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…
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,…
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,…
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…
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…
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…
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…
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. …
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…
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.…
