Source: Health Tech Newspaper (HTN)

Health Tech Newspaper (HTN) reports that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially issued a call for evidence to inform the future regulation of artificial intelligence in healthcare. This move is part of the government’s broader strategy to ensure that AI-driven medical devices and diagnostic tools are both innovative and safe for public use. The agency is specifically seeking input from clinicians, developers, and patient groups regarding the unique risks posed by large language models and generative AI in clinical settings, where accuracy is a matter of life and death.

The call for evidence focuses on three main pillars: software as a medical device (SaMD), the transparency of algorithmic decision-making, and the continuous monitoring of AI systems after they have been deployed. The MHRA emphasizes that traditional regulatory frameworks may not be sufficient for technologies that "learn" and change over time. By gathering data on current implementation challenges, the agency aims to build a robust legal structure that prevents bias in diagnostics and ensures that digital health technologies meet the highest clinical standards before reaching the market.

Furthermore, the initiative aligns with the UK's post-Brexit ambition to become a global hub for life sciences. The MHRA intends to use the feedback to develop a pro-innovation regulatory environment that reduces administrative hurdles for startups while maintaining a rigorous safety net. The consultation period will allow stakeholders to influence the technical requirements for AI certification, potentially setting a precedent for international medical AI standards. The agency concludes that maintaining public trust in digital healthcare is essential for the long-term adoption of AI in the National Health Service (NHS).