ARTICLE SUMMARY:
As artificial intelligence continues to reshape healthcare, the Global Agency for Responsible AI in Health is stepping in to help national regulators build capacity and craft governance frameworks for safe, effective AI oversight. Existing medical device frameworks provide a key foundation, but there is a lot more to do and, in many countries, resource constraints impede progress, says Paul Campbell, the agency’s top regulatory expert.
Rapidly evolving applications of artificial intelligence in healthcare present weighty challenges for governments trying to ensure safe, effective, and ethical technology use. It’s hard enough for rich countries with sophisticated regulatory frameworks to adapt and maintain a handle on hard-to-pin-down AI functionality. Countries with fewer resources and less policy infrastructure face extra hurdles, in many cases trying to put rules into place to support basic healthcare needs just as AI is coming along to offer paradigm-changing prospects alongside major risks.
“Whether we ignore it or not, AI is here,” said Paulyne Wairimu, chair of the African Medical Devices Forum and Kenya’s top device regulator. “We have equipment coming to our borders that are AI dependent and use AI for diagnosis.”
From an industry perspective, opportunities abound for leveraging AI to advance medtech innovation, but ambiguities are plenty. The rules of the road are in flux and inconsistent around the world, making it difficult to feel secure in a long-term compliance strategy for AI-driven tools.
Into this milieu of rapid technological advancement, constrained national resources, and regulatory ambiguity enters The Global Agency for Responsible AI in Health, or HealthAI. The Geneva-based nonprofit first launched under a different name in 2019, primarily as an AI/digital health research network. But over the past two years it has rebranded and reoriented itself as an organization working directly with national authorities to build governance and regulatory structures to support sensible use of AI in healthcare.
“There are about 200 countries in the world and some of them don't have any regulations at all, and many of them are really struggling with capacity and capability,” says Paul Campbell, HealthAI’s chief regulatory officer, in an interview. “We are trying to help build that capacity and capability.”
