EU regulation health data

A solid legal framework for the innovation-promoting use of health data

After the previous Policy Briefing of the German Israeli Health Forum for Artificial Intelligence (GIHF-AI) addressed the technical and security aspects of health data, the focus in the following is on the national, European and international regulatory mechanisms regarding the use of health data.

The development and use of artificial intelligence (AI) in healthcare depends significantly on the availability and usability of healthcare data. The reasons are obvious: An AI can only be as good and representative as the data available for its training.

The briefing therefore places a focus on the key regulatory mechanisms regarding primary use (use for health care) and secondary use (use for research and development) of health data in Germany, with a focus on the latter.

At the same time, a comparison is made with a country that is around twenty years ahead of us in the field of digital health: Israel. The Middle Eastern country already boasts over 700 digital health startups and a thriving infrastructure of AI-based health applications used by a majority of its population of just over nine million.

Conclusion: Legal certainty for AI-based applications and trust in AI Made in Europe should be achieved through the swift enactment of a EU Regulation on Artificial Intelligence. Furthermore, clear complementary guidelines should be obtained. The general rule here should be that a sound legal framework for the innovation-promoting use of health data must replace the existing overregulation.