On 5 September 2024, the European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) published a guidance document (the Guidance) with general principles and recommendations on the use of large language models (LLMs) in regulatory science and the regulation of medicinal products. The guiding principles for users are also summarised in a one-page
Arnold & Porter Kaye Scholer LLP Blogs
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The European AI office and other resources relevant to high risk AI systems
In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world’s first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the…
Virtual and Digital Health Digest – August 2024
This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024 from United Kingdom, and European Union.
Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy…
The EU AI Act: Impact on the Life Sciences Industry
Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689 and entered into force on 1 August 2024.
The AI Act is so-called “horizontal legislation”, meaning it applies across industries, and its impact will be felt from agriculture to aerospace and beyond. …
Virtual and Digital Health Digest – July 2024
This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union.
While it has been a relatively quiet month in the EU given elections in the European Parliament and in the UK (as well as other countries across the EU), agencies across the globe…
Virtual and Digital Health Digest – June 2024
This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2024 from United Kingdom, and European Union.
Of interest, artificial intelligence (AI) safety has been in focus over the past month, including with the publication of the Interim International Scientific Report on the Safety of Advanced AI.…
Implications of the New EU Product Liability Directive
Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.
On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years. Once the new legislation has been approved by…
Virtual and Digital Health Digest, May 2024
This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.
You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the…
MHRA outlines proposals for international recognition of medical devices
On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already “approved” in a trusted…
MHRA sets out its AI regulatory strategy
By Jackie Mulryne & Emma
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024, in which the MHRA was asked to provide details about what steps it is taking…