Liveblog Day 2: Congressional hearing on FDA regulating apps

By Brian Dolan

10:27AM: Bechtel from National Partnership for Women and Families up now. Touting the success of meaningful use and EHRs. Patients now expect health IT following the arc of adoption of EHRs among providers. Like Smith, Bechtel is reading her written testimony word for word. (Read it here, too.)


10:26AM: Smith closes with three suggestions right from his written testimony: Streamlined, predictable, transparent, risk-based regulation; A proactive regulatory and reimbursement stance on medical device interoperability; and Realistic and actionable policy to align stakeholder incentives.

10:23AM: Dr. Joe Smith from West Health up now. Says it is still undetermined if FDA is the right agency. Delays have left FDA in limbo as competent. Prospect of changing regulations to accommodate medical apps into existing regulations is daunting. Says regs need to keep up with pace of innovations and not the other way around. (Surprised to hear West's position is that FDA might not be the right agency for this.)


10:21AM: Onto the witnesses! Five minutes for opening remarks and the written testimonies will be entered into the record. Might cut down on witnesses reading the entire thing? Maybe not.

10:18AM: Rep. Waxman says we shouldn't regulate apps for EHRs as medical devices but apps that purport to diagnose skin cancer need to be regulated he said. If an app tells you not to worry about a mole, then it should be regulated. Waxman says his colleagues said Congress should act, but he said they have acted. Even if it is regulated as a medical device, Waxman says it will not be charged with the medical tax because he says that applies to very specific devices. He says don't be scared by the hyperbole from his Republican talking points which have been carefully orchestrated this week, he said.

10:15AM: Rep. Waxman said these hearings are just to scare people. Said that much of the discussion yesterday was full of partisan hyperbole. Spent far too much of yesterday's hearing discussing an imaginary tax on medical apps, which Waxman says will not apply to medical apps. He said this is a political talking point. Wants to discuss the committee's real accomplishments, which he says includes HITECH. HITECH resulted in an explosion in EHRs -- exactly what we wanted to see he said. EHRs are just like the construction of the interstate highway system, he said.


10:12AM: Rep. Blackburn is participating again today. Wonder how many others Reps are attending all the sessions? She's summing up yesterday's session. She said she believes it is up to Congress to decide what the FDA's role should be in light of the agreement among yesterday's witnesses who said uncertainty does exist about which apps are subject to regulation today.


10:10AM: Rep. Burgess says biggest impediment to innovation is the uncertainty of regulation, which will scare off investors. Says government should get out of the way and ensure responsible innovation occurs. Says this discussion about ideas that people haven't even had yet. Says lack of guidance is an indication of an inability of regulators to keep up.


10:05AM: And we are off! Rep. Pallone discussing the importance of the HITECH act and he says the risk of iPhones and Apple's manufacturing processes being subject to FDA oversight is "nonsense". Apps that make health-based claims need to be reviewed, he said.