FDA developing new rules for artificial intelligence in medicine - STAT

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The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. The agency's outgoing commissioner, Scott Gottlieb, released a white paper that sets forth the broad outlines of the FDA's proposed approach to establishing greater oversight over this rapidly evolving segment of AI products. It is the most forceful step the FDA has taken to assert the need to regulate a category of artificial intelligence systems whose performance constantly changes based on exposure to new patients and data in clinical settings. These machine-learning systems present a particularly thorny problem for the FDA, because the agency is essentially trying to hit a moving target in regulating them. The white paper describes criteria the agency proposes to use to determine when medical products that rely on artificial intelligence will require FDA review before being commercialized.


FDA chief sees big things for AI in healthcare

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At AcademyHealth's 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard. "We're implementing a new approach to the review of artificial intelligence," FDA Commissioner Dr. Scott Gottlieb said. As one example, he pointed to the agency's approval earlier this year of a new clinical decision support software that uses AI algorithms to help alert neurovascular specialists of brain deterioration faster than existing technologies. "AI holds enormous promise for the future of medicine, and we're actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies," Gottlieb said. "So, as we apply our Pre-Cert program -- where we focus on a firm's underlying quality -- we'll account for one of the greatest benefits of machine learning -- that it can continue to learn and improve as it is used."


FDA chief sees big things for AI in healthcare

#artificialintelligence

At AcademyHealth's 2018 Health Datapalooza on Thursday, the U.S. Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation and announcing a new machine learning partnership with Harvard. "We're implementing a new approach to the review of artificial intelligence," said FDA Commissioner Scott Gottlieb, MD. As one example, he pointed to the agency's approval earlier this year of a new clinical decision support software that uses AI algorithms to help alert neurovascular specialists of brain deterioration faster than existing technologies. "AI holds enormous promise for the future of medicine, and we're actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies," said Gottlieb. "So, as we apply our Pre-Cert program โ€“ where we focus on a firm's underlying quality โ€“ we'll account for one of the greatest benefits of machine learning โ€“ that it can continue to learn and improve as it is used."


FDA Chief: AI Holds 'Enormous Promise' for Tomorrow's Health Care

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Digital health tools have and continue to radically change how care is delivered and provided, helping with early detection and cutting costs. Wearable devices, telemedicine and mobile apps already enable patients to be more proactive with their health, and help care providers better tailor individual care. "Artificial intelligence, particularly efforts to use machine learning . . . He spoke April 26 at the Health Datapalooza in Washington, D.C., organized by Academy Health. "We know that to support the widespread adoption of AI tools, we need patients and providers to understand the connection between decision-making in traditional health care settings and the use of these advanced technologies," Gottlieb said.


4 Steps the FDA plan to take to improve the use of AI and RWE in clinical trials

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In a recent speech at the Bipartisan Policy Center conference, FDA Commissioner, Scott Gottlieb, discussed how the future success of clinical trials will be underpinned by new streams of real world data (RWD). This includes information collected from electronic health records, lab tests, wearable devices, insurance claims and even social media. As he made clear, "digital technologies are one of the most promising tools we have for making health care more efficient and more patient-focused". The FDA believes that these new approaches to collecting data and the utilization of new technology can radically expand the sources of data available. This will offer important evidence on both the product safety and effectiveness in settings and populations that are notably different to those used within approved trials.