Artificial intelligence (AI) is all the rage in many aspects of our lives, from student writing to new fashion designs. Its use in medicine allows physicians and other trained medical professionals to make more timely and accurate diagnoses, from patient triage to detecting abnormalities during diagnostic procedures, and guide effective treatment plans. is now possible. For example, it is particularly good at analyzing X-rays and has been used in medical imaging for many years, leading to increased accuracy and improved patient outcomes.
However, when using AI in highly regulated fields such as medical imaging, and in other unregulated technologies such as ChatGPT, other recent open AI models, or other services that do not involve medical professionals. There is a big difference between using AI in your applications.
Therefore, public policy should not paint all AI applications with the same broad brush. Congress should recognize and leave alone the regulatory oversight that is working well to balance safety, security, and innovation, and instead allows AI applications to create new and unmitigated risks. Emphasis should be placed on providing the necessary oversight in cases where
Radiologists and other trained healthcare providers use advanced AI-enabled medical imaging devices to quickly analyze vast amounts of data, more effectively detect abnormalities, and identify complex patterns. interpret and support decision-making for patients. The idea that “AI will replace radiologists” is a myth. In fact, radiologists leveraging regulated AI applications are transforming radiology, leveraging this technology to simplify their work and improve patient care and outcomes.
For example, during my last colonoscopy, the gastroenterologist used a new AI tool called GI Genius to identify abnormalities in the colon, such as polyps and adenomas (precancerous lesions), in real time. Detected. The FDA approved it in 2021 based on a study of 700 subjects who underwent colonoscopies for colorectal cancer screening. Colonoscopy combined with GI Genius identified laboratory-confirmed adenomas or carcinomas in 55.1 percent of patients compared to 42.0 percent of patients who underwent standard colonoscopy. Ta.
My gastroenterologist occasionally finds polyps that GI Genius missed, and vice versa, and as more colonoscopy cases are entered into its database, this module gets smarter. I said it’s now more accurate.
A tool like this is beneficial to everyone.
The Food and Drug Administration (FDA) has long exercised regulatory authority over AI medical imaging devices to ensure that they comply with the same rigorous and stringent level of regulation as the rest of the medical device industry. Ta. FDA oversight of AI medical imaging devices includes a premarket review process to assess safety and effectiveness, as well as robust postmarket monitoring to ensure the continued performance of the device once it is approved for use. Both are included. Prior to approval, all AI medical imaging devices must be reviewed by the FDA for safety and effectiveness, and the FDA’s strict labeling requirements ensure proper use by providing detailed information to intended users. Helps ensure. Manufacturers of AI-enabled medical imaging devices must also maintain quality control systems that meet FDA requirements.
The FDA has approved more than 500 AI medical imaging devices to date, revolutionizing clinical radiology and significantly improving patient care and outcomes. Based on his 15 years at the FDA and an additional 30 years in research, I have confidence in FDA’s ability to continue to play a strong regulatory role in overseeing AI in healthcare and medical imaging.
As policy debates over the regulation of AI continue in Washington, it is important that policymakers clearly distinguish between the regulated use of AI in medical imaging and other AI applications that may or may not require regulatory guardrails. is important. Adding additional regulations to the use of AI in medical imaging and healthcare, where effective regulations already exist, risks slowing innovation and compromising patient care.
The FDA has done an exemplary job regulating the application of AI in medical imaging, carefully balancing the need for innovation with oversight to provide safety and improved care for patients. The FDA should continue to assume oversight responsibility for AI in medical imaging while Congress, regulators, and product developers in other industries address various regulatory concerns in other forms and applications of AI.
Henry I. Miller is a physician, molecular biologist, and Glenn Swogger Distinguished Fellow. American Council on Science and Health. He was the founding director of his FDA Office of Biotechnology. Find Dr. Miller with X @HenryIMiller
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