HELP — LET’S GET READY TO INNNOVATTTEEE: The Senate HELP Committee’s Innovate markup is occurring today. Can’t you feel the excitement? We certainly can.
Health IT folk should have both eyes peeled on the bill: one eye on the modified MEDTECH Act, which includes provisions allowing FDA to regain jurisdiction over risky software; the other eye on Senate Dems’ more general amendments to the bill.
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The amendments require HHS and FDA to create a post-market surveillance system to track device safety, and ask the agency to rely on data from CMS and the VA, as well as FDA’s Unique Device Identifier system.
Some groups got their reactions in early. Here they are:
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National Center for Health Research: we don’t like this!: The National Center for Health Research, a consumer rights-oriented policy shop, is concerned that the bill will endanger patient safety by reducing FDA oversight. Center president Diana Zuckerman presented that case in a briefing to Senate Democrats Friday, saying there were 600 health IT-related recalls in the past five years.
But those recalls include software errors in physical devices as well as standalone software. The bill, however, is focused on standalone software, and the status of software-enabled devices likely wouldn’t be affected by the bill. (Zuckerman says the research, first conducted as the 21st Century Cures process took shape, cast a wide net because the law is vague.)
Moreover, she argues that the bill would deprive FDA of data on software. Because the bill excludes software from the definition of the word “device,” she said, adverse event data would no longer get sent to the agency’s device database, MAUDE, thereby weakening surveillance capabilities.
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