Updates on Legal Developments in the EU Life Sciences Industry
On March 5, 2025, the Regulation on the European Health Data Space (“EHDS”) was published in the Official Journal (see here). The text enters into force on March 25, 2025, however it only becomes applicable in a staggered manner over several years.
The section on secondary use of the…
Continue Reading European Health Data Space PublishedOn 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
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 DevicesOn 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.
On November 5, 2019, the European Commission published a report entitled “Strengthening Strategic Value Chains for a future-ready EU Industry”, which was prepared by the Strategic Forum on Important Projects of Common European Interest (“Forum”). The Forum assists the European Commission in identifying key strategic value chains that…
Continue Reading European Commission publishes Strategic Forum’s recommendations on Smart Health
On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.” In the first session, the workshop discussed the implications of the General Data Protection Regulation…
Continue Reading The Implications of the GDPR on Clinical Trials in Europe
