Rx for Apps

November 18, 2013

Jeffrey Nicholas was quoted in the NJBiz article "Rx for Apps." While the full text can be found in the November 18, 2013, issue of NJBiz, a synopsis is noted below.

The Food and Drug Administration (FDA) issued some basic regulatory guidelines regarding mobile medical apps in September, bringing some resolution to a hot-button issue more than two years after its investigation began.

According to Jeffrey Nicholas, some ambiguity remains involving clinical decision support apps, which can be used by patients and clinicians to support medical decisions.

“If it’s unclear as to what’s covered, investors may balk at providing capital until this is cleared up,” Nicholas said. “There are procedures in place to have that dialogue with the FDA.”

“Even though the final guidance isn’t perfect, it’s better to have some guidance than no guidance,” Nicholas said. “There are some unanswered questions that commentators on the law have brought up, but these guidelines have narrowed the scope of ambiguity. There are fewer unanswered questions than there used to be.”

“People can live and work and run their companies within this guidance,” Nicholas said. “There’s comfort knowing the rules of the road have been issued.”