Avicenna Alliance Feedback to the European Health Data Space Call for Feedback

The Avicenna Alliance welcomes the proposal for the EHDS. The Alliance is a multistakeholder group with the mission of accelerating medical innovation and its practical implementation to ensure safe, affordable and cost-effective health care through the large-scale adoption of in silico medicine and computer modelling and simulation (CM&S). The exchange of and secondary access to good quality health data is particularly important to the Alliance because of its potential to support scientific research and innovation, including in CM&S. There is a distinct need to boost data-driven R&D and innovation to address health challenges which are currently limited by a lack of clear and harmonised data access regulation.

While the Alliance largely welcomes the EHDS proposal, we would like to draw attention to certain aspects of the proposal that may require clarification to fully achieve its intended goals.

To address the lack of legal clarity, there is a need to better define the interplay between pre-existing and sectoral legislation with the EHDS, particularly the MDR, IVDR, upcoming AI Act and GDPR. The EHDS should ease the current difficulties and incongruencies regarding technical definitions and policy inclusion/application, and thus must clarify which policies apply at which points to ensure effective use of resources as well as avoid limiting research and innovation potential.

The regulation and data interoperability should not be focused exclusively on the EU, as there are existing rules from international organisations that foster global health research. This is especially prevalent for fields such as rare or pediatric diseases for which limited data is available and the largest, highest quality data sets possible are necessary.

The proposal also fails to directly mention the synthetic data that may be produced via innovative techniques including in silico medicine. In addition to the Commission's cautious approach to regulating the use of AI-based tools, there is a need to accept or adopt digital evidence produced by these new techniques. The Alliance recommends the Commission consider how Good Simulation Practice (GSP) could offer the regulatory guidance that industry and researchers need, as well as how to incorporate this into the EHDS legislation beyond the recognition in Article 34, paragraph 1.(g) that data can be processed for secondary use where the intended purpose is for the “training, testing and evaluating of algorithms.”

In terms of implementation, the Alliance calls on the Commission to ensure adequate representation of all stakeholders in the EHDS governing board as well as connectivity between pre-existing boards. The Alliance additionally calls on the Commission to highlight how it will support the implementation of the EHDS infrastructure such that it does not result in a bottleneck limiting data access for crucial research while data access bodies are created.

Finally, as a multistakeholder organization composed of both academia and industry, the Alliance would like to highlight the need for increased clarity regarding fees to obtain secondary data access. The unspecified fees in Article 42 must not disadvantage certain groups, such as academic and research institutions, in their ability to access high-quality data for research because of significant financial constraints.

The Avicenna Alliance believes that the EHDS is a necessary next step to support individuals’ rights as well as foster health research and innovation in the EU. It welcomes the aim of supporting research including that tied to in silico medicine, but highlights that certain points within the proposal must provide more legal clarity to avoid creating a patchwork of legislation relating to data usage, AI, clinical trials and medical innovations. The best possible access and quality as well as the largest data sets will be crucial elements to enable the rollout of in silico methods and thus achieve the many benefits that follow.

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