An interactive video screen using Kinect motion-sensors to raise awareness for Autism Speaks. The little girl avoids eye contact; one of the most prominent signs of the disorder in children.
The Kinect in this instance is used to track the head movements of the people looking into the digital billboard and continually position the child’s head and movements to avoid eye contact.

The paper produced by Bluelight and d4 examines amongst other mobile healthcare topics the regulatory framework applicable to health apps. A number of pharmaceutical companies have over the last couple of years launched a variety of apps ranging from unbranded disease resources, to branded drug dosage information and some have included physical add-ons to the mobile device. Some of these apps were subsequently withdrawn.

However in our experience few pharma companies have systematically and consistently approached the area of app development.

For all stakeholders concerned, it is in our collective interest to support responsible use of this new technology. It will take one high profile failing to cause a loss of trust that can take months, if not years, to rebuild.

The Bluelight and d4 guide makes five recommendations for all app users. We would like to pick out the two which we feel are most relevant to pharmaceutical companies;

1. Developers either in-house, agency or freelance should test their apps thoroughly and maintain adequate technical documentation to evidence this. This should be planned at the beginning of the app development. If the app is to be certified as a medical device then a technical file will be needed.

2. Publishers e.g pharmaceutical companies, should ensure compliance with the necessary regulations before releasing apps on to the market. Again compliance with the regulations should be evaluated at the start of the app. It is much more expensive and time consuming to make changes to the documentation or amends to the app retrospectively.

To discuss this paper or for further information please contact Paul or Sam
Download full paper here: 
regulation-of-health-apps-a-practical-guide-January-2012 

Press Release

Written by Sam Walmsley and Paul Dixey at Bluelight Partners

What impact does the first app to be registered as a medical device with the MHRA have upon pharmaceutical companies and the apps they produce?

EMBARGO 8am 10th January 2012

10 January 2012, London – Last week a new app, Mersey Burns, was released on the Apple App Store. It is the first in the UK to be registered with the MHRA as a Class I medical device as per the EU Medical Device Directive.

Pharmaceutical and medical device companies have developed hundreds of apps, however none so far have been registered with the MHRA as a medical device. d4 and Bluelight have published a new guidance document to help draw attention to the issue of health app regulation and provide practical guidance to manufacturers of apps for the healthcare market in Europe.

81% (1) of healthcare professionals in the UK own a smartphone, and use it regularly in their day to day practice. Smartphone ownership amongst their patients is currently at 30% in UK (2). As the number of software applications on mobile devices including healthcare apps continues to increase, we anticipate that the use of apps to aid medical diagnosis and treatment will gain in popularity with a possible increase in risk to the general public. Specific regulations that accompany this nascent technology are unclear, but should not be ignored.

It is in the collective interest of pharmaceutical companies to support responsible development and deployment of these apps. It may only take one failure or misuse of an app to cause harm to a patient.

In their guidance document, Regulation of health apps: a practical guide, d4 and Bluelight recommend that pharmaceutical companies check if their app will be associated with, contribute to or make a clinical decision. In this event they should assume that it will be classified as a medical device and therefore it must conform to the regulations. They should seek expert advice and prepare the necessary technical documentation required by the Competent Authority.

Sam Walmsley at Bluelight comments “Health apps aren’t like apps from other sectors; at the end of the day we are dealing with people’s health. The mHealth market is only going to grow, and we need to provide confidence to healthcare professionals and patients that our apps are safe. Pharmaceutical companies should consider consulting with the MHRA (or an equivalent body in another European member state) during app development and verify the apps that have already launched.

“mHealth is a new industry and the regulatory environment is evolving,” said James Sherwin-Smith, CEO of d4. ”Regulators are necessary to safeguard the public and uphold confidence in markets that would otherwise be open to potential abuse. But regulations also need to support, and not stifle, innovation. The regulatory issues that surround health apps are complex and open to interpretation. We hope that this guide provides a useful steer for individuals and organisations alike.”

References:
1) D4 research 
2) OurMobile Planet 

ENDS
Notes for editors:
Bluelight is an independent digital and mobile consultancy focusing on the healthcare and pharmaceutical sector. We deliver compliant, innovative and integrated strategies so that digital, social media and mobile can be an integral part of clients marketing and communication mix. For more information contact: Sam Walmsley or Paul Dixey on +44(0)115 912 4378 or visit the Bluelight website at: www.bluelightpartners.com

d4 is a non-profit organisation with registered charity status in England and Wales. Founded on the belief that better communication means better care, d4 aims to improve patient care by placing modern technology in the hands of doctors, nurses and other health professionals. For more information please contact James Sherwin-Smith on 0845 686 3434 or visit the d4 website at http://www.d4.org.uk

So in the absence of new rules, and even those from the PMCPA do not claim to cover every possible permutation of digital activities, how do pharmaceutical companies and agencies navigate the myriad of possible digital channels to decide which ones are appropriate for their strategy, where they can get the necessary expertise and how do they quickly and compliantly launch these activities.

Often there are not only differences between companies in what they are prepared to do online, with leaders such as GSK, Pfizer, Janssen, Boehringer Ingelheim, Roche in our opinion opening up a gap from other companies but even within companies with some brands and departments willing and able to innovate in the online space whereas others obstruct or delay often without knowledge of what is permissible and appropriate.

Often one of the main obstacles is the lack of knowledge. Both from a technology point of view; how do I buy ad words (if Google will let you that is), what is a hashtag, an API, what does W3C mean, to non-Code of Practice legal requirements e.g. Data Protection Act, Electronic Communications Directive, the new Cookies law the Equality Act etc

Then there is the lusting after new technologies; we must equip our sales forces with iPads, or the perceived need to be on new platforms; we must have a Facebook page or be on Google+ without really thinking about how these are aligned with strategy and how the organisation will support and run these for the long term.

Still amazingly we hear references to “new media” (despite the internet being more than 22 years old) or to “digital” as a stand-alone channel rather than one channel amongst and integrated with all the other communications and marketing channels.
The customer, the patient, the public, the healthcare professional are at the centre of a multi-channel world in control of what they view or listen to, how, when and via which device, often using many at the same time.

Pharmaceutical Ethics and Bluelight, in collaboration with the PMCPA, have therefore designed a one day digital communication strategy training course on behalf of the HCA specifically for healthcare communication professionals .

This workshop is designed to help participants understand the latest digital channels, Code of Practice and legal rules and in the absence of specific guidelines, equip staff with an ethical framework for decision making. Facilitators will include:
• Representative from PMCPA
• Paul Dixey and Sam Walmsley (Directors of Bluelight digital strategy specialists)
• Nick Broughton and Siân Walker (Directors of Pharmaceuticalethics.com)

Click here to view the agenda

This one-day training course on January 26th 2012 has both plenary and workshop elements – the workshops will be based around a case study of the life-cycle of a hypothetical product and designed to engender creative use of digital channels and test problem solving skills.

 

The mission of the charity is to convey the message that checking your breasts should be the ‘habit of a lifetime.’ Targeting young people across the UK, it aims to encourage and inspire people to be comfortable and familiar with their breasts in order to reduce incidents of late detection or misdiagnosed cancer.

The 3D boobs app is centred around digital billboards in London and can be seen at Holborn Eye, Euston underpass and Westfield.

The billboards feature a picture of a model posing in her bra. Users are required to download the blippar app, hold their phone towards the image, which will enable them to see the boobs in 3D, but also allow them to name them. Users are then able to share the picture via Facebook and Twitter, find out more about ‘how to check your boobs’ on the CoppaFeel! website and also sign-up to the free CoppaFeel! text message reminder service.

Giving away 50,000 free condoms in Stockholm, each with a QR code linking to a smartphone app, which when you download reminds you to use a condom, but also allows you to measure rhythm, sound and duration of every performance! When you’re done, you can share, by creating your profile and it will aggregate your stats with everyone else online, where users can find similar profiles to compare themselves with!

Really surprised by the statistics, and the amount of people want to share.

Enjoy!

The Sex Profile from ESTER on Vimeo.

Scope, a non for profit organisation wanted to change public perception of people with disabilities. Using QR codes, they managed to transform the traditional symbol for disability into a QR code which showcases some inspirational stories. 

Well done to the agency Leo Burnett, Melbourne 

Did you know in 60 seconds:

Search engine Google serves more that 694,445 queries

6,600+ pictures are uploaded on Flickr  

600 videos are uploaded on YouTube videos, amounting to 25+ hours of content

695,000 status updates, 79,364 wall posts and 510,040 comments are published on Social Networking site Facebook

70 New domains are registered

168,000,000+ emails are sent

320 new accounts and 98,000 tweets are generated on Social Networking site Twitter

iPhone applications are downloaded more than 13,000 times

20,000 new posts are published on Micro-blogging platform tumbler

Popular web browser FireFox is downloaded more than 1700 times

Popular blogging platform WordPress is downloaded more than 50 times

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100 accounts are created on professional networking site LinkedIn

40 new Questions are asked on YahooAnswers.com

100+ questions are asked on Answers.com

1 new article is published on Associated Content, the world’s largest source of community-created content

1 new definition is added on UrbanDictionary.com

1,200+ new ads are created on Craigslist

370,000+ minutes of voice calls done by Skype users

13,000+ hours of music streaming is done by personalized Internet radio provider Pandora

1,600+ reads are made on Scribd, the largest social reading publishing company