PGEU welcomes the proposal for a European Health Data Space (hereinafter, “EHDS” or the “Proposal”) and supports the general objective of the EHDS of facilitating the access of health data across the Union for primary and secondary uses, whilst ensuring citizens have control over their own health data. PGEU also agrees it is vital to strengthen health systems and the healthcare workforce, including by digital transformation, appropriate training, increasing integrated and coordinated work among the Member States, as well as by sustained implementation of best practices and data sharing, while in full compliance with the General Data Protection Regulation (GDPR) rules and by taking the necessary measures to avoid any misuse. Digital transformation shall also be seen as an opportunity to promote increased collaboration between healthcare professionals providing healthcare to the same patient.
However, to ensure a consistent application of the Regulation as well as creating a trustworthy and fit-for-purpose environment, certain aspects shall be further developed and a better balance of public interests at stake shall be achieved, including broader involvement and collaboration of the relevant stakeholders. This position paper aims to set out some proposals that we believe will further improve the text and contribute to better achieve its objectives.
The COVID-19 crisis has demonstrated more than ever the vital role of all healthcare professionals which lies on strong ethical principles and demonstrated expertise. For this reason, the EHDS shall also consider confidentiality duties of healthcare professionals when regulating data registration and shall not create disproportionate burdens for those practices that do not qualify as microenterprises.
At the same time, the proposal shall also respect the competences of Member States and be compliant with other pieces of EU legislation, including the GDPR. In this regard, the report issued by the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) notes some legal uncertainty derived from the interplay between the Proposal and the GDPR which should be properly addressed.
Moreover, due to the unprecedented impact on health data and healthcare systems, we believe that there should be a further analysis of the actual impact of this Proposal on national health systems. In this regard, we note that some elements of the Impact Assessment accompanying the Proposal, including some of its economic estimations such as the quantification of expected costs and benefits, should be reconsidered.
Read more in our Position Paper below.
 Specifically considering article 168 TFEU and existing live infrastructures in some Member States.
 Joint opinion adopted by the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS), July 2022 https://edpb.europa.eu/system/files/2022-07/edpb_edps_jointopinion_202203_europeanhealthdataspace_en.pdf