The Ministry of Health of Montenegro has presented a draft set of amendments to the Health Care Law, which are intended to lay the groundwork for the accelerated development of digital health services and bring the regulatory framework in line with modern requirements. The key changes are meant to ensure harmonization of the current legislation with the new Law on Medical Data in Health Care, предусмотрed in the government’s work program for this year.
Unified standards and integration of medical data
According to the document, the goal of the reform is to clearly define the responsibilities of all participants in the health care system in terms of maintaining, collecting, and storing medical documentation, standardizing data, and integrating fragmented information solutions into a single digital system.
This integration will be carried out within the framework of the Digital Health Development Strategy for 2024–2028, which includes the creation of a modern, functional, and secure information environment.
The Ministry of Health emphasizes that the need for a separate law regulating databases in health care became apparent only after the current health care law had been prepared. This step will make it possible tobring all patients’ medical information together in one placeand ensure strict access control and security.
Preparing for a new law on the digitalization of medicine
The proposed amendments provide that issues of digital transformation — from infrastructure to the keeping of medical records and the functioning of theIntegrated Health Information System(Integralnog zdravstvenog informacionog sistema, orIZISfor short) — will be described in greater detail in a new special law.
A number of articles are being clarified or removed entirely:
- the first two articles align the terminology with the new regulations,
- Article 3 brings the law into line with occupational health and safety regulations,
- Article 201, which dealt with electronic data exchange via