Assistance in procedures for opening, modifying or relocating healthcare and social care facilities
Healthcare authorisation is the necessary requirement for setting up and operating healthcare and social care facilities. It applies to the opening of new facilities, relocation, structural, organisational or technological changes, and any variation affecting the conditions already authorised.
The procedure requires verification of the structural, technological and organisational requirements laid down by national and regional rules. The Presidential Decree of 14 January 1997 approved the minimum requirements for the operation of healthcare activities by public and private facilities, without prejudice to regional powers in regulating authorisation procedures. In Sicily, the Regional Department for Strategic Planning identifies Regional Decree No. 741 of 4 July 2023 among the reference provisions on the authorisation and accreditation of public and private healthcare facilities.
Avv. Vecce assists private healthcare facilities, outpatient clinics, professional practices, companies and sector operators in preparing the application, reviewing the documentation, dealing with the competent authorities and managing any issues that may arise during the authorisation procedure.
Activities covered
Why it matters
Starting the activity correctly
Authorisation makes it possible to structure the opening or modification of the facility on proper legal and documentary grounds.
Preventing procedural blocks
An incomplete or inconsistent application may lead to requests for additional information, delays or negative outcomes.
Coordinating technical and legal aspects
The procedure requires coordination between healthcare requirements, premises, equipment, organisation, ownership and administrative documentation.
Protecting investments
Before setting up or modifying a healthcare facility, it is essential to verify whether the project is compatible with the applicable authorisation framework.
FAQ
What is healthcare authorisation?
It is the title required to set up a healthcare or social care facility and carry out the relevant activity. Article 8-ter of Legislative Decree 502/1992 makes both the construction of facilities and the operation of healthcare and social care activities subject to authorisation.
Are healthcare authorisation and accreditation the same thing?
No. Authorisation allows the healthcare activity to be carried out. Institutional accreditation is a further step, required for a facility to be recognised as eligible to provide services on behalf of the Health Service, according to regional planning and rules.
Is authorisation also required to modify an existing facility?
Yes, when the change affects the location, premises, equipment, organisation, activity carried out or conditions already authorised. In Sicily, the Region expressly draws attention to structural, organisational and technological changes in the procedures concerning healthcare facilities.
Who verifies the facility’s requirements?
Verification involves the competent authorities and, where applicable, the appointed technical bodies. In Sicily, the Technical Accreditation Body also prepares tools, procedures, checklists and verification activities concerning the requirements for authorisation and accreditation.
Which requirements are assessed?
Structural, technological, organisational and subjective requirements are assessed, depending on the type of facility and the services to be provided. The Presidential Decree of 14 January 1997 is the national reference for minimum requirements, while regional rules set out the applicable procedures and requirements in greater detail.
Does authorisation give the right to work with the Regional Health Service?
No. Authorisation enables the facility to carry out the activity, but it is not the same as institutional accreditation and does not automatically create a contractual relationship with the Regional Health Service.
What happens if the application is incomplete?
The authority may request additional information, clarifications or further documents. Poorly organised management of the application may cause delays, suspension of the review process or issues in obtaining the authorisation.
Request a free case assessment
I will reply as soon as possible.
