Transcript Présentation PowerPoint

25/02/13
What about regulation ?
Anaïs Althapé Arhondo - Pauline Colin - Chloé Dubroca - Olivier Heloir - Marie-Caroline Richard
 This is an independent study performed by
students from the « Faculté des Sciences
Pharmaceutiques de Lille »
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 JAMA Dermatology
 January 2013
 1st major comparative
clinical trial about
Smartphone health
Apps for the public
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 Regulatory problems
 Technology development goes faster than
regulation
 Danger for public
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 To know :
o Who the consumers of health Apps are?
o Which smartphone?
o What kind of Apps?
o Why do they use them?
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 276 answers
 Sex
o Men 37 %
o Women 63%
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 Ages
o <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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 Activities
o
o
o
o
o
o
o
Etudiant en santé : 35%
Etudiant dans les nouvelles technologies : 0%
Etudiant (autre domaine) : 9%
Professionnel de santé :15%
Professionnel dans les nouvelles technologies : 5%
Professionnel (autre domaine) : 28%
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
o
o
o
o
o
Renseignements sur des médicaments : 32%
Suivi quotidien d’une pathologie chronique : 17%
Conseils hygiéno-diététique : 11%
Informations sur des pathologies : 9%
Aide à un auto-diagnostic :15%
Aucune : 13%
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 Health’s professional validation ?
o Yes : 65%
o No : 35%
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11)
Environment
21)
Regulatory situation
31)
Cases study
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Smartphones
Applications
Health applications
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Phone
+
Mobility
=
Bluetooth
Photo
Medical
Device
Geo
localisation
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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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Global Internet Device Sales
3,000
Units in millions
2,500
Tablets
2,000
1,500
Smartphones
1,000
500
Computers
0
2000
2001
2002
2003
*Source Gartner – May 2012
2004
2005
2006
2007
2008
2009
2010
2011
2012E
2013E
2014E
2015E
2016E
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SAMSUNG
APPLE
VS
TOP 2
Q4 2012
SAMSUNG
APPLE
Smartphone sales (million)
63,7
47,8
Market share
29%
21,8%
*Source Ecoconscient
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 Which countries did use more Smartphones in 2012 ?
38%
38%
45%
27% (2011)
*Source : Sondage Ipsos – Google, Février 2012
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 Where are smartphones used ?
Home
96%
Work
69%
On-the-go
49%
Doctor's office
55%
Airport
32%
3%
*Source : Sondage Ipsos – Google, Février 2012
64%
59%
61%
44%
43%
50%
36%
School
56%
43%
59%
Public transport
76%
27%
48%
At a social gathering/function
75%
63%
70%
Café or coffee shop
78%
85%
76%
Restaurant
98%
71%
83%
In a store
Somewhere else
97%
42%
61%
64%
16%
5%
27%
3%
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 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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Apple Store
Androïd Market
TOP 2
VS
 25 billion of apps downloaded
o in march 2012 for iOS
o in september 2012 for Androïd
 Apps classification not clear
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 Top of Apps categories according to audience (in US)
35000
30000
25000
+134%
20000
15000
10000
5000
0
Déc. 2010
Déc. 2011
*Source : comScore MobieLens, 3 mon. avg. ending Dec-2011 vs. Dec-2010
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 In January 2012
17 000
Health & Fitness
apps
74%
paid
apps
*Source : Proximamobile – January 2012
6 000
Health & Fitness
apps
73%
for the
public
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Consumer Health Apps for Apple’s iPhone
Cardio
16%
Other
27%
Sleep, Emergency, Smoking
cessation, Medication
Adherence, PHR…
Diet
14%
Chronic
conditions
6%
Stress &
Relaxation
11%
Mental Health
6%
Calculator
6%
*Source : MobiHealthNews’2011 report
Strength
Training
7%
Women's
Health
7%
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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
device
o Sent to a health professional
 eLearning or Serious Game
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Guidelines
Evaluation by clinical trials
Private agencies
French practices
A manufacturer point of view
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FDA Guidance
MEDDEV
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2011
2005
1989
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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THE FDA SCOPE
MOBILE MEDICAL APPS
 Used as an accessory to a regulated medical
device
OR
 Transform a mobile platform into a regulated
medical device
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1
Displaying, storing or transmitting patientspecific medical device data in its original format
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Controlling the intended use, function, modes, or
energy source of the connected medical device
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3
4
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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OUT OF FDA SCOPE
1
Mobile apps that only automate
general office operations with
functionalities that include billing,
inventory, appointments, or
insurance transactions
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2
Electronic “copies” of medical
textbooks, teaching aids or
reference materials, or are
solely used to provide
clinicians with training or
reinforce training previously
received
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3
Solely used to log, record,
track, evaluate, or make
decisions or suggestions
related to developing or
maintaining general health
and wellness
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4
Mobile apps that are generic
aids that assist users but are
not commercially marketed
for a specific medical
indication
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 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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MEDDEV 2.1/6
 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 questions
o In which cases should a software be considered as a medical
device?
o If it is considered like a medical device, which guidelines apply?
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EXAMPLES
 Telesurgery
 Radiology Information System
are not qualified as MD
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The telecommunication system (mobile, wireless,
wire , etc…) is not as such a medical device
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Mersey Burns
 Free clinical tool
o Calculating burn area
percentages
o 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
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Melanoma detection
Blood glucose control compliance
Measure of lung function
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OBJECTIVE
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
 Primary endpoint : sensibility to categorize melanoma
*Source : www.jamaderm.com - published online January 16, 2013
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RESULTS
 Sensitivity
o + : analysed by a board-certified
dermatologist
o - : analysed by automated algorithms
CONCLUSION
 Reliance on these applications in lieu
of medical consultation
o Can delay the diagnosis of melanoma
o Can harm users
*Source : www.jamaderm.com - published online January 16, 2013
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OBJECTIVE
Comparison of mobile app and standard
diabetes management effect for glycated
hemoglobin levels in patients with type 2
diabetes
 Primary endpoint
o Glycated hemoglobin levels
 Secondary endpoints
o Diabetes distress, depression, and other clinical (blood pressure)
and laboratory (lipid)values
*Source : www.welldoc.com - Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral
Intervention for Blood Glucose Control
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RESULTS
 Glycated hemoglobin
o Dicrease of 1.2% over 12 months
o Appreciable differences were not observed
for secondary outcomes
CONCLUSION
 Mobile coaching improves compliance
and therefore reduces glycated
hemoglobin levels over 1 year
*Source : www.welldoc.com - Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral
Intervention for Blood Glucose Control
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OBJECTIVE
To compare the accuracy of SpiroSmart™
to a clinical spirometer endorsed by the
American Thoracic Society (ATS)
 Primary endpoint
o Standard spirometer measures flow rate
 Secondary endpoints
o Comparison diagnoses from pulmonologists using
SpiroSmart™ and a clinical spirometer
*Source: http://abstract.cs.washington.edu/~shwetak//papers/SpiroSmart.CR.Final.pdf
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RESULTS
 Accuracy of measures : 80-90%
CONCLUSION
 SpiroSmart™ can be used to
diagnose normal vs obstructed
spirometry
 SpiroSmart™ can be effective for
diagnosing the degree of the
obstruction
*Source: http://abstract.cs.washington.edu/~shwetak//papers/SpiroSmart.CR.Final.pdf
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 Define Benefit/Risk ratio
 Seems to be necessary to approve health apps
o For diagnosis apps mainly
o +++  If reimbursement in the future ?
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DMD
Happtique
D4
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 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
Source: http://www.dmd-sante.com/
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 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 apps
o Published in January 2012
o 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
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Responsabilities
CNIL
HON
Monitoring
Internet convention
Advertising control
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Responsabilities
Publisher
 Who is it ?
o He creates the content
OR
o He has the power to make
the editorial choice about the
content
 Total responsibility
o Respect of principles related
to content published
o Respect of rules for medical
publishing
Host
 Role
o Only technical
o No obligation to watch over
contents
 Responsibility
o None
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 An independent French administrative authority
 Aims : to ensure that data privacy law
is applied to the collection, storage,
and use of personal data
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Advice for App user
 Managing passwords
 Data confidentiality
o Coding of personal
information
o Cryption
Obligation for publishers
of App
 Collection/storage/use of
personal data
 Law on computers, files
and liberties
 Collect only personal data
necessary
 Data integrity
 Limited duration = time
required
 Internet connection
 Ensure confidentiality and
security of information
o Firewall or software
protection barriers
 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
 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
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Top des Medocs, a certified app
 Santéclair
 Medicines without prescription
o 2400 drugs
o 100 selftreatment situations (cold,
cough, bloating, stomach
heartburn…)
 Health app certified by HON
Foundation
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 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
*Source: Décret du 19 octobre 2010 relatif à la télémédecine
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 Signed between AFSSAPS and LEEM
President in 2006 (revised in 2010)
 Aims = to help pharmaceutical industries to
o Create their web pages with respect to the law
o Differentiate advertising from information
 General recommendations
o
o
o
o
Name the company
Identify population concerned
Update information regularly (specify the last update)
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
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Interview of Uwe DIEGEL - iHealth
(28/11/2012)
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 CEO iHEALTH
 Silicon Valley start-up
 An official partner of Apple
Uwe DIEGEL
 50% hypertension market share in Europe
 3 years  $ 80million
*Source : Medical Device Daily – Tuesday, November 20, 2012
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Some iHealth Products
 Blood pressure monitor
 A new glucometer
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 Regulation ≠ innovation restriction
 Against diagnosis app (illness)
 For Health management app
 Self-measures are not medical data
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 Defibrillator localisation
 First aid techniques reminder
 Call emergency ambulance
service directly
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Défibrillateurs
 Helpful
(localisation, techniques)
 All defibrillators are not listed
 Nobody check localisation
 Handy
 Don’t work without network
Dependence
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 Monitor blood glucose,
carbohydrate intake and
insulin
 Manages results
o Logbook
o Trend chart
o Statistics
 Simplifies communication
with health care professional
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 Color-coded
o Hypoglycemia
o Glycemia in medical range
o Hyperglycemia
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iBGStar
 Simple and useful
 Optimisation for
monitoring
 Color-coded dependence
to interpret glucose
results
 Device independent of
mobile
 Share with doctor
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 What is it?
o Allows patient to
know UV index/skin
type
o Checks skin lesion
and moles :
Melanoma risk ?
 How it works ?
Algorithm
•Picture
•Sexe
•Age
o Finds a
dermatologist
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Skinvision
 Easy and simple check
 Ethic
 Immediate analysis
 Reliability (Clinical trial)
 Finds an appropriate
dermatologist in your
vicinity
 To know your skin type
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 A privately held personal genomics and
biotechnology company based in Mountain View
(California) that provides rapid genetic testing
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Gives you the possibility to
o 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
 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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 App for diagnosis at home
 For common problems like ear
infections =
telemedicine diagnosis from home
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Otoscope
 ↘ medical consultations
 Rapidity
Diagnosis of pediatric ear
infections

Comfortable
for doctor
childrenvisits
= cause
30 million
annually in the United States
 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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 Apps are useful to help patient managing their healthcare
 Regulatory aspects
 under construction
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 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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 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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RELIABILITY
-
Evaluation by
clinical trials
MONITORING
-
Check and approval
by health
Medical supportDATA
professionnal
during diagnosis
≠ DIAGNOSIS
CONFIDENTIALITY
-
Cryption REGULATION
reinforcement
-
Protection
- Scope clearlyNETWORK
improvement
defined
-
PHYSICIAN
More resident
COMPENSATION
applications
-
Find a system
CONTROL
-
Agency :
Public/Private?
-
Platform  only for
health apps
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