In my previous blog post, ‘Value and ROI from Social Media: What can Health-Sciences learn from Retail?’, I discussed how visionary retail and consumer products companies were at the forefront of deploying social media (and mobility where relevant) to engage with their customers in new and exciting ways. These companies are leveraging social media (and mobility for greater reach) to “differentiate the consumer shopping and buying experience” and building loyalty thru dialog, listening and engagement with the consumer in whole new ways as was elucidated in ‘7 Stage Social Media (and mobility) Value and ROI Life cycle Model’ (figure 1 above).Given the challenges confronting companies today re, “What is the value and return on investment (ROI) from Social Media initiatives to justify continued and incremental investments”?, I also discussed how that these new forms of engagement with customers rendered possible by social media, mobility or a combo thereof, are delivering value and measurable ROI on these investments today. I further elucidated how healthcare and life sciences can indeed learn from and adapt from these best practices from retail and consumer products, going forward, given the fascinating opportunities emerging and rendered possible by the ‘Renaissance in Healthcare’ happening in the US and around the world.

How does one interpret the ‘7 Stage Social Media (and mobility) Value and ROI Life cycle Model’ illustrated in Figure 1 above? The X axis depicts progressive levels of customer engagement enabled by leveraging social media (and mobility where relevant) in ways not possible before, from the customer as a ‘Passive infomercial and customer service receptor’ (Stage 1) to the ‘Customer as proactive investor and evangelist’ in stage 7. The higher companies and organizations progress along this 7 stage framework, the higher (often exponential) the value creation and return-on-investment (ROI) on their social media and mobility initiatives as shown on the Y-axis in this framework.

But how does one tangibly measure the value created and delivered with social media initiatives? As well, which Key Success Indicators (KSIs) should companies use to quantifiably measure their success? These bases for value creation, allocation and quantification as well as the metrics and KSIs are enumerated in detail against each of these seven stages in Tables 1 and 2 below, and further elucidated for each stage in this life cycle in the sections following the table.

Here is a quick recap of the first four stages of this life cycle (refer Table 1 below)– the reader can refer to the previous blog post ‘Value and ROI from Social Media: What can Health-Sciences learn from Retail?’ for additional details.

Table 1. Value and ROI from Social Media (and Mobility) Initiatives in Retail, best practice exemplars and Key Success Indicators. (copyright Andy De. All rights reserved).

Level 1-engaging the consumer as ‘Infomercial or Customer Service Receptor’: A survey of the current literature reveals a disproportionate focus on Level 1 in this life cycle (figure 1 below) i.e. on the use of social media as an alternative channel for “push marketing” to consumers or for lowering customer service costs (assuming that the consumer is a passive “infomercial or customer service receptor’).

Value from these initiatives involve building customer loyalty at a lower cost of customer service delivery or acquiring new customers at a lower cost of message delivery relative to other marketing media and campaigns. Key Success Indicators or metrics to measure success are annuity revenues; cost of (and savings from) after-sales service; cost of new customer acquisition

Level 2 –engaging the Customer as ‘Offer Seeker’: The next level of value from social media and mobility begins with Level 2 engagement i.e. leveraging the customer as an offer seeker, as exemplified by Groupon for instance.

The value is seen in incremental revenues at a lower cost of customer adoption as well as higher lead-to-deal conversion while lowering search costs for customers. This potentially drives a win-win for the business (lower cost of new customer acquisition) and possible loyalty from these new customers subject to their satisfaction with the product or service.

Level 3 –engaging the Customer as ‘Idea Contributor’: involved proactively engaging with customers as “ideators” for ideas that can help improve the services offered as well as newer services, or the customer buying experience as a whole.

The value from this level of crowd-sourced idea contribution from customers is a lower cost of ideation and market research, as well as incremental revenues from new services potentially with a lower cost of customer acquisition. Actively listening to customers and responding visibly to their ideas and suggestions is often a formula for building brand and customer loyalty, while enabling incremental revenues.

Level 4 –engaging the Customer as ‘Community Volunteer’: usually involves developing a community networking platform integrated with social media tools like Facebook and Twitter that enable customers to share their buying, shopping and consumption experience to aid their peers.

The value here is ‘building and orchestrating a community to enable trust in the buying process based on peer reviews of the product or service’ which in turn, lowers the cost of new customer acquisition and potentially, higher lead-to-deal conversion and revenues while lowering search costs for prospects and consumers. Key success indicators are the cost of orchestrating a ‘brand community’, cost of customer reference acquisition, lead-to-deal conversion and incremental revenues and brand loyalty from the initiative. 

Let us now dwell on the best practices in Social Media from Consumer Products illustrated in the seven stage model (figure 1 above) as stages 5, 6 and 7 in detail in Table 2 and the following sections below.

Table 2. Value and ROI from Social Media (and Mobility) Initiatives in Consumer Products, best practice exemplars and Key Success Indicators. (copyright Andy De. All rights reserved).

Level 5 –engaging the Customer as ‘Word-of-Mouth Influencer’: involves using social and other online media including community platforms to trigger discussions, exchanges and drive to product or prototype trials and eventual adoption.

Perhaps, the best known exemplar of this model is Proctor on Gamble and its in-house initiatives Tremor and Vocalpoint.

Tremor is P&G’s in-house word-of-mouth (WOM) marketing organization that brings together P&G’s legendary marketing expertise with cognitive science to orchestrate electronic “Word-of-Mouth”-peer-to-peer conversations to build awareness and demand for new products, and consumer advocacy, on a national scale, leveraging Vocalpoint – a community and e-focus group of women who are active online. Tremor provides a combination of consumer market research, message development and campaign execution to enable consumer advocacy leveraging Vocalpoint’s network of more than 500,000 highly connected moms.

Tremor’s successes range from Olay Professional-Pro-X for skincare to Dinner Tool, a new recipe web-site that enables busy mom’s decide “what’s for dinner”, and is a best practice model worthy of emulation across other industries as well.

The value enabled by Tremor+Vocalpoint is lowering cost of conducting market research via focus groups and surveys while building brand awareness, accelerating time-to-market with innovation potentially at a lower cost of customer acquisition.

Key Success Indicators are cost of market research, cost of brand awareness and PR, cost of customer reference acquisition and savings thereof, as well as new product revenues.

Level 5 Implications and Opportunities for Health-Sciences: P&G’s Tremor and Vocalpoint and their social media enabled market research, focus groups and product trials to scale consumer advocacy offer a compelling model for healthcare and life sciences. The only comparable model in a healthcare context today, perhaps, is Patients Like Me. Patients Like Me provides patients with chronic or uncommon conditions an interactive platform  to share their real-world health experiences in order to help themselves, other patients like them and organizations that focus on their conditions. Over time, it would seem feasible for Patients Like Me to develop its own “Tremor and Vocalpoint like” capabilities to better address the needs of its patient communities and further advocacy.

If not happening already, it may not be infeasible to imagine wellness and disease management services, mhealth apps and devices providers leveraging communities of patients on Patients Like Me or Facebook, as well as physician communities like Medscape (owned by Web MD) for focus groups, market research and potential recruitment for clinical trials.

In this context it is indeed relevant to refer to Pfizer’s recent remote “virtual” clinical trial for its overactive bladder drug Detrol LA. For the 16-week study, which will assess the safety and efficacy of Detrol LA, Pfizer will screen potential patients online, ship them medicines to their homes and monitor the results remotely. Patients will enter their results using a patient portal or their smart phones without physician supervision, unless needed – a first in the pharmaceutical industry.

The study, which will include 600 patients from 10 states across the U.S., will compare results with a previously completed phase IV trial on the same drug in the hope of validating the “virtual” clinical approach to research. If successful, this model could hold significant potential for the Life Sciences industry in lowering costs of clinical trials, at least for certain disorders that do not need intensive trial monitoring by physicians. 

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Level 6 –engaging the Customer as ‘Product Designer’: leverages “crowd-sourcing” from individuals to drive “Social Product Development” and is perhaps best exemplified by Quirky.

Quirky, launched in 2009, is a pioneer in ‘social product development’ has simplified the complexity pertaining to financing, engineering, distribution, and legalities that have often been barriers for inventors, designers and product or concept ideators in bringing their products to market commercially.Quirky, which has mastered the art of lowering time-to-market, brings two brand new consumer products (usually priced under $ 150) to market each week, by enabling a fluid conversation between a global community and its expert product design staff. Participants on the Quirky community influence the business in real-time by submitting, rating, and voting for product ideas, product designs, names, and other elements of the product’s development. As well, Quirky participants can browse and buy products, promote Quirky products to friends and family and earn a share of the profits through ‘social sales’. Participants can also collaborate, communicate and share with other participants using Facebook and Twitter. 

A similar open innovation model/crowd-sourcing platform to enabling innovation in an enterprise B2B context is enabled by Innocentive. Innocentive is being leveraged by many large corporations to crowd source innovation ideas from its employees, customers and partners, and connect with the largest virtual ‘problem solving marketplace’ to slash time-to-market with innovation.

Innocentive’s challenge driven innovation methodology, community of millions of problem solvers, and cloud-based technology platform combine to fundamentally transform the economics of innovation and R&D through rapid solution delivery and the development of sustainable open innovation programs.

Leading commercial, government, and nonprofit organizations such as Eli Lilly, Life Technologies, NASA, nature.com, Popular Science, Procter & Gamble, Roche, Rockefeller Foundation, and The Economist partner with InnoCentive to solve problems and innovate faster and more cost effectively relative to traditional models.

The value enabled here using this ‘social product development platform’ is significantly lowering the cost and time for new product development, securing eager focus groups, early buyers and references and delivering products to pre-committed buyers at a lower cost.

Key Success Indicators or metrics to measure success include cost of market research; cost of product design, development and commercialization; time-to-market; cost of new customer acquisition; new product revenues.

Level 6 Implications and Opportunities for Health-Sciences: ‘Social Product Development’ potentially offers a compelling model for Life Sciences companies and Healthcare technology vendors to slash time to market with innovation and lower costs. Innocentive’s platform is already being adopted by leading Pharma companies like Eli Lilly and Roche, and holds significant potential for healthcare IT products and services as well.

In fact, given the recent demise of Google Health and the relatively modest success with Personal Health Records (PHRs) by Microsoft and Dossia, using open, crowd-sourced innovation platforms like Innocentive may be a viable option.  Besides the concerns pertaining to security and ownership of a patient’s health information, one of the key challenges is the “one size fits all” model provided by current vendors.

Leveraging a crowd-sourcing platform like Innocentive to aggregate product design, feature, functionality, mobility capabilities and apps to meet the specific needs of core target segments (chronic diabetes patients on Medicaid, seniors recuperating from congestive heart failure or stroke et al) would be well advised. Transforming these specific requirements into a PHR on a familiar platform like a Smart Card that is usable at the doctor’s office, the pharmacy or with the payer may well be the winning solution that patients and the healthcare market is waiting for.

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Level 7 –engaging the Customer as ‘Investor and Evangelist: involves presenting a product/service, project or idea and securing ‘micro-investments’ or pledges (as low as $ 25-50) virtually from interested investors/target customers to fund the development. If the funding is successful and the product or service is developed, then early adopters (who have also invested) evangelize to their peers and friends to further scale investment and adoption.

Perhaps, the best exemplar of this model that extends ‘social product development’ to ‘social product funding’ is Kickstarter, with its unique “all-or-nothing” funding model for innovation.

Kickstarter is a new way to fund creative projects predicted on the notion that a good idea, communicated well, can spread fast and wide and draw investments from a large group of people. Kickstarter is powered by a unique all-or-nothing funding method where projects must be fully-funded or no money changes hands. Kickstarter projects are efforts by real people to do something they love, something fun, or at least something of note. These stories unfold through blog posts, pics, and videos as people bring their ideas to life.

Kickstarter is focused on creative projects. It provides a forum and a great way for artists, filmmakers, musicians, designers, writers, illustrators, explorers, curators, performers, and others to bring their projects, events, and dreams to life.

Here is an example of an innovative new watch strap (Tik-Tok and Luna-Tik) promoted on Kickstarter that transforms the iPod Nano into arguably, the funkiest watch you have seen. I am personally proud to have invested in and purchased. My evangelism also influenced a number of my “early adopter” buddies to invest in this product line that has become a runaway success!

The key value enabled by this unique micro-funding model is for entrepreneurs to secure investors, customers and evangelists using one business model without losing equity to VCs.

Key Success Indicators are angel investments ($), number of early adopter customers and new revenues; cost of customer acquisition and product/service development; marketing and advertising costs, equity ownership in the venture.

Level 7 Implications and Opportunities for Health-Sciences: The ‘social funding and product development model’ instantiated by Kickstarter is game changing and potentially provides significant opportunities for small entrepreneurs in the healthcare arena to bring lower priced mhealth apps and devices/instruments to market. Companies like NervCell that aspire to provide an open connectivity platform for doctors and patients to exchange patient data, as well as an apps platform for apps developers are being spawned on Kickstarter as we speak. It will indeed be interesting to observe the success of Nerv Cell and similar companies to bring healthcare innovation to market.

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In conclusion, this and the previous blogpost has presented a new and innovative model for engaging customers leveraging social media and mobility platforms and tools that are being deployed by leaders in retail and consumer products. These models show enormous promise, value, return-on-investment (ROI) potential and present new and novel opportunities for life sciences and healthcare technology companies to engage patients, physicians, clinicians, nurses and other healthcare stakeholders and also bring health-sciences innovation to market.

Your comments, feedback and pointers to best practices in health-sciences that I may have missed, are welcome.

In my previous blogpost, ‘Will Social Media find meaningful usage in a Healthcare context’, I have elucidated  how social media is being adopted and leveraged in a Healthcare context and the new business and engagement models being rendered viable by social media, as well as best practices thereof.

However, the million dollar question that companies and organizations today find themselves challenged with is, “What is the value and return on investment (ROI) from Social Media initiatives to justify continued and incremental investments”? This blogpost will persevere to address this question using a ‘7 Stage Social Media (and mobility) Value and ROI Life cycle Model’ (figure 1 and table 1 below) proposed by this author, enumerating best practices in retail and consumer products.

Jane Sarasohn-Kahn (noted healthcare economist, consultant and blogger – HealthPopuli; @healthythinker on Twitter) in her presentation at the HIMSS 11 conference, asserted that in the emerging healthcare landscape, patients and consumers demand products and services that need to be ‘SO-LO-MO’ (SOcial-LOcal-MObile) for these to be useful and worthy of adoption and consumption. The notion of ‘SO-LO-MO’ that was both tantalizing and provocative, sparked research, observation and modeling by this author to understand best practices in this arena in other industries, especially early adopters like retail and consumer products.

Few industries have brought ‘SO-LO-MO’ to bear for their products and services as big box retailers and consumer products companies have, given their proximity to the consumer and their need to engage in dialogue with the consumer in ways not possible before, thanks to the advent of these newer forms of technology enabled engagement e.g. crowd sourcing as one instance. These visionary retailers and consumer products companies are leveraging social media (and mobility for greater reach) to “differentiate the consumer shopping and buying experience” and building loyalty thru dialog, listening and engagement with the consumer in whole new ways as is elucidated in the 7 stage life cycle below. It is this author’s assertion that these new forms of engagement with customers rendered possible by social media, mobility or a combo thereof, are delivering value and measurable ROI on these investments today, that healthcare and life sciences can indeed learn from and adapt, going forward, given the fascinating opportunities emerging and rendered possible by the ‘Renaissance in Healthcare’ happening in the US and around the world.

Figure 1. Value and ROI from Social Media (and Mobility) Initiatives in Retail and Consumer Packaged Goods. (copyright Andy De. All rights reserved).

How does one interpret the ‘7 Stage Social Media (and mobility) Value and ROI Life cycle Model’ illustrated in Figure 1 above? The X axis depicts progressive levels of customer engagement enabled by leveraging social media (and mobility where relevant) in ways not possible before, from the customer as a ‘Passive infomercial and customer service receptor’ (Stage 1) to the ‘Customer as proactive investor and evangelist’ in stage 7. The better companies and organizations progress along this 7 stage framework, the higher the value creation and return-on-investment (ROI) on their social media and mobility initiatives as shown on the Y-axis in this framework.

But how does one tangibly measure the value created and delivered with social media initiatives? As well, which Key Success Indicators (KSIs) should companies use to quantifiably measure their success? These bases for value creation, allocation and quantification as well as the metrics and KSIs are enumerated in detail against each of these seven stages in Table 1 below, and further elucidated for each stage in this life cycle in the sections following the table.

Table 1. Value and ROI from Social Media (and Mobility) Initiatives in Retail, best practice exemplars and Key Success Indicators. (copyright Andy De. All rights reserved).

The first four stages of the seven stage model elucidating value from Social Media (and mobility where relevant) with best practices from Retail, the measurable value and ROI and Key Success Indicators (KSIs) have been enumerated below. (refer Figure 1 and Table 1 above):

Level 1-engaging the consumer as ‘Infomercial or Customer Service Receptor’: A survey of the current literature reveals a disproportionate focus on Level 1 in this life cycle (figure 1 below) i.e. on the use of social media as an alternative channel for “push marketing” to consumers or for lowering customer service costs (assuming that the consumer is a passive “infomercial or customer service receptor’). Office supply retailer Staples has built a “Tweet Team,” five customer service agents that patrol the Twitterverse, push out promotional offers, answer customer questions and more. To minimize confusion for customers, each of the Tweeters uses a dedicated tag at the end of their posts to indicate who is talking.

Value from these initiatives involve building customer loyalty at a lower cost of customer service delivery or acquiring new customers at a lower cost of message delivery relative to other marketing media and campaigns.

Level 1- Implications and Opportunities for Health-Sciences: Most pharmaceuticals companies, physicians practices, and healthcare providers and payers are at this stage of adoption and value delivery today, leveraging social media as a channel for ‘brochureware’ and education, and stand to significantly learn and benefit from the six stages elucidated below.

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Level 2 –engaging the Customer as ‘Offer Seeker’: The next level of value from social media and mobility begins leveraging the customer as an “offer seeker”, as exemplified by Groupon for instance. Groupon offers a limited basket of products and services from businesses at a significant discount off the retail price in the form of a redeemable “Groupon” that its subscribers can buy online. The Groupon is activated and becomes valid only if a stipulated number of subscribers buy and delivers volumes of customers to businesses while enabling these customers to try the product or service at a discounted rate, and potentially driving repeat business if they are delighted.

The value is seen in incremental revenues at a lower cost of customer adoption as well as higher lead-to-deal conversion while lowering search costs for customers. This potentially drives a win-win for the business (lower cost of new customer acquisition) and possible loyalty from these new customers subject to their satisfaction with the product or service and has seen significant success though in recent times, businesses have also complained of these customers not offering repeat businesses unless offered these significant discounts over and overagain that are often not sustainable.

Level 2- Implications and Opportunities for Health-Sciences: Groupon is being leveraged at this time by dentist, optometrists and even primary care physicians to drive new patients to their offices to potentially build loyalty and an annuity generating revenue relationship. The scalability and sustainability of this model needs to be further explored in a health-science context, going forward.

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Level 3 –engaging the Customer as ‘Idea Contributor’: involved proactively engaging with customers as “ideators” for ideas that can help improve the services offered as well as newer services, or the customer buying experience as a whole. Best Buy is one of the more innovative retailers when it comes to social media,  using http://bestbuyideax.com/ , a proprietary social platform that asks shoppers to suggest ideas for the retailer, then allows other shoppers to vote those ideas up or down, for Best Buy to adopt and potentially leverage the most popular ideas crowd sourced from customers. The success of IDeaX is predicated on authenticity and the need to be genuine, and perhaps most importantly listening, sensing and proactively responding to negative customer feedback, in the absence of which, this would be deemed hypocritical and lose credibility. The value from this level of crowd-sourced idea contribution from customers is a lower cost of ideation and market research, as well as incremental revenues from new services potentially with a lower cost of customer acquisition. Actively listening to customers and responding visibly to their ideas and suggestions is often a formula for building brand and customer loyalty, while enabling incremental revenues.

Level 3 Implications and Opportunities for Health-Sciences: While seeking service ideas from patients may be considered far-fetched by most providers and life sciences companies today, their potential for crowd-sourced ideation for mHealth and similar services is huge and stands to be explored by innovators who will win at the expense of their competitors in bring these short lifecycle services to market. As well, crowdsourcing ideas from chronically ill and multi-morbid patients, for remote monitoring, telehealth and wellness and disease management services, could have significant potential, going forward.

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Level 4 –engaging the Customer as ‘Community Volunteer’: usually involves developing a community networking platform integrated with social media tools like Facebook and Twitter that enable customers to share their buying, shopping and consumption experience to aid their peers.

Online reviews are a great way to generate search engine friendly content for e-commerce sites. Getting users to actively contribute and write reviews can be tricky, but Sears and Kmart have hit upon a successful formula with their interactive sites www.mysears.com and www.mykmart.com. The sites launched in March 2009, and so far have more than 400,000 registered users.

And online reviews are increasingly important for e-tailers: According to Forrester, 64 percent of online buyers find user reviews important when making a purchase, and 47 percent of online users overall say that information provided by other consumers is more important to them than information provided by the company or its marketers.

The MySears community enables customers to share their insights, experiences and product reviews by creating a two-way dialogue through discussion forums, blog entries, ratings, reviews, polls and surveys, and  new idea suggestion area and platform to leave comments.

Whether it’s improving how customers shop online, in-store, through mobile applications, or finding ways to enhance Sears’ offerings and learn more from customers, the key objective was to empower customers to shop how they want, when they want and where they want, and helping them better manage their lives. MySears.com receives more than 2 million visitors every month and has seen a measurable increase in revenues, repeat business and customer loyalty culminating from its social media enabled community initiatives.

The value here is ‘building and orchestrating a community to enable trust in the buying process based on peer reviews of the product or service’ which in turn, lowers the cost of new customer acquisition and potentially, higher lead-to-deal conversion and revenues while lowering search costs for prospects and consumers. Key success indicators are the cost of orchestrating a ‘brand community’, cost of customer reference acquisition, lead-to-deal conversion and incremental revenues and brand loyalty from the initiative. 

Level 4 Implications and Opportunities for Health-Sciences: Peer reviewed healthcare services from a community of customers are offered today by Angie’s List for a fee based subscription. Angie’s List extends its reviews to physicians and providers of healthcare services today and is a useful resource for patients seeking references. It will be interesting to see if Angie’s List can potentially scale across geography and the depth and breadth of healthcare services that are offered today, as well as the newer wellness and disease management services that are emerging, where references by peers are key for new patients.

While the success of ‘Patients Like Me’ is well known in healthcare, the potency of the ‘Community Volunteer’ model has been demonstrated by Mayo Clinic with measurable efficacy and success. Sharing Mayo Clinic (RSS Feed) is a blog with stories, experiences and videos of employees and patients relating their experiences at the Mayo Clinic and what makes it so special, which is probably the most popular of all its blogs. For instance, a video of an impromptu performance by an octogenarian couple within the atrium of one of Mayo Clinic’s buildings that was recorded by another patient and uploaded onto YouTube by her daughter went viral on the web with over 7.2 million views (click here to read the story and watch the video)!  

Given lack of clear FDA guidelines for social media in Life Sciences that has significantly inhibited adoption and proliferation,  an early success story in pharmaceuticals centers around Alli, the obesity drug from GlaxoSmithKline (GSK). GSK developed www.myalli.com as its online community to educate and connect with patients re: the efficacy of its new obesity drug. GSK also offers its consumers a weight reduction and wellness plan (myalli plan) on-site as well as the tools to monitor, measure, analyze and improve wellness. Also offered is access to Allicircles -its community of patients on the myalli plan, to help new plan entrants learn, discuss and see real-life successes from people like them to encourage them to follow the plan and see results for themselves.

As of this blogpost, it has been estimated that GSK has purportedly seen over 30,000 members sign up for myalli.com, which is fairly significant and points to similar opportunities for other pharma companies to engage with patients leveraging social media and the web as potent channels to complement their sales and marketing and physicians who write their scripts. A similar initiative to engage Diabetes patients (www.discussdiabetes.com) has been unveiled by Sanofi-Aventis and has seen early success.

This blogpost and the ‘7 Stage Social Media (and mobility) Value and ROI Life cycle Model’ has attempted to highlight the value and ROI from best practices in social media (and mobility where relevant) in a retail context that provides key learnings and pointers for healthcare and life sciences. Levels 5, 6, and 7 highlighting best practices from consumer products companies will be elucidated in the following blogpost.

As always, your comments, feedback and pointers to additional best practices for leveraging social media and mobility to drive new value and ROI are welcome!

Milestone: The Health-Sciences Strategy Blog’s companion Tweetstream (@HITstrategy) was recognized by the HL-7 Healthcare Standards Blog as ‘One of the Top 10 in Healthcare IT and Social Media in Healthcare in 2010′ with the #HIT sm Award.

I would like to commence this new blogpost by wishing all my readers across the globe a very healthy, happy and prosperous New Year in 2011. The year definitely commenced with good tidings for me in the form of the ‘#HIT sm Top 10 Twitters on Healthcare IT and Social Media in Healthcare Award‘ from the prestigious HL-7 Healthcare Standards blog. Please feel free to follow me on Twitter (@HITstrategy), if interested – I would be honored.

Promising Years ahead for Healthcare IT and mHealth Adoption

2011, in my humble opinion, promises to be one of the most exciting years in terms of patient and physician empowerment thanks to the convergence of healthcare technologies including electronic health records (EHRs), healthcare information exchanges (HIEs), personal health records (PHRs), patient management and clinical information systems as well as the advent of exciting mobile medical devices, services and applications.The projections for the mobile market globally are impressive indeed. Gartner Group estimates that the mobile marketplace (worldwide voice, data, and services) will exceed $1 trillion by 2014, and that smartphones will outsell PCs by the end of 2011. It is also estimated that almost 50% of the 2 Billion+ people connecting regularly to the Internet will access the web thru mobile devices over the next 2-3 years.

The stellar debut of the iPad as well as advancements in smart phones is driving innovation and emergence of mHealth (or mobile healthcare) (within the context of a hospital) as well as mobile health management (in the context of the patient/consumer) at a pace, that is simply unprecedented! A good lagging indicator is the emergence of venture capital funds like the ‘iFund initiative’ from Kleiner Perkins to monetize innovation centered around the Apple iPad, as only one example.

Further acceleration is anticipated to happen given the emergence of competiting tablet form factored devices including the Playpad from the makers of Blackberry, the Galaxy Pad from Samsung and many others from similar manufacturers like HP, Toshiba etc. It is this author’s prognosis that the healthcare industry will be one of the earliest adopters of mobile devices, especially touch screen enabled tablets like the iPad across most users including patients, physicians, nurses, clinicians, hospital administrators and executives as well their counterparts from the insurance and life sciences industries. It comes as no surprise at all that life sciences companies across pharma and medical devices are among the earliest adopters of mobile devices like the iPad in an enterprise context.

As elucidated in my previous blogpost, ‘Will Social Media find “meaningful usage” in a healthcare context?’, a significant and relevant trend that has emerged is the ‘Life Blogging’ or Quantified Patient Movement’ that is enabling millions of patients to monitor, measure, share and control their health data on the web, leveraging PHRs, social media tools like Facebook, Twitter and YouTube as well as mHealth apps and devices. This trend is anticipated to further scale and accelerate with the ubiquity of smart tablet devices like the iPad and smartphones and the day is probably not very far off, when patient and physician will be sitting across the table from each other discussing the patient’s condition while looking at a factual, accurate copy of the patient’s medical history and health data on the patient’s iPad, as basis for further treatment and follow up actions!

So what does this mean from an Patient Empowerment or an ePatient perspective?

To clarify the definition, who precisely is an ePatient? The Society and the Journal of Participatory Medicine define ePatients as “individuals who are equipped, enabled, empowered and engaged actively with their physicians in their healthcare decisions“, with the express objective of improving their relationships with their doctors and the quality of healthcare services they receive to improve outcomes.

In my previous blogpost, “Can Life Sciences and Healthcare enable my transition from “Passive Patient” to “Enlightened Prosumer?” I had outlined my vision for easy access to my medical records on demand, while ensuring that the data contained therein is factual, accurate and current. This is key for enablement and empowerment in the context of patients who are interested in taking charge of their health, especially in a post-acute or chronic condition management scenario. The business imperative for this is self-evident. At this time, there is a huge gap between “demand” i.e. patients that need care from both primary physicians and specialists and the ”supply” number of physicians, clinicians, and nurses available to deliver high quality healthcare services at an affordable cost. This demands that patients also assume responsibility for managing their health, disease or chronic condition as best as is possible, across episodes of care and between visits to their doctors.

As elucidated in my previous blogposts, ‘Who will make it Win-Win for Patients to adopt Personal Health Records (PHRs)?’ and ‘My Personal Health Record (PHR) in Microsoft’s Health Vault – Confessions of an Early Adopter’, this is easier said than done! Securing paper or electronic copies of one’s medical records, prescriptions, lab results etc., scanning them or converting them into an electronic format and uploading them onto a PHR platform like Microsoft Health Vault, Google Health or Dossia is daunting indeed, especially for patients who are not very technology savvy. Happily, this is beginning to change given the drive and incentives for interoperability across hospital IT systems and PHRs, thanks to the ARRA and Hi-Tech Act championed by the current US government. The advent and early success of the ‘Blue Button’ initiative that enables Medicare and VA patients to download electronic copies of their personal health records and upload them onto PHR platforms like Microsoft Health Vault, is a significant step forward to addressing this challenge.

Case Study:How can mHealth Apps and Devices help ePatients manage their Health?

The next daunting challenge for most patients is “how can my personal health data help me manage my condition once I have it in my PHR”? As stated in my blogposts above, not having intuitive tools like a Personal Health Dashboard (PHD) that provides a summary of one’s vital signs and health implications thereof, at a glance has been a challenge. This has coerced a number of patients like my friend John Doe (his real name concealed to protect his privacy, of course) to leverage ubiquitous tools like Microsoft Excel (below) to chart and craft their very own PHDs. I thank John for consenting to be the subject of this featured case study in this blogpost and sharing his personal health information for this blogpost.

John, 45 years old, and a father of three children, is slightly overweight (high body-mass index (BMI)), has some history of heart disease, hypertension and high cholesterol in his family. He has been challenged and frustrated re: “making his blood pressure and cholesterol numbers” since he “is unable to control and manage what he cannot measure”!

Although not afflicted with any cardiac event or angina, he is a concerned ePatient and takes responsibility for managing his heart health, to minimize risks of a heart attack or stroke. John discussed his situation with his primary care physician and with him, collaboratively crafted a care plan (medication, diet and exercise) to lower and control his hypertension, cholesterol, and also reduce his weight and BMI. Key to success with his care plan is proactive measurement, monitoring and control of his key vital signs, as lagging indicators of success. To accomplish this, John decided a few years ago, to leverage currently available online and mobile tools for personal health management.

 Figure 1. John’s Personal Health Dashboard (PHD) crafted using Microsoft Excel.

John started off managing his condition by scanning copies of his medical records, uploading them onto Microsoft Health Vault and then manually entering the numbers into Microsoft Excel to create his Personal Health Dashboard (shown in figure 1 above).

However, comparing and contrasting these numbers and also setting thresholds and alerts on violations thereof, is a significant challenge. In the absence of these, it is extremely difficult for patients like John to understand how well he is doing against his peer group or whether he needs to be concerned if one of his vital signs is above or below the previously recorded number.

Happily, PHR platforms like Microsoft Health Vault (with its plethora of partner solutions from both devices and service providers) and Google Health in its new avatar are beginning to address this challenge. Since John has been an active user of Microsoft Health Vault, he is using new and novel apps (integrated with Health Vault) like the Heart 360 Cardiovascular Wellness Center Application from the American Heart Association and mobile devices like his Blackberry, and Bluetooth enabled Omron blood pressure monitor and Tanita weighing scale (see photo below) to manage his care plan and his heart health.

Figure 2. Bluetooth enabled Blackberry, Tanita Weighing Scale and Omron Blood Pressure Monitor used for Personal Health Data Capture and wireless, automated Data Entry into Personal Health Record (PHR).

1. Directly enter his vital readings online using his Health Vault ID and password.

2. Measure his weight and blood pressure using his Tanita scale and Omron blood pressure monitor (or any Health Vault compatible device) to transfer readings from the instrument onto Health Vault, especially when at home. This required him to download the Health Vault Connection Center app from Microsoft Health Solutions. In the absence of bluetooth enabled devices, John can potentially use a device like HealthPAL from MedApps to transmit data from his devices to his Health Vault PHR.

3. Leveraging the utility of setting up reminders on the Heart 360 Cardiovascular Wellness Center to send text messages to his blackberry, with prompts to enter his weight, blood pressure and daily physical activity on a daily basis, or as often as is desired. This is particularly convenient when he is travelling on business with his portable blood pressure monitor with access to the weighing scale in his hotel room.

Figure 3. My Life Check software application and Personal Health Dashboard (PHD) from the Heart 360 Cardiovascular Wellness Center - Summary Dashboard Visualization.

John can at any time, sign into his MyLife Check app using his Health Vault account ID and password online, or anytime, anywhere, on his iPad. The app greets him with a very intuitive PHD that tells him how well he is doing on his heart health on a 360 degree basis (on a scale of 1 to 10) at a glance. He can also set his heart health goals and thresholds (with recommendations based on his age and demographic factors) and see how well he is performing against his targets and thresholds on his dashboard, based on his last set of readings entered by him, or captured from the bluetooth enabled medical devices.

Figure 4. My Life Check software application and Personal Health Dashboard (PHD) from the Heart 360 Cardiovascular Wellness Center – Summary Visualization of Key Health Indicators (KHIs).

In sharp contrast to his Excel dashboard, the PHD from the Heart 360 Cardiovascular Wellness Center precisely points him to the vital sign(s) that need his attention or action to get him to his target levels with the ability to drill down and secure access to further information online, if needed. As well, clicking a button enables John to print a 10-12 page report with all of these details that he can e-mail as PDF in advance or carry in hard copy format, when he visits his primary care physician or cardiologist to discuss his current condition and continuous improvement action steps needed (changes in medication, exercise, stress levels etc.), if any.

The discipline of entering his weight, blood pressure and physical activity data almost on a daily basis, as well as his periodic progress on his cholesterol and sugar numbers (that he monitors thru visits to his physician on a bi-annual basis) has significantly contributed to his empowerment, a measurable change in his life style and enabled him to take charge of i.e. monitor, measure and control his heart health. He has lost significant weight (over 15 lbs), lowered his cholesterol numbers (to well within his threshold levels) with physical activity, yogic exercises and medication as well as his stress levels. His overall heart health score (shown on his dashboard above) at 8.8/10 tells him that he is doing really well, but also points and directs him to work on reducing his weight and BMI even further to further lower his risk of a heart attack or a stroke.

His doctors are extremely impressed with his regimen and his tools and reports and often cite him as a model and responsible patient who collaborates with them to actively manage his personal health and wellbeing!

In Summary

This blog post and the case study above are intended to go beyond the hype and provide an illustration of how well designed online and mHealth apps and off-the-counter devices like weighing scales, blood pressure and glucose monitors, when integrated well with PHRs, can enable real-world patients to monitor, manage and control their states of health, well being or chronic conditions.

While early apps have laser focused on specific conditions (like heart health, for instance, as illustrated above or diabetes), one can easily prognosize the evolution of ‘ambidextrous apps and dashboards’ going forward. These apps can potentially be configured for an array of conditions by the patient, for his/her specific condition and personalized to his/her needs, to enable and empower him/her to monitor the key health indicators (KHIs like vital signs) and manage his/her personal health on an every day basis, collaboratively with his/her physician or care provider, beyond the four walls of the hospital or clinic. In fact, this trend and its widespread, mainstream adoption by patients, can potentially be a key enabler and driver of the Patient Centered Medical Home, going forward.

Delivering well designed software applications that can be intuitively used and integrated in a patient’s everyday life style (especially data entry) without significant or disruptive changes in behavior is key to adoption, usage and success with wellness and disease management, Healthcare IT solutions and mHealth apps and devices.

We will further discuss these key design principles in the next blogpost.

As always, your feedback re: this blogpost using the comments box, the accompanying face book page or twitter are welcome!

Social networking tools or social media as they are referred to, comprise a myriad of platforms and tools like Blogs (leveraging platforms like Blogger, WordPress, TypePad, Drupal et al), Facebook, Linked-In, Twitter, MySpace, Slide Share, Skype, Podcasts, YouTube, Stumble Upon and hundreds of others mushrooming everyday.With over 400 MM active users on Facebook alone who spend over 500 billion minutes “facebooking” per month and millions joining every day, the relevance of social networking and social media is beyond doubt, and an accepted fact of life today. In fact, the use of social software and its ability to promote collaboration between patients and the rest of the healthcare value chain is often referred to as Health 2.0 – a term that is increasingly gaining widespread acceptance to describe this trend and phenomenon.

The key question this blogpost seeks to address is how are social media being adopted and leveraged in a Healthcare context (especially from a patient centric perspective), the value delivered by Health 2.0 and the challenges and barriers to adoption thereof, especially given HIPAA and stringent security needs and concerns. Despite all of these concerns some of which are well founded, there is significant evidence that the web and social media are increasingly being adopted, leveraged and actively used in a healthcare context, as evidenced by the statistics below:

* 60 MM consumers globally currently sharing their health experiences online

* There are over 1,200 communities on Facebook advocating cures for chronic diseases

* 216 Hospitals use Social Media in one form or another

* 23 Hospitals have blogs

* 83 Hospitals have Facebook Pages

* 126 Hospitals have their own YouTube channels

* 132 Hospitals use Twitter and the number is growing everyday

While a number of articles and blogs highlighting the various uses of social media in a healthcare context have been written, in this blogpost, this author will present a novel and different perspective in the form of a strategy framework outlining the various use cases and scenarios for social media adoption in a healthcare context, mapped against two significant parameters that often determine success or failure with adoption of newer technologies and media.

It is this author’s aspiration that this framework can potentially be leveraged as a blue print for social media innovation in a healthcare context and also, by extension, provide a valuable sanity check re: potential challenges and barriers to adoption and the business viability and feasibility of various innovation scenarios, business models and use cases, that seek to deploy social media in a healthcare context.

The strategy framework below has been adapted by this author from a seminal article entitled, ’Eager Buyers and Stony Sellers – Understanding the Psychology of New Product Adoption’ by John T. Gourville, Harvard Business Review (HBR), June 2006. The key premise is that the greater the level of change in customer behavior needed, the greater the barrier to customer adoption, despite the promise of value delivered by the new product or technology. Gourville makes the point that producers of innovation often overestimate the customer adoption by a factor of 3X while consumers allocate significant value to their current product or service and demand a value proposition that is practically 9X times that offered (perceived) by their current product or service.

This author has modified and adapted the framework from the paper above to craft this 2X2 Matrix (please refer to the figure below) to map various business models, scenarios and use cases for social media in a healthcare context from a patient centric perspective as follows:

The X-Axis maps “Patient Resistance to Adoption” from high to low while the Y-Axis maps the “Change in Behavior required from other Key Stakeholders that interact with Patients such as Physicians, Providers, Insurance Payers, Employers and indeed, the Government (given that it is by far the largest payer for healthcare services today).

 The Predictive Power of this Matrix (please refer to the figure below) can be leveraged as follows:

*  Upper Right Quadrant – low patient resistance to adoption with low change in behavior required from other stakeholders like physicians and providers can be prognosis for “Smash Hits” – social media models, scenarios and use cases that will succeed in a healthcare context.

*  Lower Right Quadrant- low patient resistance to adoption demanding high changes in behavior from other healthcare stakeholders like providers, physicians and payers signify “Long Hauls” i.e. patients have seen significant value from the scenario, model or use case but concerns re: security from providers and physicians, or lack of reimbursement from payers etc. could potentially slow down their traction and widespread usage.

*  Upper Left Quadrant -high patient resistance to adoption but demanding low change behavior from other Stakeholders is classified as “Hard Sells” i.e. a solution probably looking for a problem that patients see little value from adopting, and will demand considerable efforts and incentives for traction.

*  Lower Left Quadrant – high patient resistance to adoption with high changes in behavior required from other key stake holders is a non-starter or recipe for “Sure Failures” and little to no potential traction. Key message – proceed here at your own peril and risk.

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A.  Given that over 60 MM people globally leverage the web (Google and similar search engines, information resources like Web MD and other healthcare portals) and social media like blogs and wikis to search and secure information on healthcare issues, topics, therapeutic areas, treatments, doctors, hospitals, regulations and reimbursement models, this is already a “Smash Hit” and embodies the most obvious usage that can be safely prognosized to grow by leaps and bounds. Healthcare Scoop is a health infotainment site that enables its users to discuss healthcare specific issues (alphabetically indexed) and also share their experiences re: hospitals, doctors and treatments. The obvious benefit for users is lowering of search costs for health information, as well as secure the opinions and insights of others who may have already had similar experiences.

As a matter of fact, the advent of “Life Blogging” or sharing quantified healthcare data over the web and social media is being perceived and recognized as a social phenomenon referred to as the “Quantified Life Movement” as articulated in this recent Fast Company article by Jamer Hunt. Access to free or almost free social networking platforms like blogs and Facebook and cost effective analytics and visualization software deployed thru personal health dashboards such as Daytum, is enabling people concerned re: their health to monitor, measure, analyze and report their health data leveraging personal health dashboards (example illustrated in the article above) with friends, caregivers and relatives to further their wellness. The article also alludes to the significant opportunity and potential of aggregating this quantified patient data and analyzing the data to identify and perhaps even predict changes in disease patterns correlated with the underlying demographics – a virtual treasure trove of data with yet untapped potential for sure!
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 B. Another model leveraging social media that is a “Smash Hit” and growing by leaps and bounds is the advent of patient centric collaboration and communities leveraging social media to explore, discuss, collaborate and share data, news, and personal healthcare information. Contrary to oft cited concerns re: sharing of health information in an online context, a number of people who are comfortable transacting financially online and use social media are clearly comfortable doing so. As pointed out earlier there are over 1,200 communities on Facebook along seeking, advocating or discussing cures for chronic diseases. Groupware and security settings on Facebook also enable patients with chronic diseases like cancer to create their own private community of relatives and friends to share updates re: their conditions, treatment and progress periodically.

Patients afflicted with sensitive, complicated, uncommon or “orphan diseases” and disorders like Multiple Sclerosis, Parkinson’s Disease, HIV/AIDS etc. have joined Patients Like Me to find, connect, collaborate and form communities with others afflicted with similar disorders and diseases. In addition to empowerment thru kinship and collaboration, these groups are leveraging their advocacy and global community with the government, payers and pharmaceutical companies and others to seek cures for these diseases, that otherwise have a low probability of being addressed.

A somewhat similar model providing free web-sites and the ability to create a private community of relatives, friends and caregivers is enabled by Caring.com and CareFlash. The model targets people (“family caregivers”) with ailing or elderly, relatives and friends who demand greater privacy and security than that provided by Facebook or similar platforms and can leverage the tools provided by these businesses to build a private community and discussion forum centered around the patient. From engagements with caregivers to scheduling appointments with friends and relatives for visitation, discussing relevant issues with other members to blog authoring and providing uplifting videos and infotainment, these models are delivering value by enabling people to care for their relatives and friends leveraging technology and social media. While these models have seen early success, their long term viability is predicated on significant subscription and usage revenues from payers and employers who would leverage their platform and tools for their insured employees and patients.

A somewhat different model enabling people to leverage their data from their personal health records like Microsoft Health Vault and Google Health for wellness programs is provided by Keas, founded by Adam Bosworth (who had previously founded Google Health ). Keas helps people understand what their health data means and how they can use it for health and wellness thru their care plans. These care plans leverage patient data (family history, health conditions, vital signs like weight, blood pressure, cholesterol etc.) to empower people to manage or improve their condition, or leverage their lab results to deliver personalized content, alerts or action items to improve health and accomplish their health and wellness goals. Patients and plan providers pay a fee to enroll into these care plans which provides Keas with its revenue streams to build and sustain its platform and business model.

Similar to these patient centric communities, there’s Medscape (now run by WebMD), a social network for doctors that has a format similar to MySpace or Facebook and includes 100,000 physicians.

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C. A similar and closely related model and a potential “Smash Hit” that is emerging and is being widely adopted is the use of videos and web-based do-it-yourself health education and case studies leveraging social media like YouTube. While YouTube is a source of thousands of uploaded videos and even branded channels (over 126 hospitals have their own YouTube channels) that anyone can access, there are interesting models of privately owned and branded healthcare content that are also seeing considerable traction and adoption.

icyou.com is a one-stop shop proving an aggregation of health content on videos that patients, caregivers and even healthcare service providers can leverage, to make informed decisions re: health related issues. It would not be surprising if content from icyou.com is syndicated and leveraged by a number of the healthcare and patient communities referred to earlier, as well as healthcare providers and payers for purposes of quality and cost-effective health relevant education and infotainment for their patients and/or caregivers.

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D. A model that is emergent and very interesting is patient outreach and education, infotainment and marketing by life sciences (pharmaceuticals, medical devices and equipment and bio-tech companies) and indeed healthcare providers themselves. The underlying rationale is the leverage of the web and social media to create “stickiness and pull” for new drugs, treatments and devices in a life sciences context or build patient loyalty thru communities in a healthcare provider context.

 Healthcare Providers: Best practice in the usage of Facebook, Twitter, Blogs, podcasts and web-pages for patient outreach in a healthcare context is exemplified by the Mayo Clinic which began experimenting with social media around four years ago. As pointed out in this article “Healthcare meets Social Networking” by Kimberly Morrison in the Jacksonville Business Journal, Mayo Clinic, which has a campus in Jacksonville, has come a long way in just a few years, since adding a Facebook page with more than 3,000 friends, a YouTube channel with videos of doctors talking about illness, treatments and research, a health blog for patients and another for media to improve the process of medical reporting, all for an incremental initial investment of around $1,500! It’s also creating “private groups’ on Facebook to connect patients to others with similar illnesses, an area it hopes to expand in the future. As well, Mayo Clinic now provides healthcare centric infotainment for local radio and TV stations. Mayo Clinic has successfully leverage the potency of “word-of-mouth” marketing from happy patients and leveraged social media tools like Facebook, Twitter and its blogs to amplify its impact for patient outreach and loyalty that other hospital providers all across the world can learn from.

Mayo Clinic has since crafted and delivers a portfolio of blogs targeted at various audiences as below:

* Mayo Clinic News Blog (RSS Feed) provides pre-embargo resources for journalists and then makes that same information available directly to patients. It’s their “hard” news analog to Time, Newsweek or U.S. News & World Report.

* Mayo Clinic Podcasts (RSS Feed) provides evergreen health information and general medical news.

* Physician Update (RSS Feed) is aimed at the physician audience but open to anyone.

* Advancing the Science (RSS Feed) is a medical version of Scientific American.

* Sharing Mayo Clinic (RSS Feed) is a blog with stories, experiences and videos of employees and patients relating their experiences at the Mayo Clinic and what makes it so special, which is probably the most popular of all its blogs. For instance, a video of an impromptu performance by an octogenarian couple within the atrium of one of Mayo Clinic’s buildings that was recorded by another patient and uploaded onto YouTube by her daughter went viral on the web with over 7.2 million views (click here to read the story and watch the video)! 

An interesting factoid worthy of mention here is that Lee Aase, the manager for syndication and social media for Mayo Clinic, who led and orchestrated the Mayo Clinic’s social media strategy, also moonlights as the chancellor of Social Media University Global (SMUG), a free online university to help people explore, familiarize and master social media.

A real-world example of social media leverage in a small physician practice context from this author’s neighborhood, is manifested in this compelling video of Mac Arthur OB/GYN in Irving, Texas leveraging a portfolio of technologies including their patient interaction/practice portal, facebook, twitter etc. for patient engagement and outreach – clear evidence of value delivered! 

For Life Sciences companies, especially large ethical Pharma companies, that have long relied on “sales and physician push” to get their products to market, the web and social media provide potent and powerful tools to create “pull and stickiness with patients”. While big Pharma has traditionally been reluctant to embrace these new media given the stringent regulations governing them, visionary companies are beginning to embrace social media to craft relationships with their patient consumers.

An early success story centers around Alli, the obesity drug from GlaxoSmithKline (GSK). GSK developed www.myalli.com as its forum to educate and connect with patients re: the efficacy of its new obesity drug. GSK also offers its consumers a weight reduction and wellness plan (myalli plan) on-site as well as the tools to monitor, measure, analyze and improve wellness. Also offered is access to Allicircles -its community of patients on the myalli plan, to help new plan entrants learn, discuss and see real-life successes from people like them to encourage them to follow the plan and see results for themselves.

As of this blogpost, it has been estimated that GSK has purportedlyseen over 30,000 members sign up for myalli.com, which is fairly significant and points to similar opportunities for other pharma companies to engage with patients leveraging social media and the web as potent channels to complement their sales and marketing and physicians who write their scripts.
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E. A “Long Haul” opportunity that intuitively spells considerable and widespread adoption potential is healthcare consulting, interaction (video conferencing, tele-medicine and tele-health) with doctors and nurses as well as setting of appointments and reminders leveraging the web and social media. Given the reluctance and privacy/security concerns even around something as ubiquitous as e-mail communications with patients, usage of social media tools like Skype for video based interactions and consulting appear to be a distant dream at this time.

However, there is hope on the horizon for potential widespread usage of tele-medicine given the high incidence of chronic diseases today, especially in remote and rural areas where patients are often challenged to access quality healthcare. First and foremost, recent federal (USDA) and insurer grants to promote tele-medicine especially in rural areas will go a long way to promote and scale usage of tele-medicine and tele-health, going forward.

Secondly, the availability of robust tele-medicine and tele-health solutions like Cisco’s Health Presence (click on the link to check out the compelling video) and Intel’s Health Guide (click to view the product data sheet in PDF format) enables video based interaction with patients within the context of their homes just as easily as if the patient were half way across the world. Equally compelling is the ability for these solutions to connect wirelessly with medical devices for measuring vital signs like glucose and blood pressure and transmitting the data into the context of that patient’s electronic health record (EHRs).

Engaging with elderly patients as well as those afflicted with chronic diseases like diabetes, congestive heart failure, cancer etc. and their physicians or providers and having them embrace these technologies to monitor and deliver treatment while ensuring appropriate reimbursements by payors, will be key to success with this model, that is very far from ubiquity today. However, this is a very promising area of delivery high quality healthcare services at a lower cost and presents significant incremental revenue opportunities for medical devices and equipment manufacturers like Siemens, GE Healthcare, Philips Healthcare, Medtronic, Johnson and Johnson and companies like Cisco, Intel and Verizon that I have addressed in one of my previous forward looking blogposts (Will Siemens, GE Healthcare, Philips et al evolve into Senior Citizen Services Providers in the foreseeable future?)
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F. Perhaps, the most challenging model and scenario is on demand access by patients to their records, prescriptions, transactions and reports on outcomes over the web and using some form of social media. Given current HIPAA regulations, security concerns re: online access to sensitive patient data, and potential for fraudulent usage, this is a scenario that will perhaps be realized not in the immediate future but hopefully, surely in our lifetime.

The most daunting challenge today is arguably, the low penetration of Electronic Medical (EMRs) and Electronic Health Records (EHRs) in both a healthcare provider (around 17% penetration at this time) as well as small physicians’ offices (barely around 5% at this time). Implementing robust CCHIT certified EMRs and EHRs across healthcare providers and small physicians’ offices in the context of the ARRA stimulus and HITECH regulations from the current government are anticipated to go a long way to drive up adoption and scale usage. Once “meaningful usage” of EHRs is realized across the healthcare ecosystem in a US context, selectively and securely providing access to patient data, records and reports would be rendered feasible, subject to robustly addressing data security and HIPAA constraints, and aligned with data governance guidelines. Until such time, this will remain a “Long Haul” and will demand significant policy initiatives, hardware and software innovation from enterprise IT vendors, guidelines from the regional extension centers that have been set up by the government, as well as cost-effective and disruption free implementation models and services to realize this vision.
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In conclusion, this blogpost has addressed some of the most potent models, use cases, scenarios and interactions from a patient centric perspective rendered possible by social media in a healthcare context. A framework for appraising the viability and feasibility of these models has been provided.

However, this perspective would be incomplete without addressing the potential impact of newer devices like the iPad on scaling the adoption of social media in a healthcare context. Given that over a million iPads were sold within 72 hours of introduction, early enthusiasm and feedback from even elderly users (check out this viral YouTube video of a 100 year old eagerly using the iPad- then only computer she has ever used) re: the ease of usage, data consumption and mobility, points to the immense potential of the iPad as a device for healthcare information, infotainment and data communication, consumption and collaboration.

It is the prognosis of this author that widespread adoption of the iPad, content as well as healthcare specific applications and software availability for consumption on this device, will go a long way to further scale adoption of social media in a healthcare context and accelerate some of the models discussed above. This if realized, will further the promise of transparency, access and delivery of quality healthcare to patients more cost effectively, going forward.

As always, your comments, feedback and pointers are highly appreciated.

It is probably not an exaggeration to state that the recent passage of the healthcare reform bill and the Patient Protection and Affordable Care Act (PPACA) by the current administration will have profound and far reaching changes on the US healthcare system – more than we have seen in the last 30-50 years. Besides ensuring subsidized health insurance coverage for the currently 32 million uninsured Americans, those with pre-existing conditions (banning discrimination in coverage), assuring coverage to young people thru the plans of their parents until the age of 26, and better prescription drug coverage for Medicare seniors, the stated objectives of healthcare reform are to drive unprecedented transparency, higher quality of outcomes at a lower cost, often thru innovative leverage of healthcare IT and relevant technologies (thru the ARRA stimulus bill and HITECH Act passed earlier).

The incremental costs of healthcare reform has been estimated to be $940 billion over 10 years, according to the Congressional Budget Office, but is widely anticipated to exceed $ 1 trillion. While almost everyone agrees that the current increase in annual healthcare costs as a percentage of the US GDP is just not sustainable, there is wide spread disagreement and controversy on how to implement healthcare reform and ensure higher quality healthcare at a lower total cost of delivery.

While the impact of the healthcare reform will be felt over the next 5-10 years for most patients, there are current challenges that will be posed to the US healthcare ecosystem and all of its stakeholders. These challenges also bring in their wake new opportunities for collaboration, business model and IT innovation and patient and physician empowerment that I will discuss on this blog post. This presents a high level business summary of my key takeaways (eschewing the technicalities involved) and forward looking implications and analysis, as well as prognosis for some of the opportunities presented and solutions thereof, from a business and IT perspective, from a number of seminars and webinars on Healthcare reform that I have had the opportunity of attending, in the recent past.

Patients:

Challenges and Implications:

1. Given the advent of 32 million new patients in the current healthcare system, most patients will be challenged to secure appointments with their primary care physicians as easily and promptly as they may have in the past. This is anticipated to significantly burden the current system and demand additional hospital infrastructure as well as a shortage of primary care physicians and nurses in the short to medium term.

2. Given the expected rise in health insurance costs, and higher co-pays, it is anticipated that patients will also be constrained to seek alternatives at a lower cost.

Opportunities and Solutions enabled by Business and IT Innovation:

1. Substitution of less experienced primary care physicians and nurse practitioners as well as immigration of doctors and nurses from other countries to deal with the shortage in the near to medium term, is a distinct possibility.

2. Retail healthcare clinics such as those being opened at Wal-Mart (see my earlier blogpost – Wal-Mart’s retail and healthcare IT play- Implications for Patients, Providers, Physicians and the rest of us) and other retail chains as a lower cost alternative may become viable and real, especially for the lower middle class.

3. The ubiquity of electronic health records (EHRs) and physician-patient interaction via portals, video conferencing, telemedicine, wellness and disease management programs, mobile and wireless devices etc. would also enable physicians to manage interactions with a larger number of patients thru exception and ‘severity of condition” based management, subject to appropriate reimbursements models being put in place.

4. The evolution of mobile/wireless healthcare, business models and reimbursement and monetization thereof, while still ahead of the curve, is a significant opportunity, going forward. Envisioning the ability for patients to access and monitor their personal health records and/or personal health dashboards (like the one below) on their iPhones, Blackberrys and iPads, interacting with their nurse practitioners and physicians thru video conferencing enabled on these devices and accessing health related information, scheduling visits and interacting with their health centric social networks (like Patients Like Me , CareFlash or private groups on Facebook, for instance) are significant and viable market opportunities that organizations like the West Wireless Health Institute and many innovative solution providers are seeking to realize and enable, going forward.

Healthcare Providers and Physicians:

Challenges and Implications:

1. Medicare reimbursement reductions as currently stipulated (many doubt whether these will actually come to pass) is a significant challenge that will constrain profit margins for providers and potentially incomes for physicians. It is also anticipated the reimbursement models from payers may evolve to “pay for episode of care” (treatment of a fracture from cradle to grave across the primary care physician, specialist, and chiropractor or physiotherapist is treated and reimbursed as a “single episode of care”) vs. pay for interaction/procedure currently prevalent that will demand higher operating efficiencies and productivity. As well, this will demand that hospital providers find and create new and alternative sources of revenue to compensate for the anticipated reduction in reimbursement, going forward.

2. The quality and performance reporting stipulations of the hi-tech act, pay for performance models, comparative effectiveness and evidence based medicine will further demand delivery of the best possible, sustainable patient outcomes at a lower cost, while ensuring a move from the current paper based processes to automated Electronic Health records (EHRs), Health Information Exchanges (HIEs) and interoperable IT systems to assure transparency and higher levels of accuracy and efficiency.

Opportunities and Solutions enabled by Business and IT Innovation:

1. Hospital providers and small physicians’ offices will need to implement and adopt Electronic Health records (EHRs) and Health Information Exchanges (HIEs) with demonstrable “meaningful usage” by 2013 or face penalties by way of reduced Medicare reimbursements. While many providers will perceive this as a significant and onerous burden, the visionaries will actually leverage their early adoption and performance reporting as a competitive differentiator to secure patient mindshare and loyalty.

2. Visionary CIOs in industry leading providers are currently testing pay-for-performance models enabled by analytics and performance management software that enables CXOs to monitor, measure, analyze and improve performance based on outcomes rather than procedures, for the very first time. Analysis of variances in outcomes across physicians for the same therapeutic area and treatment and causal analysis there of, can be anticipated to drive us towards a true comparative effectiveness and evidence based model, going forward. This initially will meet significant resistance and will demand appropriate change management to institutionalize these. As well, leveraging similar sophisticated analytics and process improvement paradigms like Lean and Six-Sigma can enable CXOs and hospital administrators to improve performance per function and department while potentially driving up productivity and margins while ensuring superior therapeutic outcomes at a lower total cost of delivery (TCD). As well, the advent of “pay-for-performance” and evidence based outcomes may actually accelerate the drive towards targeted treatment and personalized medicine (see my earlier blogpost – ‘Personalized Medicine: The Time is Now – Are we there yet?’) vs. the one size fits all paradigm currently prevalent.

3. The advent of wellness and disease management programs and IT enablement will also enable providers to extend the “continuum of care” from the context of the four walls of the hospital to the patient’s home, and potentially provide additional and highly lucrative revenue streams and also assure reinforcement of the relationship with patients. This also holds significant promise in terms of assuring higher quality of care and diagnosis delivered within the context of “the medical home”, especially for seniors and multi-morbid patients thru leverage of video conferencing, remote monitoring,telemedicine, medical devices etc.

Employers:

Challenges and Implications:

1. Employers (who currently pay for almost 40% of all insurance coverage in the US) will potentially face higher increases in insurance coverage for employees for the next 2-3 years given the additional insurance coverage of the currently uninsured. Passing on some of the costs to employees has been the norm for many employers, and is anticipated to continue.

2. Businesses are not required to offer coverage. Instead, employers are hit with a fee if the government subsidizes their workers’ coverage. The $2,000-per-employee fee would be assessed on the company’s entire work force, minus an allowance. Companies with 50 or fewer workers are exempt from the requirement. Part-time workers are included in the calculations, counting two part-timers as one full-time worker. it is anticipated that smaller employers especially in low margin industries may explore the tradeoffs of paying penalties for non-coverage of their employees against the higher costs of insuring them especially if this is perceived to be economically unviable and unsustainable.

Opportunities and Solutions enabled by Business and IT Innovation:

1. It is anticipated that larger employers especially in high margin industries may start to leverage “health and wellness” as a tangible reward, thru the award of screening (like the Copper Clinic) wellness and disease management programs in collaboration with their health plans, to drive down their total cost of health insurance. Many companies have already instituted similar plans leveraging personal health records (PHRs) like Microsoft’s, Google’s and Dossia’s platforms coupled with wellness and care management programs leveraging tools like Keas, for education and improved employee health and maintenance thereof.

Health Insurance Payers:

Challenges and Implications:

1. Almost everyone will need to have health insurance or pay a fine, per the stipulation of the Patient Protection and Affordable Care Act (PPACA) of 2010. Expands the federal-state Medicaid insurance program for the poor to cover people with incomes up to 133 percent of the federal poverty level, $29,327 a year for a family of four. Childless adults would be covered for the first time, starting in 2014. The federal government would pay 100 percent of the tab for covering newly eligible individuals through 2016.

2. Health Insurance Payers will experience the higher cost of insuring the currently un-insured population though a large percentage of that population is anticipated to be covered thru the state run American Health Benefit Exchanges for individuals and small group of upto 100 employees (thought groups over 100 can join these exchanges starting in 2017). As well, the additional cost of insuring children and youth up to 26 within their parents’ health plans, inability to exclude children or adults based on pre-existing conditions, lowered MLRs (medical loss ratio – the ratio of premiums paid in to what is paid out for medical care and wellness) et al. It is logically anticipated that they will respond by raising premiums on their health plans for employers who may pass on a part of that additional burden to their employees. It is also anticipated that providers may respond by crafting reimbursement models for “episodes of care” versus pay-for-procedures that will add complexity and demand business rules based automation and decision support.

3. As well, health insurance payers have to simplify and standardize their plans and transactions, enable standard electronic enrollment forms, and report on their plans, enrollment and MLRs, going forward.

Opportunities and Solutions enabled by Business and IT Innovation:

1. Given the current preponderance of paper based process for claims submission, rejection and adjudication, there are significant efficiencies and productivity gains to be had (to the tune of $ BNs), by automating these thru the use of IT.

2. The evolution of “pay-for-performance” and evidence based medicine models may also see a significant support for targeted treatment and “personalized medicine” (see my earlier blogpost – ‘Personalized Medicine: The Time is Now – Are we there yet?’) to drive superior therapeutic outcomes on a per patient basis while lowering the cost for the “episode of care”.

Life Sciences Companies – Pharma, Medical Devices and Bio-Tech manufacturers:

Challenges and Implications:

1. The move to a “pay-for-performance” model will further challenge Life Sciences companies especially pharma and diagnostic manufacturers to further accelerate the development of companion diagnostics and bio-markers for ‘Personalized Medicine’ to ensure superior therapeutic outcomes for patients vs. the approximately 60% efficacy for most of the drugs in the market place today. Pharma manufacturers are also anticipated to experience cost pressures that will demand a significant reduction in the $ 800 MM to $ 2 Bn spend in bringing a new molecule to market, including the huge spend in sales and marketing.

2. The potential imposition of additional sales taxes on medical devices will also impose cost and margin pressures on medical device manufacturers and will demand innovation at a lower cost of product development, sales and marketing.

3. The need to constrain overall costs of healthcare delivery thru pay-for-performance models may potentially constrain the number of defensive CAT and MRI scans currently being prescribed by physicians today, that can potentially impact business and pricing models of medical equipment manufacturers.

Opportunities and Solutions enabled by Business and IT Innovation:

1. Pharma manufacturers can be anticipated to leverage IT extensively for managing their clinical operations, as well as enable their pharmacovigilance, product and patient safety and exception reporting business processes. The use of more sophisticated drug discovery and development tools, data mining and search capabilities to uncover new indications of existing or previously unsuccessful molecules, or for the development of companion diagnostics and bio-markers can be anticipated. As well, leveraging IT for manufacturing, supply chain planning and execution for higher efficiencies, compliance as well as serialization, tracking and tracing and authentication from the plant to the patient bedside to assure higher patient safety and medication compliance is anticipated to scale significantly, going forward.

2. Medical devices manufacturers have significant opportunities to further improve the efficiencies of their supply chain, inventory management and manufacturing processes, thru lean and six-sigma for instance, enabled by sophisticated analytics and performance management tools. Proactively monitoring patients following the implant of their devices (like pacemakers, implantable defibrillators etc.) for exceptions and events before they happen (with often life impacting implications) to monetize additional and highly profitable service revenue streams is a distinct possibility, going forward.

Unprecedented opportunity for IT, Technology and Services Vendors:

All of the challenges, their business implications and their mapping business and IT opportunities, enumerated above (and many more) present significant opportunities for innovation, for IT and technology vendors, going forward.

It would perhaps not be inappropriate to postulate that Healthcare, especially in the US, is undergoing a “renaissance” and presents unprecedented opportunities for technology and IT innovation to enable each and every node in the Healthcare Value Chain. The measurable impact, if executed and realized, would improve transparency and quality of care delivery, while reducing redundancies, waste and cut costs – this is my ‘raison d’etre’ and my purpose in life that fuels my passion and my aspirations!

This author would like to express his gratitude to the Partners Healthcare Center for Personalized Genetic Medicine and the Harvard Medical School for their invitation to author this perspective on the 2009 Personalized Medicine Conference at the Harvard Medical School, Boston, MA, on the 18th and 19th of November, 2009.

 An abridged version of this blogpost has been published within Helix - the official newsletter of the Harvard Medical School – Partners Healthcare Center for Personalized Genetic Medicine in February, 2010.

The fall of 2009 presented an interesting milestone for Personalized Medicine given the focus on healthcare reform, not only in the USA but across the world at large. Perhaps never before have we seen such a sustained impetus on measurably improving quality of treatment for patients, and ensuring superior therapeutic outcomes, while driving down the total cost of treatment. Against this backdrop of often contentious and partisan debates, landmark reforms with potentially far reaching impact looming large and the unquestionable need to improve the quality of healthcare while lowering costs, the relevance and the reality of Personalized Medicine received close scrutiny, seminal discussion and multi-disciplinary focus at the 2009 Personalized Medicine Conference, held at the Harvard Medical School in Boston, on the 18th and 19th of November, 2009.

Dr. Raju Kucherlapati, the founder of the conference and the Paul Cabot professor of genetics at the Harvard Medical School set the tone for the conference with his opening remarks. Given that the sequencing of the human genome was completed in 2003, he pointed out that attendance at the P/M conference has increased from 237 attendees in 2002 to 601 in 2009, a 3X increase over 7 years, as a key lagging indicator of success. Given the need to deliver better healthcare for the entire population at a lower cost of healthcare delivery, P/M is a key enabler and is happening now – hence the theme of the 2010 conference.

Dr. Kucherlapati alluded to the support for P/M from key constituents like President Obama, the late Senator Ted Kennedy, Secretary Kathleen Sibellius and the Genetic Non-Discrimination Act currently in place, as a key enabler of P/M. According to him, there was significant regulatory pressure to ensure that patients that will respond to drugs and treatment be proactively identified, using tools like bio-markers or companion diagnostics, to ensure the highest efficacy of treatment delivered. These diagnostics are playing a significant role as well as the data re: the sequencing of the Human Genome. He suggested that the $ 1000 genome sequencing price point may actually be around the corner to render this affordable and accessible to almost everyone. Key questions and concerns he enumerated as basis for discussion included reimbursement models that would be critical to success for the early innovators, as well as sustained availability of risk capital, and a robust IT infrastructure to accelerate P/M innovation.

Setting the stage: What is Personalized Medicine (P/M)? Why is it significant for Patients today?

In his introduction of the now re-named Partners Center for Personalized Genetic Medicine (PCPGM), formerly the Harvard Medical School –Partners Healthcare Center for Genetics and Genomics, Dr. Scott T. Weiss, Interim Scientific Director, PCPGM and Professor of Medicine, Harvard Medical School, Brigham and Women’s Hospital defined P/M in the current context as, “Personalized medicine (P/M) is the application of genomic or molecular data to better target health care delivery.” [Click here for Dr. Weiss' presentation]

Dr. Gary Gottlieb, President, Brigham and Women’s Hospital, President and Chief Executive Officer-Designate, Partners HealthCare System in his opening remarks further qualified P/M as “a tool to move from a system of fragmentation of data and healthcare delivery to a fabric that runs across the country and delivers healthcare that is specific to the needs of patients i.e. a plan for each person that is individualized for him/her”. This implies delivering treatment to patients that is proactive, predictive, personalized and participatory unlike the status quo today.

 The core objective of P/M is to ensure the best, exact treatment possible for the patient specific to his or her needs, with minimal errors.

The Promise of P/M – The Real World Impact of Personalized Medicine in Enhancing Quality of Life in Patients

Aligned with the theme of this year’s P/M conference, the Panel Discussion that followed the keynote, articulated some of the most promising success stories delivering real value to patients today:

1. Xdx (Expression Diagnostics) developed a non-invasive diagnostic test for heart transplant patients for “acute cellular rejection,” with sufficient clinical data and validity to enable confidence in its adoption and assure “event free survival” and better quality of life. Having appropriate reimbursement for the companion diagnostic, with clear basic guidelines, would go a long way to assure its continued success.

2. El Camino Hospital in California, with self-employed physicians who are not part of an integrated or academic medical center, has seen early success with web-based clinical support for physicians, genetic counseling for patients, and fully imbedded IT that includes computerized physician order entry and electronic medical records.

3. GlaxoSmithKline developed a companion diagnostic product to predict patient’s risk vs. benefit with the underlying drug product for HIV treatment resulting in a 60% decrease in adverse reactions to the drug based on the results of the diagnostic.

4. CVS Caremark announced a relationship with Generation Health, a young genetics benefits management company, through which they will make a large number of genetic tests, that are appropriate for CVS’ tens of millions customers, available and accessible. They plan to launch their combined operation in the Spring of 2010.

5. Medco Health Solutions undertook a series of trials to assess the value of genetic/genomic tests that could ensure its patient customers receive effective treatments with minimal adverse effects. They reported that thousands of its clients have benefitted from such tests.

6. DNA Direct and Humana have partnered to develop a program that will help physicians understand how genetic counseling can help Humana’s patient customers experience better treatment outcomes at potentially lesser cost than they might otherwise experience.

7. bioMérieux announced an agreement with GlaxoSmithKline to develop a predictive test, based on emerging biomarkers, to help clinicians select the most appropriate treatment for different sectors of breast cancer patients.

The discussion identified uncertainty of third party reimbursement as the biggest barrier to adoption of P/M. As well, the investment in the diagnostic tests upfront vs. the total cost of treatment and clear demonstration of superior therapeutic outcome is still a barrier in most cases. There is a need for compelling return-on-investment (ROI) to be unequivocally demonstrated. El Camino Hospital and similar success stories are clearly precedent setting for further innovation and scale up with P/M.

Further reinforcing the promise of P/M in his keynote address while receiving the Personalized Medicine Coalition’s Fifth Annual Award for Leadership in P/M, Brooke Byers, Partner, Kleiner Perkins Caufield and Byers, and a leader in driving innovation in this arena, spoke about “visualizing Personalized Medicine” and its real-world impact on improving the quality of life and/or therapeutic outcomes for patients.

He articulated these three exemplars of success which were vividly etched in his mind:

1. A lady patient diagnosed with breast cancer using the results of a diagnostic test with her physician to make the determination of whether she should undergo chemotherapy or not, given the extremely low (less than 5%) efficacy of chemotherapy in the treatment of breast cancer.

2. A general practitioner with 1,000 patients using a diagnostic test to determine which 50 (5%) of those patients are likely to convert to type 2 diabetes, and then prescribing appropriate treatment and medication to prevent the onset of the disease.

3. Female patients using cost-effective, and relatively risk-free diagnostic tests to determine the onset or extent of coronary artery disease (CAD) vs. having to undergo risky and expensive angiograms to arrive at similar conclusions.

A visionary and a pioneer in fostering innovation in this arena, Brooke expressed hope and optimism that the early successes with P/M can be scaled up despite the barriers and the roadblocks, and urged collaborative efforts across all the key stakeholder communities to accelerate the current pace and momentum.

State of the Union – Where are we Today with P/M?  

The sessions analyzing and articulating the current state, reality and challenges of P/M presented three unique yet complementary points of view: a microeconomic snapshot, a policy and political viewpoint and the Innovator’s (the Pharma and Diagnostic industry) perspective as summarized below:

I. Microeconomic Perspective:

 According to McKinsey and Company:

• Adverse drug events for patients drive $45-135 billion in incremental costs each year in the US of which, approximately 25% is avoidable, through appropriate use of diagnostics and bio-markers.
• $292 billion was spent on drugs in 2008 of which approx. 50% was ineffective.

This raises the questions:

• Why aren’t pharmaceutical companies more aggressively pursuing companion diagnostics?
• Why aren’t payers actively driving the adoption of personalized medicine?
• Why has physician adoption of some clinically validated tests been slow (and required a large sales force)?

McKinsey and Company cited the results of its survey of almost 100 stakeholders across pharma manufacturers, payers, regulators, providers, diagnostics manufacturers, analysts and venture capitalists:

• Payers were generally skeptical and did not perceive personalized medicine as a priority at this time. They are challenged by the lack of information on cost efficacy as well as longitudinal accounting visibility and patient movement (patients only average 3-4 years on one payer plan).
• Providers showed variable interest since reimbursement is activity/procedure based and billing is not standardized and scalable at this time.
• Pharmaceutical manufacturers are seeing a steady increase in use of personalized medicine (companion diagnostics and bio-markers) with pockets of opportunity and variable investment levels. Cost savings in development are unlikely. Market share is the largest swing factor, as well as pricing upside potential.
• Diagnostics manufacturers are excited about molecular diagnostics, with significant investments in targeted areas and focusing on capturing elusive “full value”. They are constrained by the tradeoffs between the companion diagnostic model that captures a lower relative value at a lower risk vs. the ‘stand-alone’ model that while potentially assuring higher value capture, comes with significantly higher risks as well as high upfront investments, uncertain approval regimes and uncertain payer adoption.

 
II. Political and Policy Perspective:

Healthcare is a high stakes issue for President Obama given the unsustainable cost curve but the reform process is still highly contentious and partisan. Regulation has come a long way over the last three years and will move forward independent of the current healthcare reform.

III. Innovators’ Perspective:

Development of bio-markers and companion diagnostics is very expensive. Identification of the best targets and the best bio-marker before Phase 3 need to be addressed, as do complexities of clinical trial design. A path for simultaneous approval of drugs and diagnostics would be a significant step forward. Getting sufficient tissue samples from patients for the genetic testing is a significant constraint.

What are the most significant Challenges to large scale adoption of P/M? How can these challenges be addressed?

Given the current landscape for P/M, what are the most significant challenges and how can these be addressed to pave the way for patient and physician adoption, scale up and ubiquity i.e. a not-so-distant scenario where indeed, medicine becomes “Personalized Medicine”. 

A. Reimbursements and Payments

The discussion identified uncertainty of third party reimbursement as a serious barrier to adoption of personalized medicine. Similarly, the upfront investment in the diagnostic tests vs. the total cost of treatment and clear demonstration of superior therapeutic outcome is still a barrier in most cases. There is a need to see clear linkage between genetic testing and clinical outcomes as well as a search for clearly demonstrated and compelling return-on-investment to be unequivocally demonstrated. Can personalized medicine prove that it will lower the cost of healthcare or demonstrate comparable healthcare value? Can comparative effectiveness data show what is the most effective and the most economic treatment to assure the best therapeutic outcome for patients?

In a keynote address Dr. John Glaser, Vice President and Chief Information Officer, Partners HealthCare System, and Senior Advisor to the Office of the National Coordinator for Health Information Technology at HHS, noted the very low adoption rates of Electronic Medical Records and Electronic Health Records (EHRs) (only 13% for large hospitals and 3-5% of small physician’s offices). To address this, substantial stimulus funding has been earmarked for the National Healthcare Information Network and for Medicare and Medicaid incentives for meaningful usage of certified, interoperable EHRs by hospitals and physicians offices.

Dr. Glaser further emphasized that the “meaningful usage” of EHRs has the stated objective of better quality outcomes at a lower cost. A key enabler to scale adoption is workforce development – an estimated 50,000 HIT knowledge workers are needed to meet demand. Interoperability standards establishment and adoption by healthcare IT vendors and the providers is essential and should take place over the foreseeable future. [Click for Dr. Glaser's Presentation]

1. The national healthcare IT infrastructure is not yet ready to support the molecular diagnostics data existing today and that will certainly increase. Reducing the costs of the testing, sequencing, storing, archiving, accessing (by clinicians), analyzing and reporting the data, and the concomitant clinical decision support, requires a more sophisticated and robust IT infrastructure than is currently available.

2. There must be enhanced capability to capture clinical outcomes data and to develop usage of the clinical data in meaningful ways.

3. There is an imperative to strike a balance between security, privacy and access. Technological lock-ins into proprietary systems is a significant challenge.

4. Cataloging companion diagnostic tests (with necessary details and insights) and making this available online in an intuitive manner is key to mainstream adoption of personalized medicine by payers, providers, physicians and patients. Providing access to physicians and training them on this catalog will be critical to educating them.

C. Business Models and Implications

Are pharma and diagnostics companies aligned? Is a new regulatory framework needed? What business models have the best chance of effecting personalized medicine?

An innovative aspect of this year’s conference was an audience participation exercise, orchestrated by Richard Hamermesh, DBA, professor of management practice, Harvard Business School, and Mara Aspinall, president and CEO, On-Q-ity, Inc. Two Harvard Business School-style case studies, specially prepared for the conference, were presented.

One discussed the considerations for labeling and marketing the colorectal cancer drugs Erbitux and Vectibix based on testing patients’ tumors for their KRAS gene. The other dealt with the opportunities and challenges presented by the explosion of genetic testing. The audience responded with rich, highly interactive and engaging discussion with often diverse perspectives articulated.

Dr. Gerardo Jimenez-Sanchez, Director General, National Institute of Genomic Medicine (INMEGEN), Mexico, pointed out that currently most of the personalized medicine research and development is concentrated in the US, home to only 4.52% of the world’s population. This, he suggested, is not sustainable economically and politically. He articulated the need to create a more international market for personalized medicine, to address the complex and demanding issues in a global healthcare context. [Click for Dr. Jimenez-Sanchez's presentation]

Sir Michael Rawlins, Chairman, National Institute for Health and Clinical Excellence, UK, provided an overview on the state of personalized medicine innovation and adoption in the United Kingdom. The key objective was to secure and deliver the highest quality of healthcare UK can afford. Personalized medicine is an additional avenue for doing that.

Dr. Rawlins noted that the UK is challenged by expectations for significantly higher standards for genetic testing as well as higher levels of quality control which present significant but potentially avoidable economic costs. Another challenge he cited is that there are now 25 million individual health records in the UK, complete with their personal details. While health data embedded in electronic medical records should be accessible on demand, they also raise privacy and security concerns.

Given the current momentum and perspectives on accelerating P/M going forward, the concluding panel discussion focused on the beneficiaries of P/M for the foreseeable future.

What is the implication of this genetic roadblock for patients with stents taking Plavix? Genotype testing at around $ 600 per test per patient reveals this early on and qualifies patients at risk of stent thrombosis. This presents significant potential to draft a tailored treatment life-cycle (statins, stents, bypass surgery etc.) for each patient subject to his/her genetic profile and lowering risks of adverse events.

The huge levels of non-compliance especially in chronic disease management, provides a basis for leveraging genetic testing and diagnosis to change and modify patient behavior.Genetic testing and information thereof, is a way to drive compliance in patients, and potentially change patient behavior. At this time there is a huge societal and patient interest in genetic testing as predictor of certain conditions and diseases. 

Besides the patients and the providers, it is anticipated that some of the obvious beneficiaries of large scale adoption of P/M will be the V/Cs and investors, the diagnostics and pharma companies and the payers, as discussed earlier.

Key Takeaways from the 2010 Personalized Medicine Conference

In conclusion, Dr. Raju Kucherlapati provided these salient points to ponder for contemplation, and to drive the P/M momentum forward: Given the momentum around Healthcare reform, there was significant regulatory pressure to ensure that patients that will respond to drugs and treatment be proactively identified using tools like bio-markers or companion diagnostics, to ensure the highest efficacy of treatment delivered. The $ 1000 genome sequencing price point may actually be around the corner to render this affordable and accessible to almost everyone.

1. Significant early successes provide incontrovertible evidence of the promise of P/M in delivering targeted treatment for each patient based on his/her genetic profile, assuring the best possible therapeutic outcome but much remains to be done.

2. Current payment systems are fundamentally flawed – payments for volumes and not value. The current healthcare reform assuring coverage for every American would be a big step forward and a significant enabler of P/M.

3. Lack of standards and best practices in gathering and storing genetic information into Electronic Health Records (EHRs) is a serious impediment, as is the extremely low adoption of both EMRs and EHRs by hospitals and physicians offices. The incentives provided by the ARRA stimulus to drive “meaningful EHRs usage” is encouraging and a key enabler of providing the information infrastructure needed to drive and sustain P/M from a HIT perspective.

4. It was extremely encouraging that P/M has now transitioned across the borders of the US, as evidenced by success in Mexico and the United Kingdom (UK) – this is key to scaling targeted treatment for people across the world and drive down total costs of healthcare.

5. The Future of Personalized Medicine (P/M) is now and needs to be collaboratively driven by all stakeholders: academia, government, payers, producers, providers and physicians to scale and enable large scale adoption of P/M and deliver value to patients.

Wal-Mart, the largest retailer in history, is betting big on Healthcare and why not!

Given the escalating costs of healthcare in a recession impacted economy with well over 47 million Americans bereft of any kind of insurance coverage, the notion of low cost retail clinics at your friendly neighborhood retail store, is an idea whose timing is night! After all, can you and should you pay for a “Mercedes Benz” like treatment at your physician’s clinic that will cost an arm and a leg for a common cold or strep throat, when a walk-in clinic at your nearest mega-retail store can offer “Toyota quality” treatment from a qualified and experienced nurse practitioner for perhaps as little as $30-60 per patient?

Wal-Mart’s Retail Healthcare Strategy

Wal-Mart currently has over 40 clinics operating in its stores and plans to partner with healthcare providers and healthcare entrepreneurs to open 600+ clinics in the next couple of years, with a potential for more than 2,000 clinics in its stores in the foreseeable future [Ref 1].

What is this significant for mainstream Americans? Given the ever escalating costs of healthcare, this is a move towards delivering right quality, right priced healthcare with price transparency accessible to millions who otherwise cannot afford treatment today, but have a reasonable expectation for “value for their healthcare dollars” similar to their spend in other areas.

The retail clinics are anticipated to be operated by third party physicians and nurse practitioners with practice management (patient registration, billing, e-prescribing) and electronic medical records (EMR) software provided by eClinical Works, a healthcare IT company located in Westborough, MA [Ref 2].

The promise in addition, to the quality of treatment delivered is the use of electronic health records (EHRs) to ensure transparency, accuracy and portability to assure a better customer experience. This would be well aligned with the Obama administration’s mandate and initiatives to drive electronic health record adoption across the country, to drive higher transparency, accuracy and quality at a lower total cost of treatment. Also implicit is the promise that medications if prescribed will be instantly transmitted to the in-store pharmacy for pickup before the patient leaves the store – “one stop shop” now acquires new meaning for many of us!

Driving Healthcare IT (HIT) adoption – Electronic Medical Records (EMRs) and Physician Practice Management

Wal-Mart’s move in healthcare does not stop at merely installing walk-in clinics at its retail stores. Given the Healthcare IT stimulus provided by the current administration that offers physicians over $ 40,000 per year in subsidies to install and embrace “meaningful usage of EHRs” to enable “evidence based medicine” i.e. treatment that can be meaningfully monitored, measured and analyzed to ensure superior patient outcomes, and also compared against peers to potentially enable “pay-for-performance” models currently unknown in healthcare, this presents a significant market opportunity for Wal-Mart.

Given the miniscule 17% or so penetration of EHRs at small physician offices unlike large hospitals (according to a recent government sponsored survey in the New England Journal of Medicine), the incentives outlined above, as well as the penalties for lack of “meaningful adoption” of EHRs, it can be reasonably anticipated that the next 5 years will see significant adoption of these technologies to move us into the 21st century. After all, isn’t it a travesty that in today’s technology enabled era, our medical records continue to languish in paper format within manila folders in doctors offices?!

Figure. Andy De’s Analysis of Wal-Mart’s Retail Healthcare (Business-to-Consumer (B2C)) and Healthcare IT for Small Physicians Practices (Business-to-Business (B2B)) Strategy

Wal-Mart’s strategy (please see the service-market opportunity matrix above) for creating and penetrating this market is the stuff that business case studies from Harvard Business School articulate, to train their next cohort of consultants and managers (there is a current HBS case study on eClinical Works referred below)! Given that Wal-Mart’s Sam’s Club subsidiary has over 200,000 healthcare providers and physicians, it will offer the e-Clinical Works EMR and/or practice management software offering loaded ion Dell’s servers, for approximately around $ 25,000 for the first physicians’ practice and about $ 10,000 for each additional doctor within the same practice [Ref 1]. Following the installation and training, estimated annual maintenance and support costs are anticipated to be in the $ 4,000 -6,500 on an annual basis. Dell will provide the installation of the hardware with eClinical Works delivering the software installation, training and maintenance. As well, physicians can anticipate a hosted option – currently offered by eClinical Works, priced at around $400/month for EMR+ Practice Management or $ 250/month for EMR alone [Ref 3].

Can Wal-Mart’s Personal Health Record (PHR) be far behind?

Given this ambitious strategy to address the needs of both physicians and patients, Wal-Mart also has a significant opportunity to drive adoption of Personal Health Records (PHRs) with a competitive offering similar to those offered by Microsoft Health Vault and Google Health.

Wal-Mart is part of a consortium called Dossia – formed by a group of companies including AT&T, Pitney Bowes, Applied Materials, BP, Cardinal Health, Sanofi-Aventis. Dossia’s goal is providing employees, their dependents, retirees and others in their communities with an independent, lifelong health record, one that is personally-controlled, private, portable and secure [Ref 4].

Dossia’s Founders are funding Dossia and its platform called Indivo, an independent secure, non-profit infrastructure for gathering and securely storing information for lifelong health records. At the request of employees and other eligible individuals, Dossia gathers health data from multiple sources. Employee participation as a Dossia user is completely voluntary and individuals have complete control over who sees their information.

Dossia’s PHR platform called Indivo, provides a secure data infrastructure that aggregates and stores health information for individuals to create a lifelong personal health record with medical information from multiple sources. Once gathered and securely stored in a decentralized database, the health information is continually updated and is available to individuals for life even if they change employers, insurers, or doctors.

Although access to Dossia’s PHR platform and database has been initially limited to the employees of founding companies including Wal-Mart, it is perhaps not inconceivable that this could be scaled to meet the needs of consumers of these companies as well in the foreseeable future. It is also not inconceivable that Wal-Mart could potentially offer this free to patients (consumers) of its in-store Health clinics as a loyalty building mechanism (similar to frequent flyer advantages offered by airlines) to build “stickiness” for both the clinics and its pharmacies. For instance, having your personal health records as well as all of your current medications on a secure server that only you can access anywhere, anytime, to retrieve your medication information for the pharmacy, or provide your physician in the event of an accident while on vacation, is compelling especially for the elderly or the technologically challenged, and could offer “barriers to switching” for Wal-Mart, going forward.

As well, bundling Dossia’s PHR platform and services along with the eClinical Works physician practice management and EMR offering (after rending eClinical Works interoperable with Dossia) would also make this even more compelling for physicians who can now not only digitize their medical records, but also potentially offer interested patients a digital and secure copy of their personal health records (PHRs) gratis, or as a fee based service. While this is perhaps easier said and done, given the lack of universally accepted Healthcare Interoperability standards, this could be a significant step in the right direction, especially given the incentives for adoption provided by the ARRA (American Recovery and Reinvestment Act of 2009) stimulus from the Obama administration, referred to above.

While this is currently strategic prognosis on the part of this author at this time, monitoring Wal-Mart’s moves in PHRs will be interesting indeed, going forward.

Hey Doc, Wal-Mart is your IT Provider and you better believe it!

While the notion of purchasing your IT software, hardware and services from your retailer may pose questions for many physicians, Wal-Mart has adroitly mitigated this risk thru its partnerships with a well known brand like Dell and a well known small practice software offering from eClinical Works (currently used by over 25,000 physicians) [Ref 1,2]. Proof of this concept will be provided to prospective physicians thru the usage of this software and hardware within the retail clinics currently in place within the Wal-Mart retail stores.

Given the high cost of sales and marketing involved with selling healthcare IT to small physicians offices, the adoption, scalability and success of Wal-Mart’s “aggregator model” could potentially be a game changer in Healthcare IT. At the same time, the provision of quality, transparent healthcare at a low cost within its walk-in clinics, if successfully embraced, may well be the panacea for millions of Americans without insurance – the next 3-5 of years will be interesting indeed, as we monitor and perceive the progress of Wal-Mart’s Healthcare strategy and execution.

REFERENCES:

1. Wal-Mart plans to market Digital Health Records System, Steve Lohr, The New York Times, March 11, 2009.

 2. eClincal Works: The Paths to Growth, Harvard Business School case study # 9-807-025 by Robert F. Higgins and Mark Rennella, February, 2007, Harvard Business School Publishing, Boston, MA.

 3. www.eclinicalworks.com, eClinical Works company website.
4. www.dossia.org, Official Dossia web-site

Milestone: This blogpost and the author were referenced by the Partners Healthcare Center for Personalized Genetic Medicine in 2008 , the Center for Personalized Healthcare at the Ohio State University and quoted by the 2009 Personalized Medicine Conference at the Harvard Medical School.

Personalized medicine in recent times, has attracted significant hype as well as pessimism from a number of quarters including the Pharma industry that has often perceived this as “avant garde” and a grandiose vision that is way out there and not yet ready for useful value delivery to real-world patients and consumers.

So it was with a mixture of curiosity laced with healthy doses of pessimism that I attended the Personalized Medicine: A Call to Action Conference, November 29th and 30th, 2007, at the Harvard Medical School. The Conference was orchestrated by Dr. Raju Kucherlapati, Scientific Director of the Harvard-Partners Center of Genetics and Genomics and Paul C. Cabot Professor of Genetics at the Harvard Medical School, a pioneer and thought leader in the Personalized Medicine arena, in close collaboration with the Personalized Medicine Coalition (PMC) led by Dr. Edward Abrahams.

I must say I was pleasantly surprised by the august assemblage of stake holders from academia, large and incipient producers (pharma, bio-tech, diagnostics, medical devices), healthcare providers (physicians and hospitals), payers, as well as regulators. Michael Leavitt, secretary of Health and Human Services (HHS) delivered the opening, inspiring keynote address clearly signaling that Personalized Medicine (P/M) is a significant agenda issue and one whose time has come(1).

 Equally encouraging was the keynote presentation by Kathleen Behrens, member of the President’s Council of Advisors on Science and Technology (PCAST) highlighting the progress made by this body on studying the relevant facets of Personalized Medicine, to craft their recommendations for the president in their report that is due in 2008. Their comprehensive recommendations will highlight pragmatic yet far reaching policy changes that will need to be implemented to overhaul the ailing US Healthcare system and bring P/M to fruition.

What is Personalized Medicine? Why is this significant for Patients and Healthcare?

“Personalized Medicine means knowing what works, knowing why it works, knowing who it works for and applying the knowledge for patients”, is perhaps the most succinct articulation of P/M from the honorable Mr. Michael Leavitt, secretary of Health and Human Services (HHS). This implies delivering treatment to patients that is proactive, predictive, personalized and participatory unlike the status quo today.

By way of the “trial and error” medicine (also sometimes referred to as “intuitive medicine”) practiced across the world today, the doctor makes a “most likely” diagnosis consistent with symptoms and them prescribes what he/she considers appropriate treatment comprising drugs, devices or surgery. If the treatment does not work and presents significant side effects or adverse events, the doctor most likely would alter dosage or prescribe an alternative medicine. This iterative cycle is repeated, until the diagnosis and treatment that actually presents the desired clinical outcome in the patient is reached. The paradigm has reached a point of diminishing returns as evidenced by the fact that most drugs prescribed in the U.S. today are effective in fewer than 60% of treated patients(2)!

Personalized Medicine, au contraire, uses far more sophisticated and refined diagnostic testing to arrive at the precise diagnosis aligned with the person’s genetic makeup at the molucular level, and hence is also often referred to as “evidence-based medicine” or “precise medicine”. P/M would first map a person’s genomic profile and then ensure mapping of this profile to the treatment to maximize efficacy and the best therapeutic outcome (often with life and death implications), while minimizing adverse events (please see the framework below). The closest real-world analogy to P/M is the recruitment process that matches a person’s job to his/her education, experience and skill sets as laid out in his/her profile (resume) to ensure the best fit for the job, or the “nirvana notion” of targeted marketing to “markets of one”. P/M is in essence, delivering “mass customization” to people in a healthcare context at an affordable cost.

Let’s consider what is perhaps the best known example of how P/M can actually save lives in the real world.

Herceptin, a monoclonal antibody delivered by Genentech (often recognized as the pioneer of the bio-tech industry), has been found to be particularly efficacious as a first line treatment with chemotherapy, in treating aggressive forms of breast cancer in women whose tumors have an overabundance of HER 2, a protein that promotes cell growth. Herceptin has been found to reduce the likelihood of cancer spreading to other parts of the body in these patients by a remarkable 53% compared with traditional chemo therapy alone, according to a 2005 study. This is also compelling from a cost-benefit perspective. The tests to detect whether a breast cancer patient has an overabundance of HER 2 protein (and thereby a candidate for Herceptin) costs a mere $ 400 and potentially saves thousands of dollars by preventing the cancer in HER2 patients from spreading to other parts of the body and by not treating HER 2 negative patients with a drug that won’t help them (2). 
 

 A very similar business case (4) also presents itself for patients with high cholesterol who are prescribed high statins for treatment – these tend to be ineffective or not completely ineffective in a significant number of these patients!
  

What are the Key Barriers to realizing Personalized Medicine (P/M)?  
The conference (1) identified six challenges that need to be collaboratively addressed to bring P/M mainstream:

1. Reimbursement – Who will pay for the incremental cost of delivering P/M? This is perhaps the most significant barrier given the already high cost of delivering healthcare today,that is growing at 10-13% annually and consumes almost a fifth of the US GDP today. According to Michael Leavitt, payment systems today are “fundamentally flawed and reward providers and physicians for volumes and not value delivered”. As well, health Insurance needs to be dramatically improved to assure affordable health insurance for every American. Besides, why should payers pay for P/M without clear, compelling and unequivocal demonstration and evidence of superior therapeutic outcomes in patients that can be delivered cost effectively?

2. Business Models – What are the new business models that companies need to enable to render P/M a reality? The Pharma industry is largely driven by the Blockbuster model (please see my earlier blogpost “Branded Pharma – Who moved my Blockbuster Cheese?!”) that is being severely constrained today, with a huge fall in innovation productivity for most Pharma companies – a mere 22 NMEs (new molecular entities) have been approved by the FDA in 2007 against 80+ NMEs in 2000. Given this constrained innovation pipeline, what will viable business models that will ensure delivery of “targeted therapeutics” to very small patient populations for superior outcomes, while assuring profitability for Pharma/Devices/Diagnostics companies look like?

3. Connectivity and lack of Business Process Integration – Given the archaic paper based processes, what is the IT infrastructure needed to integrate the Healthcare Value Chain into a coherent system that will enable P/M? Speaker after speaker at the conference pointed out the travesty of calling Healthcare a “system” given the lack of basic connectivity within the Hospitals and across the Healthcare value chain that presents really daunting challenges. These include facilitating collaboration among researchers, clinicians and the Healthcare Value Chain at large, accessing, processing and integrating clinical, genetic and genomic data from multiple, often heterogenous and disconnected sources, and having the robust IT platforms (software and hardware) built on common industry standards to do so.

4. Regulations – How soon can a new innovation be delivered while assuring safety, quality and efficacy? Current regulations and the three tier approval process significantly drive up the cost of delivering drugs to market ($ 800 MM – $ 2 Bn per molecule) with times-to-market of 7-10 years which does not lend itself to driving the agility that is imperative for P/M to become main stream. A radical redesign of the drug approval process is imperative for P/M to come to fruition.

5. Trust, Transparency and Confidence – What will it take for patients to see the clear and compelling value of P/M to enable large scale adoption? Patients today are extremely skeptical of the Healthcare and Life Sciences industries’ capabilities of delivering treatment at an affordable cost. Given the need to compile genomic profiles for each patient (priced at around $ 350,000 per profile today) at a reasonable cost while ensuring privacy, security and (laws to guarantee) non-discrimination further exacerbates these concerns.

6. Physician Behavior – How can the current mindset and practices of physicians rooted in “Trial and Error” medicine be changed across North-America and the Globe? Educating the thousands of physicians in North-America and across the globe (trained in the current paradigm) presents a daunting challenge with enormous cost and change management implications.

How can these Challenges to Personalized Medicine (P/M) be overcome in the foreseeable future?

While the conference attempted to address each of the six issues identified above, potential solutions in three areas (reimbursement, business models, IT infrastructure) were deemed the most important, tactically addressable and are summarized below:

1. Reimbursement – Who will pay for Personalized Medicine (P/M)? The Payer Perspective

A number of large insurance companies as well as government officials articulated the need to support and enable P/M for the foreseeable future, which was extremely encouraging.Partners Healthcare initiative on P/M to unequivocally demonstrate this value i.e. superior therapeutic outcomes at a lower total cost while minimizing possible adverse events.

Cost containment (“potential savings from higher efficiencies”) is a high priority hot button issue for Congress (given that the government is the largest payer), especially in the light of the highest cost of healthcare in the world in the US. This is becoming a critical, “Big Picture” issue for the budget, finance and health committees in Congress, especially since rising Healthcare costs is compromising spend in other critical areas.

Comparing effectiveness of various treatment programs, services and products (including “Value-based Insurance Design”) is already being contemplated in Congress, as a first step to enabling metrics driven quality and performance improvements in Healthcare. Also significant is the awareness on enabling “holistic longitudinal accounting” i.e. increase spend upstream on accurate diagnosis to drive down costs downstream (treatment).

For insurance companies, having clear and compelling clinical evidence of superior therapeutic outcomes from P/M with accompanying data on driving down the “total costs of treatment” is imperative to demonstrate the value of P/M and drive a business case for funding, going forward. They still have a long way to go and are looking at harbingers of P/M like the Harvard Medical School –

Given the fatal flaw in the current system that pays for volume rather than value, the ability to measure (transparency) quality of delivered healthcare, comparable pricing for similar buckets of care and properly aligned incentives across multiple stakeholders, to deliver higher quality at lower costs are significant issues that need to be addressed for this to happen according to Michael Leavitt, the secretary of HHS. Policy amendments to effect these fundamental changes to healthcare reimbursement is currently being contemplated.

It was also startling to hear that 5% of all American patients (usually indigent and multi-morbid patients who use the emergency rooms as their mode of treatment in the absence of health insurance coverage) consume 95% of all healthcare costs! While bringing the 50 MM Americans currently without any health insurance into the healthcare system was a high priority for the government, it was also suggested that the most fungible way to design benefits enabling patients to choose the level of payments by “owning their own healthcare” and eliminating unnecessary and excessive spending while empowering them to make the best choices for themselves.

2. Who will deliver Personalized Medicine (P/M) and what will that business model look like? How do Regulations need to change to make this happen? The Producer (Branded Pharma, Bio-Tech, Diagnostics) Perspective

Advances in science and technology presents real potential in rendering P/M ubiquitous in the foreseeable future. The sequencing of the human genome has helped scientists link an ever increasing number of diseases to specific genes. As well, scientists have been making great strides in mapping the molecular pathways by which a change or mutation in a gene actually manifests itself in a disease. These innovations have enabled Pharma and Diagnostic/Bio-Tech companies to develop effective diagnostic tools like biomarkers that can distinguish the subtypes of what had been considered a single disease, as well as chemical agents that target each of these subtypes. This culminates in the ability to manage many fatal cancers as chronic conditions by attacking them early, resulting in more lives saved (2).

Critical to delivering P/M is a significant departure from the current Blockbuster Drug model by Pharma and life sciences companies. The economics of delivering a large number of molecules targeted at smaller patient populations will demand a radical transformation from the current model predicated on the discovery, development and commercialization of a very small number of molecules targeted at large patient segments. Given the dramatically declining productivity of current product pipelines (see figure below) in the large Pharma majors as well the potential loss of $ 160 Bn in revenues from expiry of current patents by 2015 (I have highlighted earlier in my blog posts “The 3 Questions that keep Big Pharma CEOs awake at night” and “Branded Pharma – Who moved my Blockbuster Cheese?!”) and the demand by patients and providers for better clinical outcomes at a more affordable cost, Pharma companies may have little choice save embracing the radical transformation demanded.

Presentations from Eli Lilly, Astra-Zeneca, Siemens Medical Systems (SMS) and Celera Genomics encouraging in that these companies are proactively moving forward to enable P/M and believe they can sustain and reinforce their competitive advantage by doing so.

• Tom Miller, Group VP of Siemens Medical Systems (SMS) emphatically declared that SMS was “betting the farm on P/M” and has invested over 10 Bn Euros in acquiring companies and capabilities for “accurately characterizing diseases” in advance. He also cited the lack of an educated patient population that is prepared to “buy the vision” as well as the absence of “holistic longitudinal accounting” (invest more upstream in accurately characterizing disease to save treatment costs downstream) as perhaps the single largest barrier to success. As well, given the promise and advances in molecular diagnostics, and newer technologies like Pharmacogenomics, Toxicogenomics, Biomarkers, Imaging and Bioinformatics, the time is ripe for pharma and diagnostic companies to collaborate and move P/M forward.
• Given that almost 50% of all patients fail to respond to a certain therapy or treatment, segmentation of patient populations in clinical trials with development of appropriate diagnostic tools (“biomarkers”) to identify the most suitable target population as well as those at risk of significant adverse events. “Tailored Therapeutics” leveraging Pharmacogenomics and Biomarkers, is Eli Lilly’s answer to P/M to deliver drugs targeted for specific patient populations, with optimum dosage, at the appropriate time for intervention, with information tools to accommodate patient diversity as well as as questions specific to buyers, payers, physicians and providers. Pharma companies like Pfizer and Lilly are increasingly seeking approval for companion diagnostics (e.g. biomarkers usually based on DNA testing) to filter out patients that are likely to have adverse reactions to new drugs – a need currently fulfilled by bio-tech companies that provide DNA testing and analysis on the data as services. Adequately validated biomarkers (including their use in clinical trials) are a prerequisite for P/M to be realized viably, along with reimbursements to incent innovation and acceleration.
• Eli Lilly also presented compelling quantitative data demonstrating a business case for developing targeted therapeutics. The Return-on-Investment (ROI) from the lower total cost of treatment resulting from the superior efficacy and clinical outcomes in a smaller targeted segment, appropriately pre-qualified using companion diagnostics (enabling higher revenues from higher consumption and faster uptake), as well as the significantly reduced cost of adverse events and liabilities was higher than that of targeting large patient populations, with 50 – 60% efficacy of treatment, with the additional liability imposed by adverse events.
• From a regulations perspective, these Pharma and Bio-Tech producers expressed the imperative for granting additional periods of exclusivity for innovations targeted at smaller targeted populations, similar to the 7 year exclusivity for Orphan Drugs and pediatric drugs. Without these additional periods of exclusivity, the current economics of drug development simply does not lend itself to rendering targeted therapeutics viable – they would go out of business. As well, the imperative for shorter development cycles and costs demanding a fundamental re-thinking of FDA regulations is warranted.

3. How will Personalized Medicine be enabled from a Technology/ IT perspective?

It is astounding that in the 21st century, archaic, paper based medical records, the resulting inaccuracies and inability to access this information in life and death situations results in over 80,000 deaths annually in the US alone.“Demand-Side EHRs: Who will make it Win-Win for patients to adopt?”)

According to Michael Leavitt, connectedness and uniformity of standards in US healthcare sector does not exist today, hence does not quality this as a “system”. Lack of standards and best practices in gathering and storing genetic/genomic information into Electronic Health Records (EHRs) are not in place and are a prerequisite for wide spread adoption.
The adoption rates of (18-23%) for EHRs by physicians and an even far smaller (2- 4%) rate of Personal Health Records (PHR) adoption is a huge challenge as well as an impediment to P/M that needs to be addressed with urgency (please see my previous blogpost and analysis on EHR adoption,

Here are some of the IT solutions that were proposed, to enable the level of intra and inter enterprise connectivity across the Healthcare Value Chain, demanded by P/M:

• Pharma and bio-tech companies are “swimming in data” (per Dr. Nadine Cohen from Johnson and Johnson) – what is missing today are effective tools to analyze the data and deliver meaningful analysis that will help them commercialize drugs faster. Use of drug disease modeling and scenario simulation is an idea whose time has come, to drive decision making re: new as well as mature drugs. As well, lack of collaboration across functions and trading partners and little to no visibility into downstream demand and patient insights is costing the Life Sciences industry especially Big Pharma, billions of dollars in value leakage by way of excess inventory, stock outs with life and death implications. Also exacerbating this is little to late visibility into adverse events and complaints resulting in huge penalties that can be significantly alleviated with tools for analysis of post-marketing data to understand and proactively impact patients who show adverse reactions to new drugs.
• Empowering customers with the information and decision support they need, to result in the best possible outcomes at the lowest cost, is the key. Using Microsoft Health Vault and similar personal health record (PHR) platforms are possibly the first step to enabling Personal Health Networks (PHNs) of patients with similar therapeutic issues – the wave of the future. This is fraught with significant challenges I have highlighted in my previous blogpost, “My PHR in Microsoft’s Health Vault: Confessions of an Early Adopter”. Evolution of the PHR from a passive data base of records to a decision support tool that will proactively help patients make the right clinical choices, lower information search costs and enable better collaboration with their physicians and care givers is a compelling vision for the future that I have persevered to elucidate in my previous blogpost, “Demand-Side EHRs: Who will make it Win-Win for Patients to adopt?”
• The use of a robust computational platform as well as sophisticated predictive analytics similar to what other industries have already accomplished, is now long overdue in Healthcare to drive P/M. Bio-cities in Asia and the Middle East are developing comprising research, clinical and healthcare delivery within the context of one village or community that can deliver targeted treatment to patients.
• Enabling standards based interoperability, integration and exchange of data from EHRs (supply-side) and PHRs (demand-side), rules based decision support, as well as presenting them in a role-based context (what the physician demands vs. the patient needs) is a daunting challenge today. For instance, wouldn’t it be incredible if we could aggregate clinical and genomic data in the EHR, analyze this retroactively, to run in-silico clinical trials that will show physicians potential adverse events that may happen?
• Partners Healthcare in collaboration with Harvard Medical School has developed one of the first laboratories for P/M in this country within the healthcare system, harnessing genetics and genomics based data in the EHRs to drive decision support for real world patients. Some of the technical accomplishments at this initiative (3) are:
• Structuring and digitizing genetic and genomic information and incorporation within EHRs
  * Creating applications to support genetic discovery and research
  * Identifying computational, storage and software requirements and building the right IT infrastructure supports the P/M vision at Partners Healthcare to: Improve the quality and efficiency of research and clinical operations to positively impact and lower costs of delivering quality healthcare
  - Integrate genetic test results into EMRs and EHRs
  - Ensure the data integrity of the P/M business processes and workflows

This is a significant milestone and a harbinger to realizing P/M. The Harvard Medical School -Partners Healthcare Center for Genetics and Genomics is also driving significant thought leadership by documenting and providing the IT requirements, architecture and applications for enabling P/M, to the department of Health and Human Services (HHS). This is a significant accomplishment that can potentially help establish the standards and best practices needed to proliferate P/M across the US using a networked model.Dr. Clayton Christensen, Robert and Jane Cizik Professor of Business Administration at the Harvard Business School (HBS) and author of the seminal and immensely successful works on business strategy- The Innovators Dilemma, The Innovator’s Solution and the just released Seeing What’s Next.

Can Personalized Medicine (P/M) potentially disrupt the current US Healthcare Model?
 
Perhaps the most provocative perspective on P/M was presented by

According to Dr. Christensen, the ability of innovators to provide new products almost always outstrips the ability of most customers to adopt and utilize these innovations. Some of these are incremental while others are “disruptive” and have significant cannibalization impact on the incumbent technologies, with entrants nearly always winning! Disruption is facilitated when historically valuable and expensive expertise becomes commoditized thru scientific and technological advancements. Disruptive technologies deliver simpler, affordable, easer-to-use solutions at a lower cost of adoption for the customer. Combining disruptive technology with an appropriate business model is the recipe for assuring success

Applying his model of disruptive innovation to P/M in a healthcare context, Dr. Christensen prognosized the following:

• Molecular diagnostics and Interventional Radiology may be the “disruptive technological enablers” (“Precision Medicine” vs. “Intuitive Medicine”) of Healthcare that can potentially deliver simpler, most cost effective solutions with higher efficacy and safety for complicated diseases for patients.
• Therapeutics is where the money is made today but Diagnostics (coupled with Therapeutics) is potentially where money will be made in the Healthcare Value Chain, going forward. The analogy he provided was the shift in power in the PC industry from IBM to Microsoft and INTEL.

He however conceded that disruptive change in a Healthcare context is far more difficult given the power of the Payers and Regulators (unlike any other industry) to inhibit and constrain innovation. However, his presentation delivered some fascinating insights for the audience to ponder upon.

Key Takeaways from the Personalized Medicine Conference

 The Personalized Medicine: A Call to Action Conference was a seminal event that presented a realistic perspective and overview on the promise, the challenges, as well as the pioneering work being done to usher in the era of P/M, thanks to the thought leadership of Dr. Raju Kucherlapati, Scientific Director of the Harvard-Partners Center of Genetics and Genomics and Paul C. Cabot Professor of Genetics at the Harvard Medical School and his team and the Personalized Medicine Coalition (PMC).

Here is a concise summary of the key takeaways from this conference discussed in detail above:

• “The Future of Personalized Medicine (P/M) is now” and needs to be collaboratively driven by all stakeholders: academia, government, payers, producers, providers and physicians to bring P/M to fruition and deliver value to patients.
• Personalized Medicine is a significant line item in the current US government’s Healthcare agenda with a report and pragmatic recommendations for rendering P/M a reality to be presented to the President by his Council of Advisors on Science and Technology (PCAST).
• Current payment systems are fundamentally flawed – payments for volumes and not value. Insurance needs to be dramatically improved to assure affordable health insurance for every American. Holistic longitudinal accounting is a paradigm shift that is needed to enable appropriate reimbursement for P/M.
• Fundamental rethinking of the regulatory regime to assure safety and efficacy is needed to drive the agility needed. As well, additional periods of exclusivity may be imperative for targeted therapeutics to be rendered viable.
• Science and technology are both constraints for Pharma, Bio-Tech and Diagnostic companies to truly enable P/M as are the current economics of drug discovery and development. However, P/M is the way forward given the 50% efficacy of most treatments and therapies as well as the high incidence and cost of adverse events.
• Connectedness and uniformity of standards in US healthcare sector does not exist today, hence does not quality this as a “system”. As well, this imposes huge inefficiencies and costs that are not sustainable, going forward. Transition to an electronic medical record (EMR)/electronic health record (EHR) system is imperative and will be driven by regulations.
• Lack of standards and best practices in gathering and storing genetic information into Electronic Health Records (EHRs) is a serious impediment, as is the abysmally low adoption of both EHRs and Personal Health Records (PHRs) by hospitals and patients respectively. The EHR is the cornerstone for connectivity to drive a 360 degree view of the patient as a first step to delivering value based treatment and superior therapeutic outcomes at the lowest cost.
• Trust, transparency, confidence, protection of the patient’s privacy and non-discrimination laws need to be in place for Personalized Medicine to become a reality. Consumer activism will happen once patients see value delivered from Personalized Medicine.
• Partners Healthcare in collaboration with Harvard University has developed one of the first laboratories for P/M in this country, within its healthcare system, harnessing genetics and genomics based data in the EHRs to drive decision support for real world patients. The ability of this initiative to clearly demonstrate benefits in the form of superior therapeutic outcomes and minimal adverse events at a lower total cost of treatment will be key to drive a business case for large scale adoption of P/M.
• P/M with its associated advancements and technologies can potentially disrupt the current Healthcare model in the US and lead to new classes of service providers delivery quality healthcare to the masses at lower costs.

Personalized Medicine (P/M) despite daunting challenges, presents enormous promise in terms of not only enhancing the quality of healthcare for patients i.e. each and every one of us, but also lowering the total-cost-of-healthcare.

Pioneering efforts like the Harvard Medical Partners Healthcare P/M initiative currently underway, the current portfolio of products already developed or under development, as well as the clear yet pragmatic commitments to P/M from all stakeholders involved i.e. academia, the government, the payers, the producers, the providers and the physicians was truly encouraging and inspires me to believe that P/M is no longer a myth, nor a pipedream and while not imminent reality, definitely a realizable promise that will positively and significantly impact the quality of our lives, in the foreseeable future.

 As always, your comments and feedback are welcome.

REFERENCES:
1. Presentations and panel discussions at the Personalized Medicine: A Call to Action Conference, Harvard Medical School, November 29th and 30th, 2007

2. Realizing the Promise of Personalized Medicine, Mara G. Aspinall and Richard G. Hammermesh, Harvard Business Review (HBR), pp 109-117, October 2007

3. Collaborating to Create Personalized Medicine, Business Case Study on the Harvard Medical School-Partners Healthcare Center of Genetics and Genomics (HPCGG), Hewlett Packard Company, 2007

4. The Case for Personalized Medicine, Personalized Medicine Coalition (PMC), November 2006.

Milestone: This blogpost was referenced and the author quoted by the Washington Post in an article entitled, ‘New Ways to Manage Health Data’, March 2008.

It is a well known and incredibly shocking fact that inability to access vital, accurate and current health information especially in an emergency (usually an unforeseen event like a cardiac attack, stroke, seizure etc.) on time, leads to the loss of well over 80,000 lives in the United States alone! I actually experienced this pain while helping my 72 year old father with his triple bypass surgery in India, in May of this year.My father had a minor cardiac event while visiting us in the US a few years ago and was treated in a local Dallas hospital of repute and then discharged without any major intervention. He unfortunately forgot to secure copies of his health records before leaving this country. Having had a minor heart attack and being diagnosed with three clogged arteries that demanded a tripe bypass surgery, I needed to secure these records from his previous event for the cardiac surgeons in India.

Calling up the hospital in Dallas, sending them a written request from the doctor, having them dig up the relevant files and handing those off to my wife who then faxed them across to me in India, took all of 72 hours – and resulted in my father’s surgery being delayed by that length of time! Given his extremely precarious condition, this could have been potentially life threatening and could have been alleviated if I could have secured access to his health records on demand. Fortunately for us, my father’s surgery was very successful followed by a speedy recovery but the potentially devastating impact of not having right time access to his vital health information was an eye opening experience for me. I promised myself that this would never happen again as far as my health records and those of my family were concerned.

So given the release of Microsoft’s Health Vault Personal Health Record (PHR) Platform this year and my firm resolution to ensure right time access to our health records on demand, I enrolled myself and secured my personal Health Vault account.

In my previous blogpost (please see “The Personal Health Record (PHR): Who will make this “Win-Win” for Patients to adopt?”), I have articulated the potential barriers to adoption and also painted a comprehensive forward looking vision on the evolution of the Personal Health Record (PHR) over time. This blog post articulates my personal experience with creating my Personal Health Record (PHR) using Microsoft’s Health Vault Platform, including the challenges, for other early adopters like myself.
 

Creating my Personal Health Record (PHR) with Microsoft’s Health Vault Platform – The Process, Experience and Challenges

Once you have signed up to the Microsoft Health Vault using your e-mail and have created your profile, the key is to create your data repository with your current and accurate health records, that you will need to painstakingly collect from your doctor’s offices. Physically making the rounds of these offices and picking up a freshly printed copy of each of my reports/records in my case, was the best option since most doctors to this day, do not e-mail responses or records, and the constraint that fax copies often tend to distort data and information.

* The first step I put myself thru was to scan each record, chart or report at home and then turn these into Microsoft Word documents and PDFs for upload into the Health Vault. This, in itself, is a huge barrier to adoption for most people that are not early adopters or tech savvy like me. Microsoft has endeavored to alleviate this pain by partnering with MaxEmail that will provide you with a virtual fax number for $ 8.95/year that will automatically upload faxed copies of your records from the doctor’s office onto your Health Vault PHR. I personally did not try this service and cannot comment on its efficacy, but this again, involves a change in behaviors and hence, is a barrier to adoption for most consumers. Having a portable scanner (like a number of the low priced card scanning devices available today) that potentially, can “plug-and-play” with the option of converting the scanned documents into a format like PDF and then uploading these directly onto the Health Vault, would be eminently desirable and lower the barrier to adoption for large segments of users. As well, this is currently a static data repository and needs to enable users like myself to stratify and store records by context and content type. For instance, being able to discern my annual physical exam data from my cardiac test data or my blood examination reports would be desirable vs. seeing a listing of documents with tags I have created. Over time, this needs to become more dynamic and hopefully evolve into what I have termed a Health Historian capable of data feeds from medical devices like implantable defibrillators and pacemakers. For now, the ability to access this life saving data from any place with internet access is very gratifying indeed.

* I then proceeded to http://www.healthvault.com/ to sign into my previously created account. I would have appreciated the “sign in” or “create an account” buttons on this very screen on the left hand navigation bar to preclude having to go thru two additional screens to get to my PHR.

* I was fairly impressed by the security/permissibility of the Microsoft Platform that lives up to the Health Vault brand, and in my case secured reciprocal sharing for my wife and myself.

* Going to the health details tab enables you to create a rudimentary profile comprising name, address, gender, birthday, ethnicity etc. as well as the ability to upload a low resolution photo of yourself. Having access to more capabilities like inclusion of family history, a choice of key therapeutic areas that are relevant e.g. cardiac vs. neurological etc. would have been desirable.

* Uploading your health records in word, excel, PowerPoint or PDF (in my case I had converted all of my documents into PDF) was fairly intuitive, as is the ability to view the audit trail for each of these documents on demand on the “history” tab. Clicking on each document throws up a dialog box that enables you to download, print or delete, with the added ability to click on three tabs to view the properties, history and the people you are sharing the document with.

*  Once you have uploaded all of your health records, you have the option of securing additional free as well as fee based applications and services from a number of vendors that Microsoft has partnered with including the American Heart Association, Cap Med, Healthy Circles and others. I signed up for the ones offered by the American Health Association and Healthy Circles to be able to enter data on my weight, blood pressure and exercise regimen to be able to see charts and how well my vital signs compare with my peers. The challenge I experienced was that I had to sign in each time I needed to access apps. from a different vendor to be able to enter data or see a chart showing trends, which is painful and again, a barrier to adoption. This is an obvious area of improvement.

*  In an ideal world, Health Vault should provide me with an excel like tool where I can manually enter data or upload data directly from my blood pressure monitor or glucose monitor using the Health Vault Connection Center utility and drivers from leading blood pressure, heart rate and glucose monitoring devices offered by Omron, Polar and Johnson and Johnson’s Life Scan division – you will need to download the utility and the drivers to your computer. Having the choice of which vital signs are relevant for me (weight, blood pressure, glucose levels, cholesterol types etc.) and entering this data to be able to see a chart showing trends in my vital signs over time, would be intuitive and extremely valuable from my perspective. As an example, I entered weight, blood pressure, sugar and cholesterol for a fictitious patient I have called John Doe into Excel and then created multiple graphs to simulate a Personal Health Dashboard (PHD) showing trends over time. A close look at this data immediately reveals the effectiveness of this patient’s health regimen including diet, exercise, medication, weight loss and their impact on the vital signs over time. Having something similar online greeting me everything I go to my Health Vault PHR would serve as a fairly simple yet high impact Health Dashboard (that I have referred to in my forward looking vision on the evolution of the EHR in my previous blog post “The Demand-Side Electronic Health Record (EHR): Who will make this “Win-Win” for Patients to adopt?”). Over time, mapping this to benchmark data from sources like the American Heart Association for instance (with permission based access), could potentially alert the patient if one or more of their vital signs violates a benchmark threshold and prompt him/her to see the appropriate doctor for treatment. These data entry and online analytics capabilities are very well developed today and Microsoft would be well advised to offer these within the Health Vault Platform, perhaps for a fee that “enlightened prosumers” like myself would be happy to pay, for the incremental value these would deliver. These would be the first steps towards delivering a Healthcare Expert System that I have envisioned in my previous blog post.

* One of the most impressive capabilities of the Health Vault is the integrated Health Search capability. Searching for a term like “coronary artery disease” returns a well stratified stack of information for education and learning, research, useful tools and references neatly delivered within a navigation bar, web links as well as ads for suggested books from vendors like Amazon and other ad sponsors. This also offers the capability of including useful links and resources into a “scrapbook” that can be added to your Health Vault PHR for future reference.

My first experience with creating my Personal Health Record (PHR) using Microsoft’s Health Vault Platform was a fairly positive experience. It is user-friendly, reasonably easy to use, intuitive most of the time and perhaps most of all, backed by the Microsoft brand’s promise of security, quality and reliability. As well, having integrated search capabilities to lower search costs, as well as the capability to upload data from blood pressure or glucose monitoring devices via the Health Vault Connection Center, are significant additional benefits. Having a portable version of the PHR especially for travel to other parts of the world where the Internet is anything but ubiquitous would be eminently desirable. Being the early adopter that I am, I have actually created my portable PHR (that I can carry in my wallet without damaging it) with an exact replication of the data I have uploaded into the Microsoft Health Vault, using the really tiny yet robust USB memory device that Sony appropriately brands as the Micro Vault. The Health Vault and the Micro Vault both as PHRs – now is that a coincidence or what?!

So for now, the “enlightened prosumer” in me stands safe and secure in the knowledge that all of my vital and current health information can be easily accessed in the event of an emergency, or on demand, online via my Microsoft Health Vault PHR or thru my portable/mobile PHR on the Sony Micro Vault in my wallet. This is very reassuring and a comforting feeling indeed with the hope that I will not need to use this information under distress, in the foreseeable future!:-)

Milestone: This blogpost was referenced and the author quoted by the Washington Post in an article entitled, ‘New Ways to Manage Health Data’, March 2008.

In my previous blogpost (“Can Life Sciences and Healthcare enable my evolution from “Passive Patient” to “Enlightened Prosumer”?), I have articulated my vision for the Electronic Health Record (EHR) and the incumbent benefits that would potentially enhance both quality and span of life, predicated on a paradigm shift – proactive, intervention based healthcare that would be far more cost-effective to deliver and yet assure timely and superior therapeutic outcomes.

In this context Microsoft’s announcement of its PHR Platform, the Health Vault, for Personal Health Records (PHR) under Peter Neupert’s leadership, and the support of Microsoft’s leader Steve Ballmer and its visionary founder and philanthropist par-excellence, is indeed encouraging. Particularly compelling is the support from partner organizations like the American Heart Association, Johnson & Johnson LifeScan, New York-Presbyterian Hospital, the Mayo Clinic and MedStar Health, a network of seven hospitals in the Baltimore-Washington region, that augurs well for Microsoft, given their success in driving alliance enabled solutions into the marketplace. Given Revolution Health’s (founded by Steve Case) announcement of it’s EHR last year and potentially, a competing EHR solution from Google in the foreseeable future, large scale patient adoption of Personal Health Records (PHRs) from one of these vendors will be mission-critical for success.

As well, Healthcare Solution Providers like G E Healthcare (headed by Joe Hogan), Siemens Medical Solutions (headed by Janet Dillone), Cerner, Misys and Enterprise Software Providers like SAP, and many others also provide Electronic Health Records (EHRs) targeted at Physicians and Hospitals.

Any new solution for Healthcare needs to address the needs of the 5Ps – Patient, Physician, Payer, Producer and Politicians. Given President Bush’s mandate for EHR adoption across all US hospitals by 2010 (which addresses politicians, payers and producers), the single largest challenge for PHR adoption and ubiquity, is patient adoption on the demand side and to a lesser extent, the physician/nurses/hospital adoption on the supply side.

PHR adoption by Customers – Daunting Challenges

Key to enabling this adoption is an understanding of the issues and challenges that I have modeled on the framework below, adapted from a seminal article entitled, ’Eager Buyers and Stony Sellers – Understanding the Psychology of New Product Adoption’ by John T. Gourville, Harvard Business Review (HBR), June 2006. The key premise is that the greater the level of change in customer behavior needed, the greater the barrier to customer adoption, despite the promise of value delivered by the new product. Gourville makes the point that producers of innovation often overestimate the customer adoption by a factor of 3X while consumers allocate significant value to their current product or service and demand a value proposition that is practically 9X times that offered (perceived) by their current product or service.

This framework enables stratification of new products and the consumer change behavior needed for adoption, into four logical categories, stratified into the four quadrants as shown below:

* Low Product Change (“me-too” products) with Significant Change in Customer Behavior needed, usually is a recipe for disaster (“Sure Failure”), and is manifested in the 70% of new products and services that fail within a year of introduction or less.

* Low Product Change demanding little change in Customer Behavior (product line extensions of a very successful category like the iPod for instance) is classified as an “Easy Sell”, and primarily involves market and channel awareness to drive sales.

* High Product Change (significantly enhanced perceived value from a new category, for instance) with a Significant Change in Customer Behavior will call for a “Long Haul” and slow, phased user adoption based on psychographic and benefit segmentation (early adopters and innovators acting as references for the mainstream market). PHRs and EHRs and products like the Segway can be currently estimated to be positioned here.

* High Product Change (significantly enhanced perceived value) that demands little change in Customer Behavior is usually the recipe for a “Smash Hit”, since the compelling value proposition without significant learning curve effects, is sufficient for the customer to adopt. Apple’s new iPhone is an exemplar in this category.

Using this framework as the blueprint for EHR adoption, I have mapped PHRs and EHRs below as “Long Hauls” that will demand significant efforts from the vendors to enable large scale customer adoption to turn these into “Smash Hits“ as shown above. One can argue that legislation and regulations demanding EHR adoption in hospitals across the country, and availability of patient records in electronic format using outsourced transcription services etc. will ensure rapid EHR adoption and the more daunting challenge is getting patients to embrace PHRs like Microsoft’s Health Vault.

That is rather simplistic and does not address significant challenges associated with EHR adoption such as common industry data standards, data interoperability across competing solutions, data capture and analysis etc. that need to be solved to ensure large scale adoption, and presents a huge opportunity for healthcare solution vendors like G E Healthcare, Siemens Med. Solutions, SAP, Cerner, Misys etc.

I will choose to focus this blogpost on PHR adoption by patients in this blogpost.

The PHR Product Lifecycle’ and associated challenges - An “Enlightened Prosumer’s” Vision and Prognosis

Personal Health Records (PHRs) can be prognosized to evolve over a four stage “PHR Product Life Cycle” as below, from my “prosumer vision and perspective” with their associated challenges that will need to be addressed, to ensure significant customer adoption, as below: 

1. Personal Health Record (PHR) with Healthcare Search– a repository of patient records searchable by keyword, date and therapeutic area that can be shared with physicians and hospitals on demand i.e. the current state, exemplified by the Microsoft Health Vault Platform. The typical records Microsoft envisions being stored in the Health Vault range from fitness-related activities to basic measurements, such as blood glucose and blood pressure, discharge summaries from hospitalizations, lab results, medications and health history.

The single largest challenge today is to enable patients to collect, scan, upload, store and share electronic copies of their paper data that is currently stored in the manila folders in their physician’s offices, which is not trivial, by any stretch of the imagination. While tech-savvy “enlightened prosumers” are sold on the benefits of anytime, anywhere access and can easily scan and upload copies of their medical records, or leverage utilities like Microsoft’s Health Vault Connection Center, to do so, this can be a daunting proposition for the majority of consumers/patients, who are challenged with even mastering their computers, cameras and cell phones.

It is this author’s prognosis that there is an “Adoption Paradox” that will significantly impede customer adoption of the Demand-Side or Personal Health Records (PHRs). Most healthy patients have little incentive to create a PHR to be able to access their records on demand, anytime, anywhere. The PHR presents the most compelling value proposition as a life saving tool for patients with acute or chronic conditions who are vulnerable to sudden, unforeseen attacks that could potentially be fatal. Unfortunately, most of these patients (the prime target segment for the PHR) are also the least likely to have the technical expertise, resources or penchant for creating their PHR and putting it online, given the complexity involved.

There are at least three ways to alleviate this burden. First, provision of a scanning, and upload service ideally at a physician’s office that may demand a shared investment in the hardware and software from the EHR vendor and the hospital. This is far easier at hospitals that have already adopted supply-side EHR that usually provide PDF documents as standard outputs. Secondly, creation of a credit card sized USB based hardware device that would serve as a data capture, storage and retrieval device i.e. the mobile PHR that the patient can carry anywhere and access on any PC worldwide. Uploading the documents in PDF, word or graphic formats at the physicians office and automatic upload on linking with a broadband Internet connected PC via the USB ports at home, would go a long way towards enabling adoption. The third and most obvious, yet challenging mechanism is for patients to obtain electronic or hand written copies of their records and scan or enter them into the PHR at home at their convenience, leveraging utilities such as those provided by Microsoft(Health Vault Connection Center) above. Easing the burden of data entry, paper record scanning and upload is perhaps the single largest barrier to patient adoption that Demand-Side EHR or PHR vendors will have to transcend.

Linking content pertaining to cardiac disease management or diabetes from providers like WebMD, as well as embedded search algorithms (like Microsoft’s Health Vault Search) enables prosumers and patients to educate themselves on the latest research and their associated therapeutic outcomes and also lower their search costs on finding the best possible treatment from an array of branded, and reputed companies like Johnson & Johnson, Novartis, Pfizer, Medtronic, St. Jude Medical, Boston Scientific, Amgen, Genentech or the Mayo Clinic as examples.

Another real design consideration is the potential dissonance from Physicians and Hospitals since availability of PHRs would lower the cost of switching providers for patients and also provide hitherto impossible transparency into the costs of treatment. However, given the current regulations to drive mandatory adoption of EHRs across hospitals, this is the “new reality” that providers (physicians and hospitals) would need to reconcile themselves to and tradeoff against the significantly improved efficiency, cost-effectiveness and patient empowerment and satisfaction.

This would assure significant value to patients in terms of anytime, anywhere access to their critical healthcare information, the ability to share this information with physicians, relatives and hospitals on demand, and also lower their search costs on finding the best possible health alternatives.

 2. Personal Health Dashboard and Health Commerce – is the next stage in this evolution of the PHR, aimed at providing a single unified overview of a patient’s health, lower search costs, as well as enable online commerce to re-fill prescriptions, order home devices, and schedule physician and service provider appointments (in an ideal world).

 Given the sophistication of currently available portal technologies like Microsoft’s Sharepoint and SAP’s NetWeaver to name a few, delivering a rapidly configurable personal health dashboard, targeted at tech-savvy early adopters and innovators is highly desirable. Having a single dashboard display the results of my last annual check up, my vital signs including height, weight, blood pressure, sugar and cholesterol levels, hyperlinked to their associated medical records, physicians, and potentially content research resources (like WebMD, for instance) would be extremely useful- here is a mock up version of a personal health dashboard crafted by this author as an illustrative example.

 Additional desirable benefits would be electronic reminders (both online as well as text messages sent to cell phones or PDAs) to re-order prescriptions from mail order providers, as well as the ability to schedule appointments for annual check ups with a general practitioner or with specialists as needed. Integration of the PHR with the supply side EHRs and content from insurance providers like Aetna, would also enable access to the transactions associated with each physician visit or cost of medications, to track healthcare expenses accurately.

 Over time, with evolution of common data interoperability standards, it is not inconceivable for supply side EHRs from hospitals to be integrated with the demand–side (personal) EHRs as shown in the adoption blueprint above, that will further accelerate both patient and physician adoption.

 This would enable fairly painless data transfer from the hospital/ physician’s EHR to the patient’s PHR and also provide transparency into the costs associated with treatment, procedures and medication that is a huge challenge today.

 Key anticipated benefits to patients would be a single unified view of their critical vital signs, superior compliance with needed diagnosis and medication, higher transaction efficiency, as well as higher transparency into the procedures and associated costs.

3. Dynamic Personal Health Historian with Exception based Management is the logical next step in the evolution of the demand side PHR. Given the huge numbers of perhaps the most prosperous retirees in the history of North America who will demand proactive intervention based healthcare (as envisioned in my previous blogpost – Can Life Sciences and Healthcare enable my evolution from “Passive Patient” to “Enlightened Prosumer”?), the PHR will need to evolve into a Personal Health Historian. This will demand that diabetes monitoring meters from J&J’s Life Scan division, or implanted medical devices like pacemakers and defibrillators from Medtronic, St. Jude Medical and Boston Scientific can interact with and upload streams of vital sign data (blood pressure, sugar levels, pulse rates, electrical impulses etc.) into both demand and supply side EHRs, wirelessly (leveraging blue tooth, RFID or wireless telemetry) to enable proactive intervention when these vital signs are in violation of physician determined threshold levels.

While this is a daunting challenge, this problem of a far greater complexity has already been well addressed in a manufacturing environment. Data Historians from companies like Invensys Wonderware, G E Fanuc and Siemens Automation capture very large amounts of data at a milli-second frequency from manufacturing equipment on the plant floor and also enable data retrieval, analysis and exception based management. Companies like G E Healthcare and Siemens Medical Solutions can be anticipated to borrow these currently available technologies from their sister organizations to render them viable in a supply side EHR context. The challenge then for a demand side EHR solution like Microsoft’s Health Vault is to capture these data streams and appropriately store them for retrieval, analysis and exception management for the patient. This can potentially be accomplished thru the mobile PHR/EHR solution referred to above, with blue tooth, RFID or wireless telemetry capabilities. As well, ability to interact with this mobile PHR/EHR need to be built into the next generation of devices from companies like Life Scan, Medtronic, St. Jude Medical, Boston Scientific etc., as well as the next generation of home based monitoring devices like blood pressure monitors.

For instance, sugar levels in diabetic children being monitored by a Life Scan device could be transmitted to the PHR. Violation of physician prescribed threshold levels, could trigger alerts to parents and the physician, ensuring rapid intervention to preclude further exacerbation. A similar paradigm can be envisioned for middle aged and senior patients with wearable or implanted devices, triggering off compliance reminders or proactive intervention before a serious life impacting event takes place, that would serve to both enhance their span and quality of life as well as lower costs of treatment, by minimizing emergencies, as laid out in my previous blog-post (Can Life Sciences and Healthcare enable my evolution from “Passive Patient” to “Enlightened Prosumer”?)

 As well, bidirectional propagation of data on unforeseen outcomes in patients, transmitted to Pharma or Medical Devices manufacturers in near time would alert them on the adverse event implications of their products and enable them to address this within their innovation life cycle, to minimize the unforeseen and undesirable patient and financial impact of their new products. This is distant reality but definitely within the realm of possibilities.

 There are significant benefits that can be delivered to patients using an exception based management approach to personal healthcare as suggested above. These include a higher quality and span of life thru superior therapeutic outcomes delivered at a lower cost per patient.

4. The Personal Healthcare Expert System is perhaps the “Holy Grail of Personal Healthcare” that PHRs should aspire to evolve into. This would involve incorporation of state-of-the art heuristics, neural networks, learning agents, decision support and predictive analytics based technologies that would be integrated with the Personal Health Historians from the previous stage.

 In this paradigm, healthcare data would not only be stored but also analyzed against patient history and benchmark data from similar patient populations. Learning agents would assimilate patient history, behavior and responses to previous treatment to prognosize potential events well before they happen. This would alert patients and point them for diagnostic check ups from qualified physicians, with data on allergies, adverse reactions to medication types etc. to ensure a superior therapeutic outcome pre-empting and precluding incidence of debilitating events like cardiac or diabetic attacks or strokes, the largest causes of deaths in North America today.

 The impact of these personal healthcare systems would be significant in terms of significant life impacting events avoided for the most “at-risk” patient population as well as the huge reduction in treatment costs that would result from their adoption. As well, this would potentially free physicians from mundane checkups and free up time to devote to critical patients as well as keep up with the latest research to better equip them to deliver the best possible outcomes for their patients.

 Significant benefits for patients and providers from deployment of such systems would include reduction of life threatening events (and risks thereof) and associated costs for patients especially, the “at-risk patient population”, as well as the Total Cost of Healthcare (TCH) per patient per treatment, which would significantly contribute to making healthcare more affordable in North America.

This is my humble attempt at visioning the product life cycle that demand-side EHRs or Personal Health Records (PHRs) can be anticipated to evolve thru, to enable widespread patient adoption and also meet the needs of the “enlightened prosumers” that “passive patients” are transforming into.

It will indeed be fascinating to observe and map the trajectory that Microsoft’s Health Vault Platform for PHRs and competing solutions move thru, to enable customer adoption, against this “outside-in blueprint” and more importantly, the impact of this adoption on quality and cost of patient treatment. As always, your comments, feedback and perspectives are welcome.