Hot off the press, yesterday evening, 29 September 2026, the German Government’s expert committee presented the eagerly awaited proposal for a new “location clause” (Standortklausel) to incentivize pharmaceutical R&D and manufacturing in Germany. Under this proposal, pharmaceutical companies can apply for a reduction or complete waiver of the
Continue Reading Germany Reviews a New Pharma “Location Clause” (Standortklausel) for Pricing & Reimbursement Incentives – Improvement or Worsening for the Pharmaceutical Industry?SGB V
Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work
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 WorkGermany 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