Smart regulation is crucial to capturing the potential of future-fit innovations, like artificial intelligence (AI).
The importance of walking a fine line between discovery and safety is increasingly compounded when it comes to sensitive sectors like healthcare where matters of life and death are table stakes.
The U.S. Food and Drug Administration (FDA) announced Wednesday (Oct. 11) that it plans to establish a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as AI, machine learning (ML), augmented reality (AR), virtual reality (VR), digital therapeutics, wearables, remote patient monitoring and software.
The FDA’s move comes as the healthcare sector joins a list of industries in which the economy’s ongoing digital shift has taken hold, with a growing number of next-generation medical technologies and care delivery workflows being built on AI and ML-assisted foundations and mutable digital software.
Still, many of these technologies are not without their controversies, and the FDA has been working to expand its oversight of previously unregulated clinical software products and DHTs.
The FDA sent a public reprimand Sept. 19 to Johnson & Johnson regarding the company’s heart pump company, Abiomed, telling the company it should have submitted its software for approval before putting it on the market.
In May, the FDA also issued a warning letter to heart monitoring company iRhythm for changing its algorithm without seeking permission from the agency.
Increasingly, it is becoming clear that the FDA considers clinical software — including real-time monitoring systems — to be medical devices, and therefore subject to the agency’s oversight.
Read also: Healthcare Industry Could Be Generative AI’s Biggest Proving Ground
In a statement announcing the FDA’s Digital Health Advisory Committee, Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said: “Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards. Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”
Technology’s forward march of progress pauses for no one, and the FDA’s Digital Health Advisory Committee, which is expected to be fully operational in 2024, is meant to provide counsel to the agency and its leadership on cross-cutting technical and scientific issues, as well as how those issues could interact with the FDA’s existing policies and regulatory proposals.
The FDA has been aware of the digital transformations underway in the healthcare space for years, reorganizing its internal health IT, data management and cybersecurity under a single Office of Digital Transformation and launching a digital-health-focused center of excellence in late 2020, Fierce Biotech reported Wednesday.
The new committee will be comprised of nine core voting members whose work will be supplemented by specialized members on a topic-by-topic basis. Topics under the committee’s purview will move beyond medical devices to span issues such as decentralized trials, patient-generated health data and cybersecurity.
See also: AI Shifts Into the Next (Generative) Gear in Healthcare
Tackling a problem as broad, dynamic and rapidly evolving as AI will require a deep level of knowledge.
The generative AI healthcare market is projected to reach $22 billion by 2032, offering several possibilities for better patient care, diagnosis accuracy and treatment outcomes, but the novel technology’s myriad use cases present an equally diverse array of challenges for the regulatory bodies tasked with ensuring its safe and responsible use.
The White House Office of Science and Technology Policy (OSTP) held a roundtable discussion Oct. 6 in which the administration emphasized the growing priority to “develop and deploy advanced AI tools that benefit the health and wellbeing of all Americans.”.
One of the more immediate challenges confronting government agencies as it relates to overseeing AI and supporting effective, impactful and safe implementations of the innovation is gaining the right degree of productive understanding of how the technology operates within respective industries.
“I don’t think that we can expect any one single institution to have the kind of knowledge and capacity to address the varied problems [of AI regulation],” Cary Coglianese, founding director of the Penn Program on Regulation, told PYMNTS as part of the “TechReg Talks” series presented by AI-ID.
“The nature of AI’s uses vary widely, and many of those uses fall into categories that, first of all, already have regulators,” Coglianese added. “… There’s no question that the National Highway Traffic Safety Administration is going to be a better regulator of autonomous automobile technology than some kind of new startup AI regulator would be.”
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