health IT regulation

FDA proposes to deregulate some digital health software

By Brian Dolan 06:15 am June 24, 2014

On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that these types of devices are so low risk that they won't be regulating them at all. Examples of health software platforms that have class 1 medical device clearance as an MDDS includes Validic's...

8 types of medical apps a Senate bill asks FDA to stop regulating

By Brian Dolan 07:35 am February 12, 2014

Image from the office of Senator Deb Fischer (R-Neb.) Longtime MobiHealthNews columnist Bradley Merrill Thompson, a member of the lawfirm Epstein, Becker & Green, and one of the founders of the mHealth Regulatory Coalition and the CDS Regulatory Coalition, sent over a few examples of the types of apps that a bill in Congress, called the PROTECT Act, would instruct the FDA to stop...