Much has been written in the past few weeks about Congress' efforts to put its mark on the FDA's regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a final guidance document any week now. Why did the Senate take an interest in medical app regulation this past spring? Who asked them to? And, what exactly did their conversation sound like?
The official beginnings of that conversation lasted about six minutes. It took place just before lunchtime in the Senate's Hart building on April 25, 2012. The Senate's HELP (Health, Education, Labor & Pensions) committee held a hearing on the Food and Drug Administration Safety and Innovation Act. Toward the end of the almost three hour hearing, Sen. Michael Bennet (D-Col.), the junior Senator from Colorado, submitted his second amendment to the FDA bill for consideration. Here's how he framed it:
Sen. Michael Bennet (D-Col.): "Thank you, Mr. Chairman, and I appreciate your indulgence and the ranking members' indulgence. I have two amendments that I want to talk about briefly then I'll get out of everybody's hair. The first one is Bennet Amendment Number Two, which I am offering with [Sen. Orrin Hatch (R-Utah)] and will withdraw. [It] concerns medical mobile applications, which are the apps that people use for their smartphones. They are growing extremely rapidly. Between 2010 and 2011 the number of medical apps available in the iTunes AppStore that could be subject to FDA evaluation under draft guidance increased by 250 percent. Estimates indicate that the number of smartphone users using medical apps will grow to 500 million by 2015."
"There is huge potential in these devices, by the way. I have an app on this phone -- thanks to a Colorado company -- that can tell me as a parent where the closest places I can take my kid for a sore throat [are located], for example. This actually happened. My kids only get sick on Saturdays or Sundays, for some reason, and my wife said take her somewhere to see if she has strep. I was going to take her to the emergency room. This is why our medical costs are so high. And she said don't go there, [because] there is an urgent care center just four blocks away. I didn't know it was there. We were out of that place in 10 minutes. This device now can tell you where you can go to do that. Unfortunately, public clinics are not included because we have not made the information available, but the hundreds of millions of dollars you could save and the amount of time you could save just by [letting] people have access to information is going to make a huge difference."
"This is a large and relatively new area that is potentially subject to new FDA regulations through a draft FDA guidance on medical mobile applications. I appreciate very much the work the FDA has done to receive stakeholder input, but this interaction between health information and medical devices must be handled delicately. Technology is evolving and being adopted rapidly. I think Congress must provide the proper due diligence on this issue for our constituents, including a number of startups, small businesses, and patients in my home state."
"Rather than repeal this guidance, this amendment only puts a year-long moratorium on it so that HHS and an outside working group of various stakeholders can work together on a report to Congress to help us do the proper due diligence on this issue in this committee and in the full Senate on behalf of our constituents. Mr. Chairman, ranking member, I'd like to withdraw this bipartisan amendment and work with you on this issue moving forward before this bill goes to the floor."
Sen. Barbara Mikulski: "Mr. Chairman, I would really like to salute the senator from Colorado along with his cosponsoring colleagues. I think the Internet offers a cornucopia of opportunity. These mobile devices that we call -- in this case -- the gentleman could take care of his wonderful daughter -- who I happen to have had the pleasure of meeting a few weeks ago -- and get her what she needed when she needed it without a 'mega visit' to the emergency room. I really hope that -- I think that we could get this in a Manager's [Amendment] or an acceptable version of this, because we need to get the administrative legs of government walk--running on this issue. The apps are going to explode. The apps are exploding. They provide specific information like that. Physicians are using their technology as the PDA. In a visit with my own doctor, he rapidly knew that something new we were considering would adversely interact with something I am currently taking. He didn't have to go to a book. He didn't have to call me three days later. Zip, zip. But also, as you know, there is great information out there from weight management to urgent care [but] there is also potential for 'quackery'. You know, take an apricot juice and you will grow four feet, which I would have tried. I support what you are doing here, because the Internet is going to get ahead of the bureaucracy, and we want to make sure that everybody has every tool quickly at their fingertips and at the same time make sure that the guidance they give is excellent. So, I think you are really onto something here, and I am going to thank you for your forward thinking."
Sen. Tom Harkin (D-Iowa): "I would agree with Senator Mikulski that you are on to something here. Obviously, you are. I think it needs some further looking at. It is one thing if you have an app that tells you where your local CVS is or your urgent care center is, and another [thing if it is an] app that plugs into some device that gives you your blood pressure, heart rate, and stuff like that. There is a little bit of difference there and somehow this needs to be worked on so that if it is a medical device it is a medical device and if it is an informational tool then that is something else."
Sen. Bennet: "Well, I fully agree with that. Mr. Chairman, there is a very, very -- we have no idea how big the gray area in between is going to be. That really is the purpose of the amendment, it's just to slow things down a little bit so we can have a conversation about it and understand it better. As I said, I will withdraw it and look forward to working with you."
Sen. Harkin: "I appreciate that and we will work with you on that. [Sen. Michael Enzi (R-Wyo.)] and our staff will work with you and see if we can come up with something that would reach an agreement here."
That's it. As far as I can tell the rest of the discussion, debate and negotiations that the Senate or the House of Representatives had about the FDA's regulation of mobile medical apps took place behind closed doors.
It should be rather obvious which app Sen. Bennet referred to in his opening remarks. iTriage, formerly known as Healthagen before it was acquired by Aetna, is almost certainly the app the senator referenced. The startup was founded and based in Colorado, the senator's home state. While Sen. Mikulski and Sen. Harkin point to a handful of other use cases, including drug interaction apps for doctors, weight management apps, and blood pressure apps, neither appear to reference a specific company's offering.
Among lobbyist groups interested in the FDA's role in regulating mobile medical apps, the Health IT Now Coalition has largely led the discussion about the perceived dangers of allowing the FDA to move forward with its guidance document without additional oversight from Congress or other stakeholders. The Health IT Now Coalition's Executive Director Joel White told me a few weeks ago that his group backed the Senate version of the bill, which included a version of the amendment originally submitted by Sen. Bennet.
"I think a critical aspect of this is that we have the externals have input into this process," White said. "From our coalition's perspective that is absolutely key. The FDA may have one set of experiences and some expertise in this. The FCC brings another and ONC brings another. There are payors, employers, manufacturers, venture capitalists, patients, and providers who bring a completely different perspective. At the end of the day if you go out and get a good recommendation to Congress on what the regulatory framework should be -- [one] that promotes innovation and protects patients' safety -- you better solicit input from all those points of view. From our perspective as an organization we believe that external input is critical."
Since The Health IT Now Coalition tackles a diverse set of issues related to health IT, I asked White which of the coalition's members were active on the issue of the FDA's regulation of mobile medical apps.
He said that while he doubted they would discuss their perspective on the record, he said that "for folks who are pretty active on this one, I'd say Verizon, United... and Aetna."
White was right, not one of those three companies was interested in discussing their legislative affairs initiatives on the record, but each sent me a written statement.
After exchanging a number of emails, a UnitedHealth Group spokesperson said the insurance company would rather refer all questions to the Health IT Now Coalition.
An Aetna spokesperson suggested that White actually did not tell me that Aetna was active on this or any other piece of legislation, but that the company was just a part of the coalition's steering committee. Aetna's statement: "Aetna is an active member of the Health IT Now Coalition as part of our focus on using technology – including health apps -- to create a health care system that is more connected, convenient and cost-effective. Given our strong interest in technology we will continue to work with the FDA and both chambers of Congress as this Bill makes its way through Conference."
Verizon spokesman Rich Young sent me a similar statement, but what makes Verizon's participation in the Health IT Now Coalition so interesting is that its partially owned subsidiary, Verizon Wireless, is a member of the mHealth Regulatory Coalition, which is actually pushing for the FDA's final guidance document to be published without delay.
"Verizon is a strong supporter of advancing the use of new applications and technology in healthcare. With any new program or application, we believe patient safety is always a critical concern. We support several like-minded groups and efforts that also believe healthcare research and delivery can be improved by integrating new technologies. We are closely monitoring recent Congressional action regarding legislation in the area, but we have no specific comment on pending legislation at this time."
At the heart of the debate over the FDA and the regulation of mobile medical apps is whether a company inherently trusts or mistrusts a government regulatory body. In the many conversations I had with those in the industry these past few weeks, those that were in favor of somehow -- to use Sen. Bennet's phrase -- "slowing down" the release of the FDA's final guidance document, believe that any new set of regulations, no matter how well-intentioned in development, will likely have unintended consequences or lead to a regulatory land grab.
The idea that the guidance document is "new" regulation is another interesting nitpick. Senator Bennet described the regulation as "new", but those in favor of the guidance document generally cast it as a clarifying document for existing regulations. I have often thought of it as a cipher that helps translate decades old language into today's world of mobile devices and apps. Still, some believe such translation constitutes "new" regulations.
The most interesting comment I heard was: Does the FDA really have any teeth? Do we really need a finalized guidance document? Look at how quickly mobile health has grown in the past year, the past two years. Has a lack of final guidance from the FDA really slowed things down? Given the pace of investment -- which by the numbers is on the up and up -- and the fast growing number of health apps launching each day, it is a question worth considering.
The end result of all this lobbying was that the House and Senate agreed to keep an amendment that bears some resemblance to the one Senator Bennet suggested in late April. The final legislation calls for the Secretary of HHS to work with the FDA, ONC and FCC to develop a report to be delivered to Congress within 18 months that includes "a strategy for coordinating the regulation of health information technology in order to avoid regulatory duplication" and "recommendations on an appropriate regulatory framework for health information technology, including a risk-based framework."
Even though it needs to prepare the report to Congress, the law will not delay the FDA in issuing its final guidance.
The legislation also leaves it up to the Secretary of HHS to decide whether to appoint a committee of outside stakeholders to weigh in on the issue and contribute to that report. This is where the lobbying efforts have shifted: To convince HHS to appoint a group of private industry stakeholders to help craft the report to Congress. This will be an interesting spot to watch if the elections this November lead to a new head of HHS next year.
If they do, my bet is a stakeholder committee will be appointed some time early next year.