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.