ESIP responds to the Public Consultation on the upcoming European Health Data Space

In view of the legislative proposal for a European Health Data Space (EHDS), expected by the end of this year, ESIP took part in the public consultation process on access to and exchange of health data for healthcare provision, policy-making and research & innovation purposes, as well as on the use of digital health products & services and development & deployment of AI systems applied to healthcare.

Building on the previous response to the inception impact assessment, ESIP developed its views on the technical and governance framework for the EHDS, highlighting that access to and sharing of health data should bring clear societal benefits, in a privacy-preserving setting. First, to ensure interoperability and compatibility of health data, harmonised standards and technical requirements should be set by national digital health bodies, networked at European level. While we support patient control over their health data – access to and transmission of – for healthcare provision, access to data for research, development & policy-making should be granted at national level through an authentication scheme, based on the clear identification of authorised actors. In terms of governance, a EU body bringing together national authorities could facilitate access and legal provisions to regulate secondary uses – selecting and restricting areas for which data can be used and accessed – should also be established at EU level. Importantly, publicly-held data made available for R&D purposes should serve the public good and prices should reflect public return on public investment.

When it comes to the development and use of digital health services and products, GDPR-compliant solutions, coupled with investment in digital health literacy as well as reinforced physical services (e.g. in rural areas), could promote the shift from treatment to prevention. This would bring clear societal and economic benefits, namely improved access to healthcare and increased healthcare systems’ sustainability. While standards for tele-health equipment should be established at EU level, the uptake of digital health products and services should be managed at national level. Caution should be taken regarding the use of data generated through digital health devices (m-health data) while the infrastructure should prioritise high quality, structured and interoperable health data from public sources.

On artificial intelligence applied to healthcare, while its benefits in terms of improved diagnostics and facilitated access to care should be recognised, the risks associated with possible discrimination and violations of fundamental rights due to algorithmic injustice and pervasive data tracking should also be considered. In order to ensure a trustworthy uptake of AI solutions, the mechanisms behind AI should be transparent and well-designed. At the same time human oversight should always be maintained and clear liability and safety rules established.

Find out more in our response to the public consultation.