Shaping a European Health Data Space that boosts oncology research and strengthens cancer patient's rights
In May 2022, the European Commission put forward a legislative proposal to create the European Health Data Space (EHDS) which will comprise rules, common standards and practices, infrastructures and a governance framework for both the primary and secondary use of electronic health data across the European Union (EU).
The EHDS will, amongst other things, establish a common EU framework and infrastructure through which researchers as well as public, private and not-for-profit entities can access health data for purposes such as research and innovation, including research conducted in the oncology space. Moreover, the EHDS will also create rules and infrastructures enabling citizens to better access, control and share their electronic health data in the context of healthcare delivery, which is set to benefit patients with cancer.
Given the added value that the EHDS can deliver for oncology research and cancer patient’s rights, ESMO is actively engaging with EU decision-makers to ensure that medical oncologists’ interests are reflected in the final legislation. These interests include:
- Support to healthcare professionals: Policies should be established aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfil 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;
- Opt-out & Opt-in: ESMO strongly considers that the establishment on an opt-in system will have detrimental consequences for oncology research carried out under the EHDS. Should an opt-out mechanism be established - as an alternative to opt-in and a political compromise to secure the adoption of the proposed EHDS legislation - then it is important that such mechanism does not hinder cancer research;
- 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.
Given the impact that the EHDS is expected to have on the cancer field - both medical oncologists and their patients - ESMO will continue to liaise with EU decision-makers throughout the legislative process to ensure the design of a robust and impactful EHDS.