Health IT Reg Bill Sparks Debate; AdvaMed Tries To Address “Technical Concerns”
This article was originally published in The Gray Sheet
The PROTECT Act, introduced by Sens. Fischer, R-Neb., and King, I-Maine, earlier this month to restrict FDA oversight of software tools has already triggered some high-profile discussion, with a USA Today op-ed from sponsors and an opposition letter from consumer groups. AdvaMed, meanwhile, is playing more of a behind-the-scene role.
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The PROTECT Act, which attempts to respond to some criticisms of the House SOFTWARE Act, aims to restrict FDA’s oversight of health information technology. It is backed by IBM and Verizon, among others.
Tennessee Republican Rep. Marsha Blackburn’s SOFTWARE Act advanced to the Health Subcommittee of the House Energy & Commerce Committee Nov. 19, where representatives grilled CDRH Director Jeffrey Shuren on health information technology regulation.
The final recommendations from the FDASIA workgroup urge the government to focus regulatory attention on the highest risk products, while minimizing requirements for the large swath of health IT offerings that are lower risk. The recommendations, which largely align with a prior draft version, will inform a health IT regulatory framework proposal due to Congress in January.