In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot project went live on 9 May 2024, and government sources are citing it as a
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Virtual and Digital Health Digest, April 2024
This digest covers key virtual and digital health regulatory and public policy developments during March.
You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product…
Commission Communication on biotechnology and biomanufacturing
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.
The Communication, while directed towards the broader biotech sector, refers to the aim to…
Virtual and Digital Health Digest, March 2024
This digest covers key virtual and digital health regulatory and public policy developments during February 2024.
Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating…
Virtual and Digital Health Digest, February 2024
This digest covers key virtual and digital health regulatory and public policy developments during January 2024.…
The UK’s pro-innovation approach to AI: What does this mean for life science companies?
A version of this article was first published in Life Sciences IP Review
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government…
Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs
The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the…
The First Virtual and Digital Health Digest of 2024
Welcome to the first Virtual and Digital Health Digest of 2024!…
Virtual and Digital Health Digest, December 2023
Thank you to all who joined us for our December 13 panel titled the “Race to Regulate.” In case you missed it, unpack this year’s pivotal legal challenges impacting the 2023 — and 2024 — digital legal landscape in our Year in Review Pocket Book.…