FDA Reviewing Guidelines for AI and Health Care
Artificial intelligence (AI) is projected to revolutionize health care and make high-quality medical treatment more accessible and affordable. While drone ambulances and 3D-printed donor organs may still be on the horizon, AI tools to detect strokes, diagnose diabetic retinopathy, and help identify wrist fractures are already here.
Some of the recent AI health care tools approved by the FDA this year:
Alert for a potential stroke. Clinical decision support software uses an artificial intelligence algorithm to analyze CT images of the brain for indicators associated with a stroke. Since faster treatment may lessen the progression of a stroke, a neurovascular specialist can be automatically notified if a suspected large vessel blockage has been identified during the same time the first-line provider is conducting a standard review of the images.
Detect certain diabetes-related eye problems. It’s the first medical device to use an artificial intelligence algorithm to detect diabetic retinopathy, an eye disease in adults who have diabetes, by analyzing images of the eye taken with a retinal camera. The technology can be used as a screening tool in a primary care doctor’s office, and if a positive result is detected, patients can be referred to an eye care provider for further evaluation and possible treatment.
Screen for wrist fractures. The FDA approved AI-based detection and diagnostic software that analyzes two-dimensional X-ray images for signs of a common type of wrist fracture and marks the location of the fracture on the image.
These tools were evaluated through the FDA’s De Novo premarket review regulatory pathway for some novel, low-to-moderate risk devices.
“The FDA is adapting our regulatory approach to digital health technologies to accommodate the highly iterative nature of these tools. Our aim is to make sure that safe and effective advances can be made available to patients more efficiently,” stated FDA Commissioner Scott Gottlieb, M.D.
Rapidly evolving AI technology that affects people’s health needs up-to-date guidelines, and the U.S. Food and Drug Administration is mandated to review the regulatory framework supporting digital health technologies. The FDA announced the agency is soliciting public feedback on benefits and risks associated with certain non-device medical software functions that are currently excluded from FDA regulation under the 21st Century Cures Act, including general wellness software products, electronic patient records, and more. Comments may be submitted to the public docket by June 28, 2018.
Remember, the FDA’s Mobile Health App Interactive Tool gives a snapshot view of laws and regulations that may apply if you’re developing a health app for mobile devices.