About

HAS Missions

Evaluating Health Products and Technologies

One of the missions of HAS is to be responsible for the national Health Technology Assessment (HTA) of medicinal products (including vaccines), medical devices (including digital devices), medical procedures, and other health interventions. These appraisals inform reimbursement and pricing decisions made by the Ministries in charge of Health and Social Security. 

Clinical evaluation over existing therapies is performed in all assessments while economic evaluations (modelling and budget impact) are only performed for medicinal products or medical devices when companies claim a high added value score and a significant impact on health spending. 

For more information on the HAS methods and procedures for HTA, please refer to the webpages dedicated to the Transparency Committee (CT – Commission de la Transparence), Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS - Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé), the Economic and Public Health Committee (CEESP - Commission d'évaluation économique et de santé publique) and the Diagnostic, Prognostic and Predictive Health Technologies Evaluation Committee (CEDiag - Commission d’évaluation des technologies de santé diagnostiques, pronostiques et prédictives) . 

Early access schemes 

Since 2021, HAS has been the decision-making authority for early access decisions on medicinal products. This exceptional derogation procedure allows one or more indications of a medicinal product to be made available at an early stage, including before marketing authorization providing that the national regulatory agency (ANSM - Agence nationale de sécurité du médicament et des produits de santé) concluded that there is a strong presumption of efficacy and safety. Refer to the HAS doctrine on early access for medicinal products for more information and eligibility criteria. 

HAS can also issue recommendations on early access for other health products or interventions, notably on medical devices, including digital medical devices and telemonitoring. 

Early dialogues (scientific consultation) 

HAS offers early dialogues on evidence generation plans for new pharmaceuticals, medical devices or medical procedures. The objective of these Early Dialogues (ED) is to provide companies with recommendations on the last development phase (pivotal study/studies) and support generation of good quality evidence for proper HTA. 

For more information on EDs at HAS, please refer to the dedicated page for national ED procedures.  

Real world data 

Real-word data can be used by HAS in complement to data from clinical trials to support assessment of health products and interventions. For further information and recommendations on how to perform a real word study for HTA please consult the dedicated HAS guidance and the list of data sources referenced by HAS (French only). 

When the appraisal committees identify uncertainties, real-word data can be requested by HAS in “post-registration studies” when additional evidence is deemed necessary to perform a re-assessment. The list of post-registration studies requested for medicinal products can be found on this page (French only). For the practical arrangements concerning document exchanges with the HAS and internal procedures relative to post-registration studies, please refer to the dedicated instruction sheets for medical products (English) or medical devices (French only). 

Additionally, real-world data can be requested in the context of early access approval. For more information please consult the list of protocols for temporary use and data collection (French only). 

Providing national recommendations on vaccination 

The HAS is also tasked to provide recommendations on national vaccination policy and schedule to support decisions by the Ministry of Health. Please refer to the webpage dedicated to the Technical Committee for Vaccination (National Immunization Technical Advisory Group) for more information. 

• Drug Evaluation
• Medical Device Evaluation
• Procedure and Intervention Evaluation
• Health Economic Evaluation

Recommending Best Practices

HAS develops recommendations for professionals of both the health and social care sectors in order to optimize and harmonize practices and organizations of care.

To satisfy this objective, HAS develops best practice recommendations, promotes health and well-being pathways and elaborates tools for professionals that promote and encourage relevant care. When a population-based approach to health questions is necessary, HAS is also tasked with producing public health guidelines.

Lastly, the institution contributes to the framing of vaccine policy in France by elaborating vaccine recommendations.

• Best Practice Guidelines
• Public Health Guidelines
• Vaccine Guidelines
• Health Pathways and Relevant Care
• Tools and Patient Safety Programs
• Accreditation of Computerized Physician Order Entry (CPOE)

Measuring and Improving

HAS is responsible for measuring and improving quality care and patient safety in health care facilities and office-based practice. Since April 2018, this task was extended to include quality support in social care services and facilities. 

• Accreditation of Hospitals and Clinics
• Evaluation of Social Care Services and Facilities
• Quality and Safety Indicators of Care
• Physician and Medical Team Accreditation for High-Risk Practices
• Public Information and Quality of Care Management

Core Values

HAS carries out its activity in accordance with three core values: scientific rigor, independence and transparency.

It cooperates with all stakeholders in the service of both individual and collective interests and upholds the values of solidarity and equity in access to care, both integral of the French health system.

Public Involvement

HAS is committed to maximizing all efforts to ensure effective participation of the people who use services, carers and the public in the development of our guidance and other products.

In 2019, HAS established the Public Involvement Council to bring into perspective the public and patient view on the institution’s work.

When elaborating recommendations, HAS works with all stakeholders to foster greater mutual understanding–leveraging engagement strategies such as digital connectivity in order to achieve greater participation in health and well-being.

Work Program

HAS defines its annual work program in concertation with the Ministry in charge of Health and Social Care and the National Health Fund. With respect to article R161-71 of the Social Security Code, all authorized entities may solicit HAS by submitting topics for work program inclusion.

Annual revisions are systematically validated by the Board. Click here for HAS' complete work program.

Methodology

To respond to the various requests received, HAS provides tailored responses to meet the methodological demands and constraints of its productions.

HAS instituted a methodology shared across all productions and founded on a common set of requirements (in French only).

Each HAS production is methodologically framed and validated to ensure continuous transparency and verifiability.

Furthermore, in taking into consideration the points of views of professionals, institutions and the public this method safeguards the management of conflicts of interest and the critical analysis of scientific data.

The following framework guides all of HAS productions: 

• scoping the issue 

• literature search

• critical analysis of published evidence

• analysis and management of conflicts of interest

• report write-up through expert and/or stakeholder consultation

• evaluation and recommendation

Each document produced is validated either by the authorized committee or the Board, prior to publication and dissemination.

For more information about what we do and who we are, you may access full corporate information here (in French only).