Another proposal to overhaul health information technology regulation is surfacing in Congress, this one with a powerful Republican name attached to it, that of incoming Senate Finance Chairman Orrin Hatch. While vague on specifics, the measure marks the third recent attempt by Congress to craft a measure in answer to criticism that the current federal regulatory structure is hindering healthcare technology innovation.
The latest bill, called the MEDTECH Act, is co-sponsored by Hatch (R-Utah), and Sen. Michael Bennet (D-Colo.). Whether they plan to introduce it in the current lame-duck session or await the new session in January is unclear.
The measure proposes changing the definition of devices in the Federal Food, Drug and Cosmetic Act to exempt electronic health records and clinical-decision support (CDS) software from Food and Drug Administration oversight.
The first effect would be to remove such products from the scope of the medical device tax.
The measure would also keep the clinical-decision support software that is currently in class II and III categories under FDA authority, as well as software that is a component of or an accessory to a regulated device. The rest of the EHR and CDS category would be cut free from the device definition, but it's not clear what, if any, regulatory home they would find, and whether they would still be subject to FDA requirements like adverse event reporting.
For EHRs, the proposed act states that software should be “validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.” It's unclear how that would fit in with the existing EHR certification program run by the Office of the National Coordinator for Health IT.
Currently, the FDA can regulate many types of software. But the agency is using its enforcement discretionary power to waive regulation for many parts of the sector. The FDA, ONC and Federal Communications Commission issued a draft framework earlier this year that provided a primer for the three agencies to divide regulation among them.
In reaction to the Hatch bill, Athenahealth's Vice President of Government and Regulatory Affairs Dan Haley said, “We are pleased with any effort to rationalize the oversight framework for health IT to protect patients while encouraging continued innovation. We're very happy that two influential Senators are engaged on this issue.” Athenahealth, a cloud-based EHR company, has been a consistent supporter of health IT regulatory change.
The measure also received a preliminary thumbs-up from Epstein Becker & Green lawyer Bradley Merrill Thompson. Thompson, who served on a workgroup advising the FDA, ONC and FCC on the proper scope of health IT regulation, has been a critic of previous legislative efforts to overhaul health IT regulation.
“From what I understand of the Hatch/Bennett bill, they are doing a good job of defining software that simply doesn't merit FDA oversight,” he said.
Hatch and Bennet's offices, as well as Senate Finance Committee staff, did not respond to requests for comment.
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