FDA Issues New Guidance For Use Of AI In Health Care
WASHINGTON — The U.S. Food and Drug Administration recently partnered with Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency to issue guiding principles to align efforts and standards for artificial intelligence and machine learning medical device development in health care.
“The FDA believes that artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day,” said Jim McKinney, public affairs specialist at the FDA, in an email to The Well News.
McKinney said the 10 guiding principles grew out of collaborative discussions with Health Canada and MHRA, and learning from several sectors that applied AI and ML technologies for years and have developed good practices that can be readily applied to the medical device industry.
Evidence from published information, expert and other public perspectives and review experience was used to develop the guiding principles that will be used by the agency to lay the foundation for the development of Good Machine Learning Practice, which will unify international efforts for medical device development.
Over the past decade the FDA has reviewed and authorized a growing number of devices legally marketed with machine learning and expects this trend to continue.
Special emphasis has been placed on promoting transparency of the devices’ functioning to users and to patients more broadly. Promoting transparency, according to McKinney, is a key aspect of a patient-centered approach.
In October, the agency held a virtual workshop to gather input from stakeholders and discuss how to achieve transparency for users of these devices, such as requiring the manufacturer to include labeling and public facing information of AI and ML-enabled medical devices.
“The FDA’s traditional paradigm of medical device regulation was not designed specifically for AI/ML technologies. Medical device software, including the subset of technologies that are enabled by AI/ML, have a lifecycle that lends itself to iterative development, and FDA is committed to developing innovative approaches to the regulation of these products,” said McKinney.
Innovating approaches to regulate these devices will also mean innovating training for the use of these devices among medical providers.
Prior to FDA releasing the guidance, a study was released by researchers from Florida Atlantic University showing a lack of AI and ML training offered in medical schools.
“It’s a big gap that needs to be filled. One of things we are looking at is hiring computer engineers who specialize in medical software in medical institutions to fill that gap,” said Joel Grunhut, one of the lead authors of the study, in a phone call with The Well News.
The study also found that few plans or implementations report on how to incorporate AI into the medical curriculum making it difficult for students to understand what a machine learning algorithm can and cannot do.
“If students are not made aware of the risks of what goes into the computational methods of AI, and if they are not made aware of how the algorithm may be built, or what to look for, then putting their full trust in [these devices]… that’s an open fallacy right there,” said Grunhut.
“Machine learning at this point in time, it’s a black box. We can’t tell you why certain decisions are made. So, students have to be made aware that there is always room for error. Just because something statistically is telling you something, doesn’t mean it is the right thing to do. So, there has to be talk about the ethics of AI in medical education,” said Grunhut.
Grunhut said such training could be incorporated into ethics lectures already happening in schools. He also is hopeful that if AI is incorporated with appropriate guidance it could reduce burdens on physicians and not create more.
“AI has the capability to bring back medicine as a whole. For the last half century the EMR has been creating this enormous workload on physicians, and physicians are getting more and more tasked with office work and things they don’t want to be doing … With advanced learning and artificial intelligence, we have this capability in the future for physicians to free up all this unnecessary work and spend more time with the patient,” said Grunhut.
“Can you imagine a patient coming in and there’s already an algorithm telling you what may be possible here and what is likely, and the physician can look at this and know what to ask to hone in on the diagnosis?” wondered Grunhut.
Alexa can be reached at firstname.lastname@example.org
In The News
WASHINGTON — AT&T and Verizon on Tuesday agreed to delay their rollout of new 5G services near some unspecified airports... Read More
WASHINGTON — AT&T and Verizon on Tuesday agreed to delay their rollout of new 5G services near some unspecified airports over ongoing concerns that moving those services to a new band could cause flight disruptions. Debate has been raging for months over whether — and if... Read More
When April Schneider's children returned to in-person classrooms this year, she thought they were leaving behind the struggles from more... Read More
When April Schneider's children returned to in-person classrooms this year, she thought they were leaving behind the struggles from more than a year of remote learning. No more problems with borrowed tablets. No more days of missed lessons because her kids couldn't connect to their virtual... Read More
SAN FRANCISCO — Former Twitter CEO Jack Dorsey on Wednesday announced the creation of a nonprofit legal defense fund geared... Read More
SAN FRANCISCO — Former Twitter CEO Jack Dorsey on Wednesday announced the creation of a nonprofit legal defense fund geared towards defending Bitcoin developers from litigation. Dorsey announced the fund in a mailing list for Bitcoin developers and said its purpose was to aid software developers... Read More
SAN ANTONIO — Twitter content curated by its personalization algorithms amplifies the mainstream political right more than the left, according... Read More
SAN ANTONIO — Twitter content curated by its personalization algorithms amplifies the mainstream political right more than the left, according to a joint study conducted by the platform’s transparency and accountability team. Researchers undertook a large-scale experiment that analyzed millions of Twitter users, political parties in... Read More
GREENBELT, Md. — NASA's James Webb Space Telescope successfully metamorphosed into its final and most critical stage after unfolding the... Read More
GREENBELT, Md. — NASA's James Webb Space Telescope successfully metamorphosed into its final and most critical stage after unfolding the last of its enormous golden mirrors in outer space on Saturday. The mission’s latest developments were shared with the world during NASA’s livestream of the mirror... Read More
WASHINGTON — A federal appeals court on Tuesday upheld a 2020 decision by the Federal Communications Commission to free up... Read More
WASHINGTON — A federal appeals court on Tuesday upheld a 2020 decision by the Federal Communications Commission to free up the 6 GHz band for next-generation Wi-Fi. Writing for the unanimous three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, Judge David Tatel... Read More