The German federal government has approved the draft of the Act on Data and Digital Innovation in Healthcare (GeDIG). It addresses nearly all areas relevant to digitalization, supports the national implementation of the European Health Data Space (EHDS), and is intended to advance healthcare, research, and interoperability.
Essentially, there are three key areas:
- Primary Use of Health Data: In the future, health data should be consistently interoperable and available for healthcare purposes.
- Secondary Use for Research and Innovation: Through the EHDS data access procedure, the enhanced research data center, and new real-world laboratories, health data will become more widely available for research and innovation.
- Added Value Through Digital Applications: New digital care pathways, such as e-referrals, digital access to care via the ePA, and an enhanced DiGA framework, are designed to make everyday life easier for insured individuals and healthcare providers.
What does this mean for manufacturers of digital solutions?
The new interoperability requirement will have the most immediate impact: Providers of hospital information systems, practice management systems, or specialized systems must design their systems so that healthcare providers can store health data in an interoperable format in the future.
As the digital health agency and certification authority, gematik will play a significantly greater role in ensuring compliance and operational stability. The BSI will assume responsibility for market surveillance of EHR systems. The use of KIM will become mandatory for all service providers connected to the TI, and the ePA will be opened up to value-added applications.
Overall, new market opportunities are emerging in the areas of ePA and data usage, while at the same time, requirements for interoperability, approval, and cybersecurity are increasing.
The bill is now going through the legislative process. Changes are still possible.
You can find the law here: Law on Data and Digital Innovation in Healthcare (GeDIG) | BMG