Wednesday, February 26, 2014

A Gentle Reminder to Dan Haley of Athenahealth on FDA and Software Updates

I noticed an article in the Boston Globe about an attempt to remove safety checks on certain medical device software.

"The industry asserts that excessive regulation of software changes, for instance, could hinder the continuous software updates that are required to fix bugs."

I'd like to share with Mr. Haley my now classic one page guidance document on FDA and software updates.

"'That would essentially kill the way we do business and kill our ability to continually improve our product for doctors and patients,' said Haley of Athenahealth."

Shouldn't the dialog instead focus finding methods to not kill patients with unsafe software as recommended by the Institute of Medicine?

1 comment:

  1. Yes indeed, interesting choice of words from a man who supposedly has the best health interests of his patients at heart.

    I didn't check his pedigree, but I'll bet anything that he's a businessman, not a physician or engineer.


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