Is Your Doctor Good at Statistical Analysis? Sure, Sure, Not to Worry
February 14, 2023
I spotted an interesting story titled “FDA Has Now Cleared More Than 500 Healthcare AI Algorithms.” The write up states:
There are now more than 520 marker-cleared artificial intelligence (AI) medical algorithms available in the United States, according to the U.S. Food and Drug Administration (FDA) as of January 2023. The vast majority of these are related to medical imaging.
Missing are Google’s method for solving death and the IBM Watson cancer solutions.
Another factoid in the article is that smart software in non-clinical areas are blooming. The niches with action are:
Population health
Health tracking apps
Identifying and addressing gaps in health equity
Revenue cycle management streamlining
Hospital-wide monitoring for length of stay, bed turn over rates, early sepsis detection and readmissions
Data analytics for key performance indicators
Enabling better patient wellness and preventative care
The item I found intriguing is:
When reviewing AI products, the FDA’s Center for Devices and Radiological Health (CDRH) is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while ensuring that the safety and effectiveness of the software as a medical device are maintained. Such a regulatory framework could enable the FDA and manufacturers to evaluate and monitor a software product from its premarket development to post-market performance. This approach could allow for the FDA’s regulatory oversight to embrace the iterative improvement power of AI and ML-based software as a medical device, while assuring patient safety.
The FDA does a superb job. It makes perfect sense that the government agency can embrace smart software. No problemo.
Stephen E Arnold, February 14, 2023
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