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Mobile Apps in Healthcare
Mobile Apps in HealthcarePart I: Developing an Educational App
Jack Ward, Senior Director, Myraqa Inc. Jason King, President and CEO, Accella
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 1
FDA Requirements
Jack Ward
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 2
Mobile Apps in Healthcare
FDA’s Authority
• The FDA has legal authority to regulate medical devices, defined primarily in the “Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule: Quality System Regulation” – 21 CFR Part 820
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 3
Key Regulations
• Additional key FDA regulations may also apply: • Part 801 (Labeling)• Part 803 (Reporting)• Part 806 (Corrections and Removals)• Part 807 (Registration and Listing)• And others
• Regulations may be accessed at fda.gov
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 4
Mobile Apps in Healthcare
Draft Guidance Document
• Given the rapid expansion and broad applicability of mobile apps, the FDA has issued a draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority:• Draft Guidance for Industry and Food and Drug
Administration Staff, Mobile Medical Applications, July 21, 2011
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 5
Applicability of Guidance Document
• At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps it is calling “mobile medical apps”
• FDA “guidance” is not legally enforceable, but provides the Agency’s current thinking
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 6
Mobile Apps in Healthcare
Current FDA Status
The FDA has recently provided testimony to Congress regarding assessment and regulatory status of mobile medical appsStatement of Christy L. Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health, Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, “Health Information Technologies: Administration Perspectives on Innovation and Regulation”, March 21, 2013
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 7
FDA Testimony
• Industry estimates that 500 million smartphone users worldwide will be using a health care application by 2015. These users include health care professionals, consumers, and patients.
• FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 8
Mobile Apps in Healthcare
FDA Testimony
• FDA recognizes that mobile health application developers and manufacturers need a clear, predictable, and reasonable understanding of the Agency’s expectations.
• The Agency intends to maintain a publicly available website with information listing those apps which have been cleared or approved by FDA and those for which FDA will exercise enforcement discretion.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 9
FDA Testimony
• The FDA has been regulating medical device software for decades and medical device software on mobile platforms for more than 10 years.
• To date the FDA has reviewed approximately 100 mobile medical apps, including remote blood pressure, heart rhythm, and patient monitors, and smartphone-based ultrasounds, EKG machines, and blood glucose monitors.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 10
Mobile Apps in Healthcare
Definition of Mobile Medical App
• In the Draft Guidance, the FDA has provided the following definition for a mobile medical app:
• A mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and either • is used as an accessory to a regulated device; or• transforms a mobile platform into a regulated medical
device • The Intended Use of a mobile app determines
whether it meets the definition of a “device”
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 11
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
1 K121405*
ClearanceDate
Dec 20, 2012
HKI*886.1120*
Opthalmic Camera
The device is an attachment andsoftware used only with theiPhone 4 and 4S in conjunctionwith the Opthalmoscope to allowusers to capture, send store andretrieve images of the eye. Thedevice is intended to be used bytrained personnel within a medicalor school environment.
iPhone 4iPhone 4S
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 12
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
2 K122356*
ClearanceDate
Nov 19, 2012
DPS*870.2340*
Electrocardiograph
A heart monitor intended for useby licensed professionals orpatients to record, display, storeand transfer single-channelelectrocardiogram ECG rhythms.
iPhone
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 13
Note: Items with * can be searched at FDA.gov for additional information.
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
3 K101597*
ClearanceDate
Oct 18, 2010
NBW/JQP*862.1345*
Glucose Test System
The application is intended for usein the home and professionalsettings to aid individuals withdiabetes and their healthcareprofessionals: in the review,analysis and evaluation of bloodglucose test results to support aneffective diabetes managementprogram. The application allowsusers to download blood glucosereading automatically from themeter to an iPhone OperatingSystem Platform.
iPhoneOperating System Platform
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 14
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
4 K121590*
ClearanceDate
Sep 20, 2012
LXV*Unclassified
Vestibular Analysis Apparatus
“Sway BalanceTM”
The Sway BalanceTM System isintended for use to assess sway asan indicator of balance. Individualsuitability for assessment must bejudged on a case by base basis,by a qualified individual includingthose certified and/or licensed intheir state to prescribe and/or usebalance devices such as certifiedathletic trainers and coaches,physical therapists, nurses andphysicians.
iOSMobile Operating Device.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 15
Note: Items with * can be searched at FDA.gov for additional information.
Examples of Mobile Medical Apps
ID FDA 510(k)Number
FDA Product Code and Classification
Indications for UseIntended Use
Mobile Platform
5 K121165*
ClearanceDate
Jun 21, 2012
EFW*872.6855*
Manual Toothbrush(Class I)
The device is a toothbrush toremove plaque and debris from itsuser’s teeth and aide in theprevention of tooth decay. Thedevice collects brushing usagedata and wirelessly transmits thedata to a software application(App) that runs on the user’s ownmobile device (“smartphone”).
Bluetoothenabledsmart phone.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 16
Note: Items with * can be searched at FDA.gov for additional information.
Mobile Apps in Healthcare
Categories of Mobile Medical Apps
1. Mobile apps that are extensions of regulated medical device for the purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data. (Example – mobile platform functionality to control inflation and deflation of a blood pressure cuff)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 17
Categories of Mobile Medical Apps
2. Mobile apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions. (Example – attachment of a transducer to a mobile platform to function as a stethoscope)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 18
Mobile Apps in Healthcare
Categories of Mobile Medical Apps
3. Mobile apps that allow the user to input patient-specific information and - using formulae or a processing algorithm - output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions. (Example – calculate dosage for a specific medication or radiation treatment)
Categories of Mobile Medical Apps as shown above are defined in Appendix A, “Draft Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications,” July 21, 20115/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 19
Categories of “Non” Medical Apps
1. Mobile apps that are electronic “copies” of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received. (Example – slideshow of common conditions)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 20
Mobile Apps in Healthcare
Categories of “Non” Medical Apps
2. Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. (Example – dietary tracking logs)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 21
Categories of “Non” Medical Apps
3. Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions. (Example – determining billing codes like ICD-9)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 22
Mobile Apps in Healthcare
Categories of “Non” Medical Apps
4. Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication. (Examples – audio recording or note taking)
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 23
Categories of “Non” Medical Apps
5. Mobile apps that perform the functionality of an electronic health record system or personal health record system.
Categories of Mobile Non-Medical Apps as shown above are discussed, with examples, in “Draft Guidance for Industry and Food and Drug Administration Staff, Mobile Medical Applications, July 21, 2011
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 24
Mobile Apps in Healthcare
FDA Regulatory Summary
1. The FDA has indicated that it intends to apply its regulatory requirements solely to a subset of mobile apps it is calling “mobile medical apps.”
2. The FDA has been regulating medical device software for decades and medical device software on mobile platforms for more than 10 years.
3. To date the FDA has reviewed approximately 100 mobile medical apps, including remote blood pressure, heart rhythm, and patient monitors, and smartphone-based ultrasounds, EKG machines, and blood glucose monitors.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 25
FDA Regulatory Summary4. This presentation has provided specific examples of
mobile medical apps that have been cleared by the FDA. The examples include highlighted “search items” to allow for detailed review at FDA.gov.
5. In addition, this presentation has provided references and extended discussion of the current FDA draft guidance that should be the basis for determining the FDA regulatory requirements for a specific mobile app.
6. The remainder of this webinar will outline the process for creating an app when FDA involvement is not required. Part II of the webinar series on May 16 will further define the development of FDA-regulated mobile medical apps.
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 26
Mobile Apps in Healthcare
Building a Mobile App
Jason King
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 27
About Accella
Mob
ile A
pps
• Design• Development• iOS
AndroidWindows Mobile Web
Web
site
s
• Front-EndDesign
• Back-EndDevelopment
• Open Source CMS - Drupaland WordPress
Mar
ketin
g
• SEO/SEM• AdWords• Analytics• E-Mail
Marketing• Social Media• PR• Print Design
Branding
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 28
Mobile Apps in Healthcare
Mobile Applications
• Mobile phones will overtake PCs as the most common way to access the internet this year (Gartner)
• Android is expected to capture 63% of the market share by 2016 (Digital Trends)
• Windows Phone will overtake iOS by 2015 (Gartner)• 42% of marketing executives plan to increase
mobile marketing spend this year (Strongmail)• ~845K (Active) Apps in iTunes• ~690K (Active) Apps For Android
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 29
Building an App
AnalyzeAnalyze
DesignDesign
DevelopDevelopTestTest
Launch/PromoteLaunch/Promote
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 30
Mobile Apps in Healthcare
Dräger Isolette® 8000
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 31
Architecture
• What Will The App Do?
• What Features Will The App Have?
Functionality
• Why Will A User Download the App?
• Why Will They Keep Using It?
User Interaction
• What Will A User Gain Using the App?
• What Does Your Organization Gain?
Benefits
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 32
Mobile Apps in Healthcare
Design
Wireframes• Black & White Layout of
Your App• Represents Functionality,
Not Aesthetics• Shows Placement of Text,
Graphics, Buttons, AndOther Items
• Demonstrates The Flowof The App
What You See
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 33
Design
What Happens• Comp Images are
Created To Skin Your App• Based Upon A Client’s
Branding, Logo, andDirection
• The App Begins To ReallyTake Shape
What You See
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 34
Mobile Apps in Healthcare
Development Process
What Happens• Functionality Built In
To the App• Links & Connections to
Backend Databases• GPS, Mapping,
Accelerometer andOther Functionalityis Integrated
• All Coding IsDone Natively
What You Should Do• Join Apple & Android
Developer Program
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 35
Testing
• Build a Detailed Test Plan
• Make Sure To Look For:• Functionality• User Experience• Typos/Image Problems• Links• Database Integration• Power Consumption
Developers
Client
Third Party
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 36
Mobile Apps in Healthcare
Deployment/Submission
When Submitting Your App:• Have a Unique
App Name• Keywords
Are Crucial• Your Description
Sells Your App• Include Icons
and eye-catchingscreen shots
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 37
Analyze
• EvaluateMetrics
• Obtain UserFeedback
• Respondto Reviews
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 38
YourMessage
YourBrand
A MOBILE APP ISAN EXTENSION OF
Mobile Apps in Healthcare
Platforms
iPhoneiPad
Desktop
iPhoneiPad
DesktopPhoneTabletPhoneTablet
PhoneTablet
Desktop
PhoneTablet
DesktopMobileTabletMobileTablet
MobileDesktopMobile
Desktop
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 39
Commercial Approval Process
7-10 Days
Regulated
7-10 Days
Regulated
No Delay
User Base
Regulated
No Delay
User Base
Regulated
Up to 5 Days
Regulated
Up to 5 Days
Regulated
7-10 Days
Regulated
7-10 Days
Regulated
No Delay
User Base
Regulated
No Delay
User Base
Regulated
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 40
Mobile Apps in Healthcare
Types of Apps You Can Build
Educational• Product InfoEducational• Product Info
Monitoring• Patient• Medication• Equipment
Monitoring• Patient• Medication• Equipment
Device Control• Remote Controls• Configuration
Device Control• Remote Controls• Configuration
Internal Business• Sales• Marketing• Fulfillment• Management
Internal Business• Sales• Marketing• Fulfillment• Management
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 41
Before You Get Started…
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 42
DetermineYour
Budget
Create aMarketing
PlanSet Defined
Functions andObjectives
for Your AppSTARTSTART
DetermineYour Budget
Mobile Apps in Healthcare
43
Questions?
Or press *1 on your telephone keypad
Type your question in the Q&A box on the left side of your screen and press Enter
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org
Closing Reminders
• Please be sure to fill out the evaluation form at: http://aami.confedge.com/ap/survey/s.cfm?s=MobileI
• Don’t miss Part II of the series:• Mobile Apps in Healthcare
Part II: Developing an FDA-Regulated AppThursday, May 16, 201311:00 am – 1:00 pm Eastern
5/2/2013 © 2013 Association for the Advancement of Medical Instrumentation www.aami.org 44