If a California congressman (who ironically represents a district in California’s Silicon Valley) gets his proposed bill passed, there will be a special Office of Mobile Health at the FDA. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would provide recommendations on mobile health app issues and a mobile health developer support program at HHS to help app developers comply with US patient privacy regulations (HIPAA). Rep. Mike Honda believes that FDA’s long, winding and foggy road to approval is just another hurdle to entry for startups. He does have a point–only a few apps have made it through FDA gridlock–but somehow there are already 40,000 health, wellness and fitness apps out there, outrunning the FDA wherever they can. And the road is long for HIMTA too–a lame-duck Congress and the long and winding road from House to Senate to conference committee to signature to implementation. Lawmaker Pitches New FDA Office Of Mobile Health (Kaiser Health News)
Some suggestions for Rep. Honda to ‘think different’:
- Perhaps Rep. Honda ought to have a talk with the Happtique panel developing certification guidelines by end of this year first [TA 18 Sep], and try to incorporate them into his legislation–or get FDA to empower these guidelines as ‘first review’ on operability, privacy, security, and content.
- Or maybe a joint FDA-FCC Office of Mobile Health, as the FCC is quite determined to serve itself a heaping helping of the mHealth casserole based on the recommendations of their mHealth Task Force: a new director of healthcare plus five goals starting with ‘FCC should continue to play a leadership role in advancing mobile health adoption.’ Once again we have the time and money-wasting spectacle of two Federal agencies going on different, uncoordinated trajectories, for what they claim is the same cause. Pass the painkillers. FCC to hire healthcare director, step up health efforts (Mobihealthnews)