Open data in the health domain
To improve research and innovation in the health domain, the law n°2016-41 dated 26 January 2016 for the modernization of our health system created the national health data system.

This is a database gathering information concerning individual’s health history, such as their medical consultations, prescriptions, hospitalisations and/or the medical causes of death. This database is supplied notably by health insurance data and hospital data.

The conditions for access to this database are specified by the decree n°2016-1871 dated 26 December 2016 relating to the personal data processing entitled « national health data system » and the decree n°2016-1872 dated 26 December 2016 modifying the decree n°2005-1309 dated 20 October 2005 implementing the law n°78-17 dated 6 January 1978 on data processing, files and liberties.

According to these decrees, the following bodies are now authorized to have access to the data contained in the national health data system:

  • the bodies with public service mission whose list is laid down by the decree n°2016-1871. They have a permanent access to the national health data system;

  • the other public or private bodies, with lucrative and not-profit purpose, upon prior authorization of the French data protection authority (Commission Nationale de l’Informatique et des Libertés - CNIL).

These data can only be used to conduct research, studies or evaluations with a public interest.

In order to facilitate the formalities to access the database, the law n°2016-41 established the national health data institute which will be the sole interlocutor to manage the requests for access to the database.

To reinforce the security, the confidentiality and privacy protection, all data will be referenced under a pseudonym: no name, surname, address or social security number will be integrated in the national health data system. Furthermore, a traceability system is established in order to control a posteriori the use of the data and a security referential regulates the conditions for access to the database.

Key words: Behring – Anne-Solène Gay – Juris Initiative – Law n°2016-41 dated 26 January 2016 for the modernization of our health system – Law n°2016-41 –Law dated 26 January 2016 – Decree n°2016-1871 – Decree dated 26 December 2016 – Health data – National health data system – National health data institute – Decree n°2016-1871 – Decree dated 26 December 2016 – Decree n°2016-1872 – Decree dated 26 December 2016 – Decree n°2005-1309 – Decree dated 20 October 2005- Law n°78-17 dated 6 January 1978 on data processing, files and liberties – Law on data processing, files and liberties – Law n°78-17 – Law dated 6 January 1978 – Data protection law – Decree n°2016-1872 – Decree dated 26 December 2016 – CNIL – Data protection authority








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