French Health Authority (HAS)
Mission
Regulation
Type of actor
Institutional player
Fields of intervention
Health / Social care / Social / Medical Device
Intervention zone
National
What is HAS?
Independent public authority of a scientific nature, the Haute Autorité de santé (HAS) aims to develop quality in the health, social and medico-social fields, for the benefit of people.
Missions
- Evaluate drugs, medical devices and professional procedures with a view to their reimbursement;
- Recommend good professional practices, draw up vaccination and public health recommendations;
- Measure and improve quality in hospitals, clinics, outpatient medicine, social and medico-social establishments.
Discover HAS on video
In the field of healthcare innovation, HAS:
- Evaluates health technologies with a view to their reimbursement;
- Evaluates the eligibility of requests for forfait innovation (derogatory reimbursement scheme for innovative technologies).
In the field of business software for healthcare professionals, the HAS:
- Agrees the drug databases, medical devices and associated services (BdM) on the basis of a quality charter;
- Establishes the certification procedure and reference systems for prescription assistance software (PAS) and dispensing assistance software (DAS): ambulatory medicine PAS, hospital PAS, dispensary DAS and internal-use pharmacy DAS;
- Develops medical decision support systems: drug-indexed decision support systems (DSS) and good practice DataSets ;
- Develops quality repositories relating to certain types of decision support systems (DSS).
- Structures coordination document templates that can be integrated into business software, exchanged via secure health messaging or shared in the shared medical record (DMP).
In the field of telehealth, the HAS:
- Promotes the proper use and quality of practices for acts of telemedicine(teleconsultation, teleexpertise and teleimaging) and activities of telecare: eligibility criteria, recommendations for implementation, patient information sheets, rapid responses within the framework of Covid-19, "patient traceur" professional practice evaluation method;
- Develops tools to support the deployment of telemedicine in France.
- Evaluates, at the initiative of operators, remote medical monitoring medical devices and associated medical services with a view to their inclusion on the dedicated reimbursement list, both for the permanent framework and, upstream, within the derogatory framework of prise en charge anticipée (PECAN).
In the field of mobile health, the HAS:
- Makes available to manufacturers and evaluators a good practice reference framework for assessing the quality of applications and connected objects in mobile health;
- Develops the medical content quality repository for referencing digital services in the digital health space (ENS), a service platform for citizens, and in the service package (BS), a service platform for healthcare professionals.
I have a project. How can contacting HAS help me?
In the field of healthcare innovation, you can contact HAS to:
- Consult the referentials and good practice guides that concern me;
- Anticipate the terms of access to reimbursement for my solution.
In the fields of business software, telehealth and mobile health, HAS supports you by answering your questions sent by e-mail to: contact.mns@has-sante.fr
- If you are publishers of a drug database, a practice or dispensary management software in town or hospital, which allows to elaborate or deliver a medical prescription, if you are considering applying for LAP and LAD certification, HAS answers your questions on the steps to take (accreditation procedure and certification procedure) and on the content of the certification referentials;
- If you offer a digital telemedicine service (teleconsultation, remote interpretation of imaging examinations...), HAS guides will enlighten you on the best practices to implement;
- If you are carrying out a telemedicine project, the safety grid will help you identify and control the specific risks of your project;
- If you're an industrialist(app designer, start-up...) or an evaluator(evaluation structures, consumer associations or medical learned societies) the good practice guidelines for mobile health applications and connected objects will enlighten you on the best practices to take into account for a safe, high-quality design. This guide aims to promote usage and reinforce confidence in connected applications and objects.
At what stage of my project should I contact you?
If your product falls within the scope of HAS assessment, and in particular in the context of an application for reimbursement by the French National Health Insurance, support is available at certain key moments prior to the submission of your reimbursement application. Two types of meetings are possible for technologies that fall under medical device status or involve the creation of a new professional act, depending on how far along your development is:
- Earlymeetings if you have a clinical study project and would like to benefit from an exchange with HAS teams and their experts on a study you wish to set up. The main aim of these meetings is to discuss the questions you have concerning the methodology of the clinical study you are planning. This type of exchange can be useful before you start your study. So it's at this point, as soon as your protocol project is constructed, that you can approach us;
- Or pre-filing appointments: these appointments are set up specifically for medical devices, to help manufacturers with the technical and regulatory aspects of putting together or finalizing their dossier (LPPR scope, LATM, PECAN, dossier content in particular).
Does it finance projects?
Accessible resources
Practical guide
All the questions you need to ask about HAS.
Can the HAS provide individual support for my project?
If your project involves a healthcare technology and you'd like to find out about access to reimbursement or the innovation package, HAS has set up a support policy with regular information meetings, early meetings and pre-filing appointments. It also provides manufacturers with methodological guides and guidelines to support them in filing their applications.
.Who's the right person to talk to?
In the field of healthcare innovation:
- To request an early meeting: visit the platform SESAME ;
- For all questions relating to access to reimbursement, or a request for a pre-filing appointment: predepot.dmdmn@has-sante.fr ;
- For all questions relating to the innovation package: secretariat-innovation@has-sante.fr.
In the fields of business software, telehealth and mobile health: contact.mns@has-sante.fr
Is there a charge for HAS services?
The HAS is a public institution, all publications and services are accessible free of charge.
5 Avenue du Stade de France 93210 Saint-Denis