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

The German Bundestag has passed the “Law to Accelerate the Digitalization of the Healthcare System” (Digital Law – DigiG) and the “Law for the Improved Use of Health Data” (Health Data Usage Act – GDNG). The aim is to use digital solutions to improve everyday care and research opportunities in Germany.

As a core element of the Digital Act, the electronic patient record (ePA) will be made available to all those with statutory health insurance from 2025. It will promote the exchange and use of health data and specifically support care - in the first step by introducing a digitally supported medication process. In addition, the e-prescription will be set up as a binding standard in the supply of medicines.

With the GDNG, health data can be better accessed for research and development of innovations in the future and thus contribute to better care. The core of the law is the easier use of health data for public welfare purposes. To this end, a health data infrastructure with decentralized data storage and a central data access and coordination point for the use of health data is being built.

The content of the law in particular

Digital law

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

Health Data Use Act

  • A central data access and coordination point will reduce bureaucratic hurdles and facilitate access for research. Here, for the first time, pseudonymized health data from different data sources can be linked. The access point is intended to act as a central contact point for data users.
  • The lead data protection supervision for cross-state research projects will be expanded to include all health data = a federal state including data protection supervision can become responsible
  • The Health Research Data Center (FDZ) at the BfArM is being further developed. Eligibility to apply is no longer determined by who applies, but for what. The purposes of use that are in the common good are crucial.
  • Data release from the ePA with an opt-out procedure in the future. This means that treatment data can be made more usable for research purposes.
  • Service providers and their networks are enabled to use the care data they have for research, quality assurance and patient safety. 

    For more details see Bundestag passes digital laws.

Source: BioM Biotech Cluster Development GmbH from December 15.12.2023, XNUMX


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