Introduced by the European Commission on 3 May 2022, the European Health Data Space is a proposal for a regulation that aims to reform how patients’ health data is shared across the EU both for primary care and secondary purposes, such as research and policymaking. The proposed rules are now being examined by MEPs and by the Council, where some changes include the interoperability of wellness applications (such as health applications on phones) with the EHDS. But apart from the research and innovation, what would be the impact of the proposal be for CVD and SHD patients in particular?
The answer is not straightforward as it will highly depend on the final form of the adopted text, which will define either more flexible or a stricter use of secondary health data from researchers, healthcare professionals and the industry. It is undeniable that the EHDS framework will facilitate healthcare providers to have access to electronic health data from other healthcare providers about the CVD and SHD patients they treat, and easier for universities to access quality data to carry out research. The proposed regulation specifically mentions that it will “support health research, innovation, policy-making, regulatory purposes and personalised medicine purposes, and also aims to simplify cross-border healthcare”. Moreover it “will create a legal and technical environment that will support the development of innovative medicinal products and vaccines, and of medical devices and in-vitro diagnostics”, utterly aiding patients with valvular diseases
The EHDS proposal will also enable patients to have greater control over their health data. Patients with cardiovascular diseases often have complex medical histories, and their conditions may require ongoing monitoring and treatment. By accessing their health data, patients could play a more active role in their care and make more informed decisions about their treatment options.
However, the most important contribution of this proposed legislative piece would be the development of patient registries which will allow for the enhancement of patient care, the conduct of pragmatic randomised clinical trials, easier recruitment of patients in clinical studies and the support of the planning of health care investments. This synergy between national registries provides continuous data collection of standardised and/or harmonised variables in common cardiovascular diseases (i.e., SHD, heart failure, valve diseases), including detection, therapy, medical and instrumental interventions.
Concluding, despite its immense potential for CVD and SHD patients, it is still unclear if the final text will allow this potential to be fully harvested by the society. To this end, the EU must find the perfect equilibrium between seizing the vast benefits of health data sharing across countries, while at the same time protecting the data of every patient with the highest of standards.