Former FDA Commissioner Scott Gottlieb:
Artificial intelligence has the potential to help solve some of the most frustrating problems in health care. Clinicians may use it to stratify patients more precisely according to their personal risk and to identify increasingly tailored treatments that simultaneously account for a patient’s clinical history, genomic profile, and phenotypic characteristics. The combination of statistics and weighted observations in a neural network can be highly predictive. This is true even though each output for an individual patient is likely to differ from any other patient in a validation model, and even though the variables, when taken individually, are not likely to be nearly as predictive.
Gottlieb says the FDA is completely unprepared to deal with these developments. What he doesn’t consider: Maybe we don’t need the FDA.