BioTalk

Ambient voice technologies ("AVTs") are AI-enabled tools that automatically transcribe and document clinical conversations, and we are...

The Court of Justice of the European Union (CJEU, 2 July 2026, Case C-427/24, Diagramm Halbach) has recently issued an important judgment...

Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...

The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...

As digital health applications become increasingly sophisticated and telemedicine (the distribution of health-related information and...

On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union....

A recent EU directive will have significant consequences for Australian life sciences companies operating in Europe. Directive 2024/2853...

On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK,...

* This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team.  On 3 January 2025, the General Office...

On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...

On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...

In May 2024, the Dutch government published the draft bill for the new Cybersecurity Act (Cyberbeveiligingswet – “CSA”) for consultation...

On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23...

On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...

Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...