In the European Parliament (EP) and Council of Ministers, discussions are currently progressing on the legislative proposal for establishing the European Health Data Space (EHDS). The EHDS, proposed by the European Commission in May 2022, aims to create a health specific ecosystem establishing rules, common standards and practices, infrastructures and a governance framework for both the primary and secondary use of electronic health data.
Once established, the EHDS will make it easier for cancer patients to control, access and share their health data electronically, both within countries and across European Union (EU) Member States. The EHDS will also facilitate the use and reuse of electronic health data for secondary purposes, such as medical innovation and research in the oncology space.
ESMO has welcomed the EHDS proposal as it holds enormous potential to deliver tangible benefits to medical oncologists and patients with cancer. With the decision-making process progressing in both the EP and the Council, ESMO considers it crucial that the following elements - addressing the needs of oncology professionals and cancer patients - are addressed in the proposal:
- Support to healthcare professionals: Policies should be established aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfill their roles and obligations under the EHDS Regulation;
- Constitutional (germline) genomic data: Given its ability to further decode confidential patient information, constitutional (germline) genomic data must be strongly protected, and it should be processed separately from somatic molecular data;
- Bureaucracy in research: Academic institutions and non-commercial entities involved in cancer research should not be faced with excessive bureaucracy or high fees when accessing data through the EHDS for research purposes;
- Compliance with Clinical Practice Guidelines (CPGs): It is critical that the European Commission carries out an assessment of healthcare professionals’ compliance with clinical practice guidelines;
- Implementation milestones: Concrete and measurable targets - including as regards patient access to their data and the delivery of cross-border healthcare - should be set to support an impactful implementation of the EHDS;
- Healthcare professional involvement in the EHDS Board: Given that healthcare professionals will fulfil important new roles under the EHDS, it is crucial that healthcare professionals are represented in the new EHDS Board. What is more, Digital Health Authorities and Health Data Access Bodies should cooperate actively and closely with representatives of healthcare professionals;
- Funding of the EHDS: Given the (rightly) ambitious scale of what the EHDS is seeking to achieve, robust funding should be made available to support the establishment and implementation of the EHDS.
Throughout the legislative negotiations, ESMO will continue to liaise with EU decision-makers to ensure that its recommendations - are taken up by the co-legislators. ESMO also stands ready to collaborate with the European Parliament and Council to provide further advice and support the design of a robust and successful EHDS.