mHealth Coalition Counters Blackburn Push Against Health IT Regs
This article was originally published in The Gray Sheet
Executive Summary
Responding to the push for deregulation of health information technology, the mHealth Regulatory Coalition plans to circulate its own vision for regulating the sector, and emphasizes that it is not the right time for legislation.
You may also be interested in...
Representatives Grill Shuren, Advance SOFTWARE Act
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.
Health IT Workgroup’s Final Regulatory Recommendations Approved
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.
Lack Of Industry Involvement In Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.