A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain,
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UK government launches new Industrial Strategy and Advisory Council to boost economic growth
On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.
The Industrial Strategy will…
Virtual and Digital Health Digest – October 2024
This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.
Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life…
UK government launches new Regulatory Innovation Office to reduce red tape
On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.
The RIO, established within the Department of Science,…
EMA adopts reflection paper on the use of Artificial Intelligence (AI)
Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July 2023, and following many months of review of the feedback collected from the relevant stakeholders,…
Virtual and Digital Health Digest – September 2024
This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.
There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN…
AI: EMA publishes guiding principles on the use of large language models (LLMs)
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…
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. …