The use of patient data from diagnostics and therapy holds potential for medical progress. The last few months have also been dominated by digitalization and artificial intelligence in the healthcare industry, and the turn of the year 2023/2024 was also characterized by numerous innovations in the legal and regulatory environment.

Adopted: Health data use and digital law

To improve care and research in the healthcare sector, the legislator passed two digitalization laws in December 2023: The Health Data Utilization Act (GDNG) and the Digital Act (DigiG). These are intended to act as "enablers" of the digital transformation in the healthcare sector - and at the same time create legal certainty for patients and practitioners alike. "In medicine in general and also in haematology, digitalization, automation and artificial intelligence are not gadgets, but game changers that support excellent specialists in diagnostics and therapy," explains MLL Managing Director Prof. Dr. med. Torsten Haferlach. "Networking, interdisciplinarity and a regulatory framework that promotes innovation are the keys to success here. The noticeable shift towards digital offensives can only be welcomed by anyone interested in future-oriented healthcare for the benefit of our patients."

The Health Data Utilization Act (GDNG) is intended to enable better research in the healthcare sector and simplify the development of health data for research purposes. The law focuses on making it easier to use health data for public welfare purposes. To this end, a decentralized health data infrastructure with a central data access and coordination office for the use of health data is being established. This is intended to reduce bureaucratic hurdles, facilitate access to research data and, for the first time, link health data from different data sources for research purposes. The lead data protection supervision for transnational research projects is to be extended to all health data, the Health Research Data Center (FDZ) at the BfArM is to be further developed in a targeted manner and healthcare institutions are to be strengthened in their own research overall.

In all of this, the interests of insured persons should be adequately safeguarded: The nationwide introduction of the electronic patient record (ePA) is planned from 15.01.2025, and an opt-out procedure is planned for the release of data - only data that has been reliably automated and pseudonymized will be transmitted. Health and long-term care insurance funds can provide personalized advice to their policyholders based on billing data if this can be proven to serve individual health protection.

In future, it should also be possible to redeem e-prescriptions via the ePA apps of health insurance companies. In addition, the limitation of video consultations to a maximum of 30 percent of medical and psychotherapeutic working hours is to end, and at least 20 percent of the remuneration amount for digital health applications (DiGA) is to be determined based on success in future.

Further technological initiatives

Further technological developments are also taking place at EU, federal and state level. The European Health Data Spaces EHDS initiative is being driven forward, but associations are calling for legal terms and data-related usage scenarios to be defined more clearly in advance so that the EHDS can provide usable data for research and development in the healthcare sector. Meanwhile, stricter rules are to apply to the use of artificial intelligence (AI) in the EU in future. The "AI Act" is regarded as the world's first "AI law", but is intended to leave room for innovation. On the threshold between Europe and Germany, the Gaia-X project aims to stand for security and trust in the digital space and regulate the secure, trustworthy and interoperable handling of data systems with Europe-wide guidelines. The application for the healthcare sector, which is supported by numerous industry partners and associations, is sphin-X. At state level, the Bavarian state government is driving forward the Bavarian Cloud for Health Research (BCHR) as a Bavaria-wide cloud for health data and an association of leading scientific locations.

"In view of the data protection vs. patient protection debate, we need to reduce barriers to innovation in the use of data for research if we want to create a sustainably networked health data infrastructure," explains Haferlach. "We will therefore be following all of these initiatives with great interest in terms of the diverse potential of responsible evaluation of health data for medical research and therapy optimization."