Alice ROBERT & Alexandre FIEVEE, Derriennic , MONDAY NOVEMBER 28, 2022
Last month, five use cases were selected by the European Commission for the test version of the European Health Data Area (“EHDS”) for “secondary use” of health data. These “pilot” cases make it possible to assess more concretely the ins and outs of the proposal for a European regulation on EHDS.
1. The reuse of health data: what are we talking about?
For the record, the European Commission presented on May 3 a proposal for a European regulation on the EHDS. Among the proposed rules is the creation of a health data space for the purpose of secondary use “. In other words, it is the deployment of a space to allow researchers, innovators and public authorities to use, ” in the interest of society “personal electronic health data” high quality », and this in a secure environment respecting privacy.
To enable cross-border research, innovation, public health, policy-making or regulatory projects to be carried out, the proposal for a European regulation on EHDS notably provided for the establishment of a dedicated platform called “HealthData@EU” (or “DataSanté@EU”) on which personal health data from the Member States may be made available and made accessible. To this end, the European Commission has entrusted a consortium of around ten partners (composed in particular of national health data platforms, the European Medicines Agency, the European Center for Disease Control and Prevention, and European research organizations), led by the French entity “Health Data Hub”, the construction of a pilot of the “HealthData@EU” platform based on different use cases.
The European Commission has selected 5 use cases, among those presented to it by the consortium, to create and test the “HealthData@EU” platform.
At the beginning of last October, the Health Data Hub made these 5 use cases public.
2. What are the 5 EHDS use cases and what are they for?
Four use cases, out of the five selected by the European Commission, are related to the analysis of pathologies.
- A first use case relates to the possibility of using the EHDS to carry out the antimicrobial resistance surveillance mission incumbent, at European level, on the ECDC (European Center for Disease Prevention and Control). Health data from two Member States will be processed as part of this experiment.
- Two other use cases are related to COVID-19.
o One must allow the EMA (European Medicines Agency), as part of its regulatory mission, to carry out studies on the risks of coagulation disorders in patients with the disease. Health data from 4 Member States, as well as the Darwin@EU network (Coordination Center of the real data analysis network implemented by the EMA), will be mobilized for this project.
o The other use case aims to “to compare the use of tests, hospitalizations and adherence to vaccination in the general population and in sub-populations (…) and by socio-economic indicators. », using data from 7 Member States.
- A 4th use case concerns the analysis of clinical and genomic data from 3 Member States to identify genomic signatures characteristic of the different types of colorectal cancer.
A final use case relates to the care pathway and the use of Artificial Intelligence for predictive purposes, via the comparison of health data from at least 4 Member States.
The practical implementation of these use cases will allow “ to illustrate the feasibility and potential of reusing data from several European countries ”, according to the Health Data Hub.
The completeness and adaptability of the provisions of the proposed European regulation on the EHDS on the ” secondary use », but also its limits and the risks associated with its implementation and its delicate articulation with other existing regulations (the GDPR in particular) will, without a doubt, be put to the test by this experimental work.
To be continued…
Alexandre FIEVEE & Alice ROBERT
Alice ROBERT joined Derriennic Associés in 2012 and has been registered with the Paris Bar since 2013.
She has a great knowledge and a strong expertise in the law of new technologies and, more particularly, in Data, E-health as well as in dematerialization, computer science and GDPR.
She works both in consulting and in litigation.
Alice holds a Master 2 “Law, Innovation, Communication, Culture”, specialty “Technical Innovation Law”, from the University of Paris-XI.
She writes numerous articles, in particular for specialized journals.
Alexandre FIEVEE has been registered with the Paris Bar since 2004. He supports many players, particularly in the IT, health, insurance, banking and artificial intelligence sectors.
He has a great knowledge and a strong expertise in the law of new technologies: data, GDPR, e-health, dematerialization and computer science. He works both in counsel and in litigation.
Before joining Derriennic Associés, Alexandre worked in particular as a legal manager in the legal department of AXA France.
He writes numerous articles in specialized journals and notably has a monthly column in the journal Expertises.
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EHDS and reuse of health data: concrete use cases being tested
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