By Bradley Merrill Thompson

In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.

As I said in my original post, it’s important for us all to keep in mind that FDA is already regulating mHealth and the purpose of this guidance is to reduce the scope of that regulation. So the question is--  is it useful for FDA at this time to come out with a final guidance on mobile health?

I will explain further why I think it clearly is.

Mr. Haley offers the view that FDA guidance is unnecessary at this point because there will be a new statutory scheme within about a year. After consulting his blog that he referenced in his prior comments, it appears that Mr. Haley is a government affairs professional and an attorney, so I know that he well-understands the process for creating new statutes, but let me recite it for everyone’s benefit.

Step one -- FDA drafts a report to Congress, with the input of ONC and FCC

In section 618  of FDASIA, Congress asked for a report from FDA, together with ONC and FCC, on “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” At this juncture, because it hasn’t yet been written no one knows what that report will say, except perhaps FDA and the other two agencies that are working with FDA to write it. We in the public do not know, for example, whether the report will recommend a series of incremental improvements to the existing regulatory framework or an entirely new one.

Not to quibble, but in Mr. Haley’s comment he says we are “on the eve of a proposal for a statutory framework.” But we do not know at this juncture that it will be a statutory one. And even if there are statutory elements to it, we do not know that it will be a new, comprehensive statutory scheme, but perhaps fine-tuning of the existing statutory framework. Bottom line is, we just don’t know what the agencies will propose.

Step two – Congress may debate what to do

Presumably sometime in 2014 (the agencies aren’t always punctual in meeting deadlines), Congress will receive this report and if they are so inclined will debate it through the normal congressional channels. Now I know Mr. Haley understands that process much better than I do, but in my experience, Congress isn’t always quick to act, or decisive in its approach. And indeed, the timeline is influenced by other factors such as whether we are at war and generally other priorities of the moment.

If, and I emphasize if, Congress decides to move forward, Congress still has to draft a new regulatory program and presumably get input from all sorts of people.  Here is where I see extreme uncertainty because there is no consensus as to how software should be regulated. I just participated in the summer long process of making recommendations among the FDASIA working group, and as I’m sure others already know, that process was a difficult one that produced a number of high level observations. It also revealed a number of differences that still need to be worked out.

I’ll give an example. As I study the work product of the Bipartisan Policy Center which is one of the leaders of the organizations that signed the letter to the HHS Secretary, one of the key recommendations of that group is that Congress ought to create a new category for clinical software with its own separate regulatory scheme. It seems to me and others that there’s a major problem with that approach. The problem is that technology is trending in the direction of systems that combine medical devices with health IT and to separate the two will cause confusion and result in duplication, which the agencies were tasked in avoiding. Consider:

• Medical device hospital beds becoming electronic hubs into which the various patient monitors and therapeutic devices such as insulin pumps are connected and coordinated, and through which data are collected for deposit into the EHR.
• Medical devices being electronically networked together to directly coordinate the delivery of care, for example an oxygen monitoring device might tell an intravenous device to stop delivering narcotics if hypoxemia is detected.
• Enhancements coming from the EHR side, including middleware to directly connect the EHR to medical devices so the data might be transferred automatically.
• In the later part of the 20th century, professional care basically stopped when the patient went home.  Now we are seeing a whole slew of technologies that allow for connected health. These include cell phone apps that might extract data from a pacemaker or defibrillator and send it back to a cardiologist, as well as home-based hubs to which all sorts of medical devices might be connected, and the data ultimately relayed to a doctor and into an EHR.
• Now laboratory testing is getting into the act. There is a cell phone app that basically uses the camera to measure color changes in a test strip for urinalysis. Further, laboratory testing itself is now connected through middleware directly to caregivers and EHRs.
• Medical imaging is not to be left out, with ultrasound and other clinical images being transmitted to tablets and cell phones that the doctor can use at the bedside, or even at the doctor’s home. It seems reasonable to expect that these mobile monitors will get more sophisticated, and begin to apply computer aided diagnostic software to the images.
• Orthopedic implants can now have sensors attached that allow doctors to remotely monitor the wear and tear on the implant. All of this data then gets stored and trended in an EHR.
• Sensors can even be used preventatively, for example monitoring the environment for allergens and alerting a patient with asthma or his caregiver to potential danger. This data can get stored and analyzed in the EHR.

Given those and other technology trends, it will be increasingly difficult to separate out many categories of so-called clinical software from the connected medical device software. Developing a separate regulatory scheme for HIT that connects with medical devices represents a tremendous conceptual challenge to the design of an HIT regulatory scheme.

As I think everyone in this debate agrees, it is very difficult to serve two masters. If, for example, medical device manufacturers must satisfy FDA, and if in this example HIT developers must satisfy ONC, it is not hard to imagine complexities and duplications when the HIT is intimately connected to the medical devices.  In many of these cases, the HIT might actually control the medical device, in other cases the safety and effectiveness of the medical device will be entirely dependent on the software accurately capturing and presenting the data generated by the medical device. This is not to say HIT, regardless of risk, should be regulated by the FDA. Certainly not. The point is simply that clinical software is not some isolated product category that can be regulated unto its own without implications for other technologies like the medical devices that are more and more interconnected with that HIT.

So if Congress is considering creating a separate a new regulatory scheme for clinical software, separate from FDA regulation of traditional medical devices, legislators will have their work cut out for them. This is not an easy challenge to resolve. 

Step three – an agency must implement a broadly-worded statute

And finally, if Congress chooses to adopt by statute a new approach to HIT generally, including mobile medical apps, it will take considerable time for that new approach to be put into place. Congress will have to designate an agency to be responsible for that new scheme, and then ask that agency to adopt all the regulatory details that would be found both in officially codified regulations as well as less formal guidance. In other words, that agency would be starting from scratch with only general direction from Congress.

Given the way Congress operates, it cannot develop fully a regulatory program down to the level of detail needed to make that program operational. Thus just not the way Congress works. That is indeed the work of an agency.

Arguments for proceeding with the FDA guidance.

Now let me get back to the question of whether FDA ought to issue its guidance. FDA should do so now because:

1. FDA is the primary writer of the very report that Mr. Haley is interested in waiting to see, and so it would seem unlikely that FDA would release guidance on mobile medical apps that is somehow contrary to the report it’s writing. So why wait?
2. Mr. Haley asserts that we are likely to have a new regulatory scheme for mobile medical apps within about a year. I have to respectfully disagree. I think it’s highly unlikely that we will have a new, functioning regulatory scheme for HIT in the next 2-3 years, given the three different steps that I outlined above. And for mobile health, that’s an eternity. If we have to wait two or more years in the mobile health industry to get clear guidance from anyone on the scope of what is regulated, this industry is going to suffer greatly, and with it I think the country’s health and economy will suffer. Right now investors are very skittish about putting serious money into mHealth until they know what the contours of FDA regulation will be, because such regulation carries with it significant cost and timing implications.
3. What’s the harm of proceeding? It seems to me Mr. Haley’s argument comes down to wasted resources, either on the government side or the industry side. On the government side, there would be no wasted resources because the document is reportedly written and in fact just waiting for final sign off. On the industry side, as explained in my prior post the whole point of the document is to express legal requirements in a way that is understandable to laypeople and to de-regulate low risk mobile medical apps. So again the whole point of the document is actually to reduce the present need for hiring attorneys to interpret the FDA requirements. So what exactly is the harm of proceeding?
4. Let’s not forget about patient safety. As discussed in my prior post, many developers mistakenly believe that their apps are not regulated simply because the final guidance has not been released. Some of these companies are developing mobile medical apps - higher risk apps - without basic controls to ensure patient safety. Issuance of the final guidance will help eliminate this misperception and ensure that these higher risk app are being developed in a manner that helps ensure patient safety.

Potential Common Ground

Mr. Haley did identify I think at least one area where we clearly agree. Both of us, it sounds like, agree that FDA guidance is too slow. I am completely with him there. So much so that I will be proposing soon some substantial reforms to the FDA guidance system to make it more responsive to fast-moving technology. This is an issue that we face throughout the industries that FDA regulates. FDA has produced hundreds of guidance documents over decades, and the agency has been chronically slow to do so. FDA absolutely needs to speed that up.

But it would seem that slowness in the process would lead us to reform the guidance development process, rather than for some reason tell FDA to stop issuing guidance just because they are slow. Right now the public is left wondering whether the draft guidance on mobile medical apps is accurate because it has taken FDA more than two years to issue the final one. Slow guidance is better than no guidance, and timely guidance would be best.

Path forward: clarify the existing regulatory system while we debate more substantial changes

My proposal is we spend the next few years trying to improve the current system as much as possible so as not to choke off mobile health at this very critical time, while Congress debates the very difficult and challenging issues of coming up with something new and better. And here it would appear that my colleagues in the FDASIA work group are with me.

If you are unaware of that group, it is comprised of 29 people nominated by the three federal agencies – FDA, ONC and FCC -- to put together public input to guide the three agencies as they develop their recommendations under section 618. It is a very diverse group, as directed by Congress, to include representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise.

And today, September 4, 2013, the workgroup is making its final recommendations. With regard to regulatory changes the government should consider, by consensus the working group concluded that:

“Within current regulatory frameworks there exist mechanisms that the FDA, ONC, and FCC could use to promote innovation, protect patient safety and avoid regulatory duplication (and cost).” Specifically, the first recommendation with regard to regulatory changes is that:  “1. FDA could use the current regulatory framework to clarify ambiguities.” And under that recommendation, the working group specifically states that FDA should “expedite guidance on HIT software, mobile medical applications (MMA) and related matters”.

Frankly I was impressed that the working group came to such a strong consensus on that point because the members of the working group were so diverse, and we got input from some of the institutions that joined with Mr. Hayley in sending their letter, including the Bipartisan Policy Center. But after thoroughly debating the issue, that’s where the working group came out. To be clear, the working group also made recommendations for the longer term reform including enhancing the reporting structure for HIT generally. But equally importantly, the working group included nothing in its final report to suggest that mobile medical apps of the kind FDA described in its draft guidance should be removed from FDA oversight.

And that last point is perhaps one of the most important. As FDA defines them in the draft guidance, mobile medical apps are those apps which accessorize a traditional medical device or which do the same thing as a traditional medical device. The working group did not suggest that such apps should be removed from FDA’s jurisdiction, now or later. So while the debate over things like EHR’s rages, there is no indication in the working group’s recommendations that mobile apps that function as accessories to medical devices or do the same thing as medical devices will be regulated in a different way.

Conclusion

So I end where I began. I want to make a strong appeal for the government to let the mobile medical app guidance free, so that mobile app developers that want to make apps that FDA agrees are low risk can go about their business without the cost and other burdens that FDA regulation brings. Setting those low risk apps free from FDA regulation will do much to spur innovation while the larger debate drags on. Indeed, why on earth would we not set those apps free?   Exactly who is in favor of maintaining FDA regulation of low risk apps?