I wanted to share my thoughts on one of the FDASIA Workgroup recommendations. This blog post may be a tad long by social media standards but bear with me—this is an important topic for anyone doing work in the mobile health app space.
Regulated businesses and the public both benefit from regulatory certainty—when regulators clearly state the scope of their regulations, and leave little doubt about what is regulated and what is not. The need for such clarity is heightened in a new industry. At Qualcomm, for several years now, we’ve been working with the US government and a host of others in the private industry to gain certainty for mobile medical apps that are increasingly available for many health and medical related purposes.
In this regard, on September 4, 2013, a wide ranging group of stakeholders involved in healthcare, patient safety, the US government, and the mobile industry known as FDASIA released its final Committee Report to the Health IT Policy Committee (HITPC), which is an important Federal Advisory Committee within the US Department of Health & Human Services under the Office of the National Coordinator for Health IT (ONC). The HITPC will deliver the FDASIA report to three federal agencies including the Food and Drug Administration (FDA), ONC, and the Federal Communications Commission (FCC).
On page 37, of this report, the FDASIA group makes the following unequivocal statement: “FDA should expedite guidance on HIT software, mobile medical apps and related matters.” The report goes further (Page 51) to explain that the FDASIA Workgroup has “described current regulatory frameworks, potential new approaches, and deficiencies, ambiguities and duplication in current frameworks” in addition to having “described what we believe will be helpful to promote innovation in both the short and long term and maintain patient safety.” The word “short” is crucial because the mobile industry has been urging the FDA to finalize its mobile medical apps guidance document for a couple of years now. The report (Page 52) goes on to state that “The agencies should address the deficiencies, ambiguities and duplication the FDASIA group has identified.”
To further emphasize these points, the adjoining two-page report produced by a FDASIA subgroup provides further background: “Within current regulatory frameworks there exist mechanisms that the Food and Drug Administration (FDA), the ONC, and the Federal Communications Commission (FCC) could use to promote innovation, protect patient safety and avoid regulatory duplication (and cost). New frameworks aimed at stimulating innovation may be helpful as well.”
Taken in part or in whole, these recommendations are clear: the FDA should move forward and expeditiously release the final Mobile Medical Applications (MMA) Guidance Document, which has been in process now for several years. It’s time to give the industry and the public this much needed, educational, non-binding, deregulatory, snapshot of the FDA’s “current thinking” on what would be subject to regulation and what would not. It is our hope that the recommendations by FDASIA’s Workgroup and the adjoining Report of the Regulations Subgroup finally lay to rest any controversy surrounding the issuance of the MMA.
In April of this year I received an invitation to serve on this Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup. The origin of the Workgroup is a law titled the Food and Drug Administration Safety and Innovation Act (“FDASIA”). President Obama signed the FDASIA into law on July 9, 2012. The FDASIA Workgroup and its three Subgroups (Taxonomy, Regulations and Risk and Innovation) is composed of industry, patient advocates, healthcare providers, start-ups, health plans, venture capital investors, information technology vendors, other stakeholders and federal ex-officio members from FDA, ONC and FCC.
The thirty-two members of the FDASIA Workgroup were chosen based on our individual expertise and relevant experience. It was an honor to be selected to represent Qualcomm, and the broader interests of our industry. It was also humbling to serve along side such a distinguished group of stakeholders. I not only participated on the FDASIA Workgroup but joined two of the three Subgroups (the Regulations Subgroup and the Risk and Innovation Subgroup). During the past four months, the FDASIA Workgroup met nearly three dozen times through virtual meetings and conference calls. The meetings typically lasted 2-3 hours and sometimes we met three times per week. The schedule was intentionally grueling in order to maximize our ability to deliver a comprehensive list of recommendations.
The FDASIA Workgroup was charged to provide expert input to the FDA, ONC, and FCC, to help inform the development of a report by those three agencies on “an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.”
It’s a mouthful but consider what’s at stake here: a recommendation to create a “risk-based” regulatory framework for health IT, mobile health and mobile medical apps that would in essence replace the current regulatory framework, potentially changing the way FDA regulates all medical devices, not just health IT and mobile medical apps. Regardless of where one stands, FDA currently uses a “risk-based” regulatory framework that governs all medical devices and products. It’s rooted in over 100 years of historical legislation and events, made up of more than 200 laws that are the bulk of an incredibly complex and extensive system tailored to ensure the safety and efficacy of medical devices with the goal of protecting public health.
Thus, another way of looking at our charge was to also consider how current regulations and policy could be more effectively utilized to enhance innovation while ensuring no diminishment to patient safety. In fact, it was my deep belief that any recommendation from the FDASIA Workgroup had to contain a new or future “appropriate, risk-based regulatory framework” but also a proposed strategy and recommendations on how to address the current deficiencies, ambiguities, and regulatory duplication among federal agencies, emphasis of course on the three agencies participating in FDASIA. Simply said, a number of us interpreted Congress’ intent for “a regulatory framework” to also include existing mechanisms that could promote innovation and protect patient safety.
The rationale for this was simple. The evolving health IT industry along with the nascent mobile medical apps development community needs immediate clarity and relief from burdensome regulations. Any future or “new” framework could take years to develop, as it may require legislative action, millions of taxpayer dollars, further rulemaking and subsequent implementation. In the meantime, a nascent industry could be stopped in its infancy. Time kills innovation; and this issue has dragged on for far too long.
Over two years ago, on July 21, 2011, the FDA issued its draft guidance document. This document signaled an important and encouraging first step to notify the public and all those interested that FDA wanted to provide clarity on what constitutes a mobile medical app (i.e., explain which apps are considered medical devices based on what they do and how they are sold as defined under section 201(h) of the Food, Drug and Cosmetic Act). The issuance of this draft guidance started a 90-day comment period during which FDA accepted comments from over 100 organizations and interested parties. In addition, FDA held a public two-day workshop bringing together hundreds of stakeholders to discuss the merits and nuances of this draft guidance.
But somehow, this instructive document intended to lift the fog of ambiguity created quite a controversy in Washington policy circles. Inexplicably, a number of groups vehemently opposed the issuance of the MMA guidance. They seemed to want to stifle FDA’s ability to issue any guidance while they worked to limit the way FDA regulates medical devices, in particular health IT and not just mobile medical apps. Qualcomm did not agree with this approach and from the beginning, we argued for the immediate release of the MMA. In a presentation I prepared nearly a month ago, I surveyed my favorite myths related to the proposed MMA. They include the following untrue claims:
- The mobile medical apps guidance document regulates mobile medical apps
- FDA has not historically regulated mobile medical apps
- FDA is creating new regulations for mobile medical apps
- FDA is expanding its regulatory authority to include mobile medical apps
- The guidance expands the number of mobile medical apps FDA will regulate
- FDA intends to regulate all mobile medical apps
- If they don’t finalize the guidance, FDA will not regulate mobile medical apps
- FDA does not currently regulate software (e.g., mobile medical apps)
- The mobile medical apps guidance document is contingent on FDASIA recommendations
- FDA intends to regulate your smartphone!
All of these are of course, untrue. FDA guidance is non-binding; the FDA regulates anything with an intended use as defined by the law (including software and apps); FDA is not creating new regulations on mobile medical apps; FDA is not expanding its regulatory authority; FDA is moving towards de-regulation not regulation; FDA has always regulated medical device software; FDA does not have the authority to regulate consumer products that are not medical devices; etc. My favorite myth is “the mobile medical apps guidance document is contingent on FDASIA recommendations.” In fact, in a Senate amendment to the original FDASIA Bill, the notion of delaying the issuance of the MMA guidance document was introduced – and subsequently removed from the final FDASIA law.
Public statements by several FDA officials suggest precisely the opposite of the above list of misleading claims. In fact, FDA has maintained it hopes to deliver a document that would delineate how FDA would exercise its “enforcement discretion” – meaning the FDA intends to exercise its discretion to not pursue enforcement actions for violations of some low-risk medical devices. In other words, FDA will not actively regulate those mobile apps that may be medical devices but are of such a low-risk to human harm that it makes no sense to have those manufacturers and developers register with FDA, list their devices with FDA and then endure burdensome good manufacturing practices (all of which are part of the general control requirements for regulated medical devices). This seems like a pretty good thing for the garage entrepreneurs and developers who are the driving force of the mobile health and mobile apps development community.
Regardless, the FDASIA external Workgroup has independently delivered its final recommendations recognizing the importance of expediting guidance on HIT software, mobile medical apps and related matters. I could not agree more, which is why Qualcomm fought to keep this reference in the final Committee Report and hopes the FDA moves to finalize and publish the MMA guidance document as soon as possible.