what about regulation ? anaïs althapé arhondo - pauline colin - chloé dubroca - olivier heloir -...
TRANSCRIPT
Health Applications for Smartphones
What about regulation ?
Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard
25/02/13
2
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
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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?
102
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
105
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