The EU Council has discovered widespread floor on the secondary use of information, one of the vital essential points for gaining residents’ belief within the European Well being Information Area (EHDS), in keeping with a draft place obtained by EURACTIV.
The EHDS, introduced by the Fee in Could 2022, goals to manage the transmission and sharing of well being knowledge throughout the EU for personal people, researchers, and policymakers.
The EU lawmakers – the European Parliament and the Council of ministers – are at present getting ready their amendments to the Fee’s proposal earlier than getting into into interinstitutional talks to approve the brand new guidelines.
The Council already made some steps ahead on the file below the Czech presidency by reaching a widespread place in precept on the primary two chapters of the proposed textual content – coping with the final provisions and ‘major’ use of well being knowledge.
On Monday (23 January), the Working Get together on Public Well being – a preparatory physique of the EU Well being Council coping with technical works to facilitate EU ministers’ jobs – agreed on some amendments to Chapter IV of the Fee’s proposal, which is about ‘secondary’ use of information.
These provisions on re-using well being knowledge for so-called ‘secondary use’ are among the many thorniest, as they concern knowledge created and registered for well being providers or actions that can be utilized for functions apart from the explanation for which they have been initially collected.
For the proposed regulation, secondary use contains well being data, social knowledge, administrative knowledge, genetic and genomic knowledge, public registries, medical research, analysis questionnaires, and biomedical knowledge similar to biobanks.
The secondary use knowledge is in uncooked type, and the extra info is obtained by processing the information within the context of healthcare providers. In line with the Fee’s intentions, utilizing secondary knowledge for higher analysis and policymaking can considerably increase the modern area of personalised medicines.
Nationwide representatives within the Council preparatory physique are proposing to not permit the secondary use of well being knowledge for actions regarding public safety, defence, and nationwide safety, a provision not initially arrange by the EU govt.
In terms of the primary gamers for these providers, they’re placing ahead a extra detailed definition of ‘well being knowledge holder’, which means the entities or our bodies performing analysis with well being knowledge that may be requested to share it for secondary use.
The idea of information holder comes from the Normal Information Safety Regulation, the EU’s privateness legislation. It refers back to the organisation that controls the information, as opposed to an information processor that processes the information on behalf of the information holder.
A brand new Article 46 arrange six new standards for well being knowledge entry our bodies to grant or refuse entry to digital well being knowledge, which now contains, amongst others, enough safeguards to guard the rights and pursuits of the well being knowledge holder, in addition to the evaluation of moral points of the processing.
The Council additionally desires to empower member states to supply entry to further classes of digital well being knowledge, whereas, within the Fee’s proposal, solely nationwide well being knowledge entry our bodies are tasked with that.
Generally, the Council proposes to cut back the discretion of the Fee in adopting delegated acts to amend the checklist of classes of information for secondary use, as an illustration, if there would be the must adapt it to the evolution of obtainable digital well being knowledge, giving extra energy to member states on this regard.
The member states representatives recommended amending the ultimate textual content to have a single, extra detailed article coping with mental property (IP) rights and commerce secrets and techniques as an alternative of getting many provisions scattered within the textual content.
Conciliating the safety of commerce secrets and techniques with fostering the circulation of information can be a central level within the discussions of the Information Act, a horizontal legislative proposal to manage how knowledge will be accessed, ported and shared.
Interinstitutional talks to start out in Summer season
The Fee is hopeful that the European Well being Information Area (EHDS), one of many central constructing blocks of the European Well being Union, shall be finalised by June 2024. The purpose is to have the EHDS up and working in 2025.
A variety of stakeholders have already raised issues concerning the timeline, warning that EHDS may not be prepared as scheduled.
“It’s crucial that the work strikes ahead,” Swedish Social Affairs and Public Well being Minister Jakob Forssmed informed the European Parliament’s well being committee (ENVI) on Monday (23 January).
On the Council stage, the dialogue goes quickly, and EU ministers might already approve a place for his or her subsequent gathering in Brussels on 14 March – though they nonetheless want to seek out an settlement on one other delicate side, the European governance and coordination of the EHDS.
The draft report from the European Parliament is anticipated to be unveiled subsequent month, with the purpose to have a vote within the plenary earlier than summer time and a political settlement with the Council below the Spanish presidency, in keeping with a parliamentary supply acquainted with the file.
Luca Bertuzzi contributed to the reporting.
[Edited by Alice Taylor]