This is an executive summary of a recently published white paper (below) co-authored by Andy De et al. Please click on the cover graphic below to view/download the PDF version, or alternatively, please click on the flip book at the end of this summary to access the eBook version of the white paper. Executive Summary: As medical science has advanced, so too have the number, type, and complexity of drugs and devices available. In order to carry this burgeoning product portfolio, the life sciences supply chain network has also enlarged and grown in complexity, and there are now more intermediaries than ever before between the manufacturer and the patient. It is a major challenge to account for the movement of all products within the supply network—and moreover to prevent diversions and counterfeits. However, in this networked, globalized world, where information travels fast, it is of critical importance to be able to secure the supply chain to ensure patient safety and maintain an unblemished reputation.
Counterfeits risk harming human life by containing incorrect active ingredients—or even no active ingredients at all. If allowed to flourish in the life sciences supply chain, these sub-standard products can damage the brand and reputation of the authentic manufacturer. Moreover, money from the sale of counterfeits will not go towards supporting the research and development (R&D) infrastructure of pharmaceutical and device manufacturers and may well be used to support illegal or harmful activities. The issue of diversions can be equally damaging as certain markets are denied their medications, while middlemen and traders enjoy profit by selling them on. It is impossible to do more than guesstimate the full impact of counterfeits and diversions (which run well into tens of billions of dollars a year), but they are undoubtedly a growing concern. As the Internet becomes ever more prevalent, it is easier and easier to hide the provenance of pharmaceutical products on sale.
The world is waking up to these problems. Certain countries, including the US and many in Europe and Asia, are developing legislation to help protect the life sciences supply network. By enhancing the ability of stakeholders within the network to be able to track and trace the products, it becomes harder to divert or insert items, and easier to ensure high levels of quality and safety.
As the life sciences industry operates on a global scale, these mandates need to fit within a wider framework, which is provided by global standards such as those from GS1 and Electronic Product Code Information Services (EPCIS). With guaranteed interoperability, it is possible to achieve accurate, reliable drug tracking and authentication at each node of the drug supply chain.
For life sciences executives concerned with ensuring the highest levels of patient safety and brand protection, the solution will be to adopt an enterprise-wide approach to addressing these issues. This will include considering how to proactively comply with emerging serialization mandates across the world, while at the same time balancing the costs and benefits of serialization and authentication and determining which products and brands to prioritize.
This publication explores some of these key challenges facing life sciences companies today from the insiders’ perspective. There is an overview of the problems of counterfeits and diversions and the role that serialization and authentication plays. It also addresses the critical role of industry standards and best practices in business process enablement using advanced IT solutions, and there is a case study of Cephalon’s success in addressing these challenges. In addition to addressing the tactical needs for compliance and supply chain visibility, the publication closes with an analysis of the strategic benefits of extending serialization to the patient bedside, including the potential benefits in terms of fewer medication errors and adverse events culminating in higher patient safety.
We hope you enjoy the articles and find them useful in helping to further your understanding of the potential strengths of the life sciences supply chain environment and to derive strategic plans to realize them. - Andy De, Steve Winkler, Mandar Paralkar, Brian Brown and Michelle Grayson
Please click on the flip book above to access the full edition of the eBook in a new window, or please click on the cover graphic above to view/download the PDF version of the white paper.
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.
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.
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:
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?
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.
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.
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.
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.
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).
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.
The biggest challenge, according to the Pharma companies, is the science of drug discovery – how to identify and validate a genetic association with a disorder and then develop a molecule to address this. Pharmacogenomics and related technologies have driven significant advances in this arena, but there is still a long way to go.
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.
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, “Demand-Side EHRs: Who will make it Win-Win for patients to adopt?”)
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:
o Structuring and digitizing genetic and genomic information and incorporation within EHRs
o Creating applications to support genetic discovery and research
o 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
Can Personalized Medicine (P/M) potentially disrupt the current US Healthcare Model? Perhaps the most provocative perspective on P/M was presented by 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.
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.
Therapeuticsis 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
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.
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.
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 VaultPersonal Health 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 blog post (please see “The Demand-Side Electronic Health Record (EHR): 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 Demand-Side Electronic Health Record or 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, as well as feedback for the product management team at Microsoft.
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 theAmerican Heart Association, Cap Med, Healthy Circles and others. I signed up for the ones offered by the American Health Association and Healthy Circlesto 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!:-)
In this context Microsoft’s announcement of its EHR 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 Clinicand 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 EHRlast year and potentially, a competing EHR solution from Google in the foreseeable future, large scale patient adoption of a “Demand-Side” EHR solution for 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 what I call “Supply-Side” EHR solutions (or simply EHR) 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 EHR adoption and ubiquity, is patient adoption on the demand side and to a lesser extent, the physician/nurses/hospital adoption on the supply side.
EHR 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). Demand-side and Supply-Side 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 demand (PHRs) and supply side 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 supply-side EHR adoption and the more daunting challenge is getting patients to embrace the demand-side EHRs like Microsoft’s Health Vault.
That is rather simplistic and does not address significant challenges associated with supply-side 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 demand-side EHR (or PHR) adoption by patients and will devote my next blog-post to the issues and challenges associated with supply-side EHR adoption.
The 'Demand-Side (Personal) EHR Product Lifecycle' and associated challenges- An "Enlightened Prosumer’s" Vision and Prognosis
Demand-Side EHRs or Personal Health Records (PHRs)using a platform like Microsoft’s Health Vault, can be prognosized to evolve over afour 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 Clinicas 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 Sharepointand SAP’s NetWeaverto 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.
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 themobile 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 Systemis 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.
