Some months ago, Sen. Charles Grassley (R-Iowa), who has been investigating the safety of health information technology, sent a letter to Health and Human Services Secretary Kathleen Sebelius asking for her views on whether the Food and Drug Administration should regulate health I.T. products.
Grassley wasn't coy. One of his questions was: "With over $20 billion in taxpayer money at stake and with increasing complexity in the technologies being used in our hospitals, do you believe it is time to revisit FDA's responsibilities in regulating HIT products being used in clinical care?"
So, it is notable that when given the chance to endorse FDA regulation of electronic health records, the HIT Policy Committee, a multi-stakeholder group of advisors to the Office of the National Coordinator for Health Information Technology, punted. The committee on April 21 issued a series of recommendations for increasing oversight of the safety of EHRs, but stopped short of endorsing regulation.
The recommendation they made was tepid at best: "We recommend that ONC work with the FDA and representatives of patient, clinician, vendor and health care organizations to determine the role that FDA should play to improve the safe use of Certified EHR Technology."
But the committee didn't punt on the issue of safety, calling for a national program to collect, investigate and disseminate reports of unsafe conditions caused by health I.T. systems. Members also recommended that ONC commission a formal study of I.T. patient safety issues and actions to address those issues.
Further, later stages of meaningful use criteria should require providers to report I.T.-related safety issues, with EHRs having a "feedback button" to make such reporting easy, according to the committee. Members also called on the HIT Standards Committee to consider requiring the use of audit trails or logs of interface transactions to ease finding the sources of safety issues.
Where Grassley goes with his investigation is tough to gauge. He's known for launching investigations and sending out lots of letters, but not following up. And he seems not to have principled political beliefs, preferring to let political leaders and prevailing winds dictate his positions. His ping-pong ball performance on health reform issues, particularly "death panels," was difficult to watch for anyone who cares about good governance.
But while Grassley decides whether or not to throw the gauntlet down on the issue of health I.T. safety, it looks like the HIT Policy Committee took a bigger step to do just that.
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