Republican House members are pushing the Food and Drug Administration and Federal Communications Commission to smooth some of the regulatory bumps in the road for mobile medical apps, according to a letter sent to the two agencies last week.
The authors point out that the number of health-related apps at the iTunes App store alone grew by 250 percent from 2010 to 2011. With that pace of growth, legislators say they're 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," and allow healthcare providers to reduce costs.
"It is 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 said.
Legislators are calling the FDA and FCC to account, asking them to clarify:
- 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.
Decision support, in particular, has been a big challenge for the FDA with regard to regulation, according to an article in Politico. FDA Policy Adviser Bakul Patel told the publication that the increasing maturity of products continues to raise new questions.
M. Elizabeth Bierman, an attorney with the FDA/Healthcare based faction of Washington, D.C.-based law firm Morgan Lewis & Bockius, added that decision support struggles are nothing new.
"FDA has been struggling with how to handle clinical decision support systems for decades," Bierman told Politico.
The six Republican House members signed onto the letter include Marsha Blackburn (Tenn.), Joseph Pitts (Penn.), Greg Walden (Ore.), Brian Bilbray (Calif.), Michael Burgess (Texas), and Phil Gingrey (Ga.). Interestingly, two of the authors are physicians--Reps. Burgess and Gingrey.