Attorney for health authorizations, care activities, or heavy medical equipment

You wish to create a health company or a healthcare facility and are looking for a lawyer to request health authorizations for care activities or heavy equipment? Are you considering the installation of heavy equipment or the regrouping of health activities? Contact Macfarlanes LLP for complete handling of administrative procedures and tailored support. Our professionals work with healthcare facilities as well as project leaders.

Whether to request authorization for a new healthcare activity, renewal of an authorization, or its transfer, you can count on us to realize your ambitions. We analyze your project and assist you in preparing the files in accordance with regulations. In case of refusal, withdrawal of authorization, or disputes before administrative courts, we can also defend your interests.

Lawyer for health authorization requests, healthcare activities, equipment and heavy medical devices

Projects related to the creation of a healthcare facility, the establishment or merger of care activities, as well as the installation of heavy equipment, are governed by strict regulations. They require prior authorization from the Regional Health Agency (ARS). The list of activities concerned and equipment subject to authorization is defined by the Public Health Code.

For example:

• Nuclear medicine;
• Medical care and rehabilitation;
• Cancer treatment;
• Interventional radiology;
• Psychiatry;
• Surgery, etc.
• Imaging equipment used for diagnostic radiology;

These authorizations are granted provided that the projects are compatible with the objectives of the SRS and comply with the implementation and operating conditions defined by regulations. Furthermore, applications must be submitted within regulatory "windows," open two to three times a year for a minimum duration of two months. Before each submission period, a quantified assessment of the healthcare supply in the territory allows for evaluating unmet needs in terms of healthcare supply and establishing available facilities.

Before any decision, requests are submitted for opinion to the Specialized Committee for the Organization of Care (CSOS), then examined by the ARS. Given these requirements, you must consult your lawyer for your health authorizations for care activities or heavy medical equipment. At Macfarlanes LLP, we offer complete support for the procedures necessary to carry out your project.

To file a complete and admissible application, we refer in particular to Decree No. 2021-974 of July 22, 2021, simplifying and modernizing the regimes for authorizing healthcare activities and heavy medical equipment. We verify, among other things, the achievement of the objectives set by the regional or interregional plan and compliance with the conditions set by the Public Health Code.

Our experts advise you on all criteria and support you in analyzing needs and developing the necessary arguments to meet the expectations of health authorities. We ensure the compliance of each element, taking into account legislative and regulatory developments, to optimize the chances of success of your application.

Lawyer for renewal of health authorization, care activity or heavy medical equipment

The health authorizations for care activities and heavy medical equipment are issued for a limited period, generally set at seven years. Indeed, as this deadline approaches, the holder must initiate a renewal procedure to continue operating the authorization. This step is essential to maintain the continuity of care and ensure compliance of the activities with regulatory requirements.
The application must be submitted to the Regional Health Agency at least 14 months before the authorization's expiry date, without any obligation to wait for a specific filing period. It is important to note here that the renewal file includes specific elements, notably the commitment to maintain the conditions for the establishment and operation of the activities, as well as the status of the medical and paramedical staff assigned.

It must also include any modifications planned for the renewal period, particularly in relation to the objectives of the regional health plan or the organization of facilities. On the other hand, in the absence of an injunction from the ARS, a tacit renewal may be granted, thus simplifying certain administrative procedures. However, the complexity of regulatory requirements requires rigorous preparation to ensure the acceptance of the file.

That is why we provide lawyers specialized in the renewal of health authorizations, care activities or heavy medical equipment. Our team handles the complete preparation of the file, ensuring that each element complies with legal provisions. We also ensure the drafting of commitments, verification of data relating to staff numbers, and analysis of necessary modifications, in order to present a file that meets the required standards.

Thanks to our expertise in health law, we advise you on the strategic adjustments needed to meet the objectives of the regional or interregional health plan. If organizational changes or cooperation agreements need to be included in the file, we guide you in their formulation so that they comply with the conditions set by the regulations.

Lawyer for the purchase and sale or modification of health authorizations for care activities or heavy medical equipment

Do you have a project to acquire from another health establishment, or to transfer a care authorization in order to optimize your medical activities? The transfer of health authorizations, whether in the context of a regrouping of activities or a reorganization, requires prior confirmation from the Director General of the ARS. Furthermore, an authorization cannot be transferred before the effective implementation of the activity or the installation of the equipment concerned.

In the context of a transfer, the transferee must send a request for confirmation of the authorization to the Director General of the ARS, accompanied by a detailed file. Similarly, any modification of the conditions for executing the authorization must be evaluated by the ARS. Depending on the nature of the project, the Director General may either give their approval or request a complete file within the prescribed deadlines.

This regulatory framework requires a sharp legal expertise to ensure compliance of procedures and secure your projects. You can therefore rely on our know-how for a secure operation. Our firm of specialized lawyers for renewals of health authorizations for care activities or heavy medical equipment intervenes at every stage of these procedures for rigorous monitoring.

Whether for the transfer or modification of authorizations, we analyze the specifics of your project, prepare the necessary files, and represent you before the competent authorities. We also ensure that all procedures comply with applicable provisions, particularly in sensitive sectors such as psychiatry, surgery, nuclear medicine, or medically assisted procreation.

Thanks to our expertise in company law, you benefit from personalized support to guarantee the success of your projects. In parallel, we are also experts in the creation and merger of companies or health establishments. Our expertise includes drafting adapted articles of association, optimizing taxation and managing contractual relations. These steps are particularly strategic to ensure a smooth and sustainable organization of healthcare activities.

Lawyer for health authorizations for care activities or heavy medical equipment: litigation

Our firm also offers a personalized service, provided by lawyers specialized in health authorization for care activities or heavy medical equipment for litigation management. Whether for an implicit or explicit rejection decision, opposition to renewal, or a refusal of transfer, we do everything possible to protect our clients' rights.

Depending on the requests, an explicit or implicit rejection decision may be issued by the Director General of the ARS after a maximum processing period of six months. The absence of a response within this period may constitute an implicit rejection, while an explicit refusal must be justified and notified to the applicant. In all cases, these administrative decisions can be challenged if they appear to violate regulations.
Several remedies are available to project leaders in this context. The hierarchical appeal, although optional, can be submitted to the Minister of Health. The latter has a maximum period of six months to rule.

This type of appeal allows for an administrative review of the ARS decision and sometimes offers a favorable outcome. However, if this step does not succeed or is not considered, litigation remains an essential option to challenge the legality of the decision before the competent administrative court. In this context, our firm intervenes to assist applicants in challenging ARS decisions.

We analyze in detail the reasons for the decision of refusal or rejection to identify any irregularities or abuse of power. Then, we develop an appropriate strategy, whether for an administrative or judicial appeal, ensuring rigorous preparation of the file. With our lawyers in business law and health law, we can obtain the annulment or revision of said decision to carry out your project.