New EU strategy for developing and using AI in health and life sciences

EU healthcare regulators have published a Workplan for 2023 – 2028, setting out their strategy for maximising the benefit of AI in health and life sciences. 

The new EU AI Act will apply across all sectors when it comes into force, as opposed to the UK approach of individual regulators creating rules for the use of AI within their particular sector (e.g. the MHRA will create AI legislation and guidance for health and life sciences in the UK).  

As such, the Workplan provides an insight into how the the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) will look to interpret and apply the EU AI Act to produce guidance and specific requirements for the health and life sciences sector in the EU. 

The Workplan focuses on four key topics to facilitate the development and use of responsible and beneficial AI:

1. Guidance, policy and product support: guidance for the use of AI will be developed in Q3 2024 following the conclusion of the public consultation on the AI reflection paper. In addition, preparatory work will be undertaken in anticipation of the EU AI Act coming into force as well as the development of an AI observatory to monitor the use and impact of AI, also beginning in Q3 2024.  
2. Tools and technologies: a phased roll-out and monitoring of Large Language Models is scheduled to take place during Q2 of 2024 as well as the development of a Network Tools policy to foster collaborative AI development.
3. Collaboration and change management: collaboration and training remain fundamental to the development of AI and a Special Interest Area will be established to provide a network to facilitate continued collaboration and knowledge sharing. AI training platforms and workshops will also be developed in conjunction with stakeholders. 
4. Experimentation: experimentation cycles of up to six months will be conducted over the next few years and network research priorities will be defined to ensure a structured approach to experimentation. 

The Workplan details key events and a timeline for each topic area. 

The EMA and HMA say they will regularly update the Workplan in response to developments in AI technology. 

The publication of the Workplan comes as the MHRA formally opened its new International Recognition Procedure. The IRP is considered in our article here.

Please contact our Healthcare team if you have any questions.

This article was written by Lisa Mulholland and Rory Trust.