UK

On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”).  The AVT Guidance is intended to clarify (and essentially…

Continue Reading New UK Guidance Clarifies Medical Device Status of AI Scribes

On January 17th, 2026, the Biodiversity Beyond National Jurisdiction (“BBNJ”) Agreement, also known as the “High Seas Treaty”, entered into force.  For the first time, companies that use marine genetic resources (“MGRs”) and digital sequence information (“DSI”) originating from areas beyond national jurisdiction may be required…

Continue Reading Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences Companies