Title II: Sanitary equipment

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…

Renewal of the authorisation is subject to compliance with the conditions set out in articles L. 6122-2 and L. 6122-5. It may also be subject to the conditions mentioned in the second paragraph of article L. 6122-7. The holder of the authorisation sends the application for renewal of its authorisation to the Regional Health Agency no later than fourteen months before the authorisation expires. After examining the elements mentioned in…

The regional or inter-regional health plan and decisions to authorise activities or heavy equipment may be appealed to the Minister for Health, who will rule within a maximum of six months, after obtaining the opinion of the National Committee for Health and Social Organisation. This appeal is not a prerequisite for legal action.

All authorisations are deemed to have lapsed if the operation has not been started within three years. The authorisation is also deemed to have lapsed for any part of the activity, structure or equipment that has not been completed, implemented or installed within four years. Similarly, unless the Director of the Regional Health Agency gives his prior consent at the justified request of the holder of the authorisation, the receiver…

When the Director General of the Regional Health Agency establishes that the quantitative and qualitative targets mentioned in article L. 6122-8 are not being sufficiently met according to criteria defined by decree, he may revise the authorisation mentioned in article L. 6122-1. From the date of notification by the Regional Health Agency of the proposed revision of the authorisation, together with the reasons for the revision, the holder of the…

I.-When, during the performance of a healthcare activity or the installation of a piece of heavy equipment, it is established that the person holding the authorisation has failed to comply with the laws and regulations for the protection of public health or the continuity of care provided by medical staff, or has refused the consultation referred to in article L. 6122-5, the Director General of the Regional Health Agency will…

For the purposes of this Title, “heavy equipment” means movable equipment intended for the diagnosis, treatment or functional rehabilitation of the injured, the sick and pregnant women, or for information processing, which can only be used under particularly onerous installation and operating conditions or which may lead to an excess of medical procedures. The list of such equipment is established by regulation.

Authorisation for equipment to be used on a travelling basis in several health regions is granted or renewed by the regional health agency of the region in which the applicant has its registered office or domicile, after obtaining the opinion of the specialised commission of the regional conference on health and autonomy responsible for the health sector in this region, and after consulting the specialised commission of the regional conference…