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- Why mHealth?
- Why Health Apps Library?
- Where next?
• Even the simple stuff..
• Worldwide market penetration of mobile phones will rise
from 61.1% in 2013 to 69.4% in 2017.
• NHS 111 received 891k calls in February 2014
• Even the simplest of applications, SMS, has a huge role to
• Apollo Hospitals Group (India) use SMS as part of an integrated
diabetes management programme to help people monitor their
• Orange Healthcare system in Kenya, Cameroon and Ghana
that allows verification of medicines to combat the huge rise
in counterfeit pharmaceuticals
• These simple applications are the tip of the iceberg.
• Infrastructure already there.. networks, billing engines
and the app industry are.
• The number of mobile health apps continues to
exponentially increases- nearly 100,000 mHealth apps
already available across multiple platforms such as iTunes,
• In January 2014, nearly 1/3 of US smartphone owners,
which is about 46 million unique people, used fitness and
health apps and the number of people using wearable
devices to self-monitor or track their health, including Fitbit
which has over 3.3 million users
“Where do I find
health apps that can
“How can people find
my app easier”
Citizen App Developers
“I want rigour in the review
“Don’t need another
app store” “Don’t just want to
pile it high”
not just based on
“Don’t just want any
“Are these apps safe?”
“Don’t want an overly
somewhere to be able
to signpost “
“Not valuable if not
Apps for the public –
what the users said?
Health Apps Library
CategoriesHome App Detail
Process App Stores
App Submission process
Step 1. Submit –
Developer submits an app
Step 2. Initial triage
Apps Team review the supplied information to check
what the app does
Step 3. Clinical Review
Safety Engineer and Clinicians review the app
Step 4. Yes or No
The app is approved and published or rejected due
to not meeting our criteria
Step 5. On-going Review
The app listing is reviewed on a regular basis and if
a user flags concern to us
Critical step in the safety
process - An initial triage
checklist is completed on each
App and it’s function.
Does it pose any harm to
If Yes to Step 2 – Safety
Assurance is required.
Evidence of compliance with
the Safety Standard –
App Triage - Is the App a
• CE marked?
• functions include control or monitoring of a Medical
• response time is time critical to patient care?
The review process has been structured in a way to determine an Apps function,
type of service it delivers.
First and foremost – Section 1 of HSCIC triage process aims to establish whether
or not an App is eligible to be a medical device.
Where ISB0129 does NOT apply as the App is a Medical Device.
Example questions from the triage checklist in order to determine if the App falls
under the requirements of a Medical Device.
Note: Answering yes to one or more of the above suggests the App may be
a medical device (or a part of). Seek MHRA advice www.mhra.gov.uk
App Triage – Categorisation
of App Function?
Triage Section 2 - Establishing the categorisation of the software /
• Informational application?
• Calculation and / or monitoring application?
• Transactional application, to support booking appointments or
• Decision Support application?
Look to clarify if an App falls under requirements of ISB0129 Clinical
Risk Management: It’s Application in the Manufacture of Health IT.
App Triage – Applicable to
• provides Clinical decision support based on user input for
treating or diagnosing a specific disease or disorder
• integrates with other Health IT systems
• is a transactional system (e.g. supporting appointment
When safety assurance is required under ISB0129.
Example question from the triage checklist.
E.g. Apps providing, access to the patients GP Health IT
system, medication dosage calculators, prescribing. 14
App Triage – Applicable to
• if the App is NOT integrating with other Health IT systems
• solely automates general office functions to assist in
payments and billing etc
• performs calculations / monitoring of general health and
wellbeing with no Clinical support
• provides information from a reputable organisation
E.g. Healthy life style apps that presents information to
the user, or user records and monitors own diet, weight. 15
When safety assurance is NOT required under ISB0129.
Example questions from triage checklist.
What is required under
• Risk Analysis
• Risk Evaluation
• Risk Control
• Delivery, Monitoring and Modification
Note: Clinical Risk Management runs throughout lifecycle
Manufacturer’s evidence of ‘Clinical Risk Management’
Breakdown of apps
Tiage - Not
Triage - Sent
Total 176 142 34 11 17 6
Approved by the Clinical Safety Group
Clinical Safety Approval not required
‘App Submission’ –
Safety versus Not Safety
Tiage - Not Safety Triage - Sent for Safety Analysis
Move from informational only apps to a set of transformational apps
aligned to key health priorities
Online Care Planning
for Dementia integrated
with GP system
Online Test Results
and Care Planning
People and Carers
People and Carers
People with Sexual
and Mental Health
Internet Radio App
for new parents
for Long Term
with GP system
Where next? - PHRs
Patient access online
services through GP system
patient portal or app
app app app
Patient provides information
into a PHR and associated
with clinical information
sourced from multiple points
Secure transmission to user
Secure transmission to
Carer can access
and also enter
Focus on supporting patients in managing
Focus on clinical safety
Future is in enabling “integrated
Apps part of the patient journey