Wearables, apps won't face FDA scrutiny

Wearables, apps won't face FDA scrutiny-fiercehealthcare: General wellness apps and devices won’t face tough FDA scrutiny, as long as they only promote general wellness and present a low risk to the safety of those who use them.

Updated SOFTWARE Act: Still Too Ambiguous For Industry?

Updated SOFTWARE Act: Still Too Ambiguous For Industry?-thegraysheet: While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.

Draft Bill Shows Congress' Struggle To Define FDA's Role In Medical Software

Draft Bill Shows Congress' Struggle To Define FDA's Role In Medical Software-insidehealthpolicy: A discussion draft of Rep. Marsha Blackburn's (R-TN) planned bipartisan bill attempts to draw a sharp line between “medical” software that would fall under FDA's jurisdiction and “health” that would not, but lawmakers are still grappling with how to ensure that software intended to be regulated is not accidentally exempted