We are live blogging old school today: Hit the refresh button every few minutes for updates! (Live blog is now concluded.)
12:24PM: Rep. Ellmers very quickly concludes the hearing. That's a wrap! Next hearing is slated for tomorrow at 10AM ET.
12:22PM: Rep. Ellmers asks if medical device tax will hamper innovation. Thompson, Dagi, and Ford all said yes. Others said unclear. Rep. Ellmers says she is a nurse and understands the need for patient safety. She asks all panelists that if an app is regulated as a medical device by FDA should the medical device tax be applied? Thompson said his group opposes it being applied. Most said it was unclear. Ford said it was two totally different questions.
12:20PM: Rep. Ellmers asks Thompson how long it takes to secure 510(k) clearance. He says it depends but usually between 90 days and 1.5 years. (MobiHealthNews found average time for mobile medical apps clearance has historically been about 110 days).
12:18PM: Rep. Gardner says this is not clarity to him. Dagi says we do not have the necessary clarity. Jarrin says it depends. Gardner says if it depends then it is not clarity. Jarrin says there is insufficient clarity for low-risk medical devices. Spalter says clearly there is not sufficient clarity. This panel of expert witnesses is having trouble, imagine what the developers who are trying to dream up these innovations is going through. Let's put down on paper what needs to be understood and once we do the hockey stick of medical apps will go into the hundreds of thousands of medical apps.
12:17PM: Dagi nails it. Gives the CHF use case. Says a weight scale at an arcade is not a medical device.
12:15PM: Rep. Gardner asks if connected weight scales are going to be regulated as medical devices if they have Bluetooth. Jarrin says it depends. Jarrin says it's a scale so it depends if it is being marketed as a medical device. (Scales get FDA clearance when they use BIA for body fat composition or when used for congestive heart failure patients to determine if they have gained weight, an indication of fluid collecting in the heart.)
12:12PM: Rep. Shimkus says that as Dagi noted we should look at alternatives to FDA regulation. This is a concern that we are going to slow down mobile medical apps. He asks Dagi if he believes FDA is the right place. He says yes with right advisors, yes.
12:10PM: Rep. Shimkus says we have so many apps because there is no process to get it into market (Apple might disagree). Rep. Shimkus says the apps he has on his iPad are getting updates all the time. He wonders how regulated apps would work when it comes to updates. Rep. Shimkus claims that the hockey stick growth in apps is because they have grown in the absense of ObamaCare.
12:08PM: Rep. Shimkus wonders if chips in shoes can be regulated. Dagi says the chip might have multiple applications and the FDA traditionally regulates claims as well. If the chip is diagnosing a child (for some disease) as well as acting as a exercise tracking sensor in the shoe, it might get regulated. Shimkus interrupted Dagi because Lujan apparently wasn't paying attention to Dagi's answer.
12:08PM: Rep. Ellmers says the Ryan budget proposal does not call for that.
12:05PM: Rep. Lujan asks whether the Nike shoes that he just bought that have a chip in them to track his exercise might be subject to regulation by the FDA. Jarrin says there is no concern. Rep. Lujan agrees and says let's all put pressure on the FDA to get this document out. He says he agrees with the concerns of his Republican colleagues about the 2.3 percent medical tax, which is why he hopes they will join him in voting against Rep. Paul Ryan's budget proposal which he says relies heavily on that medical device tax to meet its revenue targets.
12:03PM: Rep. Lujan asks the entire witness panel if they agree that apps deserve varying level of scrutiny. They all agree they do. He then asks Thompson and Jarrin if there has been a slowdown in mobile health. Citing MobiHealthNews data Jarrin says there has been no slow down.
12:00PM: Rep. Latta asks Jarrin what it means to the industry if this delay causes some in mobile to work on other things outside of healthcare instead. Jarrin points to Vocel -- maker of the PillPhone app, which was one of the first consumer-facing apps to get FDA regulation. Vocel ended up spending hundreds of thousands of dollars to ensure that it fell under the FDA guidelines and it is still unclear if that was actually necessary. On the other hand, Vocel's product was likely better in the end as a result, Jarrin said.
11:59AM: Rep. Latta asks Dagi what the delay in FDA guidance might do to investments in this sector. Dagi says investors will invest elsewhere. Possibly offshore he said when prompted. Dagi thinks it is likely hundreds of millions of dollars but it's hard to guess at that number because it's unclear what a regulated mobile medical apps is.
11:56AM: Waxman asks Chodor if Happtique's process is a substitue. Chodor says absolutely not. Waxman asks Chodor if an unfettered market incentivizes patient safety or if the government needs to play a role. Chodor said it is a balance of the two.
11:55AM: Rep. Waxman cites the 500 new health apps a month -- up over 400 apps launching a month a few years ago -- as a sign of growth. Asks Thompson if FDA final guidance will even quicken it. Thompson says it likely will and that members of his coalition are not worried about over regulation from FDA.
11:52AM: Rep. Waxman is back from his other hearing. Says he believes the Republicans on this committee are mostly interested in the medical device tax. Wants to know if the witnesses believe there is a need for FDA oversight of any mobile medical apps. He says skin scan apps, if accurate, could save lives and money. On other hand, inaccurate apps could do just the opposite. Asks Chodor if FDA should be reviewing these through 510(k). Chodor says yes any app that makes a clinical decision should go through it. Thompson agrees and says the 80 apps that have gone through FDA deserved to go through it. Jarrin agrees. Spalter says he does agree, too. Also to keep eyes and minds focused on costs to developers and time it takes and importance to having a precedential document, finally, that ensures balance of patient privacy, security, and safety. Dagi agrees that there should be FDA regulation of these apps, too. Ford said she also believes there is a balance needed and depends on what claims app developers make.
11:50AM: Rep. Blackburn asks Jarrin and Thompson if Congress or FDA should set the path for regulation of IHS. Jarrin clarifies that she means that health IT systems including mobile medical apps. Jarrin says FDA is within it regulatory purview on this one. Thompson agrees and says he's optimistic but wants to see the final document first.
11:48AM: Rep. Blackburn then asks Chodor about ONC's National Patient Safety Plan and asks Chodor if a similar certification process through ONC would be better for mobile medical apps than FDA regulation. (MobiHealthNews predicted this line of questioning.)
11:47AM: Rep. Blackburn asks Dagi what the worst case scenario is of heavy-handed regulation. Blackburn sums up that the money will then find an easier path. No one wants to add to that.
11:41AM: Chodor says many of the innovators he talks to are waiting for final guidance before developing or launching anything.
11:39AM: Rep. Walden asks Qualcomm's Jarrin about the MobiHealthNews numbers. 80 apps have been cleared but something like 1,200 are in a regulatory grey zone. Does that concern you? Jarrin says it does. He believes the FDA needs to come out with final guidance immediately. Says FDA's Shuren has talked about the guidance document as a de-regulatory document.
11:38AM: Spalter says there is an impact and it might drive mobile innovators to concentrate on other opportunities instead of healthcare.
11:37AM: Dagi says the FDA oversight and more so the medical device tax is driving companies to develop and launch their medical devices in other markets instead. Rep. Walden asks: Would you say ObamaCare is driving these companies offshore? Dagi said he's not an expert on whether it is ObamaCare specifically.
11:33AM: Ford believes the draft guidance leaves the door wide open for the FDA to regulate smartphones or tablets as medical devices. Points to his written testimony for an explanation on that claim. (Linked below at the beginning of this live blog stream.)
11:31AM: Ford makes an point of distinguishing between taxes and regulations. Taxes play no apparent role in the safety of the medical device. He believes the definition of a medical device by FDA should not necessarily trigger that app to fall under the medical device definition when it comes to the medical device tax. Ford describes it as a virtue tax. The opposite of a sin tax (tobacco, alcohol, etc.) Why tax good innovations? It doesn't seem to be good policy, does more harm than good, Ford says.
11:29AM: Phoenix Center's Ford now up. He says the FDA regulating any part of the mobile industry will affect all of it. Now explaining how many jobs the mobile industry and world of healthcare supports. A bad decision on FDA regulation could have huge effects on these industries, he said. Ford wonders whether gains in efficiency and safety might be worth the tradeoff in loss of innovation.
11:27AM: Dagi promotes a regulatory framework that is predictable, consistent, transparent, and risk-based. Dagi suggests the FDA solicit broad and comprehensive input from many stakeholders. He also suggests that even those apps regulated as medical device do not be subject to the 2.3 percent medical device tax.
11:25AM: Dagi says 2.3 percent medical device tax is regressive and repressive. Has had a devastating effect on early stage medical device makers already and will be destructive to mobile medical apps makers. Most are very small and very early companies he says. Some of his portfolio companies might generate revenue, but few generate profit. This tax delays their ability to reach profitability and become cash flow positive.
11:24AM: Dagi says apps are used to screen diseases of the retina, diagnose moles, screen for cancer, coordinate phyisicans across a care facility, and remote monitoring of the ICU -- among many others.
11:21AM: HLM Venture's Dr. Dagi made it to the hearing despite the snow. He's up now. First and only bowtie of the group.
11:20AM: Healthy dose of humility and restraint when it comes to regulation is needed, but -- channeling Facebook's Sandberg -- Spalter says government needs to lean in. Spalter read his testimony -- all the written testimonies are linked to below in our first posts on this liveblog.
11:18AM: Spalter says let's not also forget that none of this would be possible without spectrum. Worth noting that needed spectrum is held by government agencies. America's eyes are on government agencies now. (Brief hijacking of the discussion for spectrum plea -- classic wireless industry maneuver.)
11:17AM: Spalter says mobile medical app guidance has been pending for two years now. (Not quite -- come July that's true.)
11:16AM: Mobile Future's Spalter is up now. Begins by talking about kids today living well into their 100s.
11:15AM: Chodor says medical device tax should not apply to medical apps. Even the threat of taxes hurts innovation, he says.
11:14AM: Chodor describes Happtique's review process for health and medical apps. (Private sector alternative to FDA regulation?)
11:12AM: Happtique believes FDA is in best position to regulate health apps because of its long history, but FDA has to release final guidance sooner rather than later. Happtique does not believe FDA should regulate apps that are not medical devices. (Of course not, Ben!)
11:11AM: Chodor from Happtique is up now. Rep. Latta (I think) had some trouble pronouncing Happtique's name. Some trouble with Chodor's mic here.
11:09AM: Brad says there was a rumor circulating -- and who knows where these start -- that people want to move the regulatory purview away from the FDA and he says that is not what his group favors. Stick with the agency he says.
11:08AM: Thompson talks about a urinalysis app that was just featured in a TED talk that in his opinion is just like a traditional urinalysis. It makes a disclaimer at the end of its description that it is not a medical device -- Thompson says all of his med device clients would love to make such a disclaimer if it gets them off the hook with the FDA.
11:07AM: Thompson says the FDA may be delaying because it wants to create the final, definitive guidance but the industry is changing so much it is hard for it to pull the trigger.
11:05AM: Bradley Merrill Thompson of the mHealth Regulatory Coalition is now taking the stand.
11:03AM: Jarrin offers up 7 suggestions for the FDA:
1.FDA should promptly finalize the MMA draft guidance document.
2.The final MMA guidance should offer specific examples of low-risk, regulated mobile medical devices that FDA, through enforcement discretion, would not regulate.
3.There should be clarity on “Intended Use” in light of ambiguous and general health claims and terms that are popularly used by the health IT industries.
4.For those apps that warrant listing as low-risk Class I devices, the Agency should consider how it will assess exemption from Good Manufacturing Practices (GMP).
5.Accessories should be classified according to their individual level of risk and not according to the device with the highest classification level.
6.FDA should continue its commitment to consistency, predictability and transparency by coordinating internal and external efforts through a single dedicated office of mobile health within FDA.
7.The agency would benefit to utilize external facing resources such “CDRH Learn”, “Device Advice” and the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) to work with app developers and their communities.
11:01AM: Jarrin quotes MobiHealthNews' stats on health apps = 27,000 UNIQUE health apps and fewer than 80 have been cleared by the FDA.
11:00AM: Jarrin now discussing chronic disease stats. You know these well.
10:59AM: Qualcomm's Robert Jarrin is up first. Talking up the widespread adoption of mobile devices and subscriptions. 2/3 of people sleep with their mobile device next to them, people check their phones about once every 6.5 minutes. Typical smartphone today has more computing power than Apollo 11 did when it landed on the moon.
10:58AM: Onto the witnesses. Dr. Dagi from HLM Ventures is delayed because of the snow in Boston. (We got about 6 inches or so up here.)
10:56AM: Rep. Waxman says this hearing should not be about criticizing health reform. Hints that might be the agenda of his Republican colleagues. Using FDA regulation and the medical tax as a way to attack the Affordable Care Act.
10:54AM: Rep. Waxman says claims that the FDA will regulate smartphones and tablets are a complete myth. He also says most medical apps will be exempt from the medical device tax because of the retail exemption since they are available for sale through retail channels.
10:52AM: Rep. Waxman says everyone wants to see medical innovation continue but we need to protect patient safety. Diet tracking apps don't need regulatory scrutiny but apps that purport to diagnose cancer does. Waxman now talking about the small study of skin scan apps and how these apps were not very accurate at diagnosing melanoma. (Funny that the app makers tell you they weren't trying to diagnose cancer.)
10:51AM: Rep. Shimkus calls medical device tax "pernicious" because it's 2.3 percent of revenue -- off the top. Says uncertainty around FDA regulation does damage to any business model.
10:49AM: Rep. Blackburn champions mobile health as a job creating sector. Attributes 500 jobs in Nashville area (?) to mobile health sector. Says "we are all concerned" about the medical device tax being applied to this. Says it is "muddy water" when it comes to FDA's plans for regulation.
10:47AM: Rep. Matsui said FDA draft guidance is a move in right direction and FDA should move quickly to publish final guidance.
10:45AM: Rep. Matsui says texting your doctor becoming more common especially among young people. Matsui is now talking about healthcare cost transparency apps and HIE implementations in California.
10:44AM: Rep. Matsui now providing her opening remarks starting with a nod to wireless-enabled remote monitoring and the importance of cloud computing in healthcare. "House calls are becoming a thing of the past." Hm?
10:42AM: Rep. Latta adding his remarks. Says the FDA regulating apps would have negative impact on overall wireless industry.
10:40AM: Rep. Walden points to IOM study that says all health IT should be considered Class III devices and should be treated as medical devices that should be taxed as such under ObamaCare's 2.3 percent tax on revenues of med devices.
10:37AM: Here we go. Rep. Walden kicking things off. Worlds of mobile developers and medical device makers are very different. Why treat a mobile app like we do dialysis machines? Are mobile apps a tempting target for the medical device tax? FDA's analysis of draft guidance are not a poster child for clarity, he said.
10:36AM: Six minutes late now. Not as late as FDA final guidance on mobile medical apps though, right? Right?
10:34AM: While we are waiting to begin, just noticed that Thursday's hearing now has confirmed witnesses. There are two, not surprisingly, it's ONC and FDA.
> Dr. Farzad Mostashari, National Coordinator, Health Information Technology, U.S. Department of Health and Human Services
> Mr. Christy Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration
10:30AM: Time to start now... still no action on the live feed. Hopefully we are about to begin.
10:24AM: Last week we reported on this week's hearings, which seem to be an attempt by some health IT companies to remove mobile medical app oversight from the FDA and make it a part of the ONC's purview. McKesson appeared to be leading that charge. Notably, an executive from McKesson is a witness in tomorrow's hearing.
10:23AM: Flashback to July 2011 when MobiHealthNews broke the news that the FDA had published draft guidance for how it regulates mobile medical apps. Revisit our coverage here.
10:20AM: Short background video to watch before we begin -- Rep. Marsha Blackburn (R-TN) on Fox News last week talking about how FDA regulation of apps and the medical device tax will drive up the costs of smartphones and tablets. She also discloses her intent to take away mobile medical app regulation from the FDA. Watch
10:05AM: MobiHealthNews writer Jonah Comstock will be live tweeting the hearings at @JonahComstock with the hashtag #FDAapps
9:37AM: Updated the witness list below to include links to each of the witnesses' written testimony. (Surprising number of references to MobiHealthNews research in these!)
9:35AM: Today's hearing is called "Health Information Technologies: Harnessing Wireless Innovation" and it includes testimony from five witnesses:
> Robert Jarrin, Senior Director, Government Affairs, Qualcomm Testimony
> Bradley Merrill Thompson, mHealth Regulatory Coalition Testimony
> Ben Chodor, CEO, Happtique Testimony
> Jonathan Spalter, Chairman, Mobile Future Testimony
> T. Forcht Dagi, MD, MPH, DmedSc, Partner, HLM Venture Partners Testimony
> Dr. George Ford, Chief Economist,Phoenix Center for Advanced Legal and Economic Public Policy Studies Testimony
9:30AM: We'll be live blogging the mobile medical app hearing today, which is being held by the Communications and Technology subcommittee of the Energy and Commerce Committee within the US House of Representatives. The live action starts at 10:30AM Eastern. You can also watch the livestream of the proceedings themselves over at the E&C site here.
