Emerging Digital Technologies in Patient Care: Dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector

The integration of the Internet of Medical Things (IoMT) and Artificial Intelligence (AI) into clinical routines is significantly impacting organisational preparedness at the point of care, raising concerns not only about the resilience of the healthcare infrastructure, but also about how physicians, clinicians, and healthcare professionals respond to, manage, and reduce new risks associated with connected and intelligent medical devices in the interest of patient safety and care.

The following report summarises findings from the workshop entitled Emerging Digital Technologies in Patient Care: Dealing with Connected, Intelligent Medical Device Vulnerabilities and Failures in the Healthcare Sector, held on 23 February 2023 at Goodenough College, London. The workshop was organised by members of the Reg-MedTech project, funded by the PETRAS National Centre of Excellence in IoT Systems Cybersecurity (EPSRC grant number EP/S035362/1), in collaboration with project partners at the BSI, the UK’s National Standards Body. 

Since October 2021, the Reg-MedTech project has investigated the extent to which current regulatory frameworks and standards address the critical cybersecurity, data governance, and algorithmic integrity risks posed by connected and intelligent medical devices. A critical finding from its ongoing research has been the need to develop standards, regulations, and policies that are better informed by the experiences of physicians, clinicians, and healthcare professionals dealing with software-based medical devices or software as a medical device (SaMD) in their day-to-day practice.