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In a paper published today in Nature Medicine, an international team of researchers, including those from the University of Oxford and TUD Dresden University of Technology, show how user trust and pathways to market for digital health applications could be enhanced.

Digital health applications

The team propose integrating transparent and mandatory feedback collection mechanisms directly into user interfaces, with feedback linked to a national platform. This could significantly improve user experience, increase patient safety by early identification of problems, and open-up faster approvals, reduce administration in monitoring tools and enable trusted digital health transformation.

AI-enabled digital health technologies (DHTs) are transforming healthcare, supporting diagnosis, therapy and lifestyle adaptation. However, the lack of real-time feedback on safety and performance limits their reliability. The authors explain that in the past regulations were often developed after medical failures. Examples being the Thalidomide tragedy in the 1960’s or defective breast implants, the latter being one of the factors leading to the implementation of the European Union Medical Device Regulation (EU MDR). The current approval process for medical devices varies widely, in contrast to the very strict regulations for pharmaceuticals. There is an urgent need for robust post-market feedback systems for DHTs to gather real-world evidence and identify safety issues as early as possible. Although some feedback mechanisms already exist, there is a lack of international harmonisation and integrated tools that allow for immediate and open user feedback. Unlike traditional medical devices such as implants, digital tools could readily include direct feedback approaches facilitating greater trust and use.

Co-author, Baptiste Vasey of the Nuffield Department of Surgical Sciences, University of Oxford, said: 'For many medical products, registries can be expensive and time consuming to build. The proposed approach takes advantage of the unique features of DHT to drastically reduce the cost and effort of generating timely feedback on technology use and related outcomes. This has not only the potential to improve performance, but also to strengthen patient safety at the same time.'

Rebecca Mathias, lead author and researcher in the team of Professor Stephen Gilbert at Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University of Technology said: 'Our work at the intersection of medical device regulations and digital health focuses on balancing innovation with safety. As digitisation accelerates, we emphasize the need to develop fit-for-purpose regulations while leveraging existing frameworks to ensure the effective and safe implementation of digital technologies – recognising that regulatory updates take time.'

Professor Gilbert’s research group studies Medical Device Regulatory Science and focusses their research on adapting innovative regulatory practices. In a series of publications, several of which co-authored with researchers from the Nuffield Department of Surgical Sciences, the team has proposed strategies to enhance transparency, feedback, accountability, performance, and robust post-market monitoring of DHTs.

The study 'Safe AI-enabled digital health technologies need built-in open feedback' is published in Nature Medicine.

This work was supported by the European Commission under the Horizon Europe Program, as part of the project ASSESS-DHT (101137347). UK participants in Horizon Europe Project ASSESS DHT are supported by UKRI grant number 10106825 (National Institute for Health and Care Excellence) and 10108522 (University of Oxford).

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