Marguerite Brac de La Perrière

Although registries (particularly cancer registries) have been regulated for nearly 20 years, it was only a few years ago that a system dedicated to Health Data Warehouses was outlined, before being regulated by the reference framework for Health Data Warehouses (applicable to “data controllers who wish to collect data for re-use as part of their public interest mission”[1], the first ones concerned being health establishments.

As a reminder, with regard to the purposes for which Health Data Warehouse data may be used, the standards state that “when implemented exclusively from the data in the warehouse by the authorized personnel of the data controller and for its exclusive use, certain processing operations may be implemented within the framework of the declaration of conformity with this standard (production of indicators and strategic management of the activity, under the responsibility of the IMG doctor ; improvement of the quality of medical information or optimization of coding; operation of tools to assist medical diagnosis or management; carrying out feasibility studies (pre-screening). “. Outside of this framework, processing for research, study or evaluation purposes in the field of health, by the data controller who created the Health Data Warehouse, or a third party in accordance with the governance of the Health Data Warehouse set up, must be implemented in compliance with a reference methodology or an authorization from the CNIL.

Thus, Health Data Warehouses and the National Health Data System (SNDS) are today the main sources of real-life data, i.e. “data that are not collected in an experimental context (particularly in the context of randomized controlled trials, RCTs), but which are generated during routine care of a patient, and which therefore reflect current practice”[2], which are of growing interest for :

– studying the use, effectiveness and safety of health products

– monitoring and improving the quality of care

– conducting epidemiological studies

– facilitate health monitoring.

With a view to mobilizing this real-life data within the framework of its missions, the French National Authority for Health (HAS) has carried out an inventory of Hospital Health Data Warehouses (HHWs) in France. This inventory was carried out by soliciting various players in the ecosystem, as there is no inventory of HHWs in France to date outside of this initiative, and the same remark can be made about private HHWs.

Among the observations made was the need for EDSHs to benefit from a multidisciplinary team that includes a health data specialist, the IT department to “integrate into the IT landscape”, the DRCI, the DIM and the clinical divisions to define and support the use cases, in addition to the legal framework for the reuse of data, particularly with regard to requests for CNIL authorizations

Private partners wishing to use the data are presented as “mainly companies wishing to improve recruitment for clinical research using EHDS data, i.e. to improve feasibility or pre-screening studies”, it being specified, however, that the studies in progress in the EDHS appear unevenly referenced on hospital sites or on the study portals of the establishments when they have them, and that “uses other than scientific studies in progress are only very rarely documented publicly”. In this respect, it is not surprising that the legal framework is not clear to those involved in innovation.

In terms of transparency, the HAS notes that “better information for patients on the reuse of data concerning them is necessary”.

As a reminder, each establishment is required, under the terms of the reference or the CNIL authorization granted, to set up a transparency portal updating the studies in progress, in order to allow patients to exercise their rights.

In addition, the HAS notes that EDHSs are very heterogeneous, particularly in terms of technical architecture, data quality monitoring, data models, variable extraction methods and data catalogs, and calls for the definition of shared data schemas and common nomenclatures, supported by national coordination on these subjects.

If the modes of governance converge thanks to the reference framework having articulated it around a steering committee and a scientific and ethical committee, institutional readability and referencing in a national catalog of EDHS are desirable.

Finally, the issue of resources for the EDSH, both human and financial, appears crucial. The €50 million call for projects will support hospital DHSs to be set up, as well as existing mature DHSs. However, an economic model must be found independently, which will be based on the conditions for the use of health data by producers, the famous sea serpent…

As the EDSs are intended to feed the Health Data Platform (formerly the Health Data Hub), which in turn is intended to feed the European Health Data Area, the challenge is now to standardize, in compliance with the regulations.

[1] Reference framework for the processing of personal data for the purpose of creating data warehouses in the health sector

[2] Report “Real-life data, a major challenge for the quality of care and the regulation of the healthcare system”, May 2017


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