Discussion on the Governance of Artificial Intelligence in Medical Equipment and Software Applications (Podcast)
In the ever-evolving landscape of healthcare, the conversation surrounding Artificial Intelligence (AI) is gaining momentum. While Narrow AI tools are currently prevalent, the future state is generative AI.
This shift towards generative AI was recently discussed at a public meeting of the U.S. Food and Drug Administration's Digital Health Advisory Committee (DHAC). The meeting, broadcasted on YouTube, aimed to address the regulation of generative AI and the use of narrow AI tools in healthcare.
One of the key figures in this discussion was Robert Califf, MD, the FDA Commissioner. Califf stated that he is not aware of any U.S. health system capable of validating an AI algorithm in a clinical care system. Prior to his tenure at the FDA, Califf was head of medical strategy and senior advisor at Alphabet Inc., contributing to strategy and policy for Alphabet's health subsidiaries Verily Life Sciences and Google Health.
The regulatory spectrum for medical devices and artificial intelligence is another topic of debate. Kavindra U. Jha, a renowned expert in the field, discussed the differences between CE marking and FDA 510(k), and the challenges in getting regulatory clearance.
Meanwhile, the American College of Radiology (ACR) is leading the way in AI implementation. Bernardo Bizzo, MD, PhD, discussed the ACR's national AI quality assurance program, ARCH-AI, which includes Assess-AI, a registry for monitoring imaging-based AI models in clinical workflows. The ARCH-AI program is currently piloting at 15 sites with four AI vendors and platforms engaged for two FDA-cleared clinical use cases, intracranial hemorrhage and pulmonary embolism on CT cases.
Tessa Cook, a cardiovascular radiologist and board-certified clinical informaticist at Penn Medicine, is a guest on the episode. Cook, who is also the director of Penn Medicine's Center for Practice Transformation in Radiology, was featured in Episode 10 of the Keeping Up with the Radiologists podcast.
The use of AI in healthcare is not without its complexities, particularly in clinical care where variables abound. However, some regulation is required for things that will impact patients and hospital care, according to Hugh Harvey, a radiologist and the managing director of Hardian Health consultants, a U.K.-based clinical digital consultancy.
Innovation in AI is not limited to the United States. Guildford Street Laboratories, a spin-off from University College London, received FDA Breakthrough Device designation for its blood-based Parkinson's disease test, PD Predict. PD Predict is a diagnostic test that measures multiple biomarkers using machine-learning analysis.
As the use of AI in healthcare continues to grow, so too will the need for rigorous regulation, careful implementation, and ongoing monitoring. The future of AI in healthcare is promising, but it's a journey that requires careful navigation.
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