for IT designs for use in hazardous settings. It is not surprising that such events are now being discovered in health IT. What is surprising is that those creating and promoting these large systems have neither anticipated them nor looked for them. The development of health IT is marked by an optimism about the effects of IT that are unwarranted and naive. And the willingness to embrace this optimism to the extent of making large-scale investments in these systems and only later asking what their impact might be on patient safety borders on recklessness.

Mounting an effort to bring device regulation to health IT will be challenging and demands both added resources and new methodologies for FDA. It is clear from a recent IOM report (IOM, 2011) that medical device regulation itself will benefit from careful review and revision. But make no mistake: health IT is a medical device. It should be regulated as a medical device now and should have been regulated as a medical device in the past.


IOM (Institute of Medicine). 1999. To err is human: Building a safer health system. Washington, DC: National Academy Press.

IOM. 2011. Medical devices and the public’s health: The FDA 510(k) clearance process at 35 years. Washington, DC: The National Academies Press.

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