Healthcare Economist September 27, 2019
FDA faces an near existential crisis: digital. New digital technologies have the capability to improve the way care is delivered to patients. The question is, how do we make sure it is safe? The FDA is certainly good at making sure drugs and devices are safe; in the case of digital however, it is less clear how they should be regulated. Do updates to software to improve run time need to be reviewed? What about changes to user interfaces? Or fundamental changes to underlying algorithms.
If the FDA does not provide oversight, unsafe products will come to market. However, providing too much oversight may decrease innovation as the cost to bring products to market may rise dramatically.
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