Health Applications for Smartphones

What about regulation ?

Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard

25/02/13

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DISCLAIMER

This is an independent study performed by students from the « Faculté des Sciences Pharmaceutiques de Lille »

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INTRODUCTION

4

Recently

JAMA Dermatology

January 2013

1st major comparative clinical trial about Smartphone health Apps for the public

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Health apps

Regulatory problems

Technology development goes faster than regulation

Danger for public

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SURVEY ABOUT APPS’ CONSUMER

To know :

o Who the consumers of health Apps are?

o Which smartphone?

o What kind of Apps?

o Why do they use them?

Why ?

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276 answers

Sexo Men 37 %o Women 63%

Results (20/02/13)

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Ageso <25 ans : 45%o 25-34 ans : 39%o 35-44 ans : 1%

o 45-54 ans : 7%o 55-65 ans : 7%o >65 ans : 0%

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Activitieso Etudiant en santé : 35%o Etudiant dans les nouvelles technologies : 0%o Etudiant (autre domaine) : 9%o Professionnel de santé :15%o Professionnel dans les nouvelles technologies : 5%o Professionnel (autre domaine) : 28%o Autres (sans emploi, retraité …) : 7%

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Have you got a smartphone ?o Yes : 80%o No : 20%

Androïd VS Iphone

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Advice for Health application ?o Yes : 14%o No : 86%

If yes, who ?

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Have you already use health app?o Yes : 28%o No : 72%

Advice for health app : professional mission?o Yes : 64%o No : 36%

Did you pay for health app?o Yes : 5%o No : 95%

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Which kind of app?

o Renseignements sur des médicaments : 32% o Suivi quotidien d’une pathologie chronique : 17% o Conseils hygiéno-diététique : 11%o Informations sur des pathologies : 9%o Aide à un auto-diagnostic :15%o Aucune : 13%

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Health’s professional validation ?o Yes : 65%o No : 35%

1) Environment

2) Regulatory situation

3) Cases study

PLAN

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1

2

3

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PART 1 ENVIRONMENT

Smartphones

Applications

Health applications

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SMARTPHONES

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Smartphone VS Computer

=Mobility

Photo

MedicalDevice

Bluetooth

Geolocalisation

+Phone

Smartphones sales

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1st quarter of 2012~144,4 million of Smartphones sold

Up 44% / 1st quarter 2011

In the same time : 2% decline of worldwide sales of mobile phones

*Source Gartner – May 2012

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2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012E 2013E 2014E 2015E 2016E0

500,000,000

1,000,000,000

1,500,000,000

2,000,000,000

2,500,000,000

3,000,000,000

Global Internet Device Sales

Un

its

in m

illio

ns

Smartphones

Tablets

Computers

*Source Gartner – May 2012

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Q4 2012 SAMSUNG APPLE

Smartphone sales (million) 63,7 47,8

Market share 29% 21,8%

TOP 2

APPLESAMSUNG

VS

*Source Ecoconscient

Which countries did use more Smartphones in 2012 ?

Smartphones use

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38% 38% 45%

27% (2011)

*Source : Sondage Ipsos – Google, Février 2012

3%

27%

64%

42%

43%

44%

61%

64%

76%

75%

78%

98%

Somewhere else

School

Public transport

At a social gathering/function

Airport

Doctor's office

Café or coffee shop

Restaurant

In a store

On-the-go

Work

Home

3%

32%

36%

59%

48%

55%

49%

70%

76%

83%

69%

96%

5%

16%

61%

50%

43%

27%

59%

56%

63%

85%

71%

97%

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Where are smartphones used ?

EVERYW

HERE

*Source : Sondage Ipsos – Google, Février 2012

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MOBILE APPLICATIONS

Definition

What is a mobile application ?

o A downloadable program (free or paying) used thanks to the operating system of the phone

o A software that can run on a mobile device such as a cell phone that will allow the device to perform specific tasks that are typically restricted to PCs

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Mobile app platforms

25 billion of apps downloaded o in march 2012 for iOSo in september 2012 for Androïd

Apps classification not clear27

Apple Store

VSAndroïd Market

TOP 2

Use of mobile apps

Top of Apps categories according to audience (in US)

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Health in

formation

Online Retail

Men's Magazin

e Content

Electronic P

ayment

Gaming Inform

ation

Job Listings

General Reference

Classifieds

Auction Site

s

Family Enterta

inment0

5000

10000

15000

20000

25000

30000

35000

Déc. 2010

Déc. 2011

+134%

*Source : comScore MobieLens, 3 mon. avg. ending Dec-2011 vs. Dec-2010

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HEALTH APPLICATIONS

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Health apps in number

In January 2012

*Source : Proximamobile – January 2012

17 000 Health & Fitness apps

74% paid apps

6 000 Health & Fitness apps

73%for the publicApple store

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Cardio16%

Diet14%

Stress & Re-laxation

11%

Women's Health7%

Strength Training7%

Calculator6%

Mental Health6%

Chronic condi-tions5%

Other27%

Consumer Health Apps for Apple’s iPhone

Sleep, Emergency, Smoking cessation, Medication Adherence, PHR…

*Source : MobiHealthNews’2011 report

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Various kinds of health apps

Health professionnals

Promotional tools (pharmaceutical industries)

Secured instructions about medecines or anything else

Social network for discussions

eLearning

Serious game

Live meeting

Public

Instructions about medecines

Medical calculation (not secured)

Follow-up of quantified data o Written by the patient himself

or thanks to a connected deviceo Sent to a health professional

eLearning or Serious Game

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PART 2REGULATORY SITUATION

Guidelines

Evaluation by clinical trials

Private agencies

French practices

A manufacturer point of view

FDA GuidanceMEDDEV

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GUIDELINES

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Draft Guidance about Mobile Medical Applications

1989

20052011

Draft Software Policy released

Policy was withdrawn because - Use of computer products

and software products as medical devices has grown exponentially

- FDA determined that computer systems and their software were too complex and diverse for one policy to encompass

The FDA stepped up regulatory efforts Mobile Apps Draft Guidance

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Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications

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FDA has the authority to regulate software if it falls within the definition of a “device”

o Class I - most Class I devices are exempt from Premarket Notification 510(k)

o Class II - most Class II devices require Premarket Notification 510(k)

o Class III - all Class III devices require Premarket Approval

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MOBILE MEDICAL APPS

Used as an accessory to a regulated medical device

OR

Transform a mobile platform into a regulated medical device

THE FDA SCOPE

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Displaying, storing or transmitting patient-specific medical device data in its original format

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2 Controlling the intended use, function, modes, or energy source of the connected medical device

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Transforming or making the mobile platform into a regulated medical device

Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data

3

4

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Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions

OUT OF FDA SCOPE

1

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Electronic “copies” of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received

2

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Solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness

3

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Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication

4

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Guidance MEDDEVs

Guide elaborated by the task force of the European Commission : European Medical Device Expert Group

Contain advice for the implementation of European guidelines

Common approach by manufacturers and Notified Bodies involved in the conformity of assessment procedures

Not legally binding

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Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices (MD)

Published on January 2012

Purpose : clarify the rules of standalone software in a healthcare environment

2 main questionso In which cases should a software be considered as a medical

device?o If it is considered like a medical device, which guidelines apply?

MEDDEV 2.1/6

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Telesurgery Radiology Information System are not qualified as MD

EXAMPLES

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The telecommunication system (mobile, wireless, wire , etc…) is not as such a medical device

Mersey Burns

Free clinical toolo Calculating burn area

percentageso Prescribing fluids using Parkland,

background fluids

1st app to be registered by the MHRA as a Class I medical device

1st publically available UK app to carry the CE mark

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USA versus EU

The FDA became aware of health apps problems a long time ago

In Europe, we are still at the stage of software problem

hard to follow innovation

Melanoma detectionBlood glucose control complianceMeasure of lung function

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EVALUATION BY CLINICAL TRIALS

Smartphone Apps for Melanoma Detection

To measure the performance of 4 smartphone applications that evaluate photographs of skin lesions and provide the user with feedback about the likelihood of malignancy

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OBJECTIVE

*Source : www.jamaderm.com - published online January 16, 2013

Primary endpoint : sensibility to categorize melanoma

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Sensitivity o + : analysed by a board-certified

dermatologist o - : analysed by automated algorithms

Reliance on these applications in lieu of medical consultationo Can delay the diagnosis of melanomao Can harm users

RESULTS

*Source : www.jamaderm.com - published online January 16, 2013

CONCLUSION

Smartphone App for blood glucose control compliance

Comparison of mobile app and standard diabetes management effect for glycated hemoglobin levels in patients with type 2 diabetes

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OBJECTIVE

*Source : www.welldoc.com - Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

Primary endpointo Glycated hemoglobin levels

Secondary endpointso Diabetes distress, depression, and other clinical (blood pressure) and

laboratory (lipid)values

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Glycated hemoglobino Dicrease of 1.2% over 12 monthso Appreciable differences were not observed

for secondary outcomes

Mobile coaching improves compliance and therefore reduces glycated hemoglobin levels over 1 year

RESULTS

CONCLUSION

*Source : www.welldoc.com - Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

Smartphone App to measure lung function

To compare the accuracy of SpiroSmart™ to a clinical spirometer endorsed by the American Thoracic Society (ATS)

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OBJECTIVE

*Source: http://abstract.cs.washington.edu/~shwetak//papers/SpiroSmart.CR.Final.pdf

Primary endpointo Standard spirometer measures flow rate

Secondary endpointso Comparison diagnoses from pulmonologists using

SpiroSmart™ and a clinical spirometer

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Accuracy of measures : 80-90%

SpiroSmart™ can be used to diagnose normal vs obstructed spirometry

SpiroSmart™ can be effective for diagnosing the degree of the obstruction

RESULTS

CONCLUSION

*Source: http://abstract.cs.washington.edu/~shwetak//papers/SpiroSmart.CR.Final.pdf

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Clinical trials interest

Define Benefit/Risk ratio

Seems to be necessary to approve health appso For diagnosis apps mainlyo +++ If reimbursement in the future ?

DMDHapptiqueD4

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PRIVATE AGENCIES

What is DMD ?o A French private company which evaluates health

mobile apps

How it works?o A medical team tests and compares apps on a totally

free platform

DMD, a private company

61Source: http://www.dmd-sante.com/

HAPPTIQUE

Founded in 2010

First mobile application store developed by healthcare professionals for healthcare professionals

App management solution that helps healthcare providers, physicians, and patients easily integrate mHealth into treatment

Draft app certification standards

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A non profit organisation based in the UK

Practical guide : Regulation of health appso Published in January 2012o Purpose : regulatory standpoint for health apps

• How are health apps regulated?• What other issues should I consider if I’m developing a health

app ?• How can I support the use of health apps across my

organisation ?

Objective : start debate on this topic across the world

D4, a private agency

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ResponsabilitiesCNILHONMonitoringInternet conventionAdvertising control

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FRENCH PRACTICES

Responsabilities

Publisher

Who is it ?o He creates the content

ORo He has the power to make

the editorial choice about the content

Total responsibilityo Respect of principles related

to content publishedo Respect of rules for medical

publishing

Host

Roleo Only technicalo No obligation to watch over

contents

Responsibilityo None

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Commission Nationale de l’Informatique et des Libertés

An independent French administrative authority

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Aims : to ensure that data privacy law is applied to the collection, storage, and use of personal data

Advice for App user

Managing passwords

Data confidentialityo Coding of personal

informationo Cryption

Data integrity

Internet connectiono Firewall or software

protection barriers

Obligation for publishers of App

Collection/storage/use of personal data

Law on computers, files and liberties

Collect only personal data necessary

Limited duration = time required

Ensure confidentiality and security of information

Declare applications to CNIL before

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A non-profit, non-governmental organization

Funded by the State of Geneva, several European projects, the French National Health Authority (HAS) and the Provisu foundation

Health On the Net Foundation

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Aims : Promotes and guides deployment of useful and reliable online health information, and its appropriate and efficient use

HONcode : “Improving the quality of online health information” Ethic

Top des Medocs, a certified app

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Santéclair

Medicines without prescriptiono 2400 drugso 100 selftreatment situations (cold,

cough, bloating, stomach heartburn…)

Health app certified by HON Foundation

App new support for remote monitoring

Remote monitoring : from a distance to interpret data to monitor a medical patient if necessary to make decisions

Safety projects implemented will ensure

o Authentication

o Patient information and consent to collection

o Confidentiality and integrity of data exchanged and hosted

70*Source: Décret du 19 octobre 2010 relatif à la télémédecine

Internet convention

Signed between AFSSAPS and LEEM President in 2006 (revised in 2010)

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Aims = to help pharmaceutical industries to o Create their web pages with respect to the law o Differentiate advertising from information

General recommendationso Name the companyo Identify population concernedo Update information regularly (specify the last update)o Indicate promotional pages

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Problems

o Technology changes faster than regulation• Quick evolution of social networks (Facebook, Twitter…)

o Future• The Internet charter is now reviewed • A new charter between SNITEM and Leem will be

published

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Advertising control

« Product » App

Advertising risk

Comment/Tweet/Like problems

« Environnement » App

Can’t name ONE product but all products of a same therapeutic area

Should be objective and complete

Interview of Uwe DIEGEL - iHealth (28/11/2012)

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A MANUFACTURER’S POINT OF VIEW

iHealth Lab

CEO iHEALTH

Silicon Valley start-up

An official partner of Apple

50% hypertension market share in Europe

3 years $ 80million

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Uwe DIEGEL

*Source : Medical Device Daily – Tuesday, November 20, 2012

Some iHealth Products

Blood pressure monitor A new glucometer

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Key points

Regulation ≠ innovation restriction

Against diagnosis app (illness)

For Health management app

Self-measures are not medical data

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PART 3CASE STUDY

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Défibrillateurs

Défibrillateurs

Defibrillator localisation

First aid techniques reminder

Call emergency ambulance service directly

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Défibrillateurs

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DIPLOME

Défibrillateurs

Helpful

(localisation, techniques)

Handy

All defibrillators are not listed

Nobody check localisation

Don’t work without network Dependence

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iBGStar®

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iBGStar® Diabetes ManagerMonitor blood glucose,

carbohydrate intake and insulin

Manages resultso Logbooko Trend charto Statistics

Simplifies communication with health care professional

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iBGStar® Diabetes Manager

Color-coded

o Hypoglycemia

o Glycemia in medical range

o Hyperglycemia

iBGStar®

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iBGStar®

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iBGStar

Simple and useful

Optimisation for monitoring

Device independent of mobile

Share with doctor

Color-coded dependence to interpret glucose results

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Skinvision

What is it?o Allows patient to

know UV index/skin type

o Checks skin lesion and moles : Melanoma risk ?

o Finds a dermatologist 

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Skinvision

Algorithm•Picture•Sexe•Age

How it works ?

Skinvision

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Skinvision

Skinvision

Easy and simple check

Immediate analysis

Finds an appropriate dermatologist in your vicinity

To know your skin type

Ethic

Reliability (Clinical trial)

93

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23andMe

A privately held personal genomics and biotechnology company based in Mountain View (California) that provides rapid genetic testing

23andMe

95

23andMe

Gives you the possibility too Know if your child will be at risk for

48 inherited conditions and learn about steps you can take

o Personalize your healthcare by knowing in advance how you will respond to certain medications like Warfarin

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23andMe

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23andMe

Can help to plan for the future

Know in advance how we respond to certain medications

Data protection

Information may be made public or released to insurance companies

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Otoscope

Otoscope

100

App for diagnosis at home

For common problems like ear infections =

telemedicine diagnosis from home

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HELP !

Otoscope

↘ medical consultations

Rapidity

Comfortable for children

Sharing data if necessary

Consultation is opportunity for a global check

Other associated symptoms?

Interpretation and quality of diagnosis

Physician compensation?

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Diagnosis of pediatric ear infections

= cause 30 million doctor visits annually in the United States

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CONCLUSION

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Apps are useful to help patient managing their healthcare

Regulatory aspects

under construction

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eHealth action plan 2012-2020

New action plan for the development of e-Health & m-Health

By the European Commission

Aim : "Improve the care of patients by allowing them to have control over their benefit care“

Assessment of cost benefits, productivity gains and business models, notably through Health Technology Assessment (HTA)

http://ec.europa.eu/information_society/activities/health/docs/policy/ehap2012public-consult-report.pdf

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asipsanté

Created in 2009 by the French government

To develop, coordinate and participate in the regulation of e-health & m-health in France

Link between the universe of the health and the new technologies: telemedicine, DMP…

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PROPOSALS

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RELIABILITY

- Evaluation by clinical trials

- Check and approval by health professionnal

MONITORING ≠ DIAGNOSIS

- Medical support during diagnosis

DATA CONFIDENTIALITY

- Cryption reinforcement

- Protection improvement

REGULATION

- Scope clearly defined

NETWORK

- More resident applications

PHYSICIAN COMPENSATION

- Find a system

CONTROL

- Agency : Public/Private?

- Platform only for health apps

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Thank you for your attention