Patient View - The need for user-defined guidelines for health apps

Dee O’Sullivan
Director
myhealthapps.net/PatientView
The need for user-defined guidelines
for health apps
mHealth Meetup
4 June 2015
Google Offices, Brussels

About PatientView
• UK-based research, consulting and publishing company
• Collects and analyses the viewpoints of thousands of patient groups (and their members)
worldwide – since 2000
• Has the capacity to reach out to 120,000 patient organisations worldwide, covering over
1,000 health specialties
• Launched myhealthapps.net in November 2013 to help patients, carers, and health-conscious
consumers find apps that have been tried and trusted by people like them

Surveys, research, reports, white papers, directories, toolkits…

Why do we need quality health apps?
• Health apps help the public and patients provide continuity of
self-care during illness
• Health apps support self-management of health and wellbeing
generally, not just the primary illness
• Health apps inform, bringing health information to the public
and patients 24/7
• Health apps can help clinicians and patients spend their limited face-to-
face time on patients’ real concerns.

Where we are today…
• Over 450 apps
• Covering 150+ health specialties
• Apps in 50 languages
• Reviews by over 650 patient organisations worldwide
• Transparency: info on and links to app developer, who funded the app, whether it was developed with a
medical adviser, if it has regulatory approval (if necessary)
• Neutral platform: only apps recommended by patient or health consumer groups included.
Myhealthapps.net/PatientView takes no money from app developers or app downloads

myhealthapps.net has worked with…

Substantial support available to
help patients and doctors
overcome their concerns….
Clinical views of health apps
Doctors’ views on health appsPatients’ views on health apps

Patients are increasingly building a repertoire of apps to support their needs

Pilot study with Sycamore House Medical Centre, Birmingham (UK)
4,000 patient practice
 To promote the use of health apps to patients, give online advice, electronic booking
of consultations - all to support self-care and improve relations with patients

Two test sites offered:
NHS Health Apps Library and myhealthapps.net

Canvassing patients’ views – a few examples…
Survey on behalf of the European Commission and the Greek Presidency (pilot study,
results published in April 2014) into the attitudes of patients and carers to:
1. Services in the home (like mobile phones, the internet, telecare, or personal health monitors) which
provide support for independent living, or which communicate with the doctor, nurse or other care
professional.
— Can these services help with the care of your long-lasting illnesses or conditions?
— Can they help you care for a person with long-lasting illnesses or conditions?
2. Supporting services based on mobile phones, the internet, telecare, or personal health monitors
(which communicate with your doctor).
— How could they be improved to help people cope with long-lasting illnesses or conditions?

Profile: respondents to the April 2014 Pilot Study
 Responses from 21 EU Member States
majority from the UK (69%), but also from:
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Germany, Greece, Hungary,
Ireland, Latvia, Lithuania, Netherlands, Portugal, Romania,
Slovenia, Spain and Sweden.
 The majority of the patients and carers
have extensive experience of coping with
the medical condition
 43% of the patients and carers have been coping
with the medical condition for more than 10 years.
 11% of the patients and carers are coping with a
condition that is lifelong.
 The patients and carers were involved with
diverse chronic medical conditions,
notably…
 Rheumatological conditions (26%)
 Cancer (13%)
 Diabetes (8%)
 Multiple sclerosis (7%)
 Rare diseases (6%)
 Mobility impairments (5%)

Profile: respondents to the April 2014 Pilot Study
 Total number of respondents: 500
 73% were patients, 27% were carers
 9% are both patient and carer
 40% of the patients have a carer
 75% of the respondents live in an urban setting, 25% in rural areas.
 60% of the respondents are aged between 41-64.

Results: the technology is rarely used by the respondents for …
 Keeping in touch with doctors online
 Arranging medical appointments online
 Electronic home health-monitoring system
collecting results to be shared with the doctor,
nurse, or hospital
… though many of the
respondents would like to do this

 Online counselling and support for the
illness/condition
 Networking with other people who have the
same illness/condition
… but again, many respondents would like to do this
Results: the technology is rarely used by the respondents for …

What do patients and carers want from health apps?
A June-Oct 2014 global survey conducted by PatientView, myhealthapps.net, and Health 2.0
 1,130 respondents
• with either a long-lasting illness, or caring
for someone who has one
 From 31 countries
• 82.3% from Europe
• 10% with diabetes
• 9.6% with cancer
• 7.6% with arthritis
• 6.6% with a mental health problem
• 6.4% with a rare disease
• 4.9% with a hormonal disorder
• 4.8% with pain
• 4.4% with a heart condition
• 4.2% with multiple sclerosis
• Plus: 39 other conditions
17

HAVE YOU USED ELECTRONIC TECHNOLOGIES (VIA YOUR COMPUTER OR SMARTPHONE)
FOR ANY OF THE FOLLOWING HEALTHCARE PURPOSES?
HAVE YOU USED ELECTRONIC TECHNOLOGIES (VIA YOUR
COMPUTER OR SMARTPHONE) FOR AN FOLLOWING
HEALTHCARE PURPOSES?
What are the main type of health apps you use regularly?
Activities are focused on
areas NOT integrated with
the healthcare system;
that can be undertaken
alone

FOR ANY OF THE FOLLOWING HEALTHCARE PURPOSES?Irrespective of what health apps you are currently using, what
do you want most from health apps?
But patients aspire to
more than
information

FOR ANY OF THE FOLLOWING HEALTHCARE PURPOSES?Do any of the following prevent you from downloading some
health apps, or using them regularly?
Not just about the
monetary cost of the
health apps …
patients want support on which ones
are most relevant to them

FOR ANY OF THE FOLLOWING HEALTHCARE PURPOSES?Which of the following would convince you to
use health apps regularly?
Patients/carers also need
guidance on which apps
to trust

Diabetes KEY NEED IDENTIFIED
→An intuitive app that calculates carb to insulin ratios advising on next best
steps, giving feedback on how proper maintenance clearly improves my health
(relevant in T1 or insulin-dependent T2 diabetes only, though some aspects may be relevant to people with
Type 2 diabetes that do not have to take insulin)
Critical design and concept features that a diabetes app should address
•Calculates carb ratios, based on information provided by the user
•Provides useful information for understanding carb to insulin ratios
•Tracks my blood sugar levels regularly throughout the day
•Takes data on my symptoms, treatment and lifestyle
•Works out how the food I eat affects my blood sugar
•Works out how the exercise I take affects my blood sugar
•Must be easy-to-enter data
•Secure messaging service with doctors/nurses for questions would also be of value
•Supports me in calculating ratios and insulin dosing based on personal historical data
•Permits me to communicate with other people like myself to get help and advice on how much insulin to take with food
•Provides access to nutritional information for accurate carbohydrate content of common foods
A PatientView / Health2.0 / TICBioMed survey of 1.130 patients and carers views on what they want from
health apps —June to October 2014

Sustainable healthcare app
FINANCIAL
• Sustainable
business model,
for example
subscription,
payer
contribution
TECHNOLOGICAL
• Works
seamlessly over
multiple
platforms
• `Smooth’
updates with no
loss of data or
negative impact
on patients
CLINICAL
• Accepted by
HCPs and
patients
because
medical content
is accurate, and
regularly
reviewed and
updated
INTEGRATED
• Accepted as
part of the local
healthcare
support system
• HCPs, patients
and carers clear
how this app
fits into the
person’s care
‘FOR LIFE’
• Able to adapt
and target
personalised
support for a
patient at each
stage of a
journey with a
long-term
condition

01
Jorge Gonzalez, Managing Director, TICBioMed
[An eHealth cluster headquartered in the region of Murcia (Spain)
whose members include the local public healthcare system, four
private hospitals, three universities and more than 30 ICT companies]
“One reason why the health app
market has failings is that more often
than not health apps are developed in
isolation from their intended users—
patients and the public.”There are compelling reasons why the quality
of health and wellbeing apps might be
improved with a set of user-designed
guidelines.
Users want apps that they can trust and
which meet their needs and developers need
clearer guidance on how to address those
needs in order to deliver better quality apps.
The need for user
guidelines

• Health apps transcend national geographic boundaries and it is unclear who or what has
jurisdiction over them—the same app can be used in many countries.
• Technology is moving so quickly it would be hard for regulators to keep up and not stifle
innovation with bureaucratic delay.
• Health apps are but one tool in the electronic delivery of medical solutions, so regulating
them in isolation may not be productive.
• EU nations are finding it increasingly difficult to keep up with the transposition and
application of regulation.
Theneedforguidelines ratherthan excessive
regulation -better outcomesforusers and developers

US Food and Drug Administration (FDA) recently updated its guidance on
regulating health apps*
*Medical Devices Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,
9 February 2015 www.fda.gov/medicaldevices
Mobile medical apps that the FDA will regulate
The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory
definition of “device” and that:
• are intended to be used as an accessory to a regulated medical device, or
• transform a mobile platform into a regulated medical device
Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk
to patients will require FDA review.
Mobile apps for which the FDA intends to exercise enforcement discretion
For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA
will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register
and list their apps with the FDA. This includes mobile medical apps that:
• Help patients/users self-manage their disease or condition without providing specific treatment suggestions
• Provide patients with simple tools to organise and track their health information;
• Provide easy access to information related to health conditions or treatments
• Help patients document, show or communicate potential medical conditions to health care providers
• Automate simple tasks for health care providers
• Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record
• (EHR) systems.

Examples of other app guidelines
British Standards Institution is set to publish guidelines on the
development of healthcare apps in 2015—primarily for health and
wellbeing
GSMA has created a set of guidelines for application developers that
enable improvements across a number of areas including application
connectivity, power consumption, network reliability and security.
http://smarterappsguidelines.gsma.com/
Highlighting those features of mobile
devices that are beneficial to people with
disabilities

12 January 2015 - Summary report on the public consultation on the Green Paper
on mobile health identifies many concerns [European Commission]
The green paper - summary of the public consultation, relevant findings to MHA Document:Summary report on the public consultation on the Green Paper on mobile health
https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health Published: 12 January 2015. Based on responses of 211 stakeholders to the
Commission’s Green Paper published on 10 April 2014.
Data protection—what is health data? What would
build trust?
Data-sharing interoperability—how important is
this to users? How important is it that data in apps
are standardised?
Big data—should users know how their data are
being gathered and used? Should users decide
which of their data they want to share?
Legal oversight—what do users want? Should law
define how personal data in apps are processed and
used? Should app developers be required to ensure
any claims they make are justified?
Liability issues—need for code of conduct among
app developers? Should there be guarantees of
reliability and functionality? Should app stores be
made liable for their content? Who should be liable if
patients pass inaccurate medical data to one
another?
Levels of transparency of the app/owner developer,
and their partners—how much and what?
Lots of questions for users and developers to consider ….

12 January 2015 Summary report on the public consultation on the Green Paper on
mobile health identifies many concerns [European Commission]
Lots of questions for users and developers to consider …
Incentives - what would make public/patients use
health apps more frequently? Should they be
prescribed by doctors?
Health outcomes - how tangible should they be?
Value for money - how important?
Levels of governance - should there be quality labels
and certification schemes? Should there be a central
registry of health apps?
Clinical input - when?
Public and patient safety - how should that be
protected?
Health literacy - how can apps be made more readily
understandable to the user? Whose role is it to educate
users in mHealth?
Accessibility - how can apps be made more readily
accessible to the user? Should government help pay for
health and wellness apps?
The green paper - summary of the public consultation, relevant findings to MHA Document: Summary report on the public consultation on the
Green Paper on mobile health
https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health Published: 12 January 2015. Based on
responses of 211 stakeholders to the Commission’s Green Paper published on 10 April 2014.

01
“Within the thousands of healthcare
apps, there are some nuggets of good
practice, and developers who came to
the workshop were demonstrating
this. They were not only eager to gain
patient and clinical input into their
app development process, but it could
be fair to say they were at times
desperate for this, having had long,
aborted and frustrated attempts to
bring patients in”
Health 2.0/PatientView/ TICBioMed
joint workshop at Health 2.0 Europe,
London, 12 November 2014

01
Next Steps
Guidelines and Indexed Directory of 350 Non-
Medical Apps [Health and wellness/Disability and
accessibility apps] to be launched at the European
Health Forum Gastein, October 2015
Guidelines and Indexed Directory of 100 Medical
Apps [Apps that provide diagnosis, treatment or
are intended to be used within a clinical setting],
to be launched at Mobile World Congress,
Barcelona, February 2016

We would welcome your input and involvement!
PatientView – UK:
Dr Alex Wyke
T: +44 1547 520965
alexwyke@patient-view.com
Brussels:
Dee O’Sullivan
M: +32 495 893925
dee@patient-view.com

Patient View - The need for user-defined guidelines for health apps

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