Should Watson, IBM’s artificial intelligence computer seen on Jeopardy, be classified as a medical device?
We should ask ourselves that question now, especially since your insurer might be using Watson to mine your electronic medical record to determine if your claim will be paid.
WellPoint, one of the nation’s largest insurers is joining forces with IBM to use Watson as a medical decision support tool:
The first Watson deployment would come early next year with WellPoint nurses who manage complex patient cases and review treatment requests from medical providers.
As such, shouldn’t such a computer program be subject to the same rigors as the medical device industry to achieve FDA clearance? Would regulators even be able to comprehend how Watson reaches it’s conclusions as it culls through "200 million pages of information in less than three seconds?"
Or will this device be grandfathered in under a 510K exemption? After all, it’s just a computer right? Seriously, what could go wrong with clinical decisions based on cold, hard, incomplete data sets that are extrapolated to patients?
Wait, I know!
It’s the Daily Double!