HHS Advances AI Priorities In Budget Ask
The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.
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A Race Against Time? One Man’s Search For Artificial Intelligence Medical Device Standards That Can Keep Up
Pat Baird – Philips Healthcare’s regulatory standards guru – says by the time artificial intelligence/machine learning standards are developed and recognized by regulators, they may already be out-of-date. To speed up the process, he’s taken it upon himself to aggregate the most critical standards to help industry and regulators alike develop guidelines on how such products should be developed and operate.
About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.
De novo summary documents published by the US FDA sheds more light on the agency’s work approving two de novos for Apple Watches last year. At the time, the approvals sparked concern from industry stakeholders on whether the company received preferential treatment. Former FDA Commissioner Scott Gottlieb pushed back against the notion in a lengthy blog post late last year.