The MHRA has published new guidance (May 2023) on reporting adverse incidents involving Software as a Medical Device.

The advice for manufacturers outlines the types of harm that are likely to occur and provides examples of incidents which may be reportable in relation to common uses of Software and AI as Medical Device (SaMD).

The guidance makes clear indirect harm is the most likely outcome of adverse incidents related to SaMD. These may occur, for example, due to medical decisions, actions of healthcare professionals, patients and the public based on information provided by the SaMD.

Examples of indirect harm include:

• misdiagnosis,
• delayed diagnosis,
• delayed treatment,
• inappropriate treatment,
• absence of treatment, or
• transfusion of inappropriate materials.

Reportable Adverse Incidents related to SaMD

The guidance goes on to give examples of adverse incidents which would be reportable:

Performance issues – including mental health tools or activity tracker tools failing to alert healthcare professionals, operating system compatibility issues, Artificial Intelligence (AI) diagnostic and triage tools failing to identify abnormalities, or software tools reading lateral flow tests incorrectly.

Diagnostic accuracy issues – such as symptom checkers identifying an incorrect medical condition or failing to identify a correct condition.

Decision support software resulting in harm – this could occur through overestimated or underestimated scores in predictive algorithms used to support medical practitioners, or the incorrect calculation of medication dosages or radiotherapy treatment.

Issues with connected hardware or software – such as a multipurpose watch running a SaMD monitoring app which causes skin burns, or the use of additional software that interferes with the performance of the SaMD.

Human-Device Interface Problems – including unclear user instructions, failure of hardware to allow the input of data, or failure to account for colour-blindness leading to a missed warning.

User error resulting in harm – this could occur due to triage tools being used off-label, human error, or the use of additional software which interferes with the performance of the SaMD.

Inadequate labelling or instructions for use – such as inadequate or missing cleaning instructions leading to cross-contamination.

Computer system security problems – this could lead to a loss of monitoring or alarm, or the corruption of patient data causing an incorrect or delayed diagnosis.

The update provides greater clarification on the types of issues manufacturers will need to take into account when developing products, rolling them out in the market and preparing associated materials such as manuals and training programmes. Ongoing monitoring and adverse incident reporting is a critical part of regulatory controls, leading to greater patient safety and, ultimately, better product development.

This is another pieces in the jigsaw of new regulations and guidance due to be issued this year as part of the MHRA’s ‘Roadmap’ of reform, which you can read about in our previous post. It comes a little over a month after the MHRA published initial guidance for SaMD, providing access to outputs of the regulator’s Software Group.

If you would like to discuss how the current regulatory regime or future changes might impact you or your products, please contact our Health Tech Team.

Article written by Rory Trust and Katy Dixon.