France is in the process of establishing a legal system ("Système national des données de santé" – national healthcare big data system) that will allow access to the healthcare data collected from the national medical insurance, hospitals and other public organisations.

The establishment of a unique healthcare database system has been requested by legislators in 2016 (art. 193 of Law n°2016-41 on modernisation of our healthcare system); its implementation has been developed and completed by several recent decrees.

The data quantity is so vast that this database will most certainly become one of the biggest healthcare databases in the world.

What’s the aim?

The new system will enable public entities, research organisations, as well as companies to carry out statistical analyses of this data. For example, these analyses may be used to improve current practices, to evaluate efficiency and risks related to health products currently on the market or to monitor development of certain pathological conditions.

What data is covered by the "Système national des données de santé"?

The data in question is the archival computer generated data comprised of medical appointment data, pharmaceutical and hospitalisation services data and treatment reimbursement data. Public data relating to disabilities and causes of death also falls under the big healthcare data category. All data will be sorted into two main categories:

  • anonymised data where a previously identifiable person, will no longer be identifiable (designated as "aggregate data") (art. L.1461-2 French Public Health Code "PHC"). The data in question will contain information on the patient healthcare history within a target population (for example, women over the age of 70) suffering from a particular pathological condition (e.g. glaucoma).
  • pseudonymised data which does not contain any directly identifiable patient information (such as a surname / a first name or a social security number or a postal address) but which falls under the definition of personal data. Therefore, French data protection regulations and even the GDPR (European General Data Protection Regulation) will be applicable, increasing penalties for breaches with fines of up to 20 million euros or 4% of annual global turnover (the penalties being enforceable as of May 25, 2018).

Who has access to the information?

Anonymised aggregate data will be open access (open data) (art. L.1461-2 PHC), meaning that any person or any for-profit organisation such as an insurance company or a pharmaceutical firm can access the information unconditionally and free of charge.

Access to pseudonymised data which allows indirect identification will be open to the public in principle, but closely supervised. A single access window was created at the National Healthcare Data Institute on April 17, 2017. The Institute experts will study the database access requests and then transmit them onto the CNIL (French Data Protection Regulatory Authority) for authorisation.

Access to the pseudonymised database will be granted under very strict conditions. In particular:

  • access will be authorised only for research and evaluation of data with a public interest (art. L.1460-1 PHC);
  • confidentiality protection of all data will be guaranteed;
  • no access will be granted for the purposes of (i) advertisement/promotion of health products; or (ii) exclusion of guarantees under insurance contracts or modification of insurance premiums (art. L. 1461-1 V PHC); and
  • the method of data analyses and the results of the analyses will be communicated to an inspection agency (art. L. 1461-3, II b. PHC).

Next steps

This is a massive and ambitious project that will require many years of work before it becomes effective.

For the time being, only two public organisations (namely the National Health Insurance and National Health Agency) and university research teams will have access to a part of the database. According to the Ministry of Health, health product manufacturers should be next in line to obtain access to the database. A group of experts is currently working on the development of access procedures. Various aspects of such access are yet to be further analysed and it is premature to judge at this point whether the database access meets the needs of companies. As shown above, healthcare big data is a valuable asset for public health issues.