The European Society of Cardiology (ESC) welcomes the provisional agreement reached by the European Parliament and the Council on the European Health Data Space (EHDS), which was endorsed by ENVI and LIBE Committees this Tuesday, 9 April, and will be voted in plenary on the 24 April.
The EHDS is about providing patients with better digital access to their data and greater control over it. It also aims to enable health professionals to access a patient's medical history across borders. For example, if a patient who resides in France visits a doctor in Germany, the German doctor will be able to access the medical history and medical images of the patient in his/her own language. The EHDS also promises to foster research and innovation and support policymaking thanks to the regulated reuse of a wide range of health data categories, such as data from clinical trials and medical registries.
Professor Piotr Szymański, Chair of the ESC Regulatory Affairs Committee said:
“The provisional agreement reached by the European Parliament and the Council on the European Health Data Space holds promise for improving cardiovascular healthcare outcomes by facilitating secure access to high-quality data. However, it is important to ensure that the new regulation is implemented in a harmonised way to achieve its ambition. As advocates for cardiovascular health, the ESC looks forward to working with regulators by sharing its expertise. Unlocking the potential of health data is pivotal to healthier lives of all Europeans, for whom cardiovascular diseases remain the number one killer”.
Being at the forefront of health digitalisation and data collection, the ESC has closely followed the negotiations over the last 22 months and has shared the recommendations of its clinical experts with decision-makers. We would like to express our appreciation for the inclusion of the following points in the agreed text of the Regulation.
- Cardiovascular registries should be leveraged when defining standards and disease
specific harmonised templates. Existing health data infrastructures and registries can provide useful models to define and implement data standards and interoperability.
They should be leveraged to enable continuity and build on existing expertise. - Development and implementation of training programmes for health professionals at a national level, to provide information on the rights and obligations deriving from the Regulation and improve digital health literacy and specific digital skills. This is crucial for health professionals to become key users and enablers of the new framework.
- Establishment of a Stakeholder Forum to provide input and advise the EHDS Board in the fulfillment of its tasks, including health professionals, researchers, and academia. Ensuring structural stakeholder participation in the governance of the EHDS is essential to facilitate implementation and ensure trust.
- Mandate for digital health authorities to actively cooperate and consult with relevant stakeholder representatives, including health professionals’ representatives and associations. The ESC is ready to cooperate with its affiliated National Cardiac Societies to provide clinical expertise and support implementation also at national
- Extension of application timelines, considering the significant harmonisation effort required by the legislation and the different levels of digital preparedness across European health systems.
On what has proven to be the most controversial issue of negotiations, we are grateful that the two different visions on secondary use ultimately resulted in the adoption of an opt-out approach, which can be overridden if a public health body or Union institution requests data for “scientific research for important public interest”. Including an opt-in clause would have caused notable challenges in ensuring the representativeness of the data.
Nevertheless, we look with some concern at the remaining room to introduce additional restrictions on specific data categories (genomic data, wellness application data and biobanks) at national level. We invite Member States to carefully consider the associated risks in terms of data quality, since complete datasets are essential to avoid biased research outcomes and decision-making, and to avoid the fragmentation issues encountered with the implementation of the GDPR, which negatively impact research. Therefore, we call for the adoption of clear guidance to define how the opt-out mechanism should be implemented, to ensure a harmonised approach among countries and with the recommendation to avoid creating an excessive administrative burden on healthcare professionals.
The ESC also calls policymakers to improve legal clarity on the interplay with established regulatory frameworks, such as GDPR and the Medical Devices Regulation (MDR), to streamline compliance and interoperability.
We regret that the provision to consider the needs of academic and non-commercial entities when setting fees to access electronic health data, introduced by the Parliament, was not included in the agreed text.
In parallel, we ask policymakers to support academic institutions and non-profit organisations to comply with their duties as health data holders.
To relieve healthcare professionals from time consuming administration so they can focus on patients, we request the provision of guidance and tools to facilitate automatisation and linkage with electronic health records and other unstructured data sources.
Since registries run by medical societies will play a key role in providing high-quality data for secondary use to support research and innovation in Europe, we ask institutions to allocate adequate funds to support their operation for the benefit of patients and the entire community.
The ESC will follow closely the latest steps of negotiations and is ready to support decision-makers with the implementation of the new framework, together with other stakeholders. We firmly believe that cooperation is fundamental to ensure the EHDS is implemented as uniformly and smoothly as possible, so that it can really achieve its ambitious goals, enhancing healthcare delivery, research, and decision-making in Europe.
ENDS
Our mission: To reduce the burden of cardiovascular disease.