THE HEALTH REGULATION ON HYGIENE CONDITIONS FOR MEDICAL SERVICE PROVIDERS INTRODUCES NEW CATEGORIES OF PROVIDERS

On 14 January 2026, the Government approved the Sanitary Regulation on hygiene conditions for healthcare service providers. The regulatory act establishes a detailed framework governing the operating conditions of healthcare providers, setting out clear requirements regarding location, equipment, operation, and infection control.

The Regulation introduces new categories of healthcare service providers — the mobile medical office and the mobile medical unit — thereby establishing forms of service delivery adapted to the current needs of the healthcare system. A mobile medical office is defined as a structure organized within a specially equipped vehicle, with minimum equipment, which operates by traveling together with medical staff to provide services, particularly in areas with limited access. In turn, a mobile medical unit represents a more complex structure, consisting of two or more mobile offices, which may additionally include temporary facilities such as tents or demountable constructions, and which typically operates for a defined period.

The Regulation provides that the activity of these structures is subject to obtaining a sanitary authorization for operation for each location where the activity is carried out, issued by the competent authority. Healthcare services through mobile structures may be provided particularly in rural, isolated, or underserved areas, subject to holding such authorization and complying with minimum requirements for equipment, hygiene, and safety. At the same time, Section 22 establishes a substantially more stringent regulatory framework in this field by introducing measurable technical standards aimed at ensuring patient and staff safety, as well as consistency of practice.

From a technical perspective, clear requirements are introduced regarding the minimum size of premises, namely at least 7 m² for a mobile medical office and at least 13 m² for a mobile medical unit, where at least two offices are present. In addition, a minimum functional layout is required, including a treatment room of at least 6 m², a storage space of at least 1 m², and essential equipment such as a sink with hot and cold water, sterilization equipment (where applicable), and cold chain systems (an insulated bag and a refrigerated container with a thermometer). Furthermore, accessibility for persons with disabilities must be ensured, and such units must be located in safe areas not exposed to natural risks. Regarding the organization of activities, the Regulation sets specific requirements for the biological sampling area, which must allow the simultaneous activity of two persons, be equipped with a climate control system, and have access to a 220 V power supply for refrigeration equipment. A notable innovation is the strict regulation of sterilization procedures, which must be carried out either in a dedicated space or outside working hours where space is limited, with the possibility of outsourcing to authorized entities, provided that contaminated instruments are stored separately. From a structural and technical standpoint, the vehicles used must comply with strict standards, including washable and disinfectant-resistant surfaces, prohibition of porous materials, and the provision of efficient ventilation with at least 20 air changes per hour, including cooling systems for sensitive compartments. In addition, the Regulation establishes detailed sanitary and hygiene requirements regarding the provision of potable and hot water, wastewater disposal, management of medical waste in accordance with Government Decision No. 696/2018, exclusive use of authorized substances, and the provision of personal protective equipment for staff in accordance with Government Decision No. 108/2022.

Overall, the adopted Regulation represents an important step in modernizing the regulatory framework applicable to healthcare service providers by adapting it to new forms of organization. The introduction and detailed regulation of mobile medical structures contribute to expanding access to healthcare services, particularly in underserved areas. Further information on the amendments introduced by this Regulation will be addressed in subsequent articles.