Mobile health apps and wearable devices that use artificial intelligence to help diagnose or even treat medical conditions pose a new regulatory challenge for the U.S. Food and Drug Administration. The government agency has responded by starting to assemble a team of computer scientists and engineers to help oversee and anticipate future developments in AI-driven medical software.
This comes at a time when medical devices have evolved from fairly self-contained gadgets into implants and wearables that communicate wirelessly with medical software on separate computers or in the cloud. The definition of medical device has also stretched as smartphone apps and online services—often backed by machine-learning algorithms—promise to deliver medical diagnoses that once would have required a visit to a doctor's office and specialized lab equipment. That is why the FDA aims to create a new digital health unit around people having both the technical expertise and industry experience to understand how machine learning AI and related subjects such as big data, cybersecurity, and cloud computing will all affect health care for Americans.
“We're trying to get people who have hands-on development experience with a product's full life cycle,” says Bakul Patel, the FDA’s associate director for digital health. “We already have some scientists who know artificial intelligence and machine learning, but we want complementary people who can look forward and see how this technology will evolve.”
The FDA has already spent years working with the medical devices industry and issuing guidance to clarify what products and services require more strict regulation. For example, the past decade has witnessed an explosion of health and wellness apps for smartphone users to download. But the FDA does not regulate most of those apps as long as they pose relatively low risk to the public, even if the health and wellness claims of such apps may be unjustified.
Examples of apps that may meet the FDA's definition of “medical device” but do not necessarily require the attention of regulators include: apps that help sufferers of psychiatric conditions such as depression and anxiety with behavioral techniques or audio messages; apps that help asthmatics track inhaler usage, asthma episodes or environmental triggers of asthma attacks; and apps that provide information about interactions between different drugs or keep track of medications being taken.
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