Two partners of DataTools4Heart (video), Lynkeus (a strategy and technology consulting firm) and PANETTA (a law firm), are pleased to organise this seminar to facilitate discussion and analysis, together with many other EU-funded projects, on the hot topic of the reuse of personal and health data for scientific research.
The EU Commission is clearly aware of the urgent need to find and implement suitable legal and technical solutions for overcoming the hurdles which to date slow down – and sometimes substantially prevent – the progress of research, particularly in the medical and clinical areas.
The 2020 European Strategy for data triggered the Commission’s plans for the European data spaces. The first of them, the European Health Data Space, has the aim of creating an EU infrastructure and coherent processes that facilitate cross-border secondary sharing and use of health data. The ambition is thus to create a network for connecting health data sources among Member States, with harmonised accessing procedures.
Notwithstanding this, from a regulatory perspective, the sharing of data for secondary use is challenging for most countries and in several respects: “Different Member States have different infrastructures, governance models, data hosts/ownership and health data stewardships which are all part of a legislative and regulatory framework” (TEHDAS’ Deliverable 5.2 – ‘Recommendations for European countries when planning national legislation on secondary use of health data’, dated 1° March 2023). Moreover, EU laws such as the GDPR, the Data Governance Act and the Medical Device Regulation, as well as proposals currently under negotiation (such as the Data Act and Artificial Intelligence Act), impact national laws and safeguards.
In this skein of European and national rules, the focus on simplifying the processes for boosting scientific research is easily lost, causing the reuse and sharing of health data to be hampered, to date, for several reasons such as:
- member States are allowed to set their own national derogations – laying down further conditions or limitations for the processing and secondary use of health data – under the GDPR;
- there is no common EU interpretation of what constitutes ‘sufficient anonymisation’ to transform personal data into non-personal data;
- there is no common EU interpretation of which techniques result in ‘pseudonymisation’ and not anonymisation;
- there is no common EU interpretation of what amounts to (and what is not) ‘secondary use’ of data;
- member States apply divergent legal bases for processing and reusing personal and health data under the GDPR;
- falling into special categories of data, health data undergo special requirements and safeguards compared to non-sensitive data, when it comes to health data ethics, management and use.
Most of these challenges are tackled by specific calls launched and ongoing projects funded by Horizon, Digital Europe and other EU funding programmes. In this context, the Commission warmly welcomed the idea of a roundtable, open to all the initiatives, to debate to discuss the different legal and technical solutions which have been, or will be, proposed and implemented in each project, also in view of the Artificial Intelligence Act, the Data Act and the European Health Data Space.
The EU Directorate General for Research and Innovation, as well as the DG for Health and Food Safety and the DG for Communications Networks will be, together with BBMRI-ERIC (which is leading the huge effort of drafting a code of conduct for health research – link), among the key attendees of the seminar, co-funded by the EU via Horizon Europe and moderated by Lynkeus and PANETTA.
Each project attending the event (1 person per project) will be offered a 10-15 min-slot to make a brief presentation and describe the proposed solutions. Accordingly, the agenda of the seminar will be published and circulated by the end of May, when all registrations will be finalised.
This roundtable will be the occasion to share recommendations and thoughts on how the European Union can become a global leader in medical research and data-driven knowledge discovery thanks to a safe and ethical reuse of personal and health data. Don’t miss it!
Reserve your spot here!