what about regulation ? anaïs althapé arhondo - pauline colin - chloé dubroca - olivier heloir -...
TRANSCRIPT
![Page 1: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/1.jpg)
Health Applications for Smartphones
What about regulation ?
Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard
25/02/13
![Page 2: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/2.jpg)
2
DISCLAIMER
This is an independent study performed by students from the « Faculté des Sciences Pharmaceutiques de Lille »
![Page 3: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/3.jpg)
3
INTRODUCTION
![Page 4: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/4.jpg)
4
Recently
JAMA Dermatology
January 2013
1st major comparative clinical trial about Smartphone health Apps for the public
![Page 5: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/5.jpg)
5
Health apps
Regulatory problems
Technology development goes faster than regulation
Danger for public
![Page 6: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/6.jpg)
6
SURVEY ABOUT APPS’ CONSUMER
![Page 7: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/7.jpg)
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 ?
7
![Page 8: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/8.jpg)
276 answers
Sexo Men 37 %o Women 63%
Results (20/02/13)
8
![Page 9: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/9.jpg)
9
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%
![Page 10: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/10.jpg)
10
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%
![Page 11: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/11.jpg)
11
Have you got a smartphone ?o Yes : 80%o No : 20%
Androïd VS Iphone
![Page 12: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/12.jpg)
12
Advice for Health application ?o Yes : 14%o No : 86%
If yes, who ?
![Page 13: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/13.jpg)
13
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%
![Page 14: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/14.jpg)
14
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%
![Page 15: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/15.jpg)
15
Health’s professional validation ?o Yes : 65%o No : 35%
![Page 16: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/16.jpg)
1) Environment
2) Regulatory situation
3) Cases study
PLAN
16
1
2
3
![Page 17: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/17.jpg)
17
PART 1 ENVIRONMENT
Smartphones
Applications
Health applications
![Page 18: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/18.jpg)
18
SMARTPHONES
![Page 19: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/19.jpg)
19
Smartphone VS Computer
=Mobility
Photo
MedicalDevice
Bluetooth
Geolocalisation
+Phone
![Page 20: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/20.jpg)
Smartphones sales
20
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
![Page 21: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/21.jpg)
21
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
![Page 22: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/22.jpg)
22
Q4 2012 SAMSUNG APPLE
Smartphone sales (million) 63,7 47,8
Market share 29% 21,8%
TOP 2
APPLESAMSUNG
VS
*Source Ecoconscient
![Page 23: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/23.jpg)
Which countries did use more Smartphones in 2012 ?
Smartphones use
23
38% 38% 45%
27% (2011)
*Source : Sondage Ipsos – Google, Février 2012
![Page 24: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/24.jpg)
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%
24
Where are smartphones used ?
EVERYW
HERE
*Source : Sondage Ipsos – Google, Février 2012
![Page 25: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/25.jpg)
25
MOBILE APPLICATIONS
![Page 26: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/26.jpg)
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
26
![Page 27: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/27.jpg)
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
![Page 28: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/28.jpg)
Use of mobile apps
Top of Apps categories according to audience (in US)
28
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
![Page 29: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/29.jpg)
29
HEALTH APPLICATIONS
![Page 30: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/30.jpg)
30
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
![Page 31: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/31.jpg)
31
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
![Page 32: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/32.jpg)
32
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
![Page 33: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/33.jpg)
33
PART 2REGULATORY SITUATION
Guidelines
Evaluation by clinical trials
Private agencies
French practices
A manufacturer point of view
![Page 34: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/34.jpg)
FDA GuidanceMEDDEV
34
GUIDELINES
![Page 35: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/35.jpg)
35
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
![Page 36: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/36.jpg)
36
Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications
![Page 37: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/37.jpg)
37
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
![Page 38: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/38.jpg)
38
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
![Page 39: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/39.jpg)
39
Displaying, storing or transmitting patient-specific medical device data in its original format
1
2 Controlling the intended use, function, modes, or energy source of the connected medical device
![Page 40: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/40.jpg)
40
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
![Page 41: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/41.jpg)
41
Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions
OUT OF FDA SCOPE
1
![Page 42: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/42.jpg)
42
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
![Page 43: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/43.jpg)
43
Solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness
3
![Page 44: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/44.jpg)
44
Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication
4
![Page 45: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/45.jpg)
45
![Page 46: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/46.jpg)
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
46
![Page 47: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/47.jpg)
47
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
![Page 48: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/48.jpg)
48
Telesurgery Radiology Information System are not qualified as MD
EXAMPLES
![Page 49: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/49.jpg)
49
The telecommunication system (mobile, wireless, wire , etc…) is not as such a medical device
![Page 50: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/50.jpg)
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
50
![Page 51: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/51.jpg)
51
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
![Page 52: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/52.jpg)
Melanoma detectionBlood glucose control complianceMeasure of lung function
52
EVALUATION BY CLINICAL TRIALS
![Page 53: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/53.jpg)
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
53
OBJECTIVE
*Source : www.jamaderm.com - published online January 16, 2013
Primary endpoint : sensibility to categorize melanoma
![Page 54: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/54.jpg)
54
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
![Page 55: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/55.jpg)
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
55
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
![Page 56: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/56.jpg)
56
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
![Page 57: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/57.jpg)
Smartphone App to measure lung function
To compare the accuracy of SpiroSmart™ to a clinical spirometer endorsed by the American Thoracic Society (ATS)
57
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
![Page 58: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/58.jpg)
58
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
![Page 59: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/59.jpg)
59
Clinical trials interest
Define Benefit/Risk ratio
Seems to be necessary to approve health appso For diagnosis apps mainlyo +++ If reimbursement in the future ?
![Page 60: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/60.jpg)
DMDHapptiqueD4
60
PRIVATE AGENCIES
![Page 61: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/61.jpg)
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/
![Page 62: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/62.jpg)
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
62
![Page 63: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/63.jpg)
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
63
![Page 64: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/64.jpg)
ResponsabilitiesCNILHONMonitoringInternet conventionAdvertising control
64
FRENCH PRACTICES
![Page 65: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/65.jpg)
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
65
![Page 66: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/66.jpg)
Commission Nationale de l’Informatique et des Libertés
An independent French administrative authority
66
Aims : to ensure that data privacy law is applied to the collection, storage, and use of personal data
![Page 67: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/67.jpg)
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
67
![Page 68: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/68.jpg)
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
68
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
![Page 69: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/69.jpg)
Top des Medocs, a certified app
69
Santéclair
Medicines without prescriptiono 2400 drugso 100 selftreatment situations (cold,
cough, bloating, stomach heartburn…)
Health app certified by HON Foundation
![Page 70: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/70.jpg)
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
![Page 71: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/71.jpg)
Internet convention
Signed between AFSSAPS and LEEM President in 2006 (revised in 2010)
71
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
![Page 72: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/72.jpg)
72
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
![Page 73: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/73.jpg)
73
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
![Page 74: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/74.jpg)
Interview of Uwe DIEGEL - iHealth (28/11/2012)
74
A MANUFACTURER’S POINT OF VIEW
![Page 75: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/75.jpg)
iHealth Lab
CEO iHEALTH
Silicon Valley start-up
An official partner of Apple
50% hypertension market share in Europe
3 years $ 80million
75
Uwe DIEGEL
*Source : Medical Device Daily – Tuesday, November 20, 2012
![Page 76: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/76.jpg)
Some iHealth Products
Blood pressure monitor A new glucometer
76
![Page 77: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/77.jpg)
Key points
Regulation ≠ innovation restriction
Against diagnosis app (illness)
For Health management app
Self-measures are not medical data
77
![Page 78: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/78.jpg)
78
PART 3CASE STUDY
![Page 79: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/79.jpg)
79
Défibrillateurs
![Page 80: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/80.jpg)
Défibrillateurs
Defibrillator localisation
First aid techniques reminder
Call emergency ambulance service directly
80
![Page 81: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/81.jpg)
Défibrillateurs
81
DIPLOME
![Page 82: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/82.jpg)
Défibrillateurs
Helpful
(localisation, techniques)
Handy
All defibrillators are not listed
Nobody check localisation
Don’t work without network Dependence
82
![Page 83: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/83.jpg)
83
iBGStar®
![Page 84: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/84.jpg)
84
iBGStar® Diabetes ManagerMonitor blood glucose,
carbohydrate intake and insulin
Manages resultso Logbooko Trend charto Statistics
Simplifies communication with health care professional
![Page 85: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/85.jpg)
85
iBGStar® Diabetes Manager
Color-coded
o Hypoglycemia
o Glycemia in medical range
o Hyperglycemia
![Page 86: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/86.jpg)
iBGStar®
86
![Page 87: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/87.jpg)
iBGStar®
87
![Page 88: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/88.jpg)
iBGStar
Simple and useful
Optimisation for monitoring
Device independent of mobile
Share with doctor
Color-coded dependence to interpret glucose results
88
![Page 89: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/89.jpg)
89
Skinvision
![Page 90: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/90.jpg)
What is it?o Allows patient to
know UV index/skin type
o Checks skin lesion and moles : Melanoma risk ?
o Finds a dermatologist
90
Skinvision
Algorithm•Picture•Sexe•Age
How it works ?
![Page 91: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/91.jpg)
Skinvision
91
![Page 92: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/92.jpg)
92
Skinvision
![Page 93: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/93.jpg)
Skinvision
Easy and simple check
Immediate analysis
Finds an appropriate dermatologist in your vicinity
To know your skin type
Ethic
Reliability (Clinical trial)
93
![Page 94: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/94.jpg)
94
23andMe
![Page 95: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/95.jpg)
A privately held personal genomics and biotechnology company based in Mountain View (California) that provides rapid genetic testing
23andMe
95
![Page 96: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/96.jpg)
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
96
![Page 97: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/97.jpg)
23andMe
97
![Page 98: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/98.jpg)
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
98
![Page 99: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/99.jpg)
99
Otoscope
![Page 100: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/100.jpg)
Otoscope
100
App for diagnosis at home
For common problems like ear infections =
telemedicine diagnosis from home
![Page 101: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/101.jpg)
101
HELP !
![Page 102: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/102.jpg)
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
![Page 103: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/103.jpg)
103
CONCLUSION
![Page 104: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/104.jpg)
104
Apps are useful to help patient managing their healthcare
Regulatory aspects
under construction
![Page 105: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/105.jpg)
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
![Page 106: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/106.jpg)
106
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…
![Page 107: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/107.jpg)
107
PROPOSALS
![Page 108: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/108.jpg)
108
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
![Page 109: What about regulation ? Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard 25/02/13](https://reader035.vdocuments.site/reader035/viewer/2022062323/56649dc75503460f94abbf05/html5/thumbnails/109.jpg)
109
Thank you for your attention