Mobile Apps in Healthcare - The Platformaami.confedge.com/.../aami/_warehouse/files/Slides_MobilePartI.pdf · Operating System Platform ... Mobile Apps in Healthcare Examples of Mobile

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



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


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



Draft Guidance Document

• Given the rapid expansion and broad applicability of mobile apps, the FDA has issued a draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority:• Draft Guidance for Industry and Food and Drug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


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



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


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.



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.


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.



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”


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


Note: Items with * can be searched at FDA.gov for additional information.



ID FDA 510(k)Number



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




ID FDA 510(k)Number



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





ID FDA 510(k)Number



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.




ID FDA 510(k)Number



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.




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)



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)




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)




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)



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)




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. 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



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.


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.



Building a Mobile App

Jason King


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



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


Building an App

AnalyzeAnalyze

DesignDesign

DevelopDevelopTestTest

Launch/PromoteLaunch/Promote



Dräger Isolette® 8000


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



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


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



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


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



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


Analyze

• EvaluateMetrics

• Obtain UserFeedback

• Respondto Reviews


YourMessage

YourBrand

A MOBILE APP ISAN EXTENSION OF


Platforms

iPhoneiPad

Desktop

iPhoneiPad

DesktopPhoneTabletPhoneTablet

PhoneTablet

Desktop

PhoneTablet

DesktopMobileTabletMobileTablet

MobileDesktopMobile

Desktop


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



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


Before You Get Started…


DetermineYour

Budget

Create aMarketing

PlanSet Defined

Functions andObjectives

for Your AppSTARTSTART

DetermineYour Budget


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


Documents

Mobile Apps in Healthcare - The Platformaami.confedge.com/.../aami/_warehouse/files/Slides_MobilePartI.pdf · Operating System Platform ... Mobile Apps in Healthcare Examples of Mobile