EU AI Act: Top 10 Changes in the Latest Draft At the end of last week, two European Parliament Committees published the latest version of the EU AI Act. The new draft reflects months of political wrangling, but it also demonstrates that EU legislators have listened to the (many) criticisms levied at the EU AI Act until now. So what’s new? We’ve set our top ten changes: Higher penalties: If you thought the previous proposal…
In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible…
The European Union’s draft AI Act is an ‘early-mover’ in the arms race towards a global blueprint for AI regulation. In December 2022, the European Council approved a compromise version of the AI Act, and next month, the European Parliament is scheduled to vote on the draft text. But despite its initial promise, the AI Act increasingly resembles the circumstances of its conception – a complex, one-time political compromise between thousands of MEPs with wildly…
The UK’s Health Research Authority (HRA) has unveiled new guidance which signposts the three essential steps to access health and care data for research purposes. The guidance delves into a point that researchers often miss: the common law duty of confidentiality runs in parallel to data privacy laws, and each regime needs to be considered separately to ensure data access requests can stand up to regulatory scrutiny. Step 1: Scoping – What are the data…
How will pharma use health data for clinical trials in the future? The power of clinical trial tokenisation On 25 October 2022 leading researchers and executives from some of the world’s pioneering drug and pharmaceutical companies came together at a Financial Times Live Webinar event to discuss “The Power of Clinical Trial Tokenisation”. Tokenisation of healthcare data is likely to be one of the next great innovations for developing life-saving drugs and treatments through the…
Synthetic datasets could change the way developers train AI models in healthcare. They have the potential to increase the size of training datasets for AI models, whilst protecting patient privacy, but is this really a solution or just hype? We’ve set out 7 things you need to know. 1. What is synthetic data? A synthetic dataset is an “artificial” dataset containing computer-generated data instead of real-word records. In the healthcare setting, the term “synthetic data” is…
The NHS’s New Data Sharing Agreement NHSX has published a new Data Sharing Agreement (DSA) template. The template is a great tool for companies collaborating with NHS organisations to access and use data for R&D, and for companies which access and use data as part of their provision of services to the NHS. We’ve set out our top 5 takeaways below: What’s in a name? Data Sharing Agreement is a misnomer – this is not…
NHSX recently launched a brand new information governance portal, providing a ‘one-stop shop’ for NHS policies and guidance. The new portal covers everything from GDPR in research to records management. But even with the new portal, navigating NHS guidance on data isn’t easy. We’ve picked out 6 essential items to have on your radar if your organisation accesses or uses NHS data: 1. The Caldicott Principles The Caldicott Principles apply to the use of confidential…
The MHRA has issued guidance on managing access to electronic personal health data processed during clinical trials. Clinical trials sponsors, via clinical research associates (CRAs) or monitors, verify and oversee the data collected and analysed during clinical trials (Source Data Verification). They review medical records to ensure this matches the data collected by the sponsor. The guidance addresses the challenges posed to patient confidentiality by electronic health records (EHRs) during this review process. The guidance…
Patient registries are where big data meets new and exciting regulatory opportunities in pharma, and regulators are keen to address the gaps between regulation and innovation in this space. The European Medicines Agency (EMA) has published new draft guidelines on registry-based studies (Guidelines) for a three-month public consultation period. The Guidelines make the case for optimising the use of registry-based studies as a source of real-world evidence. The new Guidelines will be an essential tool…