The CoR Interregional Group on Health and Well-being (IRGHW) held its first 2023 meeting on Thursday 16 March. It was an occasion for the members of the Interregional Group and interested stakeholders to discuss the design and implementation of the EHDS across the European Union, one of the major pillars of the European Health Union project. The event was an occasion to listen from both the European Parliament, thanks to the participation of Anna Prokůpková, Advisor on Health and Environment Policy at the European Parliament (GREENS/EFA), and the Committee of the Regions, with the participation of Sirle Mere, Policy officer, Secretariat of the Commission for Natural Resources (NAT), European Committee of the Regions. This event also gave the chance to stakeholders to debate several issues, such as intellectual property rights, public return of investment, digital health literacy and the role of regional and local authorities. 

In her intervention, Ms Prokůpková presented the state of play of the European Parliament’s current discussion on the dossier and underlined the Greens/EFA main priorities and concerns. In primary use of health data, she pointed to need for person-centred system and the lack of emphasis on digital health literacy – for both patients and healthcare professionals and on how to support vulnerable populations -. Furthermore, she stressed the need to consider a conformity assessment or, at least, to have ex-ante checks on economic operators when it comes to the marketing of EHR systems. On secondary use, Greens/EFA’s position leans towards better alignment with the provisions set under the GDPR and the use of opt-in systems, and the need to stratify consent to avoid a one-size-fits-all approach and giving individuals the chance to truly control their data taking into account the type of data and the possible secondary uses. The engagement of stakeholders in EHDS governance structure has been an additional crucial point for the Greens/EFA, taking however into consideration the need to prevent any conflicting financial interests related to the sharing of health data. She further touched on the necessity to strengthen the system of penalties and consumer complaint procedures towards both economic operators and public authorities. Finally, she raised her concern over the possibility to change via delegated acts the data categories and responsibilities for public authorities for both primary and secondary use. These are core provisions of the Regulation and must always be decided under co-legislation, she added. 

From her side, Ms Mere presented how, in CoR’s Opinion, the EHDS proposal could be improved: the major problem is the lack of recognition for regional and local implementation in the initiative. In this sense, a multi-level governance approach is key to reach sustainability, interoperability, and security of health data. The CoR calls on the Commission to clarify the role, the composition, and the powers of the EHDS Board, and the need for the CoR, as institutional actor bringing together regional and local health authorities, to be included in it. Ms Mere stressed the need for everyone to apply the highest protection data security standards: citizens must be sure that their data will be collected, processed, stored with careful and protected security systems. Concerning digital literacy, the level of literacy is still too heterogeneous between and within member states. The EHDS implementation relies on knowledge and skills, on which regions are, in some cases, experiencing lack of sufficient expertise: providing adequate human resources and infrastructure to store and access data, also at regional and local levels, will be vital. Ms Mere also affirmed that that cost estimates in the proposal are not realistic enough: there is the need for a more clear and more supportive funding. Lastly, Ms Mere agreed with Ms Prokůpková on the fact that several important elements have been left to be regulated and implemented by tertiary legislation thus creating questions and uncertainty on certain aspects of the regulation’s implementation. 

The upcoming meeting of the Interregional Group on Health and Well-being (IRGHW) will be held on 6 July 2023, and it will focus on the revision of the EU Pharmaceuticals legislation. More details will follow in the coming months.