The Ministry of Health of Montenegro has presented a draft amendment to the Health Care Law, which should lay the foundation for the accelerated development of digital healthcare services and bring the regulatory framework into line with modern requirements. The key changes should ensure harmonization of the current legislation with the new Law on Medical Data in Health Care, предусмотренным in the government’s work program for this year.
Unified standards and integration of medical data
According to the document, the aim of the reform is to clearly define the responsibilities of all participants in the healthcare 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 healthcare became clear only after the preparation of the current health care law. This step will allow all patients’ medical information to be brought together in one place and ensure strict access control and security.
Preparation 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 the Integrated Health Information System (Integralnog zdravstvenog informacionog sistema or, abbreviated IZIS) — will be described in more detail in the new special law.
A number of articles are being clarified or completely removed:
- the first two articles bring the terminology into line with the new rules,
- Article 3 brings the law into line with occupational health and safety regulations,
- Article 201, which dealt with the electronic exchange of data through IZIS, is being removed — its content will be transferred to the future law on databases.
New rules for healthcare institutions and staff
The draft amendments also address issues such as:
- the conditions for healthcare institutions to obtain licenses,
- requirements for the experience of members of management bodies,
- rules for extending the professional activity of healthcare workers after the age of 66,
- clearer criteria for obtaining temporary licenses and completing specializations.
The main innovation is the creation of the Digital Health Agency
The most significant structural change will be the establishment of the Digital Health Agency — a central body that will be responsible for implementing digital transformation in medicine.
The draft law describes in detail:
- the Agency’s legal status,
- the powers and operating procedures of the Board,
- the conditions for appointing and dismissing management,
- sources of funding,
- the level of transparency of its work,
- the status of employees, including the possibility of receiving a monthly bonus of up to 30%.
It is expected that the new structure will become a key driver of reforms in digital medicine and ensure a rapid transition to modern standards.
Bylaws — faster than planned
The amendments отменяют the previous one-year deadline for drafting bylaws. They will now be prepared within the framework of the new law on databases — and, as the Ministry emphasizes, much faster than originally planned.
Deadlines have also been set for appointing the Agency’s governing bodies and adopting key documents, including the statute and rules for the systematization of workplaces.
Strengthening inspection oversight
The amendments to the penalty provisions clarify the powers of the supervisory authorities, which should increase the effectiveness of law enforcement and ensure reliable compliance with digital standards in healthcare.