Montenegro is preparing one of the most significant overhauls of its health system in years, with the Ministry of Health unveiling a package of legal amendments aimed at accelerating the country’s digital health transformation. Central to the reform is the creation of a National Agency for Digital Health, envisioned as the key institution responsible for driving digitalization across the health sector.
The Ministry has submitted for public debate the Draft Law on Amendments to the Law on Health Care, designed to align the existing legal framework with the upcoming Law on Health Data Collections—a new piece of legislation included in the Government’s 2024 Work Program.
According to the Ministry, the changes will establish clear responsibilities for all health-system actors regarding the management, collection, and storage of medical records, the standardization of health data, and the integration of currently fragmented information systems into a unified, functional digital ecosystem. These steps are part of the Digital Health Development Strategy 2024–2028, which outlines Montenegro’s long-term vision for digital transformation in healthcare.
“During the preparation of the existing Health Care Law, a separate law on data collections was not anticipated. However, it has now become an essential step in the modernization of the health sector. The new framework ensures that all patient data are consolidated in one secure system, with strict controls over access and storage,” the Ministry stated.
Under the proposed amendments, key areas such as health digitalization, ICT infrastructure, the management of medical records, health cards, and the Integrated Health Information System will be further developed in the new dedicated law. Additionally, several provisions will be aligned with the Law on Occupational Safety and Health. Article 201, which previously governed electronic data exchange with Integrated Health Information System, is set to be deleted and fully replaced by detailed regulation in the upcoming law.
The draft also includes changes related to licensing requirements for health institutions, conditions for serving on management boards, continued employment for health professionals beyond the age of 66, and clearer rules for specializations and temporary licenses.
The most transformative element is the establishment of the Agency for Digital Health. The law outlines the Agency’s legal status, governance structure, responsibilities of the Council and director, financing mechanisms, transparency requirements, and the employment framework—including a provision allowing for a salary supplement of up to 30 percent for Agency staff.
The Agency is expected to become the central driver of digital health reform, coordinating national standards, infrastructure development, and data-management systems.
The amendments also remove the previous one-year deadline for by-law adoption, as these regulations will now be developed under the new Law on Health Data Collections—and earlier than originally planned. Deadlines are also set for appointing the Agency’s leadership and for adopting essential internal documents, including the statute and rulebook on systematization.
Revisions to penalty provisions introduce clearer rules for inspection bodies, aiming to strengthen enforcement and ensure effective implementation of the law.
With the launch of the Agency for Digital Health, Montenegro aims to modernize its health system, improve data security, and enhance the quality of services for citizens—marking a major step forward in the country’s digital transformation agenda.
