The European Society of Cardiology (ESC) welcomes the interim agreement reached by the European Parliament and the European Health Data Space Council (EHDS). The tentative agreement was approved by the ENVI and LIBE committees this Tuesday, April 9th, and will be voted on at the plenary session. on the 24th April.

EHDS aims to give patients digital access and greater control over their data. It also aims to give medical professionals access to patients’ medical histories across borders. For example, if a patient living in France visits a doctor in Germany, the German doctor will be able to access the patient’s medical history and medical images in their native language. The EHDS also promises to foster research and innovation and support policy-making thanks to the regulated reuse of a wide range of health data categories. data from clinical trials and medical registries, etc..

Professor Piotr Szymanowski, Chairman of the ESC Regulatory Affairs Committee, said:
“The interim agreement reached by the European Parliament and the European Health Data Space Council is expected to improve cardiovascular health outcomes by facilitating secure access to high-quality data. However, to achieve that goal, it is important to ensure that new regulations are implemented in a harmonized manner. As a champion of cardiovascular health, ESC looks forward to collaborating with regulators by sharing our expertise. Unlocking the potential of health data is critical to the healthy lives of all Europeans, where cardiovascular disease remains the number one cause of death.”.

At the forefront of healthcare digitization and data collection, ESC has closely monitored negotiations over the past 22 months and shared clinical experts’ recommendations with decision-makers. We appreciate the inclusion of the following points in the text of the agreed regulations:

• Cardiovascular registries should be utilized when defining criteria and diseases
  Specific harmonized template. Existing health data infrastructures and registries can provide a useful model for defining and implementing data standards and interoperability.
  These should be leveraged to provide continuity and build on existing expertise.
• Development and implementation of training programs for medical professionals at the national level, to provide information on rights and obligations arising from the regulations and to improve digital health literacy and specific digital skills. This is critical for healthcare professionals to become key users and enablers of the new framework.
• Establishment of a stakeholder forum to provide input and advice in the performance of the EHDS Board’s mandateincluding medical professionals, researchers, and academia. Ensuring structural stakeholder participation in the governance of EHDS is essential to facilitate implementation and ensure trust.
• Digital health authorities will be required to actively collaborate and consult with relevant stakeholder representatives, including representatives and associations of medical professionals. The ESC is prepared to collaborate with relevant national cardiology societies to provide clinical expertise and support implementation at national cardiology societies as well. level.
• Extension of application deadlinetakes into account the important harmonization efforts required by law and the different levels of digital readiness across the European healthcare system.

We appreciate that two different visions of secondary use ultimately led to the adoption of a draft agreement on what turned out to be the most controversial issue in the negotiations. opt-out approach, This provision can be overridden if a public health agency or federated agency requests the data for “scientific research in the important public interest.” Including opt-in provisions can pose significant challenges in ensuring data representativeness.

Nevertheless, we have some views concern in There remains scope for introducing additional restrictions on certain data categories (genome data, wellness application data, biobanks) at the national level. Complete data sets are essential to avoid biased research results and decision-making, and to avoid fragmentation issues associated with the implementation of the GDPR that negatively impact research. We encourage you to carefully consider the associated risks.Therefore, we have a clear Guidance for defining how opt-out mechanisms should be implementedcontains recommendations to ensure a harmonized approach across countries and to avoid creating an undue administrative burden on health professionals.

The ESC also calls on policymakers to increase legal clarity regarding interactions. with an established regulatory frameworkGDPR, Medical Device Regulation (MDR), and more to streamline compliance and interoperability.

We regret that the agreement did not include a provision introduced by Congress to consider the needs of academic and nonprofit organizations when setting fees for access to electronic health data.

At the same time, we call on policymakers to: Helping academic institutions and nonprofit organizations comply with their obligations as health data holders.

Seek guidance and tools to increase automation and collaboration with electronic health records and other unstructured data sources to free healthcare professionals from time-consuming administration and free them to focus on patients. Masu.

Since then Registry operated by a medical society invites institutions to make allocations to play a key role in providing high-quality data for secondary use to support research and innovation in Europe. Sufficient funds to support operations For the benefit of patients and the community at large.

The ESC is closely following the latest stages of the negotiations and, together with other stakeholders, stands ready to support decision-makers on the implementation of the new framework. We believe that cooperation is fundamental to ensuring that the EHDS is implemented as uniformly and smoothly as possible so that we can truly achieve our ambitious goals of strengthening healthcare delivery, research and decision-making in Europe. I strongly believe that it is.

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