Haute Autorité de Santé (HAS)

Mission

Regulation

Type of actor

Institutional player

Fields of intervention

Health / Social care / Social / Medical Device

Intervention zone

National

What is HAS?

An independent public science authority, the Haute Autorité de Santé (HAS) aims to develop quality in the health and social care field, for the benefit of people.

Three key missions:

  • Evaluate drugs, medical devices and care procedures for reimbursement
  • Recommend professional best practices, develop public health and vaccination recommendations
  • Measure and improve quality in hospitals, clinics, community medicine, and social care facilities
Go to the HAS website

Missions

In the field of health innovation, the HAS:

In the field of business software for healthcare professionals, the HAS:

In the field of telehealth, the HAS:

In the field of telehealth, the HAS:

  • Provides manufacturers and evaluators with a best practices standard for assessing the quality of mobile health apps and connected objects
  • Develops the medical content quality directory listing digital services in Health Data Personal Storage (ENS), a service platform for citizens, and in the service package (BS), a service platform for health professionals.

I have a project, how can contacting the HAS be of use to me?

In the field of health innovation, you can contact the HAS to:

  • Consult the standards and best practice guides that concern you
  • Anticipate how to access reimbursement for your solution

The HAS can assist you at certain stages of your project. Our subject-specific information meetings may be useful to you. Practical and methodological guides, as well as standards to help you in your future application for reimbursement or to build your clinical development plan are available on our website.

We are not able to assist you step-by-step in your project, but personalised guidance is possible through meetings devoted to your solution.

In the fields of business software, telehealth and mobile health, the HAS can support you by answering your questions e-mailed to sa3p@has-sante.fr

  • If you are a drug database publisher, create software for managing a medical practice or pharmacy in an outpatient or hospital setting or software for writing or dispensing a medical prescription, or if you are considering applying for the certification of PAS or DAS software, the HAS can answer your questions on what steps must to be taken (approval procedure and certification procedure) and on the content of the certification standards
  • If you are offering a digital telemedicine service (teleconsultation, remote interpretation of imaging exams, etc.), the HAS guides will help you understand the best practices to implement
  • If you are carrying out a telemedicine project, the security grid helps you to identify and minimise the specific risks of your project
  • If you are a manufacturer (app designer, start-up, etc.) or an evaluator (evaluation structures, consumer associations or medical science societies) the best practice guidelines for mobile health apps and connected objects will enlighten you on the best practices to take into account for a safe, quality design. This guide aims to promote the use of and build trust in apps and connected objects

At what stage of my project should I contact them?

On a practical level, the HAS can help you before you submit your application for reimbursement. There are two types of meetings available for technologies that count as medical devices or involve the creation of a new care procedure, depending on how far along you are in your development:

  • Early meetings if you are planning a clinical study and would like to discuss it with the HAS teams and their experts. The main objective of these meetings is to discuss the questions you have regarding the methodology of the clinical study you are considering. This type of discussion can be useful before the implementation of your study. It is therefore at this point, as soon as your planned protocol has been crafted, that you can contact us.
  • Or pre-filing meetings: these meetings are set up specifically for medical devices in order to assist manufacturers with the technical and regulatory aspects of setting up or finalising their application (scope of the LPPR list of reimbursable products and services, content of the application in particular).

If you have any questions about business software certification, telehealth and mobile health, you can e-mail your request to sa3p@has-sante.fr

What can HAS do for project leaders?

Topics involved

  • Access to reimbursement for health technologies
  • Eligibility for the Innovation Package
  • Certification of prescription and dispensing assistance software (PAS, DAS)
  • Accreditation of drug databases
  • Telemedicine deployment
  • Telecare deployment
  • Quality assessment of mobile health apps and connected objects

Accessible resources (database, observatory)

Does it fund projects?

No

Links to innovators and entrepreneurs

  • Evaluation for reimbursability
  • Development of standards

Find out more

Practical guide

Frequently asked questions about the HAS.

Can the HAS support my project individually?

If your project concerns a health technology and you would like to find out about reimbursability or the Innovation Package, the HAS has set up a support policy with information meetings, advance consultations, and pre-filing visits that are organised regularly. It also provides manufacturers with methodological guides and standards to assist them in submitting their applications.

Who is the right person to contact?

In the field of health innovation:

In the fields of business software, telehealth and mobile health: sa3p@has-sante.fr

Does the HAS charge for its services?

The HAS is a public institution, so all its publications and services are accessible free of charge.

5 Avenue du Stade de France 93210 Saint-Denis

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