Submitted feedback on the creation of a European Health Data Space

Through this feedback, Avicenna Members provided the Commission with guidance on how to ensure access to data, the interoperability of data and more importantly which technical developments can enable us to turn the health data into actionable information, including in silico and AI techniques.

The European Health Data Space, covering the exchange and access of primary and secondary use of good quality health data, is eagerly awaited by the in silico medicine community to pursue scientific research and innovations, including the use of computer modelling and simulation (CM&S) in healthcare.

In a nutshell, the members of the Avicenna Alliance from MedTech, Pharmaceutical, digital and life science industries as well as from the academic in silico medicine community and healthcare organisations, represented by the VPH Institute, call on the European Commission to:

• Consider the options offered by the so-called “visiting mode” and the generation of synthetic data as alternative data access-models preserving privacy when considering the use of privacy protection measures;
• Take into account the existing rules of international organisations (e.g., ICH, IMDRF, ISO, IHE, IEEE and HL7/FHIR) to limit disparities in the use of health data globally.
• Not only focus on ‘AI’ applications as a wide range of other in silico technologies exist in healthcare
  
• Seize the establishment of a governance framework to support the training, testing, validation and exploitation of all in silico technologies.
• Encourage the use of Real-World Evidence and data produced by CM&S as part of Health Technology Assessments and the EMA’s evaluation process
• Consider how Good Simulation Practice (GSP) could offer the regulatory guidance that industry and researchers need to ensure the robust quality and working of computer models used in health applications.

The full document can be accessed here