MOBILE MEDICAL APPLICATIONS

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1 October 7, 2013 EVOKE HEALTH POINT OF VIEW MOBILE MEDICAL APPLICATIONS FDA GUIDANCE FOR INDUSTRY FOR MORE INFORMATION: Mark McConaghy, VP, Strategy Evoke Health

2 INTRODUCTION On September 23 rd the FDA released its final guidance for mobile medical applications (apps). The document defines those mobile medical apps that are, by their intended purpose and definitions under federal regulation, medical devices. Furthermore, this guidance categorizes them based on potential level of risk to the public health. Most importantly, the document clarifies which types of apps will require FDA regulatory oversight and approval, and those for which the FDA will exercise enforcement discretion. In this Point of View, we define the Evoke Health position on this important topic, and provide an easy-to-use resource as well as additional details that will help marketers make critical decisions when deciding if a mobile app is right for their brand. Marketers are now able to proceed with their mobile application development efforts, knowing whether or not FDA regulatory approval will be required for their specific app. This affects projects that may have been previously stalled due to apprehension toward device regulation, including apps that would be beneficial to patients and prescribers, while advancing brand objectives. Examples of these include apps that are intended to provide coaching, health tracking tools, documentation or sharing of medical records and information, or disease progression details with a physician, as well as those that perform simple calculations. EVOKE HEALTH POSITION The new FDA guidance provides an opportunity for brands to move forward with concepting and developing apps that pose low risk according to the FDA. These apps will not be subject to FDA regulatory requirements and will not require a pre-market FDA submission. As a partner of marketing and commercialization teams in the pharmaceutical industry, Evoke Health is committed to achieving pharmaceutical brand objectives through innovative yet appropriate methods that are derived from a sound strategy. For this reason, Evoke will never recommend the development of an app, simply for the sake of developing an app. Our recommendations for the development of mobile medical apps will always be based on customer insights, which we define through patient journeys, touch-point evaluation, and needs analysis. Historically, those needs that may be addressed through innovative mobile applications tend to fall within the classifications for discretionary oversight by the FDA and can therefore be developed through marketing groups with little risk for regulatory enforcement, eliminating potential repercussions of an FDA warning letter. Evoke has created a decision tree, featured on the following page, to provide a reference to our teams and clients when developing mobile medical apps. This tool highlights the main considerations when determining the review requirements for mobile medical app concepts. 2

3 EVOKE HEALTH MOBILE APP DECISION TREE 3

4 BACKGROUND Previously, the FDA released draft guidance in July 2011 that defined the standards by which an app would be considered a medical device and therefore, subject to regulatory review and oversight. The guidance focused specifically on mobile apps, which in this case, can be defined as software applications designed to run on a handheld device, including apps that run locally, as well as those whose main functions are performed through an external server. According to the final September 2013 guidance, the definition of what a medical device is and is not, has not changed significantly. The determination of status is based on the primary goal of the app whether the app is either informative vs. directive. This key definition, provided in both the draft and final guidance, of an app that falls under regulatory guidelines for approval, is based on the definition of a device in the Federal Food, Drug and Cosmetic Act: Any app, that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man, is a medical device and therefore subject to regulatory guidelines for approval. Under the 2011 draft guidance, virtually all applications that utilize the functionality provided in today s smart phones and portable/tablet computers, with an intended health benefit for patients and clinicians, would fall under this definition. The result was apprehension on the part of many marketers and manufacturers to confidently proceed with the development of mobile medical apps due to the challenges of regulatory submissions for medical devices. Mobile Medical Application Categories Apps that clearly fall within FDA oversight include those that connect to and interact with an external medical device, those that perform the actions of a medical device by using attachments, and those that provide patient-specific diagnosis or treatment recommendations, such as by using patient-specific information to map out a dosage plan for radiation treatment. 4

5 The key update to the final guidance document is the acknowledgment by the FDA that many mobile medical apps fall under the definition of a medical device, pose little-to-no potential health risk to the public. For these apps, the FDA intends to exercise enforcement discretion, meaning that the FDA does not intend to proactively enforce requirements. These low-risk apps for which the FDA intends to use enforcement discretion are divided into six primary categories: 1. Apps that facilitate or supplement clinical care (e.g., a diet and/or exercise planner for patients with diabetes) 2. Apps that provide organization or tracking tools (e.g., dosing reminders, symptom trackers) 3. Apps that provide easy access to information (e.g., a drug-allergy search tool) 4. Apps that document or communicate information to healthcare providers (e.g., stored photos of a patient s skin symptoms to share with their dermatologist) 5. Apps that perform simple calculations (e.g., a Body Mass Index (BMI) calculator) 6. Apps that enable individuals to interact with electronic health records systems (e.g., a tool for patients to view their own medical history) Lastly, the guidance document also defines those apps that are not classified as devices, and are therefore not subject to review, direct or discretionary. Simple patient education apps, for example, will not require FDA review. Examples of these patient education applications include: Unbranded Disease Education FAQs Excerpts from a Peer Reviewed Text Book Clinical Data from a Medical Study To assist in avoiding confusion over the guidelines, the FDA recommends that marketers reach out directly with any questions regarding whether a specific mobile medical app concept falls within FDA oversight. Marketers can submit questions to 5

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