Examining developer perspectives on medical AI regulatory frameworks.

Abstract

Regulatory frameworks ensure the trustworthiness of artificial intelligence in medicine (AI-MD). Yet, developers' perspectives on these frameworks remain underexplored. We surveyed 122 AI-MD developers online, examining their awareness, familiarity, and adoption of regulatory frameworks, alongside their views on ethical principles and stakeholder responsibilities. About half (57.4%, n = 70) were aware of any frameworks while reporting moderate familiarity. A third (33.6%, n = 41) indicated that their organizations had formally adopted such frameworks. Developers identified robustness as the most critical ethical principle and viewed themselves as primarily responsible for implementing regulatory standards. Independent t-tests indicated marginal and significant differences in awareness (p = 0.051) and familiarity (p < 0.001), respectively, between developers from adopting and non-adopting organizations. Senior and junior developers differed significantly on both measures (p < 0.05). These findings highlight developers' strong sense of professional accountability but also reveal limited familiarity and adoption, underscoring the need for greater education and organizational support to foster responsible AI-MD practices.