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Group 17 white paper

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Group 17 white paper

  1. 1. ! 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 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.
  2. 2. ! 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 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.
  3. 3. ! 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. !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: 2 [ONLINE] Ibid. [Accessed 26 July 2015] 3 [ONLINE] Available at: opens-up-its-big-data/ [Accessed 30 July 2015] 4 [ONLINE] Available at: p.6 [Accessed 26 July 2015] 5 [ONLINE] Available at: opens-up-its-big-data/ [Accessed 29 July 2015] 6 ONLINE] Ibid. [Accessed 29 July 2015] 7 [ONLINE] Available at: Info.aspx [Accessed 29 July 2015] 8 [ONLINE] Available at: ce-mark-in-uk/ [Accessed 23 July 2015] 9 [ONLINE] u-s/ [Accessed 13 August 2015] 10 [ONLINE] Available at: devices/files/revision_docs/proposal_2012_542_en.pdf pg.2 [Accessed 30 July 2015] 11 [ONLINE] Available at: Wearables-White-Paper-20141.pdf pg.2 [Accessed 23 July 2015] 12 [ONLINE] Available at: liability/10449-healthcare-apps-comparing-the-us-and-uk-approaches [Accessed 29 July 2015] 13 [ONLINE] Available at: [Accessed 05 August 2015] 14 [ONLINE] Available at: [Accessed 05 August 2015] 15 [ONLINE] Available at: [Accessed 01 August 2015] 16 [ONLINE] Available at: software-applications-apps/medical-device-stand-alone-software-including-apps [Accessed 29 July 2015] 17 [ONLINE] Available at: [Accessed 01 August 2015] 18 [ONLINE] Available at: should-be-involved-and-how [Accessed 01 August 2015] 19 [ONLINE] Available at: [Accessed 04 August 2015] 20 [ONLINE] Available at: quickly-after-users-sex-stats-exposed/ [Accessed 03 August 2015] 21 [ONLINE] Available at: [Accessed 30 July 2015] 22 [ONLINE] Available at: quantified-self-fatality-family-says-cyclists-death-is-fault-of-ride-tracking-company-strava/ [Accessed 22 July 2015]. 23 [ONLINE] Available at: Wearables-White-Paper-20141.pdf p.4 [Accessed 21 July 2015] 24 [ONLINE] Available at: technology-46210427 p.7 & 9 [Accessed 28 July 2015] 25 [ONLINE] Available at: rate/story?id=25116837 [Accessed 27 July 2015] 26 [ONLINE] Available at: [Accessed 25 July 2015 27 [ONLINE] Available at: release-date-price-specs-not-dead-io15-hires-design-3589338/ [Accessed 26 July 2015] 28 [ONLINE] Available at: lutionize_pharmaceutical_r_and_d [Accessed 23 July 2015] 29 [ONLINE] Available at: analysis/feature/still-feeling-the-vioxx-pain/20066485.article [Accessed 02 August 2015] 30 [ONLINE] Available at: [Accessed 03 August 2015] 31 [ONLINE] Available at: [Accessed 29 July 2015] 32 [ONLINE] Available at: keogh-wearable-technology-plays-crucial-part-nhs-future [Accessed 29 July 2015] 33 [ONLINE], Ibid. [Accessed 29 July 2015]


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