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Freshfields TQ

Technology quotient - the ability of an individual, team or organization to harness the power of technology

| 2 minutes read

New regulation on access and use of research and health data in Germany

There are vast amounts of sensitive health data that are being collected, but due to the stringent regulation on the use of such data not much of it is used for purposes beyond the provision of healthcare services. That is why the German government has decided that research data should be used more effectively for innovative use cases in the coming years. Therefore, the German Federal Government has various new regulations in the making to improve and simplify access to research data and its subsequent use (read more here on how the EU wants to regulate AI in the healthcare sector).

This follows pending EU legislation such as the Data Act, which will regulate access to data generated by connected devices (I.e. the Internet of Things - IoT) in the EU (more here), and plans to create a European Health Data Space (EHDS) that will enable individuals in the EU to take control of their own health data as well as support the use of health data for better healthcare delivery, better research, innovation and policy making. The UK government has also just published a MedTech strategy paper, which includes plans to enable access to and processing of digital health data (more here).

New data access and use regulation in the healthcare sector

The German federal government plans to pass a total of three laws: a Health Data Use Act, a Research Data Act, and a Registry Act.

First, the Health Data Use Act (Gesundheitsdatennutzungsgesetz; “GDNG”) shall establish a central data access and coordination point to enable access to research data from various sources.

  • This data may, for example, come from existing silos, such as the cancer registry or health insurance data.
  • The Health Research Data Center of the Federal Institute for Drugs and Medical Devices (BfArM) shall act as the intermediary between data users and data holders.

Second, the Research Data Act (Forschungsdatengesetz; “FDG”) aims to improve access to process data for scientific research. This act serves to create a uniform framework for the dissemination, storage and safeguarding of research data. How these goals will be implemented is not yet known.

Third, the Register Act (Registergesetz) is intended to strengthen medical registers by introducing a register directory that provides an overview of the data inventory as well as the data quality and availability.

  • Medical registers are among the most important tools for reviewing treatment procedures and researching new therapies.
  • The law also aims to help improve the usability and accessibility of existing medical registry data for research and care by creating a central office for medical registries that can provide stakeholders with information about available data.

What should stakeholders do now?

According to the official draft, the Health Data Use Act shall come into force from January 2024. With regard to the Research Data Act, conceptual work is ongoing, and the draft of a register law is planned for fall 2023. Stakeholders in the healthcare sector should therefore evaluate whether the new laws bring opportunities to reap the benefits of data for research and development use cases and also consider actively participating in the legislative process, for example by submitting comments on the upcoming draft bills.


data protection, life sciences