French Health Authority (HAS)

Mission

Regulation

Type of actor

Institutional player

Fields of intervention

Health / Social care / Social / Medical Device

Intervention zone

National

This player helps you innovate in the social and medico-social sector

What is the HAS?

As an independent scientific public authority, the Haute Autorité de santé (HAS) aims to develop quality in the health, social and medico-social fields, for the benefit of people.

Access the HAS website

This player helps you innovate in the social and medico-social sector

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 the HAS on video

In the field of healthcare innovation, the 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:

  • Integrates drug databases, medical devices and associated services (BdM) on the basis of a quality charter;
  • Establishes the certification procedure and reference systems for prescribing 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 under 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 referencing for 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 the HAS help me?

In the field of healthcare innovation, you can contact the 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, the HAS supports you by answering your questions sent by e-mail to: contact.mns@has-sante.fr

  • If you are a publisher of a drug database, a practice or dispensary management software in the city or hospital, which allows to elaborate or deliver a medical prescription, if you are considering applying for LAP and LAD certification, the HAS answers your questions on the steps to take (approval 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 within the scope of medical device status or involve the creation of a new professional act, depending on how far your development has progressed:

  • 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 your study begins. 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 setting up or finalizing their dossier (LPPR scope, LATM, PECAN, dossier content in particular).

Does it finance projects?

No

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, the 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.

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Who's the right person to talk to?

In the field of healthcare innovation:

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

The Haute Autorité de Santé (HAS) plays an important role in assessing and improving the quality of healthcare in France.

For innovators in digital healthcare, the HAS represents an essential partner in the development and integration of technological solutions into the French healthcare system.

The HAS, an independent scientific public authority, contributes to the optimization of patient care and the efficiency of the healthcare system. It evaluates medical devices, including digital solutions, to guarantee their safety and effectiveness.

The HAS has set up a one-stop shop for the evaluation of digital medical devices (DMN). This initiative facilitates the evaluation process for innovators, by centralizing requests via the Sésame platform. This new system enables a cross-disciplinary assessment of DMNs, combining expertise in digital technologies, telehealth, care pathways and healthcare technology assessment.

The HAS has also developed the first classification of digital healthcare solutions, helping players in the sector to better understand and integrate these tools. This classification takes into account the purpose of use, the ability to provide a personalized response and the autonomy of solutions.

For healthcare establishments, the HAS manages the certification process, a mandatory assessment aimed at improving the quality and safety of care. This certification now includes assessment of digital risk management in healthcare practices.

The HAS College, made up of experts, is responsible for strategic orientations and mission programming. Innovators can benefit from the recommendations and guides published by the HAS to develop solutions that comply with quality standards.

By collaborating with the HAS, digital healthcare innovators can ensure that their solutions meet the needs of patients and healthcare professionals, while complying with the quality and safety standards demanded by the French healthcare system.

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