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Health Data Hub / Plateforme des données de santé

HDH

La « Plateforme des Données de Santé » (Health Data Hub - HDH) a principalement pour missions : 1° De réunir, organiser et mettre à disposition les données du système national des données de santé mentionné à l’article L. 1461-1 du code de la santé publique, leur documentation et les programmes facilitant leur exploitation. Lorsque c’est pertinent au regard de la demande des utilisateurs, elle peut élargir son périmètre à certaines données contextuelles. Elle contribue à la sensibilisation des acteurs aux risques liés à l’exploitation de telles données ; elle propose, en lien avec les acteurs concernés, des formations. Elle promeut l’innovation dans l’utilisation des données de santé, par exemple par la mise en relation des acteurs, la diffusion d’outils, l’organisation d’événements. Elle peut participer pour son propre compte à certains de ses partenariats, notamment des grands projets européens 2° D’informer les patients, de promouvoir et de faciliter leurs droits, en parti (...)

Lobbying Activity

Meeting with Véronique Trillet-Lenoir (Member of the European Parliament)

30 May 2023 · European Health Data Space

Meeting with Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides)

28 Feb 2023 · Meeting on Health Data Space

Response to A European Health Data Space

26 Jul 2022

The legislative proposal is overall suitable to address the existing barriers to the secondary use of health data at the national and European level. In particular, it should result in a reduction in the time required to access data in France and in a harmonization of the rules. It will nevertheless require the public authorities to make choices between the roles of the Health Data Access Bodies (HDAB) and data holders, and these choices will have to be accompanied by major change management efforts. 1) The proposal clarifies the conditions for reusing data, thereby disambiguating the type of the data to be shared and reproduces the concept of authorized and forbidden purposes already provided for in French legislation. 2) The proposal sets out a governance framework aiming to simplify and harmonize the rules around data access. This governance framework includes data access rules and procedures imposing deadlines for the authorization and provision of data, the establishment of Health Data Access Bodies, and the definition of the roles and responsibilities of the actors involved. a) A deadline of 2 months for data provision is imposed on data holders, which is a major advance compared to the current situation in France, and sanctions are possible. b) The text specifies the roles between the coordinator of HDABs, HDABs and data providers. As the concept of data circulation is not well accepted in France, it will not be easy to accompany the actors. The HDAB would have the role of authorizing processing, which is a major change that could reduce access delays in FR and clarify the rules. c) The HDAB may process the data and data holders receive a copy of the corrected, annotated or enhanced data set upon expiration of the authorization. The latter item is an incentive for data holders to share data but may disincentivize actors like start-ups to work with European data. d) Conditions for issuing data permits are detailed and the elements to be included in the issued permit are specified; data users are required to document what is done with the data within one year. e) An on-demand query service is added with a data delivery delay. 3) The regulation also proposes a framework for the cross-border use of health data with the establishment of a European infrastructure "HealthData@EU" and guides the actors in order to facilitate the identification and reuse of data at the European level. The text provides for the establishment of a European governance, through the creation of a "European Health Data Space Board". Such a governance mechanism could reduce fragmentation due to the alignment of standards and rules. 4) The proposed fee structure is close to that of the Data Governance Act (marginal cost oriented), which is not expected to satisfy data holders. Public sector organizations appear to be excluded from any compensation for collection costs, which could disincentivise data collection and provision. 5) Other a) Data discovery and quality: The text provides for a catalog of metadata to be supplied by data providers and available at European level as well as a quality label. The aim is to enable data users to discover what data is available (data discovery) and to be sure of the content and potential quality of the dataset to be reused. b) Information: Only general information (rather than individual information) is required, which is a pragmatic solution. c) Security: Security requirements for the secure processing environment are described.
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