Mobile Health Apps: A Primer

Size: px

Start display at page:

Download "Mobile Health Apps: A Primer"

Patience Bell
6 years ago
Views:

2 Agenda 1. mhealth Publishers 2. Status of the mhealth App Publishing 3. What is a Medical Device? 4. Final Guidance 5. FDASIA Report 6. Capitol Hill Activity 2

4 500 million Smart phones users will be using health apps by 2015 Source: Research2Guidance

5 Global mhealth Market Revenue ( ) MHEALTH APP MARKET EXPECTED TO REACH 26 BILLION BY 2017 Source: research2guidance, mhealth market Report

6 Fitness and Medical Reference Apps are the Largest mhealth App Categories MHEALTH APP CATEGORY SHARE Source: research2guidance, 808 apps from Apple, Google Play, Blackberry App world and Windows Phone Store, March

8 More than 36% Recently Entered the mhealth App Market Publishing year of the first mhealth app. Source: research2guidance, mhealth App. Developer Economics Survey

9 Target Group Share of mhealth App Publisher Chronically ill and fitness seekers are the main target groups for mhalth app publishers Source: research2guidance, 808 apps from Apple, Google Play, Blackberry App world and Windows Phone Store, March

10 Six Groups of mhealth App Publishers Source: research2guidance, mhealth App Developer Survey 10

11 Successful mhealth Publishers Do Six Things Differently Source: research2guidance, mhealth App Developer Survey 11

12 What is a Medical Device?

13 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."

14 Judging Intended Use Words External (e.g. labeling, sales lit. advertising, sales pitches) Internal (e.g. business planning, sales force memos, training programs) Actions Design features (i.e. uniquely medical features) Distribution (e.g. medical channels) Where do your sales people visit? Circumstances (Inferences) How legitimate are non medical uses? Sales volume related to medical use 14

15 Case Study IMAKE THESE. DO I NEED TO WORRY ABOUT FDA? 15

16 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 16

17 Flavors of Intended Use General Purpose General Health Purpose Specific Clinical Claims Tool Claims 17

19 Regulated Mobile Medical Apps

20 What Gets Regulated? Regulated Mobile Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps 20

21 Mobile Medical Apps Focus on functionality and risk to patients regardless of platform Look at what FDA has regulated in the past 21

22 Mobile Medical Apps 1. 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 22

23 Example CONTROL MEDICAL DEVICES 23

24 Example MEDICAL DEVICE DATA SYSTEM Yes No Storage Conversion Transfer Display Active Patient Involvement Controlled Connected Medical Device Modify Analyze 24

25 Example DISPLAY PATIENT SPECIFIC MEDICAL DEVICE DATA luciddreamingapp.com 25

26 Mobile Medical Apps 2. Functionalities Similar to Currently Regulated Medical Devices Using special medical attachments Using generic attachments Using no attachments 26

27 Mobile Medical Apps 3. [CDS] Performing patient specific analysis and Providing patient specific diagnosis, or treatment recommendations. 27

28 Unregulated Mobile Apps

29 Unregulated Mobile Apps Regulated Mobile Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps 29

30 Unregulated Mobile Apps Five Categories Electronic Copies of Medical Textbooks Educational Tools Facilitate Patient Access to Information Business Operations in Healthcare Settings Generic Aid 30

31 Mobile Apps Subject To Enforcement Discretion

32 Success May Depend on Accessories 32

33 Mobile Apps Subject to Enforcement Discretion Regulated Mobile Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps 33

34 The Law is Not Always Clear 34

35 Mobile Apps Subject to Enforcement Discretion FDA decided to exempt low risk devices, however May not meet definition of medical device May not be forever exempt Recommend quality system 35

36 Enforcement Discretion Categories Patient Motivators Connections to EHRs Simple Professional Calculators CATEGORIES Access to Contextually Relevant Information Patient Day Timers Certain Telemedicine Products

37 Open Issues Wellness versus disease Accessory definition Line between software modules The CDS conundrum 37

39 Introduction Section 618 of FDASIA Authorized by Congress to analyze comprehensive HIT regulatory framework FDA, ONC, FCC, other stakeholders Three categories of risk Four key steps to the development of a risk based regulatory framework 39

40 FDASIA Approach Rely on self regulation within the HealthIT industry itself Regulatory process focused on all states of a HIT product lifecycle Take advantage of the knowledge and capabilities in the private sector Best practices Industry led testing and certification Other tools such as voluntary listing & reporting 40

Categories of HIT Administrative Functionality Health Management

, Billing and Claims Processing e.g., Data Capture and Exchange, Medication Management, etc.

Pose no risk to patient safety Pose low risk to patient safety Pose a

41 Categories of HIT Administrative Functionality Health Management Functionality Medical Device HIT Functionality e.g., Billing and Claims Processing e.g., Data Capture and Exchange, Medication Management, etc. e.g., Real-time Alarms, Robotic Surgical Planning and Control $ $ $ Pose no risk to patient safety Pose low risk to patient safety Pose a sufficient level of risk to patient safety and warrant direct FDA regulation

43 Bills in Congress SOFTWARE ACT PROTECT ACT 43

44 EBG as a Resource Visit the website for the various alerts we have published on a wide range of issues related to mhealth and Mobile Medical Apps.

45 Presented by Rene Y. Quashie Senior Counsel

An Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference

An Update on the Activities and Progress of the mhealth Regulatory Coalition Prepared for the 2011 Medical Device Connectivity Conference Dane Stout The Anson Group September 8, 2011 MRC Background Formed