Iowa Senator Charles Grassley has asked federal officials for their views on regulating and overseeing the safety of health IT products, and has suggested a role for the Food and Drug Administration in that process.
“As I stated in recent questions to you, I strongly agree that HIT has the potential to prevent medical errors and increase the efficiency and effectiveness of health care delivery, thereby improving the safety and quality of care,” Grassley noted in a Feb. 24 letter to Health and Human Services Secretary Kathleen Sebelius. “However, I have also been surprised by the lack of discussion about patient safety concerns when, for example, HIT products are not functioning properly or when they are being used incorrectly.”
He went on to ask “Do you believe it is time to revisit FDA’s responsibilities in regulating HIT products being used in clinical care?”
Grassley, the ranking Republican on the Senate Finance Committee, has previous asked health IT vendors and healthcare delivery systems to describe their processes for handling software problems or complaints about flawed software.
This article in Health Data Management describes Grassley’s queries.
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