Significant and impactful changes targeting the Romanian healthcare sector will enter into force next year, specifically on 22 April 2026. These changes are introduced by Law No. 159/2025, amending and supplementing Law No. 95/2006 on healthcare reform (“Law 159/2025”), published in the Official Gazette No. 975 of 22 October 2025.
In a nutshell, Law 159/2025 brings some interesting novelties to the Romanian healthcare sector, such as:
Mandatory safety measures
The law introduces new obligations for public and private healthcare facilities, aiming to enhance patient and staff safety, consisting of:
▸ Installation of panic buttons: all public and private healthcare facilities that have inpatient beds will be required to install and maintain panic buttons or other alert systems in every ward used for patient admission. These systems must be easily accessible to patients, allowing them to quickly signal medical emergencies or situations of imminent danger. Healthcare facilities must also ensure regular staff training and periodic testing of the alert systems.
According to the law, the following actions constitute contraventions: a) failure to install the alert systems; b) failure to ensure their proper functioning; and c) failure to organize regular staff training.
Such violations may be sanctioned with administrative fines ranging from RON 10,000 (approx. EUR 2,000) to RON 30,000 (approx. EUR 6,000).
▸ Installation of video surveillance systems: this requirement applies to healthcare facilities that include intensive care units (e., ATI sections), emergency departments, or units for critically ill cardiac patients. Under Law 159/2025, such facilities must install video surveillance systems to enable continuous monitoring of medical activities and patients, while ensuring that patients’ privacy is not compromised. Recorded footage must be securely stored in accordance with high cybersecurity standards for a period of between 3 and 60 days.
The new legal provisions provide that access to recordings must be permitted only to authorized personnel designated by the facility’s management board. In addition, healthcare facilities must inform both patients and staff of the presence of surveillance cameras by displaying visible notices at the entrances to the monitored areas.
Failure to comply with these legal requirements may result in administrative fines ranging from RON 10,000 (approx. EUR 2,000) to RON 30,000 (approx. EUR 6,000).
▸ Major changes in pharmaceutical services: Law 159/2025 also integrates pharmaceutical services into the healthcare framework regulated by Law No. 95/2006 on healthcare reform. It strengthens pharmacists' role in preventive healthcare and authorises the administration of vaccinations directly in pharmacies.
An interesting approach to applying sanctions
Law 159/2025 seems to introduce a notable shift in Romania’s data protection framework. Under the new rules, responsibility for identifying and sanctioning breaches related to hospital video surveillance systems will rest with the county and Bucharest public health directorates, acting through the State Sanitary Inspection.
This marks the fact that GDPR compliance in healthcare facilities will be monitored not by the National Supervisory Authority for Personal Data Processing (ANSPDCP), but by the health authorities themselves.
Implementation timelines
The law enters into force on 22 April 2026, following a six-month transition period. From that point, hospitals will have 18 months to implement panic buttons and 24 months to comply with the video surveillance requirements.
Conclusion?
A new era of safety & transparency in the Romanian healthcare system. Law 159/2025 marks more than just another legislative update. It represents a strategic step toward a safer, smarter, and more accountable healthcare system. By blending public health priorities with data protection principles, the law establishes a framework where patient safety, privacy, and technological integrity go hand in hand.
