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…
New guidelines have been published on clinical trials for AI health solutions. The SPIRIT-AI extension relates to clinical trials protocols, and the CONSORT-AI extension is a new reporting guideline for clinical trial reports. These new guidelines are aimed at addressing some of the chronic issues which often underlie trial standards for AI, including the use of retrospective datasets, poor standards of reporting and lack of transparency. We’ve described these issues below: 1. Retrospective reports do…
The UK’s National Data Guardian for Health and Social Care (NDG) is carrying out a consultation seeking views on proposed revisions to the seven Caldicott Principles. The consultation is open until 3rd September. We’ve set out a summary of 4 key changes proposed in the NDG’s consultation paper. What are the Caldicott Principles? In 1997, Dame Fiona Caldicott chaired a committee which produced a report containing six principles on patient confidentiality after reviewing the transfer…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on medical device standalone software last month. We’ve set out our top 5 takeaways from the new guidance
Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…
Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…