On July 1, 2024, Germany implemented new regulations under Section 393 SGB V, which impose stricter requirements on the processing of health data using cloud-computing services. This legislative change aims to standardize data security across the healthcare sector, which serves approximately 90% of the German population. The new rules require that health and social data be processed only within Germany, the EU, or EEA member states, or in third countries with an adequacy decision by the European Commission. This move seeks to enhance data protection by ensuring that sensitive health information is managed in secure environments.
The regulations also introduce stringent technical and organizational requirements for cloud service providers. To comply, these providers must secure a current C5 certificate from the German Federal Office for Information Security, which ensures adherence to rigorous security standards. The law specifies that until June 30, 2025, a C5 Type 1 certificate is acceptable, after which a C5 Type 2 certificate will be required. These measures are designed to bolster data protection and ensure that cloud-computing services used in healthcare meet high-security benchmarks.
The impact of Section 393 SGB V on medical research is a significant concern. Research projects involving health data, such as non-interventional studies, post-market clinical follow-ups, and registry studies, may face new compliance challenges. These studies often process health data collected from patients treated under the statutory health system, which could now be subject to the stringent requirements of the new law. This raises questions about the feasibility and cost implications for researchers relying on cloud-computing services for data processing.
In conclusion, while Section 393 SGB V aims to enhance the security of health data within Germany’s cloud-computing framework, it could also introduce complexities for medical research involving real-world health data. Pharmaceutical and medical device companies should carefully assess how these new regulations may affect their research operations and data management practices. The Life Sciences Team at Covington & Burling LLP in Frankfurt will continue to monitor these developments and support clients in navigating the evolving regulatory landscape.
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