Draft Health Data Usage Act (GDNG): https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/gesundheitsdatennutzungsgesetz.html

BfArM Health Research Data Center: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Forschungsdatenzentrum/_node.html

In June 2023, the German Federal Ministry of Health publicized a draft Health Data Use Act (GDNG) as part of the government’s digitalization strategy for the health sector. The Act aims to facilitate the use of health data for research purposes, which could have positive implications for the pharmaceutical and medical device industry. The GDNG also seeks to prepare Germany for the European Health Data Space (EHDS).

The Act proposes to establish a central data access and coordination point to enable access to research data from various sources, such as existing silos like the cancer registry or health insurance data. The Health Research Data Center of the Federal Institute for Drugs and Medical Devices (BfArM) is expected to act as the intermediary between data users and data holders.

The Act also introduces an “Opt-Out” procedure for data sharing from the electronic patient record (ePA). From 2025, all insured patients will automatically receive a digital file unless they actively object. This procedure is expected to drive the exchange and use of health data and support targeted care.

However, the Act has sparked debates around data privacy and potential misuse. Critics argue that anonymized or pseudonymized data do not sufficiently protect against misuse, and there is a lack of legal obligation to encrypt the data. There are also concerns about the plans to transmit health data of millions of insured individuals not only to the EHDS but also to the USA.

On the other hand, proponents argue that the use of health data is essential for research, innovation, and medical care in the 21st century. They believe that the real ethical question is not how we can justify the use of health data, but rather, how we can justify not using it.

The Act is expected to come into force from January 2024. As the Act progresses, it will be crucial to balance the potential benefits of increased access to health data for research and innovation with the need to protect patient privacy and prevent data misuse.