MHRA seeks input on using EHR data to inform clinical trials
The MHRA is asking stakeholders to help shape new guidance that outlines how greater use of real-world data in clinical trials improve treatments.
AI and Analytics
Health apps developers take note: new MHRA rules are here
As the MHRA expands the range of apps falling under the medical devices regulations, Justyna Ostrowska looks into what developers need to know.
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EMIS joins Yellow Card Scheme for reporting adverse drug reactions
The update allows the 4,000 practices using EMIS Web can report to the Yellow Card Scheme, which acts as an early warning for adverse drug reactions.
Clinical Software
Regulatory sandbox for AI needed to test and build systems, NHSX says
The heads of 12 healthcare regulators and organisations met on January 28 to discuss the role of AI in healthcare and how to proceed with its delivery.
AI and Analytics
Digital health and genomics ‘should form new pillars of life science industry’
Three industries, genomics; digital health; and early diagnosis be critical to the UK continuing to lead in the field of life sciences, Sir John Bell said.
AI and Analytics
HIV/AIDS home test kits seized over potential false results
More than 100 Hightop kits, which have not met EU regulations, have been seized as agency warns consumers against using them.
Digital Patient
Explainer: when is an app not an app (but a medical device)?
New guidance has been released on when an app becomes a “medical device” but attempts to control which apps creep into the NHS have had a rocky history, Ben Heather discovers.
Clinical Software
QRisk2 in TPP “fixed” but up to 270,000 patients affected
Up to 270,000 patients have been affected by errors in a cardiovascular disease risk calculator, which is being blamed on a “code mapping” issues.
AI and Analytics
RCP apps guidance attacked
Recent guidance from the Royal College of Physicians that says doctors should only use medical apps carrying a CE mark has come under fire from Charles Lowe, managing director of the Digital Health and Care Alliance.
News
Appropriate regulation
The regulation of healthcare apps emerged as a hot topic at the end of last year; and will be the subject of a lively discussion at the HANDI spring symposium that forms part of EHI’s Digital Health Festival. Lis Evenstad reports.
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