1. Geneva, Switzerland, 25-26 September 2012 Mobile Medical Applications The FDA Regulatory Approach Prof. Lucien Rapp, Avocat au Barreau de Paris, Watson, Farley & Williams LLP lrapp@wfw.com ITU Experts Group Meeting on m-Health: Towards Better Care, Cure and Prevention in Europe Geneva, Switzerland, 25-26 September 2012

2. The FDAs Path 1989 : FDA preparing a general policy statement : « Draft Software Policy » (withdrawn in 2005) 2011 (Feb.15) : FDA regulation down-classifying certain computer-or software-based devices (MMDS - Medical Device Data Systems) from Class III (high-risk) to Class I (low-risk) 2011 (July 21) : FDA issuing its Draft Guidance on Mobile Medical Applications 2012 (July 31) : FDA Safety and Innovation Act (FDASIA) (including the MDUFA - Medical Device User Fee Amendment III) 2012 (December) : the FDA to finalize its MMA Guidelines

3. The FDA Approach of MMA Medical apps include a variety of functions, ranging from assisting individuals in their own health and wellness management to improving and facilitating the delivery of patient care 500 millions smartphone users worldwide will be using a healthcare application by 2015 The use of mobile medical apps is revolutionizing healthcare delivery The draft approach calls for oversight of only the medical apps that present the greatest risk to patients when they do not work as intended The FDA recognises the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps and potential benefices and risks to public health

4. The Scope of the FDAs Draft Guidance on MMA The agencys draft guidance defines a small subset of mobile medical apps that impact or may impact the performance functionnality of currently regulated medical devices The subset includes medical apps that are used as an accessory to medical device already regulated by the FDA (for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image on smart phone or mobile tablet) transforms a mobile platform into a regulated medical device (for example an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms)

5. From Mobile Products to Medical Devices MOBILE PRODUCTS Mobile platform defined as commercial off-the-shelf computing platforms with or without a wireless connectivity that are handled in nature (ex. mobile computers such as I- Phone, Blackberry phones, Android phones, tablet computers, personal digital assistants) Regulated Medical Device defined as a product that definition in section 201(h) of the Federal Food Drug and Cosmetic Act and that has been classified, cleared or approved or cleared by the FDA MOBILE MEDICAL APPS (MMA) Mobile app (software application that be run on a mobile platform or a web-based software application that is tailored to a mobile platform but is executed on a server) Which meets the definition of [a medical] « device »; and either, is used as an accessory to a regulated medical device ; or, transforms a mobile platform into a regulated medical device

6. Exclusions Mobile apps that are electronic copies of medical textbook, teaching aids or reference materials (do not contain any patient-specific information/ show examples for a specific medical specialty ; ex. flashcards or quizzes) Mobile apps that are solely used to log, record, track, evaluate or make decision or suggestions relating to developing or maintaining general health and wellness (not intended for curing, treating or seeking treatment ; ex. dietary tracking logs, appointment reminders or dietary or posture suggestions) Mobile apps that only automate general office operations (billing, inventory, appointments or insurance transactions) Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication (ex. magnifying glass, recording audio, note-taking) Mobile apps that perform the functionnality of an electronic health record system

7. MMA Manufacturer Defined as any person or entity that manufactures mobile medical apps Excludes any entity that exclusively distribute mobile apps without engaging in manufacturing functions (ex. owners and operators of Android market, iTunes store, BlaclBerry App World) The FDA expects that distributors to cooperate with the regulated apps developers in the event of a correction or a recall Includes any person or entity that creates designs, develops, labels, relabels, remanufactures or creates a software system from multiple components (ex. a person that uses commercial off-the shelf software components and market the product to perform as a mobile medical app) Includes any person that provides mobile medical app functionnality through a web-service or web- support for use on a mobile platform (ex. a manufacturer that allows users to access the applications medical device functionnality over the web) Includes any person that initiates specifications or requirements for mobile medical apps or procures product development/ manufacturing services (ex. a developer)

8. Regulatory Approach for MMA Based on a device classification into three classes I, II and II (requirements described in the applicable device classification regulation) Class I (General controls : registration, QOS regulation, labelling requirements, reporting corrections and removal) Class II (General controls + premarket notification Class III (General controls + premarket approval)

9. Top-five requests to the FDA Clarify the difference between a medical app and a wellness app (ex.exercise apps that measures how many miles I run in a given week) Clarify the difference between diagnosing and monitoring (ex. apps that offer a photo galery of skin conditions) Establish the risk level threshold for FDA enforcement (ex. apps that functions as a simple calculator for an infants Apgar score) Define the limits of the FDAs rule on apps that serve as device accessories (ex. apps that display the blood pressure reading) Make a plan for how to handle « modular » apps ( programs that work together to form a health-management system either by sharing data with each other or by controling one another ; ex. diabetes app that takes data from patients glucose meter, that borrows the data and tells what I should have for lunch, that helps to order insulin from my pharmacy)

10. Conclusions and Recommendations The EU regulatory environment is way behind in terms of sophistication and level of details provided The reasoning of the FDA fits into the EU regulatory system (ex. Exclusions : largely similar under EU law) On-going need to harmonize and coordinate efforts accross the world The EU should use FDA Guidance to its advantage to take a much-needed and due step in the clarification of its regulation of software under the MDD 10 Geneva, Switzerland, 25-26 September 2012