If this is the way most House hearings go, I can see why nothing gets done in Washington. On the third day of hearings about FDA regulations of mobile medical apps, there was still lots of fear about uncertainty and the medical device tax. Dr. Farzad Mostashari and Christy Foreman of the FDA testified in front of the Oversight and Investigations subcommittee of the Energy and Commerce committee.
Republicans wanted to discuss all the flaws of the Affordable Care Act and the HITECH and meaningful use. Democrats wanted to drive a stake through the heart of the iPhone tax myth.
There were a couple nuggets of helpful information, a speck of humor, and a few bizarre comments thrown in for good measure. Here are my top 10 comments from the last day of testimony.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
10. “The final guidelines will be out by the end of this fiscal year.” Christy Foreman, director of the Office of Device Evaluation, Center for Devices and Radiological Health.
9. “What about the entire mobile network? All health IT?” – Rep. Henry Waxman. He ran through a laundry list of devices and infrastructure that fall outside the scope of the FDA’s planned regulations.
8. “The first clearance of a mobile medical app was in 1997.” – Foreman. About 80 apps have been approved so far, including the Beam Brush, MobiSante, and Mobile MIM.
7. “We get less than 20 applications per year from mobile health apps and that is .5% of our workload.” – Foreman. That makes it easier to believe that the average approval time for mobile medical apps is 67 days, as the FDA has stated.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
6. “We are planning that many of those iterative changes will not require new 510Ks.” – Foreman. This is also good news because we all know how often software is updated.
5. “I can’t recall that we ever saw the randomized clinical trials for electronic health records. Are those trials in existence? Were they done? Do we have that data?” – Rep. Mike Burgess, MD. Dr. Burgess wanted to debate the value of EHRs with Mostashari. The director of the ONC said that moving away from his and Rep. Burgess’ handwriting and paper records are key to making progress and improving saftey. Mastashari said that “The preponderance of the evidence is absolutely that when implemented appropriately, health IT is gonna improve quality, safety and efficiency.”
4. “The only thing that would change our mind is a strong saftey signal.” – Foreman. This was her answer to Rep. Morgan Griffith‘s question if the agency might — at some point in the future — want to regulate the laundry list of items that Waxman cited earlier.
3. “I’m just an old country lawyer, and I got on my tablet here and found an article yesterday…” – Rep. Griffith brought his Android device to the hearing and described a hack to an iPhone that allowed scientists in Tanzania to diagnose intestinal worm infections in kids. He closed with, “Y’all regulating that or not?”
2. “I’m not inherently opposed to double-sided tape.” – Foreman, in response to the country lawyer’s question about regulating an iPhone hack that turned the phone into a microscope.
1. “Dr. Mostashari, why don’t you just make that happen?” – Dr. Burgess’ closing question to Mostashari about interoperability. Apparently Dr. Burgess thinks Mostashari has a magic wand he could wave and make all HIT and EMR systems get along.
Read Mostashari’s testimony here and Foreman’s testimony here.
Watch all 90-some minutes yourself and pick your own top 10.
