We are live blogging old school today: Hit the refresh button every few minutes for updates! (Liveblogging is now concluded!)
10:26AM: The hearing is now adjourned! Apparently they cut it short to vote.
10:25AM: Final question goes to Mostashari from Burgess around why the ONC doesn't just make interoperability happen.
10:23AM: Rep Griffith is now asking about the diagnostic device that was recently in the news that uses a smartphone to detect parasites in children. Griffith says if you regulate it how much would this $8 device cost after it was regulated? Foreman says the FDA is not in the business of pricing medical devices.
10:21AM: Rep. Griffith is now up after a lengthy EHR discussion between Tonko and Mostashari. Griffith asks Foreman if the FDA has talked to the IRS about the medical device tax in relation to medical apps. Foreman says it sent the IRS some ideas about that, Griffith asked for a copy of that letter. Griffith asks that while FDA has no plans to regulate the apps and devices that Rep. Waxman asked about, might it change its mind in the future? Foreman says only if those examples become medical devices or are causing some kind of safety risk.
10:15AM: Rep. Tonko is now asking Mostashari about medical software around billing and fraud. Mostashari is discussing how EHR and related software can help the feds police fraud better.
10:14AM: Rep. Long now asking Foreman about REMS guidance, which Foreman says is not under her purview. Long had a question about how that might apply to apps that help people with prescription refills.
10:13AM: Rep. Butterfield asks how will FDA keep up? Foreman says we will focus as we said. We get about 20 a year right now. That is 0.5 percent of the medical devices we get in our 510(k) process each year. (Really interesting statistic!)
10:08AM: Rep. Butterfield says we have learned that FDA plans to regulate only a small subset of mobile medical apps, as described in the draft guidance. He's explaining the three classes of FDA regulated medical devices. Foreman is now explaining the different classes. She says they have not yet encountered a Class III mobile medical device. Rep. Butterfield asks Foreman which class will most mobile medical devices fall under? She says Class 1 or Class 2.
10:04AM: Rep. Ellmers asked Mostashari about the benefits of EHRs apparently. Mostashari now citing some data about EHR adoption and engagement. Ellmers is now pushing back on interoperability between these systems (still hard to hear her since her mic is off).
10:02AM: Rep. Waxman said he's not going to ask his last question on advise from his staff. Now Rep. Ellmers is up and her mic is apparently off.
10:00AM: Now Rep. Waxman asking about medical device. Foreman says FDA is a public health agency not a tax agency. Questions are better directed to IRS, she said. Her guess is no though. She says consumer mobile devices would not be regulated as medical devices so they would not be subject to the medical device tax either -- but she once again deferred to IRS. Waxman also asked about the retail exemption, and she said, her understanding is that would mean it would not apply, too. Waxman says let's put this myth to rest then.
9:58AM: Back to Rep. Waxman who wants to focus on FDA regulation again. He says past few days made it seem like FDA intended to regulate anything and everything. Is now asking about particular examples that have come up in past few days. Mobile devices in general? iPhone, iPad, BlackBerry, PDAs? Entire mobile network? Each new mobile device released on the market? All health IT? An iPad to help track the number of steps tracked a day? App to remind one to refill a prescription? App to help MD search a medical textbook? App to help patients search drugs and medical records of their babies? Foreman says "no" to each of those questions.
9:58AM: Rep. Bill Johnson now wants to know how many physicians were involved in the ONC's development of a roadmap for health IT (MU). Mostashari didn't have time to respond.
9:53AM: Sound just cut out here as Rep. Bill Johnson began talking... and we are back... Mostashari responds to Johnson's question, which we didn't hear. Rep. Johnson says just because something can be automated, doesn't mean it should be. Johnson's mic is not working very well. Now Mostashari is explaining the different stages of Meaningful Use, but Johnson cut him off. Johnson discussing difference between data and information. Not discussing regulation of FDA apps, more focused on MU framework and related patient safety issues.
9:51AM: DeGette: How is FDA eliminating uncertainty for investors and others? Foreman says final guidance will do that. DeGette asks how long it takes for mobile medical apps to get clearance? Foreman says it takes about 67 days on average for mobile medical apps to get FDA clearance through the 510(k) clearance.
9:50AM: Rep. DeGette cites Qualcomm's Robert Jarrin as an industry witness earlier this week who said FDA has been working well with industry to ensure it does not over reach. Foreman agrees and says it is refining its regulatory approach rather than over reaching.
9:48AM: Rep. DeGette is up now. She says past hearings included claims and worries app developers are facing over regulation and potential medical device taxes on phones. Is it within FDA's jurisdiction to regulate mobile medical apps? Foreman says yes it is. Some examples that FDA is trying to regulate? Foreman says it has been regulating apps for a decade. Apps that translate heart rate, SpO2, ultrasound technology that allows transducers to plug into an iPhone. Why regulate those types of technology? Foreman says those types present patient risk. DeGette asks if it is about how it is used or how it is intended? Foreman says exactly. Foreman says first clearance of a mobile medical app goes back to 1997. Which apps will the FDA not regulate? Foreman says an e-version of a textbook. If risk is low, FDA would rather focus on higher risk ones. Pedometers, for example, will not be regulated.
9:46AM: Mostashari says best thing to do for patient safety in general is to "get off of paper". He cites CPOE and eRx as ways to get aware from handwriting issues.
9:44AM: Burgess asks Mostashari about randomized control trials for EHRs. Were those studies ever done he asked? Mostashari says RCTs might not lend themselves to measuring health IT's ability to improve quality, efficiency, and safety.
9:43AM: Burgess asks if the guidance document is binding or if the FDA can deviate from it. Foreman says it is not binding.
9:42AM: Foreman says the final guidance will come out in the coming months and is a priority for the agency. Rep. Burgess asks if she means fiscal or calendar year? Foreman says fiscal year.
9:41AM: Rep. Burgess asks if the FDA's final guidance will say that it won't regulate consumer devices like smartphones or tablets. FDA's Foreman says it does not plan to change its stance on that in the final guidance. Burgess says that kind of uncertainty is the problem.
9:40AM: Stop the clock! Some representatives disagree with the rules Burgess just laid out -- answers don't have to be "direct" as a rule. Burgess admits that's not a rule and says take it as a suggestion. (Whoa!)
9:39AM: Onto the questions. Rep. Burgess says he wants to stress that the witnesses answer in as direct a manner as possible.
9:38AM: Mostashari now discussing the FDASIA working group that ONC convened. Now reviewing nominations for that committee. The written testimonies stress that FDA, ONC, and FCC are reviewing those nominations.
9:36AM: Mostashari says mobile apps can help patients be more engaged. He says ONC has advised FDA on mobile medical app regulation where it relates to EHRs. FDA advised ONC on medical devices.
9:34AM: ONC's Dr. Mostashari is up now. Reading his testimony, which doesn't get into the FDA's role in regulating mobile medical apps too much. Mostly discussing EHR adoption and other ONC initiatives. Read the full testimony right here.
9:31AM: Foreman now sharing an overview of the FDA draft guidance. Specifically says it will not regulate consumer smartphones, tablets, app stores, companies that make or offer those services just because their devices or stores support mobile medical apps. She said FDA has been regulating mobile medical apps for decades. It has reviewed about 100 mobile medical apps, she said. (By our count it is about 80, wonder if the other 20 didn't get clearance?)
9:30AM: Curious to see how this being a hearing where the witnesses are under oath changes how open the discussion becomes following the written testimony readings.
9:29AM: FDA's Foreman is now up and reading her testimony. You can read the whole thing here, but we'll include a couple highlights, too.
9:28AM: Witnesses are now up. These hearings will be under oath and both said they will not be advised by counsel during this session. Now they are taking an oath. Different from hearings of past two days, which were not investigation hearings.
9:26AM: Rep. Waxman says these hearing are not a good use of time. He is now listing a series of hearings he wishes the committee would hold instead. Climate change hearings, for example. Waxman said these discussions amount to an inaccurate talking point over FDA over regulation and a non-existent iPhone tax.
9:23AM: Rep. Waxman says Republicans seek to find out if FDA is regulating with too heavy a hand and impeding innovation of mobile medical apps. Approving them too slowly. Waxman says this is not a new responsibility for FDA. It's been balancing innovation and patient safety for 100 years, he said. Waxman said from what he has heard in the past few days, there is little cause for concern. Anxiety over FDA regulation but no specific examples of over regulation yet, he said. On the tax issue, Waxman says the concern over the medical device tax applying to a consumer's iPhone is misplaced. Any cell phone bought at a retail store, he said, will not be taxed as a medical device.
9:19AM: Rep. Burgess now discussing that the uncertainty of pending regulations that is the real issue.
9:16AM: Rep. DeGette says we have already learned the the threat of an "iPhone tax" has been put to bed and that exercise apps are not going to be regulated. She also says we learned that the FDA will continue to regulate apps like blood glucose monitoring apps to ensure they do what they are supposed to do. DeGette says concerns about the FDA over-reaching are not new ones. The FDA addressed all of these concerns in a letter that was addressed to the committee yesterday.
9:14AM: Rep. DeGette now talking about EHR adoption rates. (Have to say the discussion of EHRs seems rather off-topic.) DeGette says FDA's role is kind of redundant since it is the third hearing.
9:12AM: Now Rep. Murray is talking about trouble with interoperability of health IT systems that physicians in his district have brought
9:11AM: Rep. Murray says the hearing is not about scaring people to think that the regulation is going to drive up the cost of their smartphone, but rather how it might affect the development of mobile medical apps. (Good to hear!)
9:08AM: And we are off! Rep. Murray is introducing the hearing. He's discussing the letter that the committee sent earlier this month. Murray says they are here to discuss the FDA's oversight. Where does an app that transmits photos of healing wounds or apps that let you review xrays or monitoring blood glucose levels or heart monitors or neurology tests -- the list goes on and on he said. Murray said the message from both sides of the aisle agree we need final guidance from the FDA and clarity on the medical device tax's applicability. (FDA testimony says they won't comment on that!)
9:05AM: Appear to be a few minutes late. This has been the trend for the past few days, too.
9:00AM: Today is the third and final congressional hearing on the FDA's role in regulating mobile medical apps. This one is convened by the subcommittee on Oversight and Investigations. It's the hearing we have all been waiting for -- the one where ONC and FDA take the mic. Here are today's witnesses and links to their written remarks, which they will likely read in full before the real action begins:
> Dr. Farzad Mostashari, National Coordinator, Health Information Technology, U.S. Department of Health and Human Services TESTIMONY
> Ms. Christy Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration TESTIMONY
