We are live blogging day two of the Congressional hearings on FDA regulation of mobile medical apps. Hit "refresh" on your browser every few minutes for updates! (Liveblogging is now concluded!)
1200PM: With that Rep. Pitts concludes the hearing after saying it has been a very interesting hearing on an important issue. Members may have follow-up questions and they have 10 business days to submit questions and witness are asked to respond to them quickly. Adjourned!
11:59AM: Bialick adds that we should not think about this just as a rural area opportunity. Telehealth is helpful in occupational health and other areas among urban populations and others, too.
11:57AM: Rep. Bilrakis now asks about how these technologies can help reduce medical costs. Smith says telehealth and telemedicine can help reduce costs absolutely and cites data from NEHI and others. Bilrakis next asks Smith whether technology can help enable doctors to treat more patients and new patients. Smith says it is especially true for patients in remote areas and/or to save trips to the emergency room. Smith says it is not enough to have the technology in place but the payment reform is necessary to drive adoption. If providers don't get paid for it, they won't use it.
11:55AM: Rep. Gingrey says these apps don't draw blood, they are not invasive, they just provide information. They are just giving alerts to people, he argues.
11:53AM: Bialick says increased regulation will mean less apps will be free. Changing the regulation will mean the business model for health apps will need to change.
11:52AM: Rep. Gingrey asks who makes mobile medical apps? Smith says companies building apps are all small. He's met with a thousand of them. They are usually naive about the bigger problems, he said. It is not enough to solve the problem they are setting out to solve but to do so in the face of the wider issues of the healthcare system. (Only small companies? Really?)
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.
11:21AM: Rep. Hall up now. He asks Bialick how technology can make the lives better of new parents and newborns. He then specifically asks how mobile medical apps and devices might do that? Bialick says babies with congenital heart defects are super users of the healthcare system. Right now to stay at the center of your care you need to be the one to coordinate your care yourself. Bialick says mobile apps allow us to do that. We can now hold in our hand the electronic record not just because we now have increasing access to our information, but being able to bring it with you to different providers enables you to get to answers more quickly. Hall says that maybe if babies could count (sheep?) they would be able to go back to sleep.
11:20AM: Just lost the feed here!
11:18AM: Rep. Christensen from Virgin Islands asks Bechtel for some more good news about meaningful use and health IT. Bechtel obliges.
11:17AM: (Really frustrating technical issues going on with the live feed.)
11:15AM: Rep. Shimkus and Bialick now discussing remote care, nursing call centers, and eICUs. Shimkus draws parallels between telemonitoring via video conference technology in clinical settings to mole apps. How does that (telemonitoring technology) get regulated, he wonders.
11:14AM: Rep. Shimkus is harping on the IOM report Appendix E comment that suggests all health IT be regulated as Class III medical devices.
11:12AM: Rep. Shimkus pushes Bialick to explain all the different things that happens to an app if it becomes regulated by FDA. After getting a number of answers from him, he prompts: They get taxed as medical devices!
11:10AM: Bialick says no one entity should regulate mobile medical apps. It's too complicated. (Feed cut out but I think Waxman said that if there is too much shared responsibility then nothing will get done?)
11:08AM: Waxman asking Bialick about his testimony. Bialick wants to deliniate apps that connect to regulated mobile medical devices like pulse oximeter. Smartphone apps that connect to the pulse ox should not be regulated Bialick says. Waxman doesn't seem to understand that FDA regulates apps that connect to regulated medical devices. (I think Bialick's testimony is referencing issues like the ones we brought up in this past MobiHealthNews story.)
11:05AM: Waxman asks Mitus if apps that aim to diagnose moles should be regulated by FDA. Mitus cites Dr. Mole app by name. Says it potentially be regulated by FDA. Waxan taking Mitus to task on her testimony in which she describes various apps as potentially being regulated by FDA when he says the FDA specifically said that those types of apps would not be regulated in its draft guidance. Mitus says she is worried about the gray area. Waxman pushes her to confirm that medical devices should be regulated. She agrees. She says she does not presume to say who should draw the line and that it is a difficult line to draw. Waxman says saying it is difficult does not help.
11:03M: Device connects directly to patient and has automation that allows it to independently act on that patient is a medical device, Mitus says. Fundamentally different from health IT software that helps a physician make a decision.
11:01AM: Rep. Burgess asks for difference between app and traditional devices. Smith says absolutely, his experience was previously working in implanted cardiac devices. Huge difference. Information on the web as an app is quite a different thing from data coming out of an implanted device. (Don't quite understand the point of this, but Burgess leaves it as is.) Burgess then underscores power of having medical information at fingertips and being able to download Merck Manual and other texts. He asks McKesson's Mitus: How does regulatory environment effect that?
10:59AM: Rep. Burgess wonders if there is going to be an app for regulatory apps with a chuckle. That's why we are here today I guess, he says. Burgess now explains his experience as a doctor dealing with meaningful use. Asks Smith about moving to an outcomes-based healthcare system instead of fee-for-service and Smith is now describing issue of perverse incentives, payment reform and the need for accountable care enabled by some remote technologies and health IT system.
10:55AM: Rep. Pallone says hearing is missing forest from trees when it comes to mobile medical app regulation. He says the administration has helped accelerate the proliferation of mobile medical apps by opening up government data. He cites iTriage as a success story. Asks Bechtel how the federal government's actions on that front have helped patients. Bechtel says the data is phenomenal and the federal government took an important leadership position there. (Lots of old hat here and background on Open Data Initiative.)
10:54AM: Rep. Pallone asked Bechtel about adoption of EHRs and whether they are just being adopted so provides can "check a box". Bechtel is extremely bullish on the benefits of EHRs and related technology as well as how well adoption has gone so far.
10:52AM: Pitts asks Bialick for examples of patients whose lives were changed thanks to this kind of technology. Bialick says these technologies enable the new house call.
1051AM: Pitts asks if FDA is the right agency does it have the right experience. Smith says in short no. Bialick says it does have the right experience to regulate apps that are actually medical devices. Mitus says FDA should regulate medical devices but health IT requires a different process. Classen says, citing IOM, if FDA got further involved in HIT beyond medical devices then a new framework should be created.
10:49AM: Bialick says the definition of an app is changing thanks to widespread adoption of cloud computing. Definition of an app has changed since the draft guidance was written he argued.
10:48AM: Rep. Pitts asks if data should be classified as a medical device. Everyone says no but Bechtel. Bialick asked if apps should be regulated as medical devices and he says as the draft guidance is written he says they should not.
10:48AM: Classen now explaining that health IT doesn't necessarily work the way it is intended to right "out of the box."
10:44AM: Classen is largely extolling the success of health IT implementation and the reduction in medical errors. He's going deep into the way that health IT can lead to threats to patient safety. Very complex system problem he argues. Here's a snippet from his testimony that he just read: "Safety is an emergent property of a larger system that takes into account not just the software but also how it is used by clinicians. That larger system – often called a sociotechnical system – includes technology (e.g., software, hardware), people (e.g., clinicians, patients), processes (e.g., workflow), organization (e.g., capacity, decisions about how health IT is applied, incentives), and the external environment (e.g., regulations, public opinion). Adopting a sociotechnical perspective acknowledges that safety emerges from the interaction among these various factors."
10:42AM: Dr. Classen from Pascal Metrics is up next.
10:41AM: Mitus concludes with suggestion of three tier regulation from Bipartisan Policy Center:
The first category includes technology linked to or used to operate a medical device; again, technology that directly touches the patient. This technology would continue to be regulated by the FDA as a “medical device”.
The second category includes technology that informs the treatment of a patient, such as clinical decision support software or EHRs. This software would be subject to a rigorous process of accreditation by an independent third-party, or perhaps ONC.
Finally, the third category, non-clinical technology such as billing and scheduling software, would not be subject to any regulatory oversight.
This proposed framework recognizes the fundamental difference between traditional medical devices that are directly involved in the treatment of a patient, and medical software that helps guide the physician in the diagnosis or treatment of a patient.
10:38AM: Mitus says health IT does not replace physician judgement but provides support. FDA has authority to regulate medical devices thanks to an amendment of act from 1976. She says it is broad and not well suited to health IT. Does an iPad that reminds a patient to refill a medication make it a medical device? An app that lets physicians view medical literature online? Safety of medical device almost entirely rests on how it is manufactured. Safety of health IT is based on how it is implemented. Medical devices unlike health are directly involved in treatment of patient with little or any opportunity for clinician to intervene. Health IT provides data and guidance and has a learned intermediary that distinguishes it from medical devices.
10:37AM: McKesson's Dr. Mitus is up now. Making two key points today. Health IT is crucial to healthcare. And we need a new risk-based, specific regulatory framework that is specific to health IT.
10:32AM: Bialick from Newborn Coalition is up next. He's reading his testimony too. (TESTIMONY) He says mobile apps are important to helping parents and providers care for newborns. Pulse oximeters are especially important to monitor babies with heart issues when at home. Apps can capture readings from remote monitoring devices. Lets parents take less time being nurses and more being parents. Bialick says that FDA draft guidance is not risk-based enough. Health information management apps and actual medical devices need to be distinguished. Be foolish to think integration of consumer technologies and health devices won't happen. We need to think about regulation fo technology differently. Flexible enough to regulate what we are using today and adaptive enough to future. A new regulation framework is daunting, he says, but existing regs not enough.
10:30AM: Bechtel citing Blue Button for VA members. Citing patient experiences that Blue Button had helped them prevent medical errors and potentially readmissions. Simple but powerful innovation that will help consumers play a powerful role, she said. Ensure that every provider in country has health IT, she says. Expand meaningful use to home health and other areas. Along with pay reform it will help transform healthcare, she said. (No mention of FDA and medical apps. Puzzling.)
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.
10:00AM: Today's hearing is being held by the Health subcommittee within the Committee on Energy and Commerce. The witnesses and links to their written testimonies can be found below:
Witnesses:
> Joseph M. Smith, M.D., Ph.D., Chief Medical and Chief Science Officer, West Health Institute TESTIMONY
> Jacqueline Mitus, M.D., Senior Vice President, Clinical Development and Strategy, McKesson Health Solutions TESTIMONY
> Mr. Jim Bialick, Executive Director, Newborn Coalition TESTIMONY
> Ms. Christine Bechtel, Vice President, National Partnership for Women and Families TESTIMONY
> David Classen, M.D., Chief Medical Information Officer, Pascal Metrics, Associate Professor of Medicine and Consultant in Infectious Diseases, University of Utah School of Medicine TESTIMONY
