Chapter II: Authorisations.

Projects relating to the creation of any healthcare establishment, the creation, conversion and grouping of healthcare activities, including alternatives to hospitalisation, and the installation of heavy equipment are subject to authorisation by the Regional Health Agency. The list of healthcare activities and heavy equipment subject to authorisation is set by decree in the Conseil d’Etat.

Authorisation is granted, taking into account the elements of the certification reports issued by the Haute Autorité de santé which concern the project for which it is requested and which are relevant on the date of the decision (1), when the project: 1° Meets the health needs of the population identified by the plan mentioned in article L. 1434-2 or in 2° of article L. 1434-6 ; 2° Is compatible…

Authorisation may only be granted to : 1° One or more doctors, who may be associated for the purposes of their professional practice or for the pooling of the resources necessary for such practice; 2° A health establishment ; 3° A legal entity whose purpose relates, in particular, to the operation of a health establishment, a healthcare activity or a piece of heavy equipment mentioned in article L. 6122-1 or…

The authorisation is given before the start of the works, the installation of the heavy equipment or the implementation of the planned care activities or alternative care structures. It is automatically deemed to be an authorisation to operate, subject to a declaration of commencement of activity to the Regional Health Agency and, where applicable, the carrying out of the compliance visit provided for in the third paragraph, followed by a…

The authorisation referred to in Article L. 6122-1 is subject to compliance with commitments relating, on the one hand, to the expenditure to be borne by the health insurance scheme or to the volume of activity and, on the other hand, to the completion of an evaluation under conditions laid down by decree. This evaluation takes into account compliance with the benchmarks mentioned in the first paragraph of article L….

The grouping referred to in article L. 6122-1 consists of bringing together in one place all or some of the care activities previously authorised on separate sites within the same region or spread across several regions. The conversion referred to in article L. 6122-1 consists of transforming all or part of the nature of its care activities. By way of derogation from 2° of article L. 1434-3, authorisation for grouping…

The authorisation may be subject to specific conditions imposed in the interests of public health and, where applicable, specific defence requirements identified by the plan referred to in article L. 1434-3. It may be limited, at the request of the authorisation applicant, to specific therapeutic practices specified by decree in the Conseil d’Etat. It may also be made subject to a commitment to implement cooperative measures to promote the joint…

Authorisation is given for a fixed period, set by regulation. This period may not be less than seven years, except in the case of healthcare activities requiring special provisions in the interests of public health. Where appropriate, the authorisation sets quantitative and qualitative targets for the healthcare activities or heavy equipment authorised. In this case, the authorisation sets out the penalties applicable if these targets are not met. In the…

Authorisation for activities or facilities covered by a regional plan is granted or renewed by the regional health agency after obtaining the opinion of the specialised commission of the regional conference on health and autonomy responsible for the health sector. Authorisation for activities or facilities covered by a national or inter-regional plan is granted or renewed by the regional health agency for the region in which the applicant has its…

By way of derogation from the provisions of articles L. 6122-2, L. 6122-8 and L. 6122-9, in the event of a serious health threat identified by the Minister for Health under the conditions provided for in article L. 3131-1, the Director General of the Regional Health Agency may authorise, for a limited period of time, a healthcare establishment to carry out a healthcare activity other than that for which it…