February 1, 2018
The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process....
January 26, 2015
HHS' Office of Civil Rights, which oversees the administration of HIPAA, will begin working closely with mobile health companies to make sure HIPAA rules are clear and unambiguous, according to a letter HHS sent to Representatives Peter DeFazio (D-OR) and Tom Marino (R-PA) in November.
The letter, signed by HHS Secretary Sylvia Burwell, was sent in response to a request Marino and DeFazio sent in...
September 19, 2014
Rep. Tom Marino (R-PA) and Rep. Peter Defazio (D-OR) sent a letter to US Secretary of Health and Human Services (HHS) Sylvia Burwell asking her to help make HIPAA regulatory guidance clearer for app developers.
The congressmen wrote the letter a few days after ACT — The App Association and a number of its mobile health company members sent a letter to Marino encouraging him to do so.
September 15, 2014
This morning ACT -- The App Association and a number of its mobile health company members sent a letter to Rep. Tom Marino (R-PA) to encourage Congress to push HHS to make HIPAA regulations clearer for mobile app developers.
"We see a huge chunk of our membership engaged on both fitness and the more health-specific side," ACT's Executive Director Morgan Reed told MobiHealthNews in an interview. "...