Dive Brief:
- A draft bill backed by two senators would exempt most EHRs and all clinical decision support software from FDA supervision.
- The proposal would change the definition of medical devices in the Food, Drug and Cosmetic Act to exempt EHRs (but not diagnostic imaging data) from agency review as long as the software was approved prior to marketing.
- The measure would also exempt most clinical decision support software from FDA oversight, as well as software used to organize and present clinical lab test data and lab test report findings.
Dive Insight:
EHR vendors, not surprisingly, like the idea of facing less agency scrutiny. For example, vendor athenahealth's vice president of government and regulatory affairs, Dan Haley, said that any attempt to "rationalize the oversight framework for health IT" would probably be beneficial. His peers are likely to feel the same way. After all, federal regulation inevitably adds costs to the R&D process and extends the timeline for rolling out products.
Still, even if the bill becomes law and liberalizes EHR regulation a bit, it leaves some oversight mechanisms in place nonetheless. For example, the measure would still allow the FDA to continue its oversight of software associated with medical devices of medium or high risk, and it's not at all clear how EHRs fit into that picture. Besides, there's no guarantee that the senators actually plan to file the bill, notes Politico.