I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds.
Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The group seems to be concerned that regulatory systems adopted years ago may not make sense for the technology of today. I happen to agree with them in many respects. In fact, this week my law firm will submit to the federal government our white paper entitled: “Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization.” The paper is designed to encourage innovation in e-health, and especially mHealth, and outlines specific changes needed to modernize the FDA regulatory system to effectively address unique aspects of e-health.
But somehow, from the fact that the FDA regulatory system is antiquated and in need of modernization, this DC advocacy group concluded that FDA publishing this summer its final guidance on mobile medical apps is a threat to what they want to accomplish on Capitol Hill. I do not understand that. Their concerns do not seem to be based in the substance of the guidance or the regulatory realities facing mHealth entrepreneurs today.
Nevertheless, in a letter that was obliquely written, the advocacy group, together with other groups they invited to join in, requested that HHS slow down its policymaking. Specifically they asked HHS not to release any new agency guidance on HIT until after January 2014 when HHS is scheduled to make strategic recommendations to Congress called for under section 618 of FDASIA. The apparent target for that requested delay is the publication of this FDA MMA guidance.
It’s that action-- working to stall the FDA guidance-- that I believe is hurting mobile medical app entrepreneurs. And the crazy thing is I believe it’s mostly based on a misunderstanding.
Before I explain all of that, I want to invite you to do something. In the comments section after this post, I want you to challenge me on any fact contained in this post. If I can’t prove any fact I state in this post, frankly you should never listen to me again. We have simply got to get away from rhetorical flourishes and baseless assertions that are so prevalent in Washington, and get down to the facts that can be demonstrated. So please, hold me to that standard.
Okay, let’s look at the facts.
Fact No. 1--FDA already regulates mobile medical apps.
FDA has regulated mobile medical apps for as long as mobile medical apps have been around. Delaying the release of the final guidance won’t change that. Ironically, as I discuss in Fact No. 4 below, it is actually the release of the final guidance that will change that.
FDA has regulated software used for medical purposes since at least 1976. Paraphrasing slightly, section 201(h) of the Federal Food, Drug and Cosmetic Act subjects to FDA regulation any software (the statute uses the word “contrivance,” which FDA long ago concluded included software) intended for use in the diagnosis or treatment of disease. It's really that simple. FDA has reviewed scores of medical software premarket submissions and published numerous guidance documents on a wide variety of software issues over the last 30 years.
To illustrate this point, according to a report published by this website, there are over 75 mobile apps that FDA has already reviewed and cleared for market. To further illustrate this point, this spring FDA brought an enforcement action against Biosense because they were making a mobile app that would be used to perform urinalysis. The app used the camera on the phone to analyze the color change in a reagent test strip after it's dipped in urine. Before the mobile app, this kind of analysis was done using a machine about the size of a cash register.
Some people are living either in denial or ignorance, thinking FDA doesn't regulate mobile medical apps now and if we can just keep them from publishing this guidance they won't in the future. But they are simply wrong. FDA already regulates mobile medical apps and will continue until the final guidance is issued.
Please recognize that throughout these last few paragraphs I have steadfastly used a very precise term: mobile medical apps. FDA does not regulate all apps, just those that qualify under the statute. Want to know which apps qualify? Read the proposed guidance on mobile medical apps! You will see that there are scads of mobile apps that FDA does not regulate, even though they might be found in the health or medical section of iTunes.
Fact No. 2 – FDA guidance is only for educational purposes and cannot create regulatory requirements.
It might surprise you to know that being a lawyer actually can be useful. For one thing, we are trained to know the difference between a regulation and a guidance. Nonlawyers could be excused for breezing by that distinction, but the difference is critical. Agencies publish “regulations” to create law, and they publish “guidance” to explain it.
The question we are debating is whether FDA should publish a mobile medical app guidance to explain the requirements in plain English, not to create any new requirements.
In the old days, before the mid-1990s, if you wanted to understand FDA requirements you needed to hire a lawyer like me. It took someone like me to explain the requirements because the law was written in obscure statutory language and voluminous regulations, and explained in (1) personal interaction with agency officials, (2) speeches to small groups and (3) private enforcement letters. If you were not an insider, you really couldn’t understand the law. Instead you needed to find and hire an insider. Life was good, at least for attorneys like me.
In the mid-1990s, coincidentally as a result of a citizen’s petition I filed with FDA, the agency agreed that it needed to start being more transparent in a way that laypeople can understand what the law requires without hiring a lawyer. Filing a petition was probably not the best business decision I’ve ever made, but it seemed like the right thing to do. Getting FDA to agree to go in that direction was a lot of hard work over several years, and I had to testify before Congress and encourage legislation. But eventually FDA adopted a comprehensive set of “good guidance practices” through which FDA would level the playing field and let all people, and especially nonlawyers, understand how the agency was applying the statutes and regulations.
Equally importantly, it’s quite clear that guidance cannot replace regulations and cannot be used by FDA to expand its jurisdiction or to impose new requirements. Indeed now, by law, every single guidance document has to contain the disclosure: “Guidance documents represent the Agency's current thinking on a particular subject … [and] do not operate to bind FDA or the public.” And thankfully, we lawyers are ever vigilant to read guidance documents in an effort to make sure that they do not go beyond the existing law.
Bottom line: as explicitly stated in FDA’s regulations, a guidance can’t create new law; it merely explains the law in language that is more accessible to all, so people don't have to hire me. Most people, except my accountant, think that’s a good thing.
Fact No. 3 -- Innovators need the guidance to understand their existing obligations.
Okay, this one’s going to be a bit hard to prove for every innovator. Instead, I’ll have to resort to anecdotal evidence. Let’s take Biosense, the developer that produced the urinalysis app. They seemed to genuinely not know or understand that a mobile app for urinalysis would be regulated in the same manner as a dedicated instrument for urinalysis. Candidly, this is a common misperception.
Part of the problem is that all of the media coverage over the summer has confused people into thinking that somehow FDA’s failure to publish its final guidance means that apps are not regulated. But that’s simply not true.
To illustrate why it’s so important that we let FDA clear the air on what is regulated, I frequently read errors in the blogsphere where someone tries to characterize the scope of FDA regulation in relation to mHealth. Take an article published by Forbes last Thursday. The author, commenting on whether there really is a business opportunity in mHealth, used the example of an EKG tracker. After commenting on some practical challenges, he went on to observe:
"… there are regulatory … [challenges], as well. When medical information is sent directly to the physician or imported to the patient’s medical record, the tracker becomes a “medical device” and must be approved by the Food and Drug Administration (FDA).
Imagine if these regulations applied to a bathroom scale. Of course, there is no regulatory oversight necessary if a doctor instructs a patient to monitor his own weight. But if that same patient’s weight is sent directly to his physician, the scale would need to be approved by the FDA – adding significant cost to device manufacturers, consumers and the health care system."
I don’t want to nitpick, but there are multiple errors in those statements. Not to get too technical, but:
1. Whether an app is somehow connected to the doctor or the patient’s medical record does not determine its FDA regulatory status. What matters is whether the app is intended to be used in the diagnosis or treatment of disease. That includes monitoring. So even if the patient never shared data with her doctor, if the app is intended to be used in in the diagnosis or treatment of a disease, FDA regulates it.
2. If all the app does is transmit data to the physician or the medical record, then it is considered a Medical Device Data System and it is regulated by FDA in Class I. That means no FDA approval is required.
3. The second paragraph involves the distinction between intended use and actual use. “Intended use” is a term of art and is what FDA looks at to determine if something is regulated. The point here is if the maker of the scale did not claim that the scale and any software used to connect to the Internet had any special features that somehow make it safe and suitable for monitoring weight in connection with a disease, it would not be regulated. It doesn’t matter whether in actual use the patient decides to send data to his physician. It’s still not regulated.
4. If, on the other hand, the maker of the scale decided to make claims regarding the suitability of the scale specifically in association with monitoring disease or health condition, the scale would likely be in Class I, and, again, not subject to FDA approval.
I want to be clear that this is not the author’s fault. There is so much bad information out there right now on this topic that it’s almost impossible to know what the rules are. I am simply trying to make the point that we would all be better off if we let the FDA publish guidance that explains these regulatory parameters in language that all stakeholders can understand.
Further, it defies reason that a group of organizations would sign a letter to the HHS Secretary objecting to FDA's attempt to explain clearly and cogently what the law already requires. These people who are opposing the guidance are in effect saying that software entrepreneurs should be kept in the dark about what the existing law requires. This seems to hurt entrepreneurs for all the obvious reasons but it also potentially creates the risk of criminal violations. The FDA laws are, after all, criminal statutes.
Fact No. 4 – FDA is trying to deregulate certain mobile apps.
While FDA can’t create new law through guidance, it actually can shrink the law. Federal law gives the agency discretion not to enforce certain laws if they deem them unnecessary to protect the public health, and this is one of those instances.
A lot of people could be excused for not reading the footnotes in the draft mobile medical app guidance. But footnote 13 of the draft is incredibly important. It says that FDA would like to use its enforcement discretion to not impose its regulation on certain categories of apps that it believes fall within the statute. This category includes those apps that, among other things, “allow individuals to self-manage their disease or condition.” That is huge for mHealth.
Many of the most exciting apps are those designed to give consumers the ability to take better care of their disease. The following is a list of mobile apps that FDA believes fall within the medical device definition, but that FDA would like not to regulate:
1. Medication reminder apps for therapy adherence
2. App for tabulating an apgar score
3. App for calculating drip rate for IV solution
4. BMI calculator apps for use by patients and physicians
5. Apps that help flag drug-drug interactions for physicians as they prescribe
6. Diabetes management guide apps such as nutritional guides or pre-diabetes risk assessments
7. Apps that offer behavior guides to help, for example, wean off smoking
8. Calorie counters that would be specifically marketed to obese people or other people with health conditions trying to manage weight
9. Cancer management apps manage medication schedules, and allow the patient to diary side effects and symptoms for reporting to their doctor
10. Asthma management apps to assess symptoms, medication use and breathing data entered by the user to tell the user when their risk is changing
11. Hypertension apps to help users log and chart their blood pressure, set medication reminders, record medicine taken, and share data with their doctor
12. Arthritis management apps containing screening tools and questionnaires to help users determine the type of arthritis, provide treatment strategies and medication information, as well as information on diet and nutrition
13. Chronic pain (fibromyalgia, headaches) management apps to help users track symptoms and triggers; weather conditions (humidity, pressure); photo attachments to document swelling, rash, discoloration; and interactive graphs of symptoms vs. weather to be shared with their doctor
14. An app to help users who suffer from Chronic Kidney Disease (CKD) or End Stage Renal Disease (ESRD) make better decisions about their diet, by tracking their daily intake of certain nutrients and comparing their consumption to guidelines their nephrologist and nutritionist have set for them
15. Digestive disease (Crohn’s disease) management apps to help users record and track their food and fluid intake along with when symptoms arise and the time they take pain medication, all logged so a report may be generated for the doctor to review and analyze
There are entrepreneurs wanting to make apps in those categories who need the final guidance so that they can avoid the costs associated with complying with the FDA requirements. But unfortunately, politics seems to be holding that regulatory action hostage, so in the meantime these apps remain actively regulated.
Keeping FDA from publishing the final guidance is also keeping FDA from letting these consumer apps off the hook. FDA uses guidance to not only express enforcement discretion to the public, but also to direct its internal personnel. FDA needs to publish this guidance both to let entrepreneurs know what’s regulated, and likewise to let its own reviewers know that they can stop regulating some of these low risk apps.
Freeing the guidance will free these apps!
Fact No. 5 – Section 618 of FDASIA does not require FDA to wait to publish its guidance.
The Washington advocacy group argues that the publication of the final guidance should await the completion of the FDASIA section 618 process. I sit on the FDASIA workgroup, and indeed I co-chair the Regulations Subgroup. The opponents of the FDA guidance raise the existence of this workgroup as a reason that time should stand still in all HHS policymaking related to HIT. I do not understand that argument.
For starters, the issue of whether FDA should await the completion of the FDASIA process was specifically discussed on Capitol Hill in 2012 when the legislation was written. Indeed, the first draft of section 618 included a moratorium on the FDA publication until after the process was completed, precisely what these Washington advocates are now requesting. But as the people on the Hill discussed the issue, they came to realize that there was no reason to wait and the moratorium language in the legislation was removed. Since the issue was resolved legislatively over a year ago, that should end the discussion. But, alas, I have to admire their persistence.
So let’s get on to the substance. Given the content of the FDA guidance, why on earth should the agency wait to publish it until after the FDASIA process is completed? The two topics bear almost no relationship. In this working group, we have never even discussed the need for FDA to change its approach to the MMA guidance.
Further, the working group will finish its activities on September 4. The next step is for the agencies to develop the strategic recommendations they plan to make to Congress. Since the agencies have publicly explained that they worked together on the MMA guidance, there would seem to be no reason to wait until they finish that strategy. They already agreed on the content of the MMA guidance. What could change this fall?
So all that leaves is Congress. That’s the only variable that could impact the MMA guidance. But any congressional action is quite uncertain and almost certainly quite some time off. Surely these Washington advocates don’t intend to tell these entrepreneurs trying to bring new consumer apps to market that they should simply subject themselves to FDA regulation while they wait for Congress to get all of these issues resolved?
As a public record reflects, the FDASIA working group discussed the need to release the FDA guidance as part of its deliberations and recommended in no uncertain terms that FDA move as quickly as possible to publish the MMA guidance. There simply is no reason to wait.
Conclusion
Exactly why should FDA not publish this particular guidance? What harm does it do? It doesn't expand regulation one iota, and indeed FDA is trying to deregulate some of what it already regulates. Those who are opposing the publication of the final guidance are stifling medical mobile app entrepreneurs by (1) denying them educational materials written in a way that translates complicated legalese into simple language, and (2) delaying FDA action designed to let a whole slew of consumer apps out of existing FDA regulation. That doesn’t sound like good policy to me.
