Liveblog Day 2: Congressional hearing on FDA regulating apps

By Brian Dolan

11:51AM: Rep. Gingrey asks if mobile medical apps have changed healthcare already. Smith says he believes they are a game change but the real impact is to come and basically requires the system change first. The other panelists all agreed.

11:49AM: Rep. Ellmers asks Mitus why doctors are not being paid to talk to each other. Mitus says because they are not paid for care coordination under the current fee-for-service model. Then Ellmers asks about CommonWell (the recently created non-profit McKesson/Cerner and others launched at HIMSS) and Mitus explains it and how it is designed to help solve the problem of moving data between different sites of care.

11:45AM: Following comments from Bechtel and Smith about the important of health IT, Rep. Ellmers making some remarks. She says she is pointing out that health IT is not the "nirvana" some of the witnesses make it out to be. She says adoption is occurring because of the mandate in ObamaCare. Health IT's importance should be duly noted she said but so should the significant costs that physicians, which she describes as small business owners, are incurring because of the mandates. She asks Bechtel to acknowledge that it is in fact a mandate. Bechtel says absolutely. Ellmers then asks about patients being able to download their health information. Ellmers says the topic today is focused on FDA regulating these apps and how the medical device tax is going to keep people from innovating. Then she asks Bechtel what the timeline is for making health information available to patients. Bechtel says VA can do it now as can some others, now discussing the Direct Protocol to help physicians and patients talk to each other.

11:40AM: Rep. Sarbanes is citing NIH's Francis Collins column over at ScientificAmerican which he notes mentions WellDoc's efficacy data. (Read it here).

11:35AM: Smith says we are here in part today because the draft guidance from mid 2011 still has not been updated with final guidance. He said it is slow for those already engaged with FDA on regulating apps, but perhaps even more so for those who are waiting for clarity. Bialick says the experience of the medical app develop is critical for this discussion today.

11:31AM: Mitus responds that if the app is actually health IT software that is being used by a provider as an intermediary it should not be regulated by the FDA.

11:29AM: Rep. Green says regulations through FDA comes with challenges since it is far too slow to clear devices. Green worries about stifling innovation. Had the recent mishap with Apple Maps affected a glucose monitoring app there could have been serious consequences he says. He asks Mitus: What ways can FDA regulate mobile medical apps without slowing regulation?


11:28AM: Bialick says the threshold for a blockbuster app is now millions of dollars. Rep. Griffith: FDA is risk-averse or that they won't approve something even if there is any level of risk.

11:27AM: Feed is terrible now. Hard to make out what is being said.