehensive health data collections—including electronic medical records, public health registries, and screening program databases.
These legislative changes align with EU GDPR standards and establish clear principles for lawful data processing, including legality, accuracy, standardization, interoperability, and data accessibility coupled with robust protection measures. The framework regulates secondary processing of health data for research and planning purposes while implementing strict security requirements and oversight mechanisms.
The reforms represent a significant step toward a faster, more integrated healthcare system. However, successful implementation will require effective enforcement of security measures and penal provisions to maintain patient trust and ensure genuine protection of health data rights.
The authors of the article are Partners Marija Živković, and Alma Karađuzović Đinđinović, from JPM Podgorica office.
