In a rather interesting move, it’s been revealed that Republican House members are urging both the FDA and FCC to move faster in approving mobile medical apps.
In a letter sent to both agencies last week, House members asked for easier regulatory hurdles facing mHealth app developers, in addition to helping speed up the process of getting new apps submitted, approved and available to users. The authors pointed out that the number of health-related apps for iOS alone grew by more than 250% from 2010 to 2011.
Looking at the growth, legislators are concerned that the “complex regulatory framework” between the various agencies could “inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care.”
In their letter, legislators asked the FDA and FCC to clarify the following:
- Spell out the specific wireless health initiatives underway at both agencies
- Identify how they’re coordinating mobile health clearance activity with ongoing EHR initiatives at the federal level — to ensure interoperability.
- Give a timeline for when the wireless “testbeds” that the agencies have promised will be ready, and how they’ll be used to promote interoperability.
- Detail how the FDA and FCC are coordinating their approval processes, to accommodate the ever-increasing number of wireless and mobile app clearance applications.
“It’s critical that the two agencies act in concert to provide regulatory predictability, consistency and swiftness so that needed innovation in wireless medical technology may thrive,” the authors noted in the letter.
