IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year
This article was originally published in The Gray Sheet
Centralized institutional review board approvals for device trials, and removal of HIPAA privacy provisions that block registry data-sharing are among the ideas that are likely to make it into a draft bill planned for release in January as the next step in the House’s 21st Century Cures initiative.
You may also be interested in...
For the 2015-2016 congressional campaign election cycle, House and Senate party leaders, as well as incumbents sponsoring industry-supported bills, are attracting significant donations. But one of industry's own, former St Jude Medical employee Angie Craig, is making a run as a Democrat for a House seat in Minnesota's 2nd congressional district. She has received the most donations from industry, in particular from her former St Jude colleagues, campaign funding data compiled by The Gray Sheet shows.
The targeted FDA Device Accountability Act mirrors select device sections of the House 21st Century Cures legislation seeking to strengthen the use of "least-burdensome" provisions, allow use of centralized IRBs for device trials and refining standards for diagnostic CLIA waivers.
A review of the medical device trade group's “Innovation Agenda” for the coming year and the recent 21st Century Cures proposal in Congress suggests a supportive environment for the association's priorities.