​EMA publishes workplan on how to
harness data and AI for public health

A key player for the implementation of this workplan is the joint HMA/EMA Network Data Steering Group (NDSG). It discusses the NDSG’s main strategies and objectives that will be needed to ensure that large amounts of complex data is managed, analysed and shared effectively. Some aspects of the workplan include: 

Strategy and governance 

The workplan talks about ensuring that high quality standards are met and data assets are managed and standardised. It also includes several timelines and details of when public workshops are expected to take place and when key guidance will start to be drafted. 

Data analytics 

There are different types of data that will be essential for strengthening regulatory decision making, for example, clinical study data as well as non-clinical and real-world data. However, it addresses the need for data quality management, ensuring compliance with the AI Act and EUDPR/GDPR. 

Artificial intelligence  

The workplan talks extensively about the use of artificial intelligence (AI) and highlights several useful tools such as the AI Network Tools framework that will be created to help improve the operational efficiency of automated systems. 

Stakeholder engagement and collaboration 

The workplan stresses the need for collaboration internally and on an international level.  

It says that ‘listening to stakeholders, increased transparency and excellent communication are critical to build trust.’ Partnerships with stakeholders, creating changed management strategies, and international initiatives will be crucial for success. 

Summary 

The EMA said that the purpose of the workplan is to ‘facilitate safe and responsible use of AI that benefits public and animal health.’  

It will be frequently updated to ensure that the strategies are being properly implemented and goals are being met.