FDA Regulation for Mobile Apps, Concerns and Challenges Life Sciences and Tax and Finance Practice Groups Mid-Year Luncheon At Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions January 24, 2014  12:00-1:15 pm Eastern) Presenters: Kim Tyrrell-Gantt, Epstein Becker Green PC, San Diego, CA, KTyrrellknott@ebglaw.com

Topics Medical Device Basics Which apps does FDA regulate? Regulated, unregulated and enforcement discretion Apps made by Doctors What’s Next Case Study

Device Definition Section 201(h) of the Federal Food, Drug, and Cosmetic Act, defines a medical device as: "... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals."

Basic Intended Use Framework Under 21 CFR 801.4, the words “intended uses” … refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised…

Intended Use –Totality of Circumstances How legitimate are intended uses Sales volume related to intended use Actions Design features (i.e. uniquely clinical features) Distribution (e.g. medical sales and distribution channels) Where do your sales people visit (shows and customers)? Differential pricing Words External i.e. labeling, sales lit. advertising, sales pitches Internal i.e. business planning, sales force memos, training

I make these. Do I need to worry about FDA? Case Study I make these. Do I need to worry about FDA? Case Study Case Study

Determining the Intended Use of a Stick Statements suggesting Popsicle Stick It’s a popsicle stick Sterilized to food grade Kids love it Makes popsicles last longer Statements suggesting Pediatric Tongue Depressor It’s a Pediatric Tongue Depressor Sterilized to medical grade Young patients love it Narrow enough to access those hard to reach places in a kid’s mouth Tastes Great

Mobile Medical Apps: What gets regulated? Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps Makes sense to start here because this is the defined category, the other two to some extent are merely everything else

Mobile is just a Delivery Platform Mobile Medical Apps Focus on functionality and risk to patients regardless of platform Look at what FDA has regulated in the past. To some extent this is easy, because the guiding principle is nothing has changed, FDA regulates what they always have regulated. The key is not to get hung up on form or platform, but to look simply at functionality, or intended use. Mobile is just a Delivery Platform

Mobile Medical Apps Accessories to a medical device Mobile apps that are an “extension” to a medical device by connecting to the device to Control the device or Display, store, analyze, or transmit patient-specific medical device data Examples: Extension of medical device: PACS, MDDS Display, store, transfer data in original format mobile apps that control medical device: - Control inflation or deflation of blood pressure cuff. Such apps are “accessories” of medical device because they “extend the intended use and functionality of the connected medical device Footnote 23 says: Controlling the intended use, function, modes, or energy source of the connected medical device: this makes the category very broad You might look at that second category and say, oh, MDDS. You would be wrong. MDDS is indeed included, but this uses the word “analyze” which is forbidden for MDDS

Mobile Medical Apps Mobile apps that transform the mobile platform into a regulated medical device by using (or not) attachments, display screens, or sensors or including functionalities similar to those of currently regulated medical devices. Attachment can either be Clearly medical like blood glucose strip reader or ECG electrodes General like heart rate monitor Also, don’t need attachment—can use built in accelerometer or microphone or camera

Mobile Medical Apps [CDS] performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. Examples: Computer Aided Diagnosis Calculate dosage or create a dosage plan for radiation therapy Discussion of CDS. FDA said that the guidance does not address CDS. This example is indicative however of some the elements FDA will look at when regulating software: Performs patient specific analysis Provide patient specific diagnosis or treatment recommendations These types of apps are similar to or perform the same function as those types of software devices already approved or cleared

Unregulated Mobile Apps Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps How about apps? Let’s start at the bottom: 5 categories

Unregulated Mobile Apps 5 categories Electronic copies of medical textbooks Educational tools Facilitate patient access to information General operations in healthcare settings (accounting, billing) Generic aid (e.g. magnifying glass) Essence of the first 2 is generality Third category includes access to educational materials and shopping aids—to find doctors and medicine Examples: Electronic copies of medical textbooks (Physicians’ Desk Reference) Educational tools: surgical training videos, games that simulate cardiac arrest to train HCP Facilitate patient access to information: match patients with clinical trials General operations in healthcare settings (accounting, billing) Generic aid: magnifying glass- but not in the sense of reading glasses, recording audio

Mobile Apps subject to Enforcement Discretion Regulated Mobile Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps

The Law is Not Always Clear Ihatepeas.com

Enforcement Discretion Categories Patient motivation Patient daytimers Access to contextually relevant information Certain telemedicine products Simple professional calculators Connections to EHR’s Why this is important: the labeling may refer to diseases, but these apps are meant as behavioral tools Note on category #2: Comparison of regulated MMA (MDDS functionality to store or transfer data) and category 2 in enforcement discretion: apps to log, track or trend events or measurements So on one hand, FDA says that apps to store or transfer data is MDDS And on the other hand, if the app “trends” the event- which implies some analysis over a period of time, and therefore more complex than MDDS- this would be enforcement discretion Note on category #3: apps provide easy access to information related to patients’ conditions. These apps match patient-specific information to reference information routinely used in clinical practice. Discussion: Appendix A: not a device so not regulated (from the language on page 20): Not medical intended use Does not facilitate a HCP’s assessment of a specific patient Does not replace HCP’s judgment or perform a clinical assessment   If it does all the above, but it is “routinely used in clinical practice” then it’s enforcement discretion? I am not sure they were common to all the enforcement discretion examples but • Not replacing treatment- just supplementing care • Not making recommendations • The concept of “routinely used in clinical practice” is used to further limit the category of apps that provide contextually relevant reference information or perform simple calculations In the “not a medical device” category – the key for the reference and educational materials, including the patient specific educational materials, is that it is not to facilitate a HCP’s assessment of a specific patient, replace the HCP’s judgment or perform a clinical assessment

Apps Made by Doctors Doctor’s apps for their own professional use are unregulated May share with colleagues in their group practice Questions What is a group practice? Does the doctor need to code?

What’s on the Horizon?

Medical Device and Technology Health IT Regulatory Framework FDA, FCC, ONC Joint recommendation Feb 2014 FDA regulation active and evolving Clinical Decision Support guidance in development Accessory and Wellness vs Disease guidance Enforcement Proposed Legislation – SOFTWARE Act International Medical Device Regulators Forum- IMDRF US, Australia, Brazil, Canada, China, EU, Japan, WHO Harmonization

Medical Device and Technology Health IT Regulatory Framework FDA, FCC, ONC Joint recommendation Feb 2014 FDA regulation active and evolving Clinical Decision Support guidance in development Accessory and Wellness vs Disease guidance Enforcement Proposed Legislation – SOFTWARE Act International Medical Device Regulators Forum- IMDRF US, Australia, Brazil, Canada, China, EU, Japan, WHO Harmonization

Case Study

Diabetes Tracking App Description of the device: Intended use: App allows users to enter their blood glucose data. App can read QR codes for food labels, provide carbs count and meal options and recipes. Intended use: App intended to help patients with diabetes Maintain healthy, diabetes-friendly diet Track their blood glucose, carb intake, exercise Remind user to take blood glucose reading and insulin at pre-set times Calculate the amount of insulin based on carbs ratio, correction factor, glucose reading and target glucose level, and other relevant factors App is developed by a physician and distributed to his/her patients with diabetes www.diabeticnerd.com apps.structiva.com

Kim Tyrrell-Knott ktyrrellknott@ebglaw.com Questions? Kim Tyrrell-Knott ktyrrellknott@ebglaw.com