According to the research quoted by NHS over a fifth of patients with diabetes will have experienced a largely avoidable hypoglycemic episode whilst in hospital. Wearable technology may help doctors to detect deterioration early and act without delay. NHS England hopes, that connected sensors will be used to monitor health of people with long term conditions such as diabetes, heart failure, liver disease or asthma. The information gathered by wearable technology will be uploaded directly into patients’ records through the digital health services platform.
Nowadays, NHS maintains highly successful application (50 million hits per month) NHS Choices, that allows UK citizens to search and register for GP visit, book prescription and register for other services. NHS Choices provides also preliminary symptom checker, medical knowledge database and health related news promoting healthier lifestyle.
From the pharmaceutical marketing perspective embracing wearables in healthcare clear opportunity. Wearable (but also ingestible and implantable) devices and sensors will provide us with valuable real world evidence.With the mass adoption of such sensors assessment of treatment efficiency and drug safety will improve on unimaginable scale. Use of wearables in healthcare may also greatly impact treatment adherence (making patient to take medication as and when prescribed). In general, it moves medicine from population-based to individual data based, truly personalized healthcare. The types of physiological data points and the wearable sensors under development or on the market to monitor them. – Nature.com
Technology providers seeing vast business opportunity are joining those efforts. Then, they go back seeing how hard it is to operate in strictly regulated market.We all may remember how Google’s Larry Page and Sergey Brin were discussing their work on sensor contact lenses for diabetes (with Novartis/Alcon) and longevity medicine project of Calico. Their learning was in Sergey Brin’s words:
“Generally, health is just so heavily regulated. It’s just a painful business to be in. It’s just not necessarily how I want to spend my time. Even though we do have some health projects, and we’ll be doing that to a certain extent. But I think the regulatory burden in the U.S. is so high that think it would dissuade a lot of entrepreneurs.”
For pharmaceutical companies and healthcare providers this regulatory burden is given for their core business. For them, raise of wearable devices and mobile health applications raises some issues. Our smartphones, fitbits, jawbones and misfit shine wearables are not meant to be medical devices. Data acquired by wearables may not be accurate as they do not hae to be. They are not designed to the clinical and healthcare standard – there are no backup systems if the battery goes down, if user switches the phone in silent mode etc. Today wearable technology for pharma is still not good enough to bet patients safety on it. FDA’s guidance allows wearables in healthcare only as general wellness, low risk devices.
The solution may come from the alliance of pharma and technology. Novartis with Google and Qualcomm, UCB with MC10, GSK with Medidata have chosen this direction. Another may be innovative startups companies willing to align with regulatory and compliance burden for a benefit of entering profitable niche leftover by more established players.
K-message believes that finally wearables and more generally, the internet of things will change and shape the future of healthcare and pharmaceutical industry. If you know or, even better, make a product or service intended to be a part of this future we will be happy to cover your story.
Digital marketing loses against traditional interaction with HCPs says Cegedim Strategic Data (CSD). According to the study called Global Promotions Audit, traditional interactions are still much more common and more efficient in impact on prescription behavior.
To be honest, such a result is completely against what we preach at K-message. Digital tactics are supposed to reach wider audience, and properly executed can change behavior efficiently. What is more, we know that efficiency of digital can be measured.
CSD’s study, at the first sight, says otherwise. Why is that?
CSD collects data from physicians in Top 5 EU, USA, Japan, Brazil, Russia, China, Belgium, Canada and Poland. The research is part of syndicated panel, and respondents are physicians from primary and secondary care disciplines.
Obviously, digital maturity of surveyed markets differs, and CSD provides results by country. Even in the most advanced Japan, only 34% of contacts is classified as digital. For USA it is 24%, Poland 20%. Other countries have much lower proportion of digital interaction – Germany 5%, Brazil, Italy and Russia 2%, China just 1%. Digital contacts by country Cegedim Strategic Data
This has to skew results. We do not know the size of the sample of German or Chinese HCPs, but even if it is 100 doctors per country, we cannot say anything relevant about impact of any factor that affected only few respondents in the group.
From CSD data, we can see that in 11 of 13 markets, a predominant channel of digital interaction with HCPs is emailing. This again puts digital in unfavorable light. Does an e-mail from sales rep counts as an interaction with HCP? Can we reasonably expect that e-mail alone will change HCPs decision for prescriptions? We should not, and this brings another surprise.
The most positive impact of digital interaction on prescription is declared in Canada where 55.6% of digital interactions led to positive intention to start or increase prescribing promoted brand. The most skeptical towards the digital were doctors from France, still 17.1% of those declared positive impacts.
CSD says that in every country impact of traditional interaction with HCPs was higher than for digital. But what are we comparing here? It is an email campaign versus face to face and telephone detailing, on-site meeting or event, delivery of printed materials.
Those results mean that HCPs should receive a proper, multi-channel campaign that combines e-mail (automated with marketing automation tools), remote detailing, on-site events supported with webcasts, websites that allow rich interaction and include order form for additional materials in print or in automated detailing.
CSD’s story is that their result shows a need for more of traditional approach. This is simply impossible due to market environment. But it would not be smart either. What we read from the data is that emailing alone can bring 20 to 50% impact on prescription, so pharmaceutical marketing job is to invest more in multichannel approach.
The recent FDA’s Office of Prescription Drug Promotion (OPDP) draft guidance on Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices effectively bans Twitter for pharma advertising. It does the same with Google Sitelink ads.
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K-messsage’s take on the FDA’s social media guidance from June 17th:
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1. DO NOT use Twitter for promotional messaging about prescription drugs and medical devices
2. DO NOT use Google Sitelinks for promotional messaging about prescription drugs and medical devices
3. DO PERFORM social media monitoring to identify and engage in conversation about your prescription drugs and medical devices with misleading information on prescription drugs or medical devices
4. KEEP your Twitter presence for corporate and employer branding and for correcting misinformation
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K-message believes that this is not what the Agency wanted to achieve, but we strongly suggest to all risk-averse pharmaceutical companies to cease any promotional activities for prescribed drugs in both space limited channels.
While the guidance includes imaginary examples of legally approved tweets and ads, in the real world it will not be possible to recreate such compliance for any of the existing products. Or at least it would cause a serious “Headhurtz” for the pharma marketing teams. Headhurtz example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations
FDA requires to include in the tweet both benefit and risk information, and to link from the tweet to full page with Important Safety Information, preferably using word “risk” in an URL. As tweet has only 140 characters, it would be almost impossible to crunch in risks related to the product, even if you decide to skip benefit part.
Nofocus tweet example Draft Guidance for Industry- Internet-Social Media Platforms with Character Space Limitations
The same happens with FDA’s proposal on how to use Google Sitelink ad format. The Agency may not know that, but what is displayed in the ad depends on the Google’s own algorithm, that tries to increase CTR. The chance of having very similar, risk focused links displayed under the ad, even if we manage to be always on the top of SERP, is limited. From our perspective the risk of not being able to follow the guidance is too high. Our recommendation is to use other Search Engine Marketing tactics instead.
Above does not mean, that pharma marketing on twitter is no longer possible. From the global perspective, the new regulation (if adopted without changes), affects only the United States market. Globally, there is no promotional activity directed to consumers, so there is no need to send promotional tweets. Instead, pharmaceutical firms focus on their corporate brands and disease awareness education – without promoting or even mentioning prescription drugs in the communication. So, yes, advertising prescription drugs and medical devices on twitter seems to be forbidden. But you should keep your presence there for
On the brighter side of the regulatory proposals, another draft guidance has been published. The Internet/Social Media Platforms: Correcting Independent Third-party Misinformation About Prescription Drugs and Medical Devices document paves the way to correct misleading or false information on pharmaceutical products and medical devices that is spreading over the web.
It will hopefully encourage pharma marketing departments worldwide to take a closer look into the social media and web monitoring in a search for online conversations around pharmaceutical brands and products. As the recent Accenture’s study shows, patients are expecting more of such engagement from the industry.
Cannes Lions Health 2014 festival was supposed to be the world’s first contest of creativity in healthcare and pharma advertising. Made by advertising agencies and for advertising agencies, Lions Health could not find a grand prix winner in Cannes this year. Does it prove lack of creativity, or rather that the whole concept of advertising in the healthcare industry is wrong?
No grand prix of Cannes Lions Health 2014 was awarded. A Jury made only from the advertising agencies, focus on vague “creativity” and not measurable effects or validity of choice. From K-message perspective it is all failed, with the only exception of a Grand Prix for Good award given to Colombian League Against Cancer for its Cancer Tweets campaign.
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Brand: LEAGUE AGAINST CANCER – BOGOTA
Agency: LEO BURNETT COLOMBIANA, COLOMBIA
Target: Disease Awareness Social Media Campaign
Credits:
Name
Company
Position
Fernando Hernandez
Leo Burnett Colombiana
General Creative Director
Mauricio Sarmiento
Leo Burnett Colombiana
General Creative Director
Carlos Oviedo
Leo Burnett Colombiana
Creative Director
Alexis Ospina
Leo Burnett Colombiana
Creative Director
Rafael Reina
Leo Burnett Colombiana
Creative Director
Andres Salamanca
Leo Burnett Colombiana
Copywriter
Alexis Ospina
Leo Burnett Colombiana
Copywriter
Andres Lopez
Leo Burnett Colombiana
Art Director
Rafael Reina
Leo Burnett Colombiana
Art Director
Julian Velez
Leo Burnett Colombiana
Art Director
Alejandra Melo
Leo Burnett Colombiana
Community Manager
Camilo Mendivelso
Leo Burnett Colombiana
Community Manager
Camilo Torres
Leo Burnett Colombiana
Community Manager
Cesar Peralta
Leo Burnett Colombiana
Community Manager
Carlos Leguizamon
Leo Burnett Colombiana
Community Manager
Carlos Oviedo
Leo Burnett Colombiana
Community Manager
Andres Salamanca
Leo Burnett Colombiana
Community Manager
Maicol Vera
Leo Burnett Colombiana
Web Designer
Natalia Valencia
Leo Burnett Colombiana
Account Director
Campaign Description:
A cancer that follows you virtually. Cancer is a silent disease, every year millions of people die for ignoring their symptoms. That’s why we created Cancertweets, an act that make people feel what it is like to have cancer and how easy is to ignore it. We created 7 Twitter accounts that represented 7 types of cancer and ‘spread out’ the virtual cancer throughout thousands of accounts. Virtual cancer acted as a real cancer: at first, followed silently. Then, started to manifest subtle; finally expressed its symptoms directly. Those who detected on time, virtual cancer stopped following them. Those who ignored it, received a final message.
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Unfortunately other campaigns did not bring anything innovative, striking or at least, very efficient in terms of communication, as you can see for yourself clicking at the entries list. At K-message we were not even disappointed, as this whole concept seems bit weird to us. Take a look at the President of the Jury explaining why no GrandPrix was awarded:
From our perspective it is not about “setting the bar” too high. Pharma marketing is just different. We talk about serious issues, we should base our communication on scientifically proven statements. The idea of “promoting” a pharmaceutical product to patients is from the very beginning dangerous and thus forbidden in most of the world. For the healthcare professionals, we should bear in mind that any additional noise may adversely impact their decisions and, in effect, patients well-being. Human brain while making decision can process 5 to 6 factors. In medicine there are usually hundreds of factors to be taken into account. Do we really need to produce more of it? Or shall we rather focus on making the process easier to congest, by making tools for better processing the scientific information about our products and diseases to be treated? .
Saying that, feel free to take a look at the Cannes Lions Health 2014 Gold Lions awarded campaigns. While they are not worth a Grand Prix, they are well executed. Our pick from those three would be Mind Your Meds. It puts digital tactics at the core, provides not only emotional message but also valuable information.
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Cate Jackson
Brand: Simponi – Janssen
Agency: MCCANN HEALTH AUSTRALIA
Target: Promotional Communication to the Healthcare Professional: New Product Launch
Credits:
Name
Company
Position
June Laffey
Mccann Health
Executive Creative Director
Thomas Dirnberger
Mccann Health
Art Director
Kate Chisnall
Mccann Health
Art Director
Bob Johnson
Mccann Health
Art Director
Sophy Myer
Mccann Health
Account Director
Dick Sweeney
Louis/Co
Photographer
Glenn Edwards
Castirian
Editor
Tristan Coelho
Composer/Produce
Campaign Description:
When you treat RA with Simponi, it only takes about ten minutes, once a month. This means Simponi is the treatment you hardly even notice. Great news when often RA is burden enough to a patient. We wanted to capture the non-invasive nature of Simponi in our creative. So we set out to capture a month of a Simponi patient on film and show how non-invasive it is. Literally. This film features a typical RA person – female between 50 and 60. It shows hundreds of moments (selected from over 10,000 shots captured by our photographer) that represent a month in the life of a Simponi patient, Cate Jackson. Amongst the hundreds of shots, there is only one that features Cate injecting herself with Simponi. The shots are run together so quickly in the film, it is near impossible to spot the moment that treatment takes place. This technique/idea highlights the fact that Simponi is very non-invasive, so you’ll hardly notice. After watching a collage of her life, a super tells us in the many shots/moments we just watched only one featured Simponi. The super then challenges: “Bet you hardly even noticed. Neither did Cate Jackson.”
Spasticity is a symptom that develops late in the course of multiple sclerosis (MS), causing muscle spasm, weakness and stiffness. Patients lose their independence and are forced to rely on family members and carers to accomplish basic tasks. The limited treatment options have significant side effects, or require an implanted pump.
Sativex is a novel treatment developed from particular strains of cannabis that significantly improves symptoms of spasticity in responders. Because it is delivered as an oral spray, patients can adjust their dose as and when they need to. However, HCPs have been equivocal about its value, and concerned about its cost.
To drive re-appraisal of the brand among prescribers, we used the unifying idea of ‘cost’ to bring together the effect of MS spasticity on patients with its broader social impact and the financial realities, increasing their motivation to gain budget approval for Sativex.
Brand: MEDICINE ABUSE PROJECT – Partnership at Drugfree.org
Agency: HILL HOLLIDAY Boston, USA
Target: Communications to Non-Healthcare Professionals
Credits:
Eric Stoltz
Disorderly Conduct
Director
Lance Jensen
Hill Holliday
Chief Creative Officer
Scott Woolwine
Hill Holliday
Designer/Animator
Kevin Daley
Hill Holliday
Group Creative Director/Art Director
Trish Fuller
Whitehouse Post
Editor
Tim Cawley
Hill Holliday
Creative Director/Copywriter
Alejandra Alarcon
Disorderly Conduct
Producer/Post Producer
Crash
Disorderly Conduct
Cinematographer
Amy Hardcastle
Hill Holliday
Account Team
Jenn Dodds
Hill Holliday
Project Manager
Campaign Description:
Teen medicine abuse is a pervasive and devastating problem, with one in four teens admitting to using a prescription drug to get high or change their mood. Most teens who report medicine abuse say they get those medications from their family or friends. The Medicine Abuse Project is a multi-year effort led by The Partnership at Drugfree.org and is designed to help combat this public health crisis deemed an “epidemic” by the Centers for Disease Control and Prevention. The Medicine Abuse Project aims to help educate parents, teens and the public about the dangers of medicine abuse and unite parents, educators, health care providers, coaches, government officials, law enforcement officers and other partners to help save lives.
Gartner Cool Vendors in Life Sciences report may be a good predictor of what will be a hot topic in pharma. But what Gartner Cool Vendors in Life Sciences 2014 really do? Is it really worth to jump the bandwagon right away?
Why Gartner Cool Vendors in Life Sciences and similar reports are important?
The mode of action is simple, consultants from Gartner and other agencies are basing on similar rankings with their sales pitches. As Richard Meyer points out, pharma marketing insiders are not the best breed.
If the sales pitch sounds good and has a supporting proof in an expensive research report, your average pharma marketer will swallow it like a hungry pelican. In the effect, any company mentioned by big consultancy has a chance to gain market and its product may be listed as a rising trend for the year to come. Regardless of the value generated for business. While you look into the Gartner Cool Vendors 2014 list, you may guess what it will be about this time.
Blueprint Clinical
Blueprint Clinical is an U.S.-based monitoring technology company founded in 2012. It’s team has a profound experience in healthcare, and especially in clinical trials. Courtney McBean, CEO of Blueprint Clinical, has over 15 years of experience in research and medical devices business.
The main product of Blueprint Clinical is web-based product called Blueprint Compass for risk-based statistical monitoring of the study performance. It provides real-time monitoring of site performance, focusing on metrics critical for the study and with possibility to assign targeted actions to relevant performance indicators.
R&D and Clinical Research is obviously the huge chunk of pharma spending, and risk-based monitoring as such is required by FDA. Does Blueprint Clinical answers the need for that well, it is hard to assess. So far the company provides its service together with consulting service, which means that it is rather customized offer than a mature, standard service.
Liquid Grids
This one is, to be honest, a very surprising choice. Liquid Grids, a Gartner Cool Vendor in Life Sciences 2014 is PaaS solution for social media monitoring and engagement (well, they call it a “precision marketing”). Started in 2010, Liquid Grids positions itself as dedicated to health care industry. It claims that it offers “direct to patient” marketing. The problem is that from the global perspective it means a clear no go.
Pharmaceutical marketing directly to consumer is allowed only in specific markets, specifically the United States and New Zealand. What is more, from European perspective any attempt to obtain personal data and target communication to the patient without direct consent is clearly illegal.
It may be a cool vendor for Gartner, but for any pharma marketer outside of U.S. working with Liquid Grids may end with a very cold shower from your legal team (or even worse from the regulatory agency). Let us be clear, for pharma digital marketers it is extremely hard to implement even social media monitoring for product related keywords, as there is a constant awareness of drug safety obligations.
Ontoforce is one of the big data vendors. Founded in 2011 company from Belgium as its main product offers a semantic search engine disQover.
Clearly, making the tons of data we have gathered in pharma searchable in a contextual way that allows discovery of unknown connections is something that may change the paradigm of research. While we are sceptical about replacing scientific method with brute force statistics on big amounts of data, there is a potential there to find new insights. On the other hand, even if Ontoforce is really Cool Vendor, the competition in this field is very strong
Pitcher is another surprising choice. eDetailing is obviously a big trend, but Pitcher is not the only one in its field. We can easily name strong contenders (or even leaders) with similar feature set. Veeva, Agnitio, Showpad and Cegedim are all offering the same service as Pitcher. We love disruptive startup companies entering digital marketing space in healthcare, but Pitcher has yet to prove its coolness.
Scigilian Software – Gartner Cool Vendors in Life Sciences 2014
Scigilian is a cloud-based software platform for managing logistics of Pharma R&D. At K-message we are specialized in digital marketing, and we cannot assess this tool capability, but the sales pitch sounds very well. Normally we could build an ERP or LIMS system for such purpose, but the solution would never be ideal. ERPs are too complex and hardly customizable, and LIMS would not cope with the complexity. The solution is to build your own software, or… ask Scigilian. Being outside of the lab, we really like the idea. As you may see not all of the Gartner Cool Vendors in Life Sciences 2014 are cool enough to make us excited. The trends are clear, however. In pharma marketing the focus is on e-detailing, CLM and Social Media Management. In R&D hot topics are big data, clinical research support and logistics for labs. Be prepared, consultants are coming!
The US Healthcare and Pharmaceutical Industry 2014: Digital Ad Spending Forecast and Trends, a new report from eMarketer shows that Pharma Marketing spending on digital remains on steady 3.0% of the total digital ad spending level. Unfortunately half of it is spent wrong.
This has been a common joke of marketers and advertisers for a long time: If I only knew which half I spend on wrong tactics I would make myself and my company rich. However, jokes aside, at K-message we can clearly see which quarter of this budget is going wrong way. We talk serious money here, healthcare and pharma ad spending is now at USD 1.41 bn level, and by 2017 we will pass the threshold of two billions. US Healthcare and Pharma Industry Digital Ad Spending 2012-2018. Source: eMarketer.com
eMarketer takes into account all healthcare and pharmaceutical digital marketing spending in the United States. It includes prescribed (Rx) and over the counter (OTC) products, specific products and services addressed to healthcare professionals, as well as direct to consumer advertising of products, services, hospitals, health insurers etc.
More than half of this budget (56%) goes for direct response advertisement. The remainder of 44% is spent on branding campaigns. This is an artificial segmentations, as the objective of campaign usually is not so clear in the American, DTC driven market. Every branding effort may bring direct response.
What is more striking in eMarketer’s report is the share of spending on healthcare and pharma digital marketing by channel. It seems that mobile is still an ugly duckling for pharma marketers, who dedicate only 26.5% of their budget to mobile formats.
It is incredible if you look at this from the perspective. The same crowd that claims “we want more direct response and we spend more than half of our budget for it” in the same time neglects the channel that is the best to accomplish this objective.
Healthcare and pharma marketing is the single industry that spends on mobile the smallest chunk of its budget. Even PC makers spend 33% of their budget on mobile, but we in Pharma remain connected to the desktop. If we go mobile, pharma marketing focus mostly on mobile search advertisement. US Digital Ad Spending by Industry and Channel 2014, Source: eMarketer.com
We can try to persuade ourselves, that there is some logical reasoning behind this inefficient budget allocation. However, at K-message we tend to believe that the only reason to avoid mobile advertising in pharma is simply change-aversion. Mobile advertisement is well regulated, rules are clear, and results are easily measurable. It allows better interaction than PC in many dimensions: it can be geo-located, instant, personalized. The only disadvantage over display ad on PC screen? It requires additional work.
Digital marketing is not a rocket science that Pharma R&D are performing. You can start simply with text messaging in your next multichannel campaign. Make sure that your next edetailing is part of the CLM. Give your audience some thrill with elements of gaming. Do not fly everyone to the remote conference site, use virtual one instead. This is pharma digital marketing, not putting banners every here and there.
We really hope that pharma marketers will surprise eMarketer by proving they know how to use digital marketing tactics efficiently. Fingers crossed!
Multi-channel marketing strategies usually include old tactics such as telemarketing, direct mailing and printed detail aids to accompany more fancy mobile applications, eDetailing on tablets and over the Web. Good old SMS text messaging is forgotten in the era of smartphones. Is it really so smart?
Text messaging is a tactic that pharma marketers used in the past. There were successful pharma marketing campaigns with text messaging at the core of the execution.
One such example is Pfizer’s recruitment for a study that targeted teenage smokers with a radio campaign. The call to action instead of traditional “call us now” was replaced by “text us now” which allowed young audience to discreetly make a contact with researchers, even if they listened to the spot in their (unaware of teen’s deadly habit) parents’ car.
Novartis with its SMS for Life campaign allows better access to malaria treatment in Africa. A successful pilot in Tanzania that has been running since 2009, has encouraged the company to roll it out in other markets, including Kenya, Ghana and Cameroon. So far the results were very impressive, allowing company to reduce stock-outs of the antimalarial ACTs from 26% to just 1% of the facilities. GSK is using text messaging to increase childhood vaccination rates in Mozambique and to fight counterfeit products in Tanzania. Merck is running a diabetes sms campaign in Kenya and Uganda…
But wait a moment, it is all just marginal actions, and never the core of the brand strategy in the product lifecycle. It seems that text messaging is no longer considered as a part of still trendy mobile marketing. Ask your average pharma marketing expert for mobile tactics, and you will get a standard list: – build a mobile app – build a mobile or responsive website – make your e-mails mobile ready
This is all fine, but:
– a mobile app is usually a costly mistake that with limited reach and extremely short lifespan
Only 30% of apps is downloaded. Of those, only 30% is ever opened. For free apps, only 5% are still being used after one month. Astonishing 80% of mobile apps have less than 1000 downloads.
Yes, you can be lucky and make an app that is actually useful and used, as Merck was with its Clarityn’s Pollen Forecast app. But if you are in the Rx world, there is a very slight chance that a mobile app will work for you.
– a mobile or responsive website is good to have, but to convey a scientific message you need a big screen anyway. Check your current web entities for stats of mobile usage and you will be surprised how rarely HCPs are visiting it with the mobile device that is not a tablet. And for tablets, a standard website is perfectly fine.
– the e-mails are often read on mobile, that is true. Therefore, it is worth an effort to make your e-mails mobile friendly, but never stop here. If your e-mail reached a user on the mobile, the landing page should be optimized for mobile as well. Do not expect anyone to read a scientific paper on an iPhone or, even worse, Blackberry. Instead make the user journey mobile end-to-end – let them order delivery of the paper with one tap, rather than providing a download button as you would do for PC or Mac users. Limit length of the survey, make sure the landing page is light on text, etc. etc.
What your consultant probably forgot to add, a text message is much more friendly for phone users than e-mail. It can be even richer in content, especially if you decide to embed in your campaign OTT messages.
[box type=”note” ] Text message marketing vocabulary Short Message Service (SMS) – the oldest standard for text messaging. It allows sending 160 characters, plain text. It is extremely cheap and can be very narrowly targeted. It can reach every phone, which gives you maximum potential reach. Arriving SMS is accompanied with buzz sound set by the user, thus it is important to set silent hours for SMS campaigns. Multimedia Messaging Service (MMS) – a standard to send messages with multimedia content to and from mobile phones. MMS can convey messages much longer than SMS, up to thousands characters or up to 1MB content. Unfortunately, its implementation differs from operator to operator and from device to device. Quality of the video and its length is also restricted, so limit yourself to 30 seconds, or use OTT instead. Push notification – a service that allows an app installed on the device alert user with a message.If a push notification is received, an app will display it with its icon on the status bar of the device. It is useful for e-commerce applications (ie. while searching for an item, you may receive a push notification with a special time-limited offer from the merchant nearby). Unfortunately, the reach is limited to smartphones. On the other hand, users are keen on accepting Push while installing an app easier than to opt-in for SMS campaigns. Push is also cheaper than SMS. Cross-channel messaging – messaging service can be used to seamlessly put content on other channels (ie. it is possible to receive and post Facebook comments via text messages, or use MMS to upload images on Flickr). Over-The-Top messaging (OTT) – messaging with multimedia content that is enabled by mobile applications not associated with mobile operators (ie. Apple iMessage, WhatsUp, Blackberry Messenger). Messages are downloaded via data connection. If WiFi is used to send/receive OTT messages, it allows geolocation of the device. The best practice is to combine SMS/MMS with Push and OTT services. Instant Messaging (IM) – real time text based communication over the Internet. From a mobile device it is non-discernible from OTT, and in some applications also merged with SMS/MMS service in one application view. Short Code – a short, 5-6 digits, number for standard and premium rate use on assigned territories. Used for mass marketing campaigns. You can use a shared short code from your vendor to launch your campaign faster, but it will limit available keywords (each can be used only once per code). The best practice is to register single short code for your brand, especially in the long term campaigns. Long Code – 10 digits phone numbers, as used by standard subscribers in person to person communication. They may be used for campaigns that happen across different territories, but the limitation is the amount of messages that can be processed via long code at the time.
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Advantages of SMS marketing for pharma and mobile health
Forgotten by external consultants in the age of pharma cross-channel marketing, mobile messaging is still alive and growing. Actually, it is the most-used non-voice channel in the world, with 14.7 trillion messages sent worldwide in 2012. With the rise of OTT and IM applications the growth of this way of communication may be even faster than expected, going well beyond an estimated 28.2 trillion threshold by 2017.
Everyone gets now text messages from banks after transactions, from airlines when the flight is ready to board, from retailers who offer us their special deals. Pharma marketers could learn from their clients how to use text messaging.
Healthcare providers are sending messages to:
– manage appointments,
– provide information,
– inform on the prescriptions
– remind patients that there is some FSA money left to be spent before the end of the year.
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FSA stands for Flexible Spending Account and allows to pay for some medical and dental procedures or products and deduct it from the tax
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Pharmacies are sending out pick-up notices, links to package inserts content, and allow text-to-refill service to their customers.
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SMS and mobile messaging advantages for pharma marketing:
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Improved relevance: Message can be easily tailored for the specific recipient, embedding itself into the CLM concept with tracking capabilities.
Cost efficiency: Efficiency much better than e-mail notification in terms of Open Rate (~90%). Response rate is also very high ranging from 5 to 25%, around eight times better than for e-mail.
Always within context: Text messages are opened at the time of receipt. You can make sure that the message content is aligned to the schedule (or even location with Push and OTT) of your recipient.
Providing value through the whole process of customer relationship management, from the initial opt-in confirmation at an appointment, through reminders to thank you messages. Always interactive and fully tracked!
Compliant: SMS/Texting follows similar pharma/healthcare industry regulations as other communications channels.
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Use cases for text messaging in pharma marketing and medical affairs:
[checklist]
Patient recruitment for clinical trials
Patient adherence (in clinical trials and after marketing authorization during therapy)
HCP and Sales Representative relationship: appointments, reminders, additional information in two-way communication
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How to make a text messaging campaign that converts?
If you reached to this point, you are probably convinced, that text messaging is the tactic to include in your strategy. That is fine, but to make sure you are successful, we have prepared some tips and tricks, that will make your campaign better. We are all about digital marketing, so we assume you know the basics – your KPIs are already defined, and you will measure your conversion rates. So how to make sure your text message will convert?
Some of the tips are no brainers, but differ a bit in messaging campaigns from an e-mail world.
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Tips for converting text messaging campaign
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Carefully consider timing of the campaign. With an e-mail, you targeted specific days of the week. With mobile campaigns, you need to be perfectly clear about an hour (and a time zone!) when the message buzzes in your audience pockets.
Targeting your audience is similar to what you do in other digital channels. However, your text message will probably come from the same code through the campaign, and your audience may respond. To ensure success, first shape your communication to the audience group (ie. cardiologists), then make a tree of possible reactions and answers to them.
It is somewhat similar to what you would do providing a script for telemarketers. You need to think about the message as a part of longer conversation. Never repeat the same message, always refer to the previous state, and make the user journey interesting with different call-to-action.
Whenever you can, do A/B testing of your messages. We are aware you need to submit them to the regulatory, thus submit different versions of the message, just in case the original one is not working as well as supposed.
Call to action is really important, especially if you have 160 characters, and you need to make sure that there is a Fair Balance in your message. Therefore, try to embed your messaging into other elements of the campaign. The most important will always be the landing page, but text messaging allows more response types than other channels.
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After receiving and viewing your message, recipient can:
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call back (make sure there is a call center ready)
schedule an appointment with rep
start remote detailing
order samples or research paper delivery
watch video, document or website content
download an app or bookmark page
share some content via social media or e-mail
answer a short survey
enroll to the program
opt-out from the communication (you have to always provide this possibility!)
probably you can imagine some other responses as well
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As you can see there is a lot that you can do with simple message, and the more options you have in your campaign, the better results. You just need to test and fine-tune your campaign to select what works the best to deliver your key message and build valuable conversation with your audience.
Regulatory constraints for an SMS marketing in Pharma
As with every pharma marketing tactic, you must be aware of certain regulatory constraints while planning your text messaging campaign. The most important document to follow is CTIA Compliance Assurance Solution Mobile Commerce Compliance Handbook.
For U.S. run campaigns, you also need to be compliant with TCPA, HIPAA and (if you address children) COPPA regulations.
The key considerations from a regulatory compliance perspective for use of text messaging in pharma marketing:
[checklist]
You have a permission from the consumer to send messaging from your company (Prior Express Written Consent)
The short code used is the same for which consumer opted-in
Your campaign has been approved by carriers
All medical information is governed by HIPAA in terms of privacy protection
Consumer has always an opportunity to opt-out from all communications and is always informed about any cost that may be charged against him due to participation in your program.
In the U.S., according to 21 CFR 314.81(b)(3)(i), all advertisements and promotional labeling for a particular drug product must be submitted to the FDA at the time of initial publication or dissemination. Each submission is required to be accompanied by a completed transmittal Form FDA-2253.
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Rich Communication: the future of mobile marketing
Mobile messaging campaigns with SMS, MMS, Push and OTT is already very efficient channel. However, the technology is going forward, and new capabilities are being rolled out. Rich Communications Services (RCS), marketed as “joyn”, is the platform that enables the delivery of communication experiences beyond voice and SMS, providing consumers with instant messaging or chat, live video and file sharing – across devices, on any network.
With RCS, we will be able to combine in one interaction a message, video, call, and remote detailing. Joyn does not need any additional setup from the end-user. It is provided by a carrier and ready to use within compatible devices. Supported by GSMA, the technology is already being rolled out across the globe. This new standard will be yet another reason to think “messaging” as the first option where it comes to mobile marketing.
Success in pharmaceutical industry depends on innovation. We are in the constant race with mutating microbes, viruses and cells. New regulations, stakeholders and disruptive competitors are changing industry landscape every day. Innovation (Photo credit: Thomas Hawk)
At the recent Pharma Customer Experience Management Summit in Berlin, where I was one of the speakers, the innovation was a leitmotif. One particularly strong accord was played by Alexander Simidchiev from GSK. In his presentation, Customer-Centric Approach in Pharma: Future of Healthcare?, Alex has pointed out what I believe is the best approach to smart innovation in pharmaceutical marketing.
Inspired by Daniel Burrus’ methodology described in the book Flash Foresight, Alex advises pharma marketers to look for the “hard trends”.
[box type=”info” ] Hard trend is a projection based on measurable, tangible, and fully predictable facts, events, or objects. It is something that will happen: a future fact that cannot be changed.
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In the day to day practice of pharma marketing we can often see urge to innovate based on the opposition of the hard trend. Something, that Burrus would call a “soft trend”, something, that only might happen.
[box type=”info” ] Soft trend is a projection based on statistics that have the appearance of being tangible, fully predictable facts. It’s something that might happen: a future maybe.
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Such “soft trend” is easy to be sold by marketers and consultants. You may hear that we should go mobile (the smartphones are on the rise, aren’t they?). You may learn, that eDetailing on tablets is a must (everyone has an iPad, buy one too, quickly!).
It is not a bad thing to identify such soft trends and use them for your innovation. The thing is, however, that soft trend can be influenced and changed. It is the change of this trend that innovator should capitalize on. Followers of those soft trends risk being punished with the next disruption.
However, such approach is not enough. As Alexander Simidchiev said, basing on his experience in pharmaceutical industry, for K-message.com:
Most of what I currently percieve is cosmetic changes in the industry which has changed little since the hayday of anilin based medical wonders, currently addressing mainly short term priorities and tactical issues. The result is that the industry chronically suffers from suboptimal reputation, and we are always “on the back foot” trying to defend past practices, instead of treading the virgin soil (together with other partners and stakeholders) of how to overcome the current challenges facing the healthcare system, for which (my personal deep belief) pharma is one of the possible, if not dominantly positive solutions. This requires that current marketing practices refocus from talking product to joint solutions for societal needs.
To be prepared for what will happen, you need to look at hard trends. This will not change, and it provides a solid foundation for growth. Hard trends are derived from demographics, regulations and technological advances (in terms of growth of “three digital accelerators”: processing power, storage and bandwidth).
Alexander Simidchiev in his presentation has applied this approach to look at pharmaceutical industry. Hard trends derived from demographics facts are stunning. Simple combination of current knowledge of age profiles for public expenditure on healthcare in EU countries (how much is spend for the healthcare of people in certain age), with data on ageing of the population shows, that current system cannot be sustainable in the near future.
Age profiles for public expenditure in health. Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations” p. 34 [PDF]. An arrrow added by K-message.comOn the other hand the same fact of ageing population affects how HCPs of today are working. 2014 was a tipping point, when the majority of HCPs in the EU is digitally native. All newly qualified doctors now, were born after 1988, and started their studied in 2005, which means they used the Internet to learn medicine (PubMed has started in 2006). They find digital more natural than printed materials for acquiring professional knowledge.
Those are hard trends, not guesses, and pharma marketers have to face it or their companies will struggle. We need to be prepared for dramatic shift in our business model, with less money for much bigger population in public healthcare system. We have to use digital channels to be understood by new generation of HCPs, and to provide information the new, digitally savvy patients.
It is not about nice mobile apps or shiny presentations on iPad. It is about the future. As Alexander Simidchiev, quoting Peter Drucker, has closed his presentation: The best way to predict the future is to create it.
Dallas Buyers Club is a powerful movie. Based on true story of Ron Woodroof it shows how patient has to fight the system instead of receiving a treatment for the deadly disease. Everything seems to ally against suffering patient. Health Care Professionals driven by greed offer inefficient therapy under strict clinical trial regime. FDA officers are enforcing cruel regulations confiscating “illegal” but life-saving medications. Even the judge from liberal California, although compassionate is forceless. Dallas Buyers Club is a coalition of suffering people turned into outlaws for trying to save their lives.
Is pharmaceutical industry and its regulators really so cruel? Why Woodroof and his club were persecuted instead of receiving help? Is it possible that such story happens today with some other disease?
Clinical Trials – Why Ron could not get AZT in the proper dose in the hospital.
At the moment depicted in the Dallas Buyers Club, AZT (zidovudine, also known as azidothymidine, trade name Retrovir) in the U.S. was in the clinical research, probably in Phase III of the process.
English: AZT (zidovudine), the first medication shown to be effective against HIV. From the National Institutes of Health website. (Photo credit: Wikipedia)
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Phases of Clinical Research
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Phase 0: The first in-human research of new drug is called an exploratory investigational new-drug study or phase 0 study. It is done before traditional phase I trials. Smaller than therapeutic doses of a new drug are given to a small group of patients (typically fewer than 15) for roughly a week to determine pharmacodynamic and pharmacokinetic properties.
Phase I: Researchers test a new drug or treatment in a small group of healthy volunteers for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group (about 100 -300) of people who have the disease or condition that the product potentially could treat. In this phase researchers see if the medicine is effective and are able to further evaluate its safety.
Phase III: The drug or treatment is given to large groups (1000 to 3000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
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[/box] Phase 2 and Phase 3 clinical trials generally involve a “control” standard. It means that some of the participants do not get tested substance, but inactive placebo or other, existing treatment if available. To avoid any bias, there is a special process to randomly decide who gets a tested substance, called randomization. At this point no one knows if the new therapy is efficient or maybe dangerous, so getting placebo is not necessarily worse option. Additional process to avoid bias in the results of the research is called blinding. Single-blinding means, that patients do not know whether they are treated with tested substance. Even better procedure, double-blinding means that also the research team does not know who receives what. Patient is informed about the substance s/he receives only at the specified time of the study, when it cannot impact the results. Due to this procedures, it is not possible for patient to decide a dosage or even to be sure that the specific drug is given. In the story of Dallas Buyers Club, Ramona starred by Jared Leto could not be sure that her medicine is AZT and not just placebo. Clinical studies are necessary to identify adequate dosage and eliminate risks that could overwhelm benefits of new therapy. There is always limited number of participating patients with specific conditions, so it takes long time to gather representative sample and see the results of the study. The whole process takes years to be completed, but it is needed to approve new drug to be available on the market.
Expanded access – Would it be possible to import medicine for Ron legally?
AIDS patients could not wait for clinical trials, this is why Dallas Buyers Club and other similar communities existed. In that time, there was no easy, legal way to provide access to the treatment for patients in need. This experience affected current regulations in the U.S., and now there is a number of ways that allow access to the investigational or non-approved therapies for serious or life-threatening conditions, including but not limited to HIV/AIDS. Additionally, there is a way to expedite process of approval for the treatment in so-called FDA fast track drug development program.
Access to Investigational Drugs Outside of a Clinical Trial (expanded access)
Expanded access, sometimes called “compassionate use,” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for:
[checklist]
individual patients, including in emergencies
intermediate-size patient populations
larger populations under a treatment protocol or treatment investigational new drug application (IND)
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To permit treatment of a patient with an investigational drug under an expanded access program, FDA requests following conditions to be met:
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The patient’s disease or condition has no satisfactory approved therapy. An example of this is a rare type of cancer that has no known or approved treatment. Or, it may be the case that the available treatments did not work for the patient.
The potential benefit for the patient justifies the potential risks. An example of this is the potential for longer survival with a disease or condition.
The expanded availability of the untested drug will not interfere with that product’s development. For example, access to an investigational drug should not interfere with enrollment in clinical trials needed to demonstrate the drug’s safety and effectiveness.
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Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. These safeguards are in place to avoid exposing patients to unnecessary risks.
Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug. [box type=”info” ]
How to Get Expanded Access to an Investigational Drug?
The process must begin with your healthcare provider, who should follow these steps:
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Your healthcare provider must contact the company that manufactures the drug to make sure it is willing to provide the drug.
Your healthcare provider must submit an Investigational New Drug (IND) [link to section below] application to the appropriate FDA review division.
In an emergency situation, the request to use the drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. With emergency INDs, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request.
In a non emergency situation, the IND must be received by FDA before shipment of and treatment with the drug may begin. These non emergency requests are known as individual patient INDs.
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The IND Application
The IND application is required to gain access to an investigational drug outside a clinical trial. The application should include the following information:
Statement that this is a request for an individual patient IND for treatment use (specifying whether it is an emergency IND or individual patient IND), which should be included at the top of the correspondence and on the mailing cover.
Brief clinical history of the patient including:
Diagnosis
Disease status
Prior therapy
Response to prior therapy
Rationale for requesting the proposed treatment, including a list of available therapeutic options that would ordinarily be tried before the investigational drug, or an explanation of why use of the investigational drug is preferable to the use of available therapeutic options
Reference for a published protocol or journal article, if appropriate
Proposed Treatment Plan including:
Dose (how much and how often)
Route of administration (by mouth, injection, etc.)
Planned duration (how long the product is to be taken)
Monitoring procedures
Modifications (e.g., dose reduction or treatment delay) for toxicity
Chemistry, Manufacturing, and Controls Information and Pharmacology and Toxicology Information, including a description of the manufacturing facility. This can be done by providing a letter of authorization (LOA) that refers to this information if it has been previously submitted to FDA (for example, to an existing IND or new drug application). The treating physician should contact the sponsor of the previously submitted information for the authorization and letter. The LOA should include identifying information, such as the sponsor’s application (e.g., IND) number.
Informed Consent Statement noting that informed consent and approval by an appropriate institutional review board (IRB) will be obtained prior to beginning treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.
Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a curriculum vitae typically contain this information and are usually sufficient.
FDA Form 1571 completed with the treating physician listed as the sponsor. Download Form 1571 and view the instructions.
For the drugs that are the first available treatment or have advantages over existing treatments, the Food and Drug Administration has developed four distinct approaches to make such drugs available as rapidly as possible:
[checklist]
Priority Review
Accelerated Approval
Fast Track
Breakthrough Therapy
[/checklist]
Priority Review
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. Since 1992, under the Prescription Drug User Act (PDUFA) a Priority Review designation is used to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). Priority Review does not affect the length of the clinical trial period.
Accelerated Approval
It takes many years to fully assess whether a drug provides a real effect on how a patient survives, feels, or functions, and brings a clinical benefit. To make drugs for serious conditions that filled an unmet medical need approved earlier, FDA can use Accelerated Approval process and base its decision on a surrogate endpoint. A surrogate endpoint is a marker of therapeutic effect, that is thought to predict clinical benefit but does not measure it. Drug still needs to be evaluated after approval in Phase IV studies, and basing on the results of this Phase IV FDA can change its initial decision on approval (ie. withdraw one of labeled indication, or completely withdraw drug from the market if confirmatory tests do not prove enough clinical benefit).
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
A drug that receives Fast Track designation is eligible for some or all of the following:
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More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
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Breakthrough Therapy
Breakthrough therapy is the latest program at FDA that will complement the programs listed above. It facilitates and expedites drug development and review for serious conditions and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
A drug that receives Breakthrough Therapy designation is eligible for the following:
[checklist]
All Fast Track designation features
Intensive guidance on an efficient drug development program, beginning as early as Phase 1
Early access to the innovative drugs is still a topic for regulators not only in the U.S. In the United Kingdom the latest development is an Early Access to Medicines program unveiled by the Government on 7th of March 2014. The program aims to accelerate access to innovative medicines for serious conditions, allowing doctors to prescribe the drugs after an initial scientific assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA). The program, funded by pharmaceutical companies, will be launched on April 2014. Suitable drugs will receive a “promising innovative medicine” (PIM) designation. PIM designation will be based on several years of clinical data assessed by MHRA, but before completion of Phase III trials. This will probably save several years in comparison to the standard process for approval, that will be run in parallel to the new program. Early Access to Medicines is modeled after the FDA’s breakthrough therapy designation. British regulatory agency estimates that one or two therapies could be designated under the scheme each year.
It seems there is no need for Dallas Buyers Club anymore.
Quantified self, mHealth and wearable technology. While you could hear about those trends in the past, the tipping point has been reached at the CES 2014. What was supposed to be the future is our present much faster than industry expected. Enterprise market is again far behind consumers. Health care industry tethered by regulations just cannot catch-up quickly enough.
At K-message however, we can take a look at the forefront of the consumer technology and assess its possible impact on the industry, and our focal point – pharmaceutical marketing. But first, let us define what we are talking about.
What is quantified self? Who wears technology? What is mHealth?
Quantified self (QS)
Quantified self (QS) is a trend of personal data collection via technology. The idea is to acquire data on person’s state, actions and performance using wearable technology and/or mobile applications.
Track Yourself Map of Quantified self apps by Rachelle DiGregorio
Wearable technology is a description of any electronics that one can wear. It may be something with a sensor for quantified self purposes, but it can be also a T-shirt with LEDs intended just to look nice. From quantified self perspective, wearable technology is a trend that enables the whole movement by devices that can capture personal data.
mHealth is a general term for usage of mobile devices (mobile phones, smartphones, tablet computers etc.) in connection to medicine or health care. mHealth includes providing information to the patients or HCPs, but also collecting patients data.
Is Quantified Self big and mature enough to have an impact on health care industry?
The topic is huge. On the Quantified Self Guide – a website that collects different Quantified Self applications, there are 505 different tools listed at the time of writing this article. Of those 65 are tagged with medicine and 124 with fitness category tag. Wearable technology was main topic of CES 2014. If you look around in the office of any healthcare corporation (or, even better, on the jogging path) in the developed world, you will notice wearable sensors in form of bracelets, chest bands or small items in the shoes used by increasingly high population. Users of the smartphones install “measuring” applications on their devices.
Gary Wolf: The quantified self
What are the numbers? Runtastic, a mobile app dedicated to track running performance has recorded 60 million downloads worldwide and 25 million registered users on Runtastic.com. Similarly targeted device and app Nike+ platform claims 18 million users. Fitbit.com, the website that allows to see the results of tracking with Fitbit range of devices according to Quantcast has around 2 million users from the U.S. only. Quantified Self is definitely mass market now and it will not fade away. Instead it seems it will get more devices and applications as the tech industry embraces it.
Quantified self: dangers versus benefits
From the pharma marketer perspective quantified self may be even more disruptive than the raise of social media (which, by the way is still not accommodated properly). As it gives more knowledge to the user it takes away control from the HCPs. Fitness trackers are obviously beneficial as they encourage the best prevention against disease – exercise and movement. On the other hand the trend brings some risks with it.
PBS: The Quantified Self: Data Gone Wild?
Interpretation of the data gathered by the device or application, even if supported with some mHealth resource filled with scientifically proven knowledge may lead to wrong decisions. Innocent life-logging app that counts calories intake may lead to starvation, or at least to non-balanced diet for some users who want to lose weight too quickly (not mentioning here eating disorders). A non-calibrated blood pressure and pulse tracker may put people with cardiovascular issues at risk (I cannot breath but the reader says I can still run…). The device alone can affect users health by allergy (that happened with Fitbit Force recently), heat, permanent exposure to radiation. There was also at least one occurrence when using activity tracking device, and competing for better score was connected with a tragic death of one too motivated biker. In pharmaceutical industry there is a lot of pressure put on the patient data privacy. Quantified self puts those data in open, sharing the very personal information on the activity publicly, sometimes without informing user about it. This was a real case when Fitbit.com allowed public to see users who were logging their 30 minutes very active sexual encounters. What is fascinating in Quantified Self movement is how the application can change focus from empowering by giving the knowledge to the patient to enslaving by enforcing control over users behavior. In one of the quantified self business use cases, not related to health care, a QS device called Hitachi Business Microscope worn by office workers was mapping their communication patterns within organization, pinpointing unnecessary meetings, organization social graph and communication issues.
If we take it to the field of pharma marketing, QS may be seen as a great tool to improve patient compliance or to provide personalized healthcare, but also as a menace of higher insurance rates for any misbehavior – be it sitting too long on the couch or having one drink too much.
Yuri van Geest – The quantified self: within 20 years no doctors needed
Quantified self and EHR, EMR and PHR solutions
One of the promising features of the quantified self is possibility to include the data acquired by sensors directly into electronic health records systems (EHR). Electronic Health Record is not exactly what industry widely embraces as EMR – electronic medical record. Although the data gathered, stored and processed in EHR are more or less the same, the source is different. EMR can include only data provided by medical institutions and healthcare professionals. EHR is open to any source of data. It includes what can be gathered from EMR, but also accepts patient input, quantified self devices and applications feeds and other sources. A specific range of EHR, that includes only data provided and managed by the user (in this case – patient) is Personal Health Record (PHR). The most renowned solutions of this kind are Google Health (decommissioned) and Microsoft Health Vault, but there are also other providers.
Microsoft HealthVault – an example of PHR
This brings new opportunities as we get really Big Data in EHR, but also some risks. Data in EHR and PHR cannot be really trusted, as they come from not validated sources and can be contradictory. The sampling (how often you take a data point) is not standardized and quality of the input is questionable. Nowadays, adoption of EHR and PHR is very limited, as is their functionality and usability. However with the growth of the quantified self we can expect rising importance of such hubs for the medical information.
Quantified self and regulatory compliance: HIPAA and HITECH
Quantified self movement adoption is nowadays limited to developed nations, and the biggest market for those solutions is in the United States of America. There are two regulatory bodies in the US that overlook quantified self devices and applications. For non-medical use the main authority is FTC. Privacy and access to the health related data is regulated by HIPAA and HITECH regulations.
HIPAA Compliance Checklist
Have you formally designated a person or position as your organization’s privacy and security officer?
Do you have documented privacy and information security policies and procedures?
Have they been reviewed and updated, where appropriate, in the last six months?
Have the privacy and information security policies and procedures been communicated to all personnel, and made available for them to review at any time?
Do you provide regular training and ongoing awareness communications for information security and privacy for all your workers?
Have you done a formal information security risk assessment in the last 12 months?
Do you regularly make backups of business information, and have documented disaster recovery and business continuity plans?
Do you require all types of sensitive information, including personal information and health information, to be encrypted when it is sent through public networks and when it is stored on mobile computers and mobile storage devices?
Do you require information, in all forms, to be disposed of using secure methods?
Do you have a documented breach response and notification plan, and a team to support the plan?
If you answered no to any of these questions you have gaps in your security fence. If you answered no to more than three you don’t have a security fence.
Quantified self and regulatory compliance: FDA guidance on medical mobile applications
For medical mobile applications relevant authority is the FDA. The Agency considers mobile phone as a medical device as soon as it meets one of the following:
It works expressly for medical purposes and offers medical or health-related apps
It acts as an effective accessory or component to aid medical health
While assessing medical mobile applications the FDA applies the same risk-based approach as for other medical devices. The guidance document provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C. 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 discretion 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 organize 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 healthcare providers;
Automate simple tasks for healthcare providers; or
Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
The quantified self will gain more importance in the healthcare industry. However, there are still some issues to be addressed before embedding them in the marketing strategy. Before building your own application or choosing one from the market consider them carefully.
Tracking versus privacy
Regardless of HITECH privacy considerations, the pharmaceutical company has to be extremely careful about patient data privacy. It has to be absolutely clear to the patient and the organization, that all data are owned by the user of the application and not the company. You need to have users’ direct consent if you are going to aggregate, store, process, or use the data in any way.
Data reliability
Your quantified self-application or device will gather data in connection to patients’ health. Therefore it is important to achieve possibly high level of accuracy and ensure the integrity of this data. It should be also clearly stated what are limitations of the sensors and technology used.
Fallback in case of failure
You need to make sure that in case of failure or loss of the device, patients will still be able to be treated or diagnosed with a fallback solution.
Interoperability
If your application allows data exchange with EMR, make sure it uses open standards, so that it can be used regardless of the health care provider chosen by the patient. This applies also to interoperability with PHR solutions.
Clear guidance for the interpretation of data
Make sure that the data gathered and provided to the patient are not subject to misinterpretation. There should be a clear explanation of the result provided, and if not possible the instruction should point the patient to the HCP who will be able to interpret the data. Even the best result on the application should not encourage patients to be not compliant with the treatment ordered by his doctor.
Co-operation with HCPs
If every patient comes to his GP with gigabytes of life-logging data, there is no time for a proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Not to mention different UIs of the applications and general annoyance with non-standard requests coming out of the blue. To avoid this you need to provide HCPs with clear instructions on what to look for and make sure they will know it at the first glance. Think about a separate dashboard for the physician or even better – distribute the app through the trained HCPs.
Example of quantified self in pharma marketing: Eli Lilly’s Talking Progress.
Talking Progress – Eli Lilly & Company Quantified Self mHealth App Screenshots
Talking Progress (this name applies for UK & Ireland markets) is an application available for iOS and Android, that was presented by Claire Perrin on the recent Social Media in the Pharmaceutical Industry conference in London. Talking Progress is dedicated for adults suffering from depression. Using this app patient can record his/her mood to produce progress charts which can track the recovery and help inform discussions with the doctor. It is extremely important, as one of the symptoms of depression is lack of focus and gaps in the memory.
The app also contains useful hints and tips about lifestyle changes as well as information on causes of depression and treatments. Talking Progress Features:
Educational information about depression
Mood Diary
Note pages
Healthy living advice
Medicine reminder alarm
Together with an app Lilly provides a booklet for the patient and small information desk stand for the HCPs. Embedding quantified self elements (diary and note pages) with mHealth features (educational information, lifestyle advice and compliance reminder) makes this app a perfect companion for patients suffering depression. Providing HCPs with the information pack (they are supposed to “prescribe” an app) guarantees that the data gathered via the app will be used and understood by the doctor.
Quantified self in pharma marketing – an opportunity for everyone
It looks like the quantified self movement will stay with us for longer. Lilly’s example described above shows that properly used it may be beneficial for all – patients, HCPs and pharmaceutical industry. We can without doubt add payers to the list. Correctly applied quantified self is great way for prevention via changing lifestyle habits, increasing disease awareness and improving patient’s adherence to the prescribed treatment. Will we use this opportunity? Quantified self may save lives and money. It seems that even regulatory bodies are up to date with the trend, so the only thing missing is pharma marketers involvement. Do you plan to include quantified self and mHealth elements in your brand strategy?
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This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
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