As part of the Squared Online digital marketing course, we were tasked with completing a white paper on the future of the Pharmaceutical industry. Our paper focused on the emerging trends around, digital healthcare and the quantifiable self.

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1! QUANTIFIED SELF Authors: Group 17, 26/07/2015!
Quantified Self is here to stay. Are you ready to take advantage?
Abstract: Analysis of the Quantified Self trend including its historical impact, future impact and
recommendations in the context of the Pharmaceutical Industry.
1. The Trend
The ‘Quantified-Self’ is a trend of personal data
collection via technology such as ‘Mhealth’ and
‘Wearables’. ‘Wearables’ is a term used to describe any
electronics one can wear that can be adapted to capture
medical data. An example is the ‘Iwatch’, which can
monitor heart rate. ‘Mhealth’ is a term that refers to the
usage of mobile devices (smartphones, tablets, etc) or
software Applications (Apps) in connection to medicine
or healthcare, including the provision and collection of
information to or from Patients and Health Care
Providers (HCP). The idea behind the trend is to acquire
quantifiable data on a person’s state, actions and
performance using wearable technology and/or mobile
applications.
2. The Impact
2.1Current impact 2012 to 2015
It is not surprising that the impact of the Quantified Self
movement, within an industry still struggling to come to
terms with social media has thus far been limited. This
sentiment is perhaps best expressed through Google
Health, a service that collated Quantified Self data, and
was decommissioned in January 20121
due to its limited
impact. Although, it was adopted by some tech savvy
patients, their HCP’s and by fitness enthusiasts, it failed
to have ‘the widespread adoption in the daily health
routines of millions of people’2
.
Though in the same year that Google Health was
decommissioned, there began a new way of doing things
in our industry, that has directly impacted the daily
health of millions of people. A way of doing things, that
just may just be the precursor, that was needed to pave
the way for the Quantified Self trend to disrupt Pharma
marketing, perhaps even more so than the rise of social
media.
Our industry’s’ standard method of operation was
transformed from one of secrecy and fierce
competiveness, to one of transparency and collaborative
working3
, when in 2012, giants of our industry with
multi-billion transnational operations, such as
GlaxoSmithKline (GSK)4
decided to openly share their
clinical trials data online with their competitors, through
platforms such as www.clinicalstudydatarequest.com
and www.transceleratebiopharmainc.com5
.
In July 2014 there were six other major drug
manufacturers who followed in GSK’s footsteps6
, and in
the space of a year, that figure has doubled to twelve7
heavy weights of the Pharmaceutical industry, all
sharing ‘big data’ to develop the drugs that the world
wants.
With the benefits of sharing ‘big data’ clear, coupled
with developments in factors that have historically
curtailed the trend, only now are industry leaders
beginning to have interesting conversations, about the
trends potential to make possible, what was once
considered impossible over the next five years.
2.2 Developments in factors that have
historically curtailed impact 2012-2015
Regulatory compliance
Until 2014 there was a lack of clear regulatory
compliance specific to Mhealth Apps and supporting
Wearables in the UK. A summary of our industries slow
regulatory compliance development, compared to the
development of an Mhealth App, by a software
company, relatively untethered by regulations, is shown
below for illustrative purposes.
Regulatory Compliance Software Development Company
In January 2012 there
was only ONE App,
‘Mersey Burns’ which was
registered with the
Medicines and Healthcare
products Regulatory
Agency (MHRA), the
competent medical
authority in the UK, as a
medical device according
to D4, a non-profit
organisation that equips
physicians and nurses with
communications devices.8
In the same first quarter of 2012,
Runtastic, a fitness App, had already
ventured into launching
accompanying hardware products
for their Mhealth App, in order to
broaden their reach in the health
and fitness Industry9, amidst the
growing popularity of the Quantified
Self trend.

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2! QUANTIFIED SELF Authors: Group 17, 26/07/2015!
On the ‘Quantified Self Guide’ there are over five
hundred Quantified Self Apps. Only sixty are
categorised under medicine, whilst more than fives times
that number fall under health, fitness and sleep 17
.
Software development companies may have their own
capabilities, but they don’t have our experience in
understanding the Patient, the Caregiver and the
Healthcare professional18
. The impact of Mhealth and
Wearables within fitness and exercise is clear, but its
impact within healthcare is arguably only beginning.
Privacy concerns
Privacy concerns pertaining to heavily regulated medical
information has contributed to HCP’s being less inclined
to work with alternative data sources, outside of the
scope of a Patient’s confidential Electronic Medical
Records (EMR). For example, Electronic Health
Records (EHR), such as such as Microsoft(R)
HealthVault(TM)19
, which allow individuals to collate
data using Mhealth Apps and Wearables.
An example of privacy management gone wrong
through poor App design, is the negative publicity that
Fitbit.com attracted, when it was revealed that anyone
could view users, who were logging their ‘very active
sexual encounters’ online.
The solution was simple, they reconfigured the default
privacy settings in their App to not show that data,
unless the user selected otherwise20
. Unlike software
development companies, again we are uniquely
positioned with a wealth of experience, not only in
Patient consent capture techniques, but also in managing
and communicating medical information in confidence,
through the cumbersome healthcare universe.
New risks, device malfunction & data
misinterpretation
The new risks potentially posed by flawed design or
incompetent testing specific to Mhealth Apps and
Wearables has also contributed to limiting the trends
impact, within a risk-averse industry. For example
nutritional Apps leading to non-balanced diets; or
incorrectly calibrated pulse trackers encouraging over
exercise in those suffering from heart disease, placing
them at risk of relapse.
In the case of ‘Fitbit Force’, the wearable device itself
was the centre of complaints from users pertaining to
causing rashes.21
Then there is the tragic story of the
cyclist competing for a better score, using an activity-
tracking device resulting in a fatal accident22
.
In September 2012, a proposal
suggesting amendments to the
aged regulatory Directives in force
since the 1990’s was put forward
to the European Parliament. It
aimed to counter the criticism, that
the dated directives, “in light of
technological and scientific
progress, were hindering the
assured safety of medical devices,
and their free movement within
the internal market”.10
In 2013, approximately a year
from Runtastic’s Hardware
launch, research conducted by
a leading Think Tank, found
that 1 in 10 Americans over
the age of 18 owned a
‘Wearable’11
In September 2013 the FDA, the
U.S Regulator, publishes specific
guidance for the development of
Mhealth Apps & Wearables in a
medical context.12
By 2015 Runtastic have 18
Apps13, which they claim have
been downloaded in excess
120 million times worldwide,
with 60 million registered users
on their website14, and has a
global ranking of 5110 on
Alexa based on daily visitors
and page views of the website
over the last 3 months15.
In March 2014 the MHRA finally
follows in the footsteps of it’s U.S
counterpart, releasing specific
guidance for the development of
Mhealth Apps & Wearables, with
a further clarification published as
recently as August 201416.

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3! QUANTIFIED SELF Authors: Group 17, 26/07/2015!
It is inevitable that change on this level, will bring with
it new risks. However they can to a greater or lesser
extent be mitigated by learning from the experiences of
software companies within our sister industry of ‘Health
& Fitness’, as well as through enhanced design, testing
and formulating well-thought out, fail-safe solutions.
Short-term engagement with Mhealth App or
Wearable
Research conducted in 2013 did show that one in ten
Americans over the age of eighteen owned a Wearable,
but it also cited that one third stopped using it within six
months of receiving the device23
. A finding,
which if mirrored in clinical trials over a six-month
duration, would find Wearables not fit for purpose.
A 2015 report by Ogilvy, suggested that the underlying
cause might be the fact that todays Mhealth Apps and
Wearables ‘function more as purveryors of data rather
than changers of health behaviour’. In the report they
noted six key behavioural change techniques (BCT),
from a catalogue of ninety-three that were particularly
effective at changing a persons level of physical activity,
and compared the application of these six in four popular
Wearables within the market24
Behavioural analysis in the development stages of your
Mhealth App or Wearable is good practice, though this is
part of the solution to solving the ‘engagement’ issue.
The second part is focused on developments in
technology. Through smart phones, to wristbands, to
headphones and watches; and in the near future clothes
and optical equipment, the pattern is clear. Wearables are
evolving towards becoming less intrusive, and more a
part of a your daily attire. You may stop wearing your
‘Fit Bit’ wrist band, but its unlikely you’ll stop wearing
your shirt, trousers, jackets, or even underwear which can
be adapted to monitor your heart rate, and notify your
HCP if your vitals falter.
It is no science fiction. The technology is already here!
The Ralph Lauren polo tech shirt that measures your
heart rate is a good example. 25
Furthermore, the
commercial viability of digital clothing is likely to
become a reality through Google’s ‘Project Jacquard’,
which has developed a conductive thread capable of
being weaved on any standard industrial mill26
. Then
there is the pending re-release of ‘Google glass’27
, and if
you wear glasses as most elderly Patients do, here is a
wearable that is familiar, and one you are likely to use on
a daily basis.
2.3 Future impact 2015-2020
Industry is already sharing ‘big data’ with one another,
and have reaped the benefits year on year since 2012 on a
B2B level, the next five years presents us with an
unprecedented opportunity to add a whole new
dimension to the ‘big data’ available through the
Quantified Self trend. Here is a glimpse into that future:
Data integration
‘Smart’ algorithms linking laboratory, clinical and ‘big
data’ from the Quantifiable Self trend to create automatic
reports that raise red flags concerning safety or efficacy
about new drugs28
. Potentially saving lives, enhancing
PR capability, and avoiding controversies such as those
that plagued Vioxx29
and Avandia.30
Enhanced clinical trials
Leveraging data from sources other than medical records,
such as social media and Mhealth Apps, we would be
able to consider more factors than possible at any point in
the past, with regard to setting clinical trial selection
criteria; resulting in smaller, shorter, cost-effective and
more revealing clinical trials.
Personalised healthcare through real-time
monitoring
Sir Bruce Edward Keogh, former National medical
director of the NHS Commissioning Board31
cited an
eight month study in 2013-2014 of ninety-two residents
of a nursing home who had typical ailments of old age
such as congestive heart failure, diabetes, respiratory
problems and urinary tract infections. They were
supplied with tablets, fitted with an app that enabled staff
to ask the Patients questions regularly, about how they
were feeling, with the information then analysed
remotely by four “admission avoidance matrons”.
The ability to pick up on safety signals from the ‘real-
time’ information exchange, which cost just ninety-pence
a day per patient, led to a seventy-five percent drop in

4. !4! QUANTIFIED SELF Authors: Group 17, 26/07/2015!
those who had to be admitted, as Staff were able to
intervene earlier and, for example, change their drug
regime. Sir Bruce Edward Keogh has also gone on record
to state that the NHS is minded to push forward with “a
huge rollout” of such devices as part of “a revolution in
self-care”32
.
3. Recommendations
In developing your Mhealth App or Wearable you should
keep the following recommendations in mind with regard
to:
Patient Data
It is clear between the User and your business who owns
the data, and how it will be stored, aggregated, processed,
shared or used. Furthermore, that it complies with Data
protection legislation, and that you have the User’s
consent at all relevant times to use the information in the
stated manner. It is also recommended that high-level
encryption is built into the Wearable or App amongst
other data security measures, and a software security
company independently tests these.
Data integrity, accuracy and interpretation
Maximum accuracy and integrity of health data captured
or communicated should be in-built into the design
through robust testing. Any limitations of the sensors or
technology should be made clear. Results should be easy
to interpret through clear user-interfaces. Furthermore, if
applicable the Patient is sign-pointed to their HCP, who
is trained to interpret the data as in the NHS pilot noted
earlier, or in a position to undertake independent clinical
tests to corroborate the data. It must also be made clear
that even the best result, should not encourage non-
compliance with any prescribed treatment.
Fail Safe Solution
You need to make sure that in case of failure or loss of
the Wearable or App data, a patient will still be able to be
treated or diagnosed with a fail-safe solution, such as
periodic encrypted backing-up of the data on a cloud
storage solution or secure servers, such as an EHR or
even directly onto the Patient’s EMR. Another example
would be routine maintenance checks or appointments to
ensure the device or App is calibrated and functioning
correctly.
Creating for collaboration
If your Mhealth App or Wearable allows data exchange
with the Patient’s EMR or even the Patient’s personal
EHR such as Microsoft(R) HealthVault(TM), make sure
it uses open standards so that it can be used regardless of
the HCP chosen by the Patient.
White-glove support
Ensure it is designed with the User in mind; be it the
Patient, their GP or another HCP. For example, too much
information can be detrimental to a quick diagnosis.
Customised User Interfaces are recommended, along
with easily accessible on-boarding I.T support, and on-
going routine training.
Developing for the future
Develop your Mhealth App for the next generation of
Wearables – clothing and optical wear. Strategically
sponsor expert ‘Think Tanks’, vet the technology now
and work towards being the first to market, for it’s only a
matter of five years or less before Sir Bruce Edward
Keogh’s vision is realised;
“I see a time where someone who’s got heart failure
because they’ve had a previous heart attack is sitting at
home and wearing some unobtrusive sensors, and his
phone goes, and it’s a health professional saying: ‘Mr
Smith, we’ve been monitoring you and we think you’re
starting to go back into heart failure. Someone’s going to
be with you in half an hour to give you some diuretics’33
Is your company ready to take advantage?
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
1 [ONLINE] Available at: http://googleblog.blogspot.com/2011/06/update-on-google-
2 [ONLINE] Ibid. [Accessed 26 July 2015]
3 [ONLINE] Available at: http://www.technologyreview.com/news/529046/big-pharma-
opens-up-its-big-data/ [Accessed 30 July 2015]
4 [ONLINE] Available at: https://www.gsk.com/media/603031/annual-report-2014.pdf p.6
[Accessed 26 July 2015]
5 [ONLINE] Available at: http://www.technologyreview.com/news/529046/big-pharma-
opens-up-its-big-data/ [Accessed 29 July 2015]
6 ONLINE] Ibid. [Accessed 29 July 2015]
7 [ONLINE] Available at: https://www.clinicalstudydatarequest.com/Study-Sponsors-
Info.aspx [Accessed 29 July 2015]
8 [ONLINE] Available at: http://mobihealthnews.com/15707/first-mobile-medical-app-to-get-
ce-mark-in-uk/ [Accessed 23 July 2015]
9 [ONLINE] http://techcrunch.com/2012/02/13/runtastic-launches-hardware-line-enters-
u-s/ [Accessed 13 August 2015]
10 [ONLINE] Available at: http://ec.europa.eu/health/medical-
devices/files/revision_docs/proposal_2012_542_en.pdf pg.2 [Accessed 30 July 2015]
11 [ONLINE] Available at: http://endeavourpartners.net/assets/Endeavour-Partners-
Wearables-White-Paper-20141.pdf pg.2 [Accessed 23 July 2015]
12 [ONLINE] Available at: http://www.inhouselawyer.co.uk/index.php/product-
liability/10449-healthcare-apps-comparing-the-us-and-uk-approaches [Accessed 29 July
2015]
13 [ONLINE] Available at: https://www.runtastic.com/en/apps [Accessed 05 August 2015]
14 [ONLINE] Available at: http://mediacenter.runtastic.com/company [Accessed 05
August 2015]
15 [ONLINE] Available at: http://www.alexa.com/siteinfo/runtastic.com [Accessed 01
August 2015]
16 [ONLINE] Available at: https://www.gov.uk/government/publications/medical-devices-
software-applications-apps/medical-device-stand-alone-software-including-apps [Accessed
29 July 2015]
17 [ONLINE] Available at: http://quantifiedself.com/guide/ [Accessed 01 August 2015]
18 [ONLINE] Available at: https://www.intouchsol.com/blog/health-wearables-why-pharma-
should-be-involved-and-how [Accessed 01 August 2015]
19 [ONLINE] Available at: https://www.healthvault.com/us/en [Accessed 04 August 2015]
20 [ONLINE] Available at: http://www.forbes.com/sites/kashmirhill/2011/07/05/fitbit-moves-
quickly-after-users-sex-stats-exposed/ [Accessed 03 August 2015]
21 [ONLINE] Available at:
http://www.wsj.com/news/articles/SB10001424052702304703804579383510605069066
[Accessed 30 July 2015]
22 [ONLINE] Available at: http://www.forbes.com/sites/kashmirhill/2012/06/20/a-
quantified-self-fatality-family-says-cyclists-death-is-fault-of-ride-tracking-company-strava/
[Accessed 22 July 2015].
23 [ONLINE] Available at: http://endeavourpartners.net/assets/Endeavour-Partners-
Wearables-White-Paper-20141.pdf p.4 [Accessed 21 July 2015]
24 [ONLINE] Available at: http://www.slideshare.net/OgilvyCommonHealth/wearable-
technology-46210427 p.7 & 9 [Accessed 28 July 2015]
25 [ONLINE] Available at: http://abcnews.go.com/Lifestyle/us-open-shirt-measure-heart-
rate/story?id=25116837 [Accessed 27 July 2015]
26 [ONLINE] Available at: https://www.google.com/atap/project-jacquard/ [Accessed 25
July 2015
27 [ONLINE] Available at: http://www.pcadvisor.co.uk/news/wearable-tech/google-glass-2-
release-date-price-specs-not-dead-io15-hires-design-3589338/ [Accessed 26 July 2015]
28 [ONLINE] Available at:
http://www.mckinsey.com/insights/health_systems_and_services/how_big_data_can_revo
lutionize_pharmaceutical_r_and_d [Accessed 23 July 2015]
29 [ONLINE] Available at: http://www.pharmaceutical-journal.com/news-and-
analysis/feature/still-feeling-the-vioxx-pain/20066485.article [Accessed 02 August 2015]
30 [ONLINE] Available at: http://www.bbc.co.uk/news/health-11397634 [Accessed 03
August 2015]
31 [ONLINE] Available at: http://m.hsj.co.uk/5081864.article [Accessed 29 July 2015]
32 [ONLINE] Available at: http://www.theguardian.com/society/2015/jan/19/prof-bruce-
keogh-wearable-technology-plays-crucial-part-nhs-future [Accessed 29 July 2015]
33 [ONLINE], Ibid. [Accessed 29 July 2015]