Digitising cross-border care - Making secondary data available for research and AI.

In spring 2020, the EU Commission presented its European data strategy. In the area of health, it announced the establishment of an European Health Data Space (EHDS). The purpose of the EHDS is to use the health data available in the EU for

• high-quality health care in Europe
   
• improved access to healthcare and
   
• improved access to health data for research and innovation.
   

A legal framework enabling the collecting, accessing, storing, primary use as well as the secondary processing of health data in the interest of citizens and also ensuring that sensitive personal data remains protected will be proposed during the 4th quarter of 2021.

Cross-border data exchange and digital services

Until now, the cross-border exchange of health data (e.g. e-patient files, e-prescriptions) has been made possible through voluntary cooperation between member states who participate in the e-health network.

The view of the EU Commission is that the continued lack of interoperability of e-patient records and fragmented implementation of the e-health network guidelines or the recommendations for a European Electronic Health Record Exchange Format (EHRxF) restrict EU-wide circulation of digital products and services.

The lack of mandatory action to implement the initiatives affects the availability and use of health data. The resulting lack of access to data and its exchanging hinders scientific research and innovation (secondary data processing), according to the EU Commission.

Research, innovation and AI

According to the EU Commission, with the increasing availability of health data, there is also the need to make data accessible for scientific research and development, AI and innovations in addition to the primary use of health data in care.

In the White paper covering AI, which describes a cross-sector strategy, the EC pointed out possible special requirements for the health sector that exceed a horizontal approach. A legislative proposal to this effect has been announced for the first quarter of 2021.

For example, specific requirements will include non-discrimination of datasets, training, testing and validation of AI systems as well as the related rights, obligations and liabilities.

Shaping the European Health Data Space

The EC’s present combined roadmap and impact assessment focuses on two application areas. First, more binding cooperation to coordinate the cross-border exchanging of health data. Second, making data available for secondary use via the data governance structure. The following objectives have been formulated:

• Access, sharing and optimised use of health data for providing health services as well as the secondary use of data for research and innovation, policy-making and regulatory action should be made possible. Health data made available across borders must be subject to data protection and data security requirements and it should be provided in a prompt, reliable and transparent way through an institutionalised governance structure.
   
  
• The common single market for digital health, digital health services and products such as tele-health, tele-monitoring and mobile-health should be strengthened.
   
  
• The development, provision and application of reliable digital health services and products, including AI applications, should be expanded.
  

The consultation process for an EHDS began in the first quarter of 2021. The draft legislative text is expected to be presented during the fourth quarter of 2021.