Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor removal accuracy.
University of North Carolina Health CareAug 26 2024 Artificial intelligence has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor removal accuracy. Despite their potential benefit to doctors and patients alike, these tools have been met with skepticism because of patient privacy concerns, the possibility of bias, and device accuracy.
Although AI device manufacturers boast of the credibility of their technology with FDA authorization, clearance does not mean that the devices have been properly evaluated for clinical effectiveness using real patient data. With these findings, we hope to encourage the FDA and industry to boost the credibility of device authorization by conducting clinical validation studies on these technologies and making the results of such studies publicly available.
"A lot of the devices that came out after 2016 were created new, or maybe they were similar to a product that already was on the market," said Henderson. "Using these hundreds of devices in this database, we wanted to determine what it really means for an AI medical device to be FDA-authorized." Types of clinical validation and a new standard In the realm of clinical validation, there are three different methods by which researchers and device manufacturers validate the accuracy of their technologies: retrospective validation, prospective validation, and subset of prospective validation called randomized controlled trials.
Because retrospective studies, prospective studies, and randomized controlled trials produce various levels of scientific evidence, the researchers involved in the study recommend that the FDA and device manufactures should clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.
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