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.'
Read the full story on the Nuffield Department of Surgical Sciences website.