A foggy minefield: Experiences of regulation among developers of AI and other medical software in the UK, survey and focus group study

Introduction: Regulation is important for medical software, but advances in software, notably developments in artificial intelligence (AI), are developing quickly. There are concerns that regulatory processes are not keeping up and that there is a need for more pro-innovation approaches. Methods: We conducted a survey (n = 34) and four focus groups to discuss experiences of regulation among UK-based developers. Results: In the survey, 35% agreed/strongly agreed that they were confident in their knowledge of relevant regulation, while 50% agreed/strongly agreed that poor regulation was allowing bad products to come to market. The focus groups identified 10 themes around challenges with current processes: the process of obtaining regulatory approval is uncertain; lack of knowledge about regulatory approval; difficulties in obtaining reliable advice; complexity and slow pace of approvals; difficult to get NHS clinician involvement; process is costly and difficult to fund; implications for competition; international differences; incentives to develop lower classification products; and lack of harmonisation between NHS and MHRA. Respondents' suggestions for solutions to improve processes fell under four themes: financial and structural support; regulatory collaboration and commissioner involvement; process efficiency and adaptability; and education and guidance. Discussion: Developers are unhappy with the process of regulation for medical software in the UK, finding it confusing and expensive. They feel systems compare poorly to international comparators. Integration between the MHRA system and NHS commissioning is considered poor.