Bundestag passes digital laws for better care and research in the healthcare sector

As a core element of the Digital Act, the electronic patient file (ePA) will be made available to all people with statutory health insurance from 2025. It will promote the exchange and use of health data and provide targeted support for healthcare - initially by introducing a digitally supported medication process. In addition, the e-prescription will be established as a binding standard in the supply of medicines.

With the GDNG, health data can be made more accessible for research and development of innovations in the future and thus contribute to better care. The core of the law is to make it easier to use health data for public welfare purposes. To this end, a health data infrastructure with decentralised data storage and a central data access and coordination centre for the use of health data will be established.

The content of the law in particular

Digital Act

• ePA with opt-out as a future comprehensive data source
• Digital health applications (DiGA) will be integrated more deeply into care processes and their use made transparent. Extension of DiGA to digital medical devices in risk class IIb, including for more complex treatment processes
• Data availability (interoperability factor) and quality: New process for the creation and definition of data standards
• Digital advisory board created for gematik
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Health Data Utilisation Act

• A central data access and coordination centre will reduce bureaucratic hurdles and facilitate access for research. For the first time, it will be possible to link pseudonymised health data from different data sources. The access point will act as a central point of contact for data users.
The lead data protection authority for international research projects is extended to all health data = one federal state including data protection authority can become responsible
• The Health Research Data Centre (FDZ) at the BfArM will be further developed. The decisive factor for authorisation to apply is no longer who is applying, but for what. The decisive factor is the purpose of use in the public interest.
Data release from the EPO with opt-out procedure in future. This will allow treatment data to be better utilised for research purposes.Providers and their networks will be authorised to use the care data available to them for research, quality assurance and patient safety.

 

Further details can be found at Bundestag passes digital laws.

Source: BioM Biotech Cluster Development GmbH from 15 December 2023