Life Sciences & Digital Health

On November 12, 2025, UNESCO’S General Conference adopted its Recommendation on the Ethics of Neurotechnology (“the Recommendation”)–the first attempt at establishing a global legal framework for the ethical development and use of neurotechnology. The Recommendation aims to set out a comprehensive rights-based framework for the entire life cycle of neurotechnology, from the design of neurotechnology products and services to their disposal.

While not legally-binding, the Recommendation states that its provisions should be considered by, among others, UNESCO Member States, research organizations, and private companies involved in neurotechnology, and that they establish how best to honor fundamental human rights in the development, deployment and disposal of this technology. It is therefore possible that in the future, they may be a starting point for binding legislation, or could be used as persuasive authority to support enforcement actions arising under existing legislation protecting fundamental human rights, e.g., the GDPR and other privacy laws around the world. In that regard, it is notable that the EU AI Act was inspired, at least in part, on UNESCO’s November 2021 Recommendation on the Ethics of Artificial Intelligence. There is, therefore, a real possibility that private sector companies developing neurotechnologies will be subject to rules specifically regulating such technologies in the future.Continue Reading UNESCO Adopts First Global Framework on Neurotechnology Ethics

On December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act.  The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector.  The Commission took the opportunity to broadly revise the Clinical Trial Regulation (“CTR”) – see our blog post here.  In particular, it sought to better align the CTR requirements with those of the General Data Protection Regulation (“GDPR”).  This blog post provides an overview of those revisions relating to the processing of personal data during clinical trials.Continue Reading EU Biotech Act Suggests Clarifying Data Protection Rules For Clinical Trials

On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic…

Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

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

On March 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal.  In April 2024,we wrote several blog posts on EHDS based on a provisional compromise text.  We have now updated those to reflect the final version and included references to the correct provisions.

This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS generally, see our first post in this series.Continue Reading EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines

On March 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal (see here).  In early April 2024,we wrote several blog posts on EHDS based on a provisional compromise text.  We have now updated those to reflect the final version and included references to the correct provisions.

This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).Continue Reading German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications

On 21 June 2023, at the close of a roundtable meeting of the G7 Data Protection and Privacy Authorities, regulators from the United States, France, Germany, Italy, United Kingdom, Canada and Japan published a joint “Statement on Generative AI” (“Statement”) (available here). In the Statement, regulators identify a range of data protection-related concerns they believe are raised by generative AI tools, including legal authority for processing personal information, and transparency, explainability, and security. The group of regulators also call on companies to “embed privacy in the design conception, operation, and management” of generative AI tools.

In advance of the G7 meeting, on 15 June 2023, the UK Information Commissioner’s Office (“ICO”) separately announced that it will be “checking” whether businesses have addressed privacy risks before deploying generative AI, and “taking action where there is risk of harm to people through poor use of their data”.Continue Reading UK and G7 Privacy Authorities Warn of Privacy Risks Raised by Generative AI

On 31 May 2023, at the close of the fourth meeting of the US-EU Trade & Tech Council (“TTC”), Margrethe Vestager – the European Union’s Executive Vice President, responsible for competition and digital strategy – announced that the EU and US are working together to develop a voluntary AI Code of Conduct in advance of formal regulation taking effect. The goal, according to Vestager, is to develop non-binding international standards on risk audits, transparency and other requirements for companies developing AI systems. The AI Code of Conduct, once finalized, would be put before G7 leaders as a joint transatlantic proposal, and companies would be encouraged to voluntarily sign up.Continue Reading EU and US Lawmakers Agree to Draft AI Code of Conduct

On May 1, 2023, the White House Office of Science and Technology Policy (“OSTP”) announced that it will release a Request for Information (“RFI”) to learn more about automated tools used by employers to “surveil, monitor, evaluate, and manage workers.”  The White House will use the insights gained from the RFI to create policy and best practices surrounding the use of AI in the workplace.Continue Reading White House Issues Request for Comment on Use of Automated Tools with the Workforce