We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App




FDA to Establish Oversight Rules for AI in Medicine

By HospiMedica International staff writers
Posted on 17 Apr 2019
Print article
The US Food and Drug Administration (FDA; Silver Spring, MD, USA) is developing a framework for regulating artificial intelligence (AI) products used in medicine that continually adapt based on new data.

In a white paper published in March 2019, the FDA details the criteria the agency proposes for rules that will be used to determine when and if medical products that rely on AI will require FDA review before being commercialized. The FDA review may include examination of the underlying performance of a product’s algorithms, a manufacturer’s plan to make modifications, and the manufacturer’s ability to manage the risks associated with any modifications.

The FDA has already approved medical devices that rely on “locked algorithms,” which do not change each time they are used, but instead are changed by a manufacturer at intervals, using specific training data and a validation process to ensure proper functioning of the system. Among such devices approved during 2018 were a device that is used to detect degenerative diabetic retinopathy, and another one designed to alert providers of a potential stroke in patients.

According to the FDA, the proper performance of those locked algorithms, and others like them, is crucial to ensuring that doctors base life-and-death treatment decisions on accurate information. That task is harder for products that learn and evolve on their own, in ways that are difficult even for the manufacturers of such systems to understand. An example of such one system uses AI algorithms to identify breast cancer lesions on mammograms and learns to improve its confidence and identify new subgroups of cancer, based on its exposure to additional real world data.

“A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world. It would be a more tailored fit than our existing regulatory paradigm for software as a medical device,” explained FDA outgoing commissioner Scott Gottlieb, MD. “I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today.”

The FDA recently launched a fellowship program with Harvard University (Boston, MA, USA) on AI and machine learning, which is focused on designing, developing, and implementing algorithms for regulatory science applications. One such example is innovative clinical decision support software that uses AI algorithms to help alert neurovascular specialists of brain deterioration.

Related Links:
US Food and Drug Administration

Gold Member
POC Blood Gas Analyzer
Stat Profile Prime Plus
Gold Member
Real-Time Diagnostics Onscreen Viewer
GEMweb Live
Silver Member
Wireless Mobile ECG Recorder
NR-1207-3/NR-1207-E
New
Vital Signs Monitor
Aurus 10

Print article

Channels

Critical Care

view channel
Image: Researchers have developed an advanced shear-thinning hydrogel for aneurysm repair (Photo courtesy of TIBI)

New Hydrogel Features Enhanced Capabilities for Treating Aneurysms and Halting Progression

Aneurysms can develop in blood vessels in different body areas, often as a result of atherosclerosis, infections, inflammatory diseases, and other risk factors. These conditions lead to chronic inflammation,... Read more

Surgical Techniques

view channel
Image: The living replacement knee will be tested in clinical trials within five years (Photo courtesy of ARPA-H)

Living Knee Replacement to Revolutionize Osteoarthritis Treatment

Osteoarthritis is the most prevalent type of arthritis, characterized by the progressive deterioration of cartilage, or the protective tissue covering the bone ends, resulting in pain, stiffness, and impaired... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.