Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly
Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkSGB V
Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog…
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices