The EU is gearing up for massive reform concerning the use and accessibility of health data, and Germany is taking note. Recently, Germany proposed several draft legislation focusing on the use of health data. The Health Data Use Act, (Gesundheitsdatennutzungsgesetz, (GDNG)); The Digital Act, and A Law to Promote the Quality of Inpatient Care through Transparency (Hospital Transparency Act) are just a few of the newest pieces of proposed legislation designed to improve the use and accessibility of health data for German citizens. This move by the German Federal Ministry of Health is part of an EU-wide reform effort under the European Commission’s (“Commission”) European Health Data Space (EHDS).
Germany’s new legislation is designed to align with EHDS principles and these laws not only impact healthcare providers and hospitals in Germany but also companies that collect the health data of German residents. Below are the main takeaways of these proposed laws and what U.S. companies can expect moving forward.