1. 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,

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

3. 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."

4. 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…

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

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

16. The Law is Not Always Clear
Ihatepeas.com

17. 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

18. 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?

19. What’s on the Horizon?

20. 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

21. 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

22. Case Study

23. 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
apps.structiva.com

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