By (Several friends commented on this draft, and I would like to thank them.)
Warning, this article contains explicit and sometimes graphic depictions of possible FDA regulation.
If you've been reading the prior articles in the series, you know I've been leading up to this last article in which I offer some predictions as to where FDA regulation will end up with regard to mHealth technology. Rather than just give you my predictions, however, I'm going to show you how I arrive at them. In this article, as the basis for my prediction, I use the political science equivalent of Newton's second law of motion: the acceleration of an object is directly proportional to, and in a direction determined by, the net force acting on it. I also throw in a little portfolio theory, just to spice it up.
Borrowing from Newton’s law, I identify the vector forces that represent each of the primary social and political constituents affecting FDA regulation. As I identify them, I estimate both the magnitude and the direction of the force. Actually it's easier to communicate this in a graph.
Function
If that graph doesn't help you, just forget it, and go to the next section. But if you'd like to know more about how I designed it, read on. I'm a visual person, so I always try to draw myself a picture.
Innovation and protecting against adverse events can be inversely related, at least in certain instances. Requiring medical devices to go through FDA approval, for example, restricts the freedom to innovate in some measure (you can't just put a beta version out on the market and see how it does), while presumably reducing the risk of adverse events if FDA reviewers catch problems. On the other hand, there are places where regulation may actually enhance innovation by providing a framework to ensure the vigor of the analysis. Some argue that design controls lead to better, and in a sense more innovative, products. But for purposes of this analysis, let's assume that there's a trade-off between innovation and protecting against adverse events.
So basically Congress and FDA pick where on this graph they want to be in terms of that trade-off between permitting innovation and protecting against adverse events. But what determines their choices? Ideally they would like maximum innovation and maximum protection against adverse events. So they want to be at the far, upper right hand corner.
Unfortunately, it's not that easy. Their choices are constrained by reality. Perhaps limited by our collective creativity but also by the fundamental conflict between a business process that encourages creativity and innovation, on the one hand, and a business process that drives toward zero risk on the other, trade-offs are necessary. We haven't invented the perfect regulation that allows both maximums.
On the right-hand side of the graph, I depict those constraints, calling it the efficient frontier of regulation. I got kind of carried away, making an obscure reference to an economic theory developed by Nobel prize winner Harry Markowitz. In his famous graph, he shows the trade-off between risk and return from owning various bundles of stocks. His efficient frontier was a curved line representing the best trade-offs you could make in terms of risk and return. That line represented choices in the perfect market.
At my frontier, I show different best case trade-offs between levels of regulation and the associated freedom to innovate in a perfect world. In a perfect world, we have flawlessly written regulations that:
oCommunicate clearly the regulatory requirements, fully answering any question you might have
oAre perfectly sensible in that they completely avoid any unnecessary impediment to innovation, always imposing the least burden to get the safety job done
oAre soundly supported by evidence
oAre clever and creative, choosing the most efficient and effective way to achieve safety, and never the product of historical anomaly or political compromise.
We don't live in that world.
That’s why I have current FDA regulation inside the efficient frontier. I've done that if for no other reason than because I believe we could increase innovation, with no compromise in public health protection, if we simply clarify the regulatory scheme so that everyone understands what it is. Everyone—whether you are at FDA or in industry—should want to move as close as possible to that line. The difficult question is, to where on that line should we aim?
Clearly I could have added another dimension in which we evaluate whether regulation advances the public health by allowing important new products onto the market. But I don't know how to draw in three dimensions, and Brian Dolan was no help.
Forces
At a high-level, this graph depicts how industry generally pushes in the direction of innovation. Many in industry don’t mind at least some regulation if it keeps unscrupulous companies out. Such companies hurt the reputation of the whole industry, and drive down consumer confidence in their products.
At the other extreme, in my subjective view, the media (except Brian) often flagrantly seizes upon indications of patient risk, while not being terribly concerned about the need for innovation. FDA's mission, by statute, tends to be predominantly focused on assuring safety and effectiveness through regulation, while Congress must be concerned with jobs and assuring adequate access to the best health care (and getting elected). So the task now is to tease apart each of those forces.
Part one of this article will identify those existing forces at work, and part two of this article to be published next week will calculate the applied net force, and show at least where I think FDA regulation will likely end up.
I. Framework: Crying Wolf or Chicken Little?
Before I dive into this analysis, because portions of it are subjective, in the interests of good journalism I should disclose my own biases. I'm prompted to do this in part because of Nick Hunn’s thought-provoking article on whether we should even discuss the likelihood of FDA regulation of mHealth. Nick's article advances the argument that too much talk about possible FDA regulation scares away potential entrants into the US mHealth market, those who might have allergic reactions to graphic discussions of such topics. (I tried to warn them away.) Nick's article is worth a read, and not just because he calls my articles “excellent”.
At the same time, I have to disagree with Nick’s conclusions.
Over the years, I've learned that business people of all types, and particularly investors, highly value information about changes in the regulatory environment on the horizon. While Nick seems to feel discussion of FDA regulation is tantamount to fear mongering, my hope is that this information will provide the reader a rational basis for business planning.
In the end, you can judge the value of this information by whether you feel there is an objective basis for the conclusions offered. That's why I'm going to take a little bit of time to lay out my specific observations. You be the judge.
II. The Nature of FDA Regulation
I understand full well some readers will never believe FDA regulation is anything but bad news for an industry. Frankly some people (like me) simply have trouble accepting authority. So I understand they will never welcome the idea of Washington telling them what to do. They blog for a living (just kidding Nick), or only enter businesses that are largely unregulated. I honestly get that.
But through this series of articles, I have advanced the idea FDA regulation can benefit the industry. At the most fundamental level, assuring the safety of technology helps protect the image of an industry and the confidence of its customers. Beyond that, the regulatory system itself becomes a barrier to entry, and helps ensure that companies willing to make a higher investment are protected enough to earn profits proportionate to the investments they must make.
The proof is in the pudding, of course. The medical device industry has been one of the healthiest industries over the last 20 or 30 years, and particularly measured by most indicators of the robustness of innovation. The industry has attracted high levels of venture capital, and has produced high numbers of patents. More anecdotally, the breakthrough technologies reaching the medical device market over the last 20 years in many cases have been breathtaking.
At the same time, it goes without saying that we can have too much regulation, and misdirected regulation can stifle innovation. The trick is to find the right balance, the sweet spot where regulation is flexible enough to allow innovation and strong enough to provide adequate protection to the public health. Abiding by that regulation constitutes the dues that any company must pay if it wants to supply medical technology that can impact the health and safety of our citizens.
Part One -- The Existing Forces At Work.
III. Society and the Healthcare System
In this article, I'm not even going to try to analyze where the health-care system is headed. Instead, based on reading probably many of us have done, I will list the major trends (assumptions) I've factored into my analysis.
oHealthcare costs are high, and getting higher. Throughout the last year, we've all been bombarded by stories discussing the rising cost of health care, and the need for reform. Whether or not you believe the recently enacted health-care reform will drive down costs, it's fair to say in the foreseeable future we will need to identify every possible way to reduce those costs. mHealth technologies have been touted as one possible way to treat people in lower cost care settings, and better manage chronic conditions that are driving up the cost of healthcare.
oMany U.S. citizens live in areas underserved by the health-care system. mHealth technologies, as with other remote monitoring and telehealth devices, can be used to expand access in these underserved areas.
oOutside of healthcare, the world is going digital. The growth of mobile phones into a nearly ubiquitous communication tool is well-established.
So it's no great revelation to anyone reading MobiHealthNews that the societal forces driving the adoption of mHealth are strong. One way or another, society in general and our healthcare system in particular will demand access to mHealth technologies.
IV. Industry and Technology Trends
Scores of articles in MobiHealthNews describe where the industry is going. Allow me just to highlight a few trends pertinent to FDA regulation.
oThe predicted growth of mHealth is enormous. Driven by the trends identified above and more, most folks in the industry expect it to grow by leaps and bounds.
oWhile many of the apps used in mHealth reflect nothing more than portable information sources, some are much more than that. The future is wide open to technologies that will facilitate collecting information directly from sensors on the body and transmitting the data back to caregivers for treatment decisions. In the realm of medicine, even with sophisticated caregivers such as nurses, erroneous information can affect treatment. Further, it is not hard to imagine moving beyond simply sending information from the patient to the caregiver, but actually giving some of the devices along the way an ability to make therapeutic adjustments affecting the patient. All those factors affect risk, and that draws FDA’s interest.
oIn terms of business and technology models, in many quarters there is a clear desire to achieve interoperability. In a perfect future world, we may well have many technologies out there that can all speak to each other in a common language, working as one integrated system to share information and potentially make machine-driven decisions. The regulatory implications of what would effectively be an open network are mind-boggling, and discussed below.
oSome hospitals and other care providers are moving in the direction of purchasing components and developing integrated care systems. Further, some of these system developers, to achieve economies of scale and efficiencies, are renting out access to their systems to smaller hospitals and care providers. The implications of this were discussed in my last article on FDA regulation of care providers.
oTraditional medical device companies are diving into the connected health arena. Seeing the benefits of having their sophisticated medical devices plugged into HIT systems, these companies are exploring ways to connect most effectively.
oReimbursement for most areas of mHealth and indeed remote monitoring generally has been stingy. As a result, many companies exploring these markets are focusing on direct to consumer sales where the patient would pay out-of-pocket. That's important to FDA, because it directly implicates the agency's recently announced medical device home use initiative. In that initiative, FDA expresses both the positive benefits of providing better care in the home, but also questions the risks associated with untrained users trying to manage sophisticated equipment and the use of wireless communications.
Each of those trends directly affects the likelihood and possible nature of any future FDA regulation of mHealth. More on that later.
V. Political and Regulatory Trends
Two articles ago, I noted that Washington was signaling likely FDA regulation. I won't repeat that article here, but rather highlight a few trends in Washington.
oThe most direct trend is the language coming out of FDA quite specifically suggesting they plan to regulate HIT, and presumably many of its incarnations. Dr. Jeff Shuren, the Director of the FDA's Center responsible for regulating devices, said basically that in a February speech. Part of the basis for his declaration was the injuries reported to FDA due to hiccups in HIT systems. In the first couple articles in this series, I outlined the legal basis for FDA regulation of certain hardware and software involved in mHealth.
oOver the last six months, Sen. Grassley, an influential Republican, has been sending out letters expressing concern and asking questions about risks associated with HIT, and what FDA is doing about those risks. If you've read those letters, you might very well conclude the senator is not done addressing this topic.
oEarly in his presidency, near the height of the recession, Pres. Obama obtained authority to invest roughly $20 billion in HIT. That's the good news. Some critics have said the investment is premature because rolling out new systems is a complicated and delicate task that will take quite a while to do safely. As a result, while the Obama Administration seems committed to proceeding with its plan, clearly they will want to do so in a way that also protects the public from weaknesses in those systems.
oWith Congress and FDA focused on the safety of HIT systems, many policymakers have apparently concluded they need more data. To that end, FDA sent a letter to numerous hospitals a couple months ago asking them to more systematically and regularly report any problems associated with HIT. FDA apparently is trying to build a database on which to base future policy.
oThis spring, the FCC released The National Broadband Plan: Connecting America, which included sections encouraging FDA to work with FCC to devise a coordinated regulatory approach for connected health. On the one hand, it should be welcome news that FDA and FCC would coordinate to avoid duplication and inconsistency. On the other hand, that news probably prompts the fear of the unknown, since we really do not know where the agency collaboration might lead.
oOver the last couple of months, in discussions before the HIT Policy Committee, FDA's role in regulating HIT has been actively discussed, including the testimony of Dr. Shuren mentioned above. On April 25, the HIT Policy Committee sent its recommendations to Dr. Blumenthal. With regard to FDA, after discussing the pros and cons, the committee suggested that “the ONC work with the FDA and representatives of patient, clinician, vendor, and healthcare organizations to determine the role that the FDA should play to improve the safe use of Certified EHR Technology.” Wow, that’s helpful. In a speech on April 29, Dr. Blumenthal is quoted as saying “although [the] advisory committee concluded that more information was necessary, he called the evidence of the reports "anecdotal and fragmented" at best. I would infer Dr. Blumenthal wants to keep FDA out of mHealth. Indeed, the committee discussed creating its own regulatory scheme that would feature adverse event reporting. Last time I checked, though, ONC doesn’t tell FDA what to do.
oIn a May 24 workshop on the medical device home use initiative referenced above, the FDA confirmed it was drafting a guidance document on medical device use in the home environment with a particular interest on clarifying “wireless issues” related to medical devices used in the home. It is unclear what aspects of “wireless issues” the agency hopes to focus on, how broad that focus will be and what guidance is likely to come from the agency.
oFDA has started to receive premarket notifications for new cell phone apps related to mHealth. Apparently the agency is struggling somewhat to grant clearances for new apps on the basis they lack what is referred to as a predicate device. Consider the experience of MIMvista reported earlier this year, whose iPhone app for medical imaging failed to clear FDA reportedly because there was no predicate. As explained in the third article on software, for a new medical device to reach the market through the clearance process, there must be an existing, substantially equivalent software device on the market. If no such substantially equivalent device exists, the manufacturer is forced to go through the much more expensive and demanding premarket approval route.
Those developments each affect the likelihood and manner of possible future FDA regulation.
VI. The Fourth Estate
That's the media. And in our political and regulatory systems, the role of the media is important. Media attention to an issue routinely spurs our elected officials and even our regulators to act. For the good of society or for profit, the media has been paying attention to the question of FDA regulation of HIT and mHealth.
oIn some of the more ominous attention paid to this topic, the Huffington Post has been conducting an investigative report on injuries and other adverse effects of HIT systems. The Huffington Post has been sifting through FDA records analyzing trends associated with the use of these software-based products. Throughout this spring they have been publishing articles quite critical of the risk associated with these software products, and what they claim to be as FDA's inattention to the problem.
oAunt Minnie’s website in similar fashion has been doing investigative reporting on the need for FDA regulation of devices in this area.
oEven more mainstream publications have focused on this issue. In April, an article in Scientific American raised questions about how these important mHealth devices could escape FDA regulation.
oThose feature articles have caused a fair amount of discussion among bloggers.
And before Nick says anything, my articles have been educational, not critical.
So those are, in my view, the major vector forces to consider as we ponder what the future might look like for FDA regulation of mHealth. The next task is to add all those vectors up to see where they might take us. I'll do that in part two of this final article.
Part Two -- Calculating Applied Net Force
In part one of this article, I described the major forces bearing on the question of if and how FDA should regulate hardware and software used in mHealth. I laid out almost a Newtonian analysis of those political science forces. In this part, I add all of those forces together to calculate (okay, guess) where FDA is going. Actually, I wish it were as simple as the following diagram.
I'm guessing you want to know a little more specifically where FDA might end up.
I. Where do these forces collide?
The starting point is to understand where exactly these existing forces collide. In broad terms, they collide in two areas: proactive and reactive discussions.
There currently are a half dozen forums sponsoring proactive, constructive discussion.
First, as I mentioned in Part I of this article, FDA has undertaken to define home use medical devices through the creation of a special initiative. Until now, FDA has not articulated a clear regulatory pathway for devices intended for home use. In order to facilitate the development of medical devices that are safe for home use, FDA will develop a guidance document within 8-10 months recommending actions manufacturers should take to receive FDA approval. During a May 24 workshop, FDA signaled a strong intention also to address “wireless issues” pertaining to home use medical devices.
Second, various trade associations such as the Continua Health Alliance are engaged in dialogues with FDA regarding the requirements for interoperable devices. An important example of that is an ad hoc roundtable discussion among several participants in the FDA's January public meeting on medical device interoperability. That group meets periodically to develop what would basically be a mock FDA submission for an interoperable medical device platform. The goal is to develop a submission the agency would find acceptable, such that other folks in industry can use that submission as a model for their own.
Third, there is a very good opportunity to discuss these issues in an upcoming public workshop on “Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development.” This June 24 workshop will focus on identifying health needs that 1) affect many individuals (2) could be significantly improved by new devices and (3) the devices are not being developed due to barriers caused by FDA. To me, they might as well have said we would like to hear about mHealth. As I discuss below, the ambiguities around FDA regulation are significantly impeding investment in technologies that could make an enormous difference for those suffering from chronic disease. I would urge people to consider attending or commenting in writing, but don't mention I suggested it.
Fourth, there are governmental policy forums beginning to study and debate FDA regulation of mHealth. An example is an NIH initiative to gather leaders from throughout government and the private sector to look broadly at the policy and regulatory issues associated with mHealth research. A small group of those people met June 7-8 to debate some of the basic issues, and then the NIH Foundation will hold a broader meeting on November 8-10 to “convene leaders in research, technology and policy to share their expertise and draft a blueprint for the future of mobile health.”
Fifth, per the National Broadband Plan, the FCC will engage FDA directly in a meeting at the end of July. While that announcement has not yet come out (expect it very soon), the meeting is likely to address specifically the areas of overlap between the two agencies. At the same time, it's clear that FCC sees the benefit of mHealth and wants to identify ways to encourage it through public policy.
Sixth, at least some industry participants are beginning a dialogue with members of Congress regarding the nature and scope of the regulatory issues. At this juncture, those meetings seem to be mostly educational for members of Congress, but they may at some juncture result in further letters from members to the Administration expressing opinions on where the Administration should take mHealth policy.
Those proactive discussions may not be the last word: we may see some reactive discussions. As an observer of FDA over the years, I'm guessing that in addition to the direct dialogue, we will see the agency reacting through an enforcement action or two against what the agency considers to be egregious conduct. Often the agency will pick activity that is both egregious and high profile to be the subject of a warning letter. Sending such a letter begins a dialogue with the recipient, but also communicates to a broader audience. There may be some high profile products out there stepping over the line in a way that makes them likely targets.
II. The open substantive questions
Okay, so these forces collide in either proactive or reactive communication: where does that mean FDA is going? To address that, I will identify six basic open questions, and suggest how they might be resolved through these discussions.
1.Scope of FDA Regulation
Hardware and software companies need to know which mHealth products FDA regulates, but unfortunately the answers aren't always clear. For example, FDA generally regulates medical intended uses for products, but not products directed at general wellness or fitness. The problem is there's a whole lot a gray area between those categories. As examples, there are mobile phone apps focused on helping people with weight loss and everyday management of diabetes. When might certain claims in those areas trigger FDA regulation?
Further, it might be obvious that a blood glucose meter is a medical device. But as that device connects to a cell phone which connects to a server somewhere which connects to a doctor's computer, where does FDA regulation begin and end?
Rather than just focusing on what the statute authorizes, I would hope that industry and FDA through discussion could arrive at a risk-based model that limits FDA's active regulation to those devices where a malfunction could realistically hurt someone.
2.The Level of FDA Regulation
FDA's medical device regulatory scheme is deliberately risk-based and stratified. Currently, high-risk medical devices such as certain cardiovascular therapeutic devices are regulated quite extensively. When those devices get connected to a doctor's office either through a dedicated pathway or through a mobile phone, it is unclear whether the communication devices that carry the signal should also be considered medical devices regulated to that same highest level.
Here again the resolution is likely to be risk-based. Industry and FDA will need to bring many of their various risk assessment tools to bear on assessing at which junctures in the connected lines of communication risk is the greatest, and the regulatory requirements will likely focus on those junctures. By using risk assessment tools, industry may be able to convince FDA the cell phone is not a significant source of risk, and therefore should not be subject to much regulatory scrutiny.
3.Network Intended Use
The existing medical device regulatory scheme does not embrace a network mentality. Individual medical devices are cleared or approved for specific, individual uses. Very rarely would FDA clear a medical device for unspecified interoperability with a whole class of other medical devices. But that interoperability is precisely Continua’s business model. Further, FDA has a long-standing rule that when two articles are sold together expressly as a kit, the combination of devices changes their intended use and requires special clearance for the kit unless exempt or the individual clearances already contemplate the kit.
FDA will need to come up with a regulatory model to address devices cleared to a standard that allows them to interoperate with other such devices, where the range of other possible devices is open-ended. As with its other regulatory challenges, FDA likely will develop this model on the basis of risk management tools. The agency will have to identify the features and characteristics that produce risk, and develop appropriate regulatory requirements to assure the safe and effective performance of devices with those features and characteristics. Compliance currently is especially difficult in the area of design controls, which do not contemplate open-ended, interoperable claims.
The development of this new regulatory model will require substantial interaction with industry to arrive at something practical. Indeed, this is part of the work of the ongoing dialogue between Continua and FDA, stemming from the January meeting on interoperability.
4.Standards for Clearance
For those mHealth products that do require FDA clearance, manufacturers need to know whether FDA has any minimum requirements addressing such areas as--
oLatency
oHuman factors design issues
oLimits on appropriate user
oAbility to use open source platform
oAcceptable use environments
oUsability issues
oProtection against interference by other software
oSecurity
Again working with industry, I suspect FDA will develop basic standards in those areas based on risk, but don’t expect those standards to be written any time soon. Normally FDA hangs back on committing such information to writing until they have substantial experience with a new technology.
5.Hospital-Directed Modifications
As I discussed in the seventh article in this series, hospitals and other healthcare providers often modify systems or even act as integrators of a variety of components to produce mHealth remote monitoring systems. Under the law, when they do so, FDA might decide the hospitals are functioning as manufacturers and regulate them. In that article, I ran through a variety of factors that impact the likelihood of FDA regulation.
Eventually, FDA hopefully will come out with some guidance to define the circumstances in which hospitals and others can serve as systems integrators without having to meet the specific requirements of FDA's medical device laws. This can be done under the FDA's enforcement discretion. The factors that FDA might consider would be probably similar to the ones contained in my earlier article, including the risk associated with the specific activities of the hospital, the scale of the activities, and the availability of suitable systems designed and made by FDA-registered manufacturers.
6.Multiple Vendors—Post Market Compliance Issues
Often multiple hardware and software components are connected to form an mHealth system, for example a blood glucose meter, a cell phone, a server, and a PC in the doctor's office. In those cases, when something goes wrong and an erroneous result is displayed on the doctors monitor, which component manufacturer has the postmarket obligations to report the so-called adverse event to the FDA? If it's not clear where the hiccup occurred, who would have responsibility to investigate and fix the breakdown?
The medical device laws contemplate relatively clear responsibility, and do not take into account the concept of a network of interconnected devices. As a result, these postmarket obligations are ambiguous in this context. FDA will have to work out some practical rules for assigning responsibility to one particular manufacturer when a network produces erroneous results for unknown reasons. Through discussion with industry, the FDA will probably come up with rules of thumb for identifying the device that either embodies the most risk or is otherwise most likely to be responsible for the failure.
III. Suggestions for Advocacy
1.Arguments to Use
I don't want to pick on Nick, but the sentiments he expresses in his Crying Wolf post are similar to what many in the IT industry are saying. At its essence, they're suggesting mHealth technologies are too important for FDA to regulate. To be blunt, I would urge all those connected with the mHealth industry to stop making that argument. Rather than helping, it's hurting your cause.
The issue of importance actually cuts the other way, in favor of regulation. Saying that mHealth is too important for FDA to regulate is a little bit like saying a patient is too sick to need a doctor. FDA only regulates products that are important, and the more important they are, the more FDA feels the need to regulate. FDA expends its greatest amount of time and resources on class III medical devices, which are arguably the most "important" in a clinical sense.
Second, please don't simplistically argue FDA shouldn't regulate mHealth because we need innovation. The argument suggests that we don't need innovation for those areas FDA does regulate, like traditional medical devices, but that's kind of silly. I suspect most patients would say that they want innovation in medical devices that can save their lives.
At the end of the day it's not the importance of the technology or the need for innovation that determines whether FDA should regulate, but rather balancing the benefits of regulation against the harm of regulation. And the benefit of regulation is the protection of the patient. So in my mind, the policy debate should be around whether the risks of any particular mHealth technology merit the cost of regulation, where that cost includes not just the cost of compliance by the company but also the inhibition on innovation of helpful products.
2.A New, Temporary Coalition
Nick and I probably share quite a bit of common ground in that I suspect we both believe there are a number of technologies used in mHealth where balancing those factors would lead a reasonable person to conclude that regulation is unnecessary. Because of that, recently several of us got together and announced the formation of a coalition—the mHealth Regulatory Coalition or MRC-- to develop a consensus among industry participants regarding the scope of what FDA should and should not regulate in the area of mHealth technologies, and propose that approach to FDA for adoption. Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health of FDA, as the recent annual meeting of FDLI invited industry to propose guidance documents on policy issues of importance to industry. FDA will take those documents, make any changes they feel are necessary, and then propose them for formal adoption. We think this topic is ideal for a proposed guidance.
The MRC is very narrowly focused on the one task, and indeed is only temporary. It will only continue so long as it takes to complete that task, hopefully within months. We are inviting members of the mHealth industry to participate alongside existing trade groups to be inclusive. We plan to have our first meeting on July 8 in Washington, to get organized.
Our concern is that there are a variety of companies and investors sitting on the sidelines out of fear they may be regulated. The uncertainty is helping no one. We plan to tackle the scope of FDA regulation head on by developing a proposed list of mHealth technologies and intended uses that FDA should regulate, and a list of those they should not. Our preference is to achieve as much specificity as possible, so we can move closer to the efficient frontier.
IV. Speculations
FDA obviously will regulate at least certain hardware and software used in mHealth, such as the blood glucose meters they already regulate. As to exactly where the line will be drawn around the scope of FDA regulation is yet to be determined, and I suspect will be very much risk-based, and determined by an evaluation of the evidence. FDA doesn’t have to actively regulate everything the statute says is a medical device, and the agency routinely draws lines short of everything it could theoretically regulate. Helping them figure out where to draw that line is industry’s job, subject to all of the other forces being exerted on the process.
The mHealth industry will thrive: it has to. We need it to. But along the way industry will adapt to whatever regulatory scheme ultimately emerges, and likely much of that adaptation will be accomplished through partnerships typical of a network technology industry. So, to ensure mHealth reaches its potential, we need to figure out creative and effective ways to work together. I'm confident we will succeed.
