1. HIMSS 2012 is focusing on mHealth with several sessions and will have a kiosk on the vendor floor which features speakers on the mobile aspect of healthcare
2. AAMI has published in their IT World column a synopsis of mHealth (requires login credentials)
3. Here in Europe, the Mobile World Congress, Barcelona Feb 2012, sponsored by the GSM Association, has a track devoted to mHealth (filter for Mobile Health), a day of demonstrations and a specific plan on embedded mobile medical functionality.
4. Additionally, the FDA has come out with draft guidance and has promised final guidance regarding mobile medical apps.  The European Commission has entered into an MOU with the HHS to work together on the regulatory aspects of healthcare.  I wouldn’t be surprised if they come out with similar regulatory guidance regarding mHealth as that promulgated by the FDA.
5. Lastly, from a market perspective, “The mobile health market has a year-over-year growth rate of around 17% since 2010 and is estimated to be worth $2.1 billion at the end of 2011. The report also said the mobile health market is expected to grow …. nearly 22% from 2012 to 2014.”

One might ask, what is mHealth?  It has many different definitions and from a product offering perspective could range from texting information on a mobile phone to a provider and/or specifying a provider geographical location to a patient to bi-directional interaction with a medical device to/from an electronic medical record application via mobile phone or telecommunications frequencies (or the medical device could be embedded with the mobile telecommunication appliance).  As with the traditional Healthcare industry, as one progresses up the interaction functionality chain, the design and interoperability gets more complex.  Most of the latest news items I read about successful mHealth applications describe the ‘easier’ applications:  texting, scheduling, location, etc.  There is still growth and development in the marketplace for interactive medical-device integrated/connected products.  Additionally, from a market perspective, most of the current product offerings are proprietary in nature and vertically integrated.

Mobile telecommunication vendors are keenly interested in providing for the healthcare market.  They are closely watching as well as working to influence the regulatory environment.  From a provider perspective, this means adding another large player to the mix.  You may already provide some internal mobile telecommunications support, but providing healthcare monitoring over that infrastructure changes the rules of the game.  In addition, the mobile telecommunications market plays to the consumer market, which has faster turnaround times, and higher customer expectations.  The consumer market expects the ability to smoothly transition service when changing a ‘product provider.’  In addition, with social media, the pressures are higher; witness the recent policy and product turnaround of Verizon to a charge for customers using a specific billing mechanism.  The healthcare provider is not used to this type of oversight or pressure yet.

Down in the healthcare provider trenches, testing remote monitoring and the use of mobile telecommunications offerings continues.  Here in Europe there are two larger projects that are interested in demonstrating the efficacy of remote monitoring.  One, the Whole System Demonstrator based in England and their National Health System (NHS),  has just published its preliminary results.  Another, Renewing Health, is based on a nine European country pilot for remote monitoring of chronic diseases. In the case of the Whole System Demonstrator, initial results have been very positive for the clinical outcomes regarding the use of remote monitoring models for chronic disease management with a “15% reduction in A&E visits, a 20% reduction in emergency admissions, a 14% reduction in elective admissions, a 14% reduction in bed days and an 8% reduction in tariff costs” along with a “45% reduction in mortality rates.”

Renewing Health is still in its trial period, however, the initial technical results have been published.  A basic summary of the technical aspects of the nine solutions follows:

1. All pilots sites used proprietary solutions,
2. The most widely used standards were protocol and telecommunication standards, but even with some of those standards, there were issues with product development and rol-lout.  This has resulted in some technology system re-design as well increased expenditure on patient education.
3. Moreover, the market has dealt some variables, by either not continuing distribution of a mobile phone model or changing the implementation of a medical device transport protocol.  Additionally, intermittent wireless coverage and/or limited bandwidth for a teleconferencing function have led to design changes or required infrastructure upgrades.
4. The market has a dearth of standards-based products for purchase.  In Europe this is complicated by language requirements (most of the countries have healthcare systems which specify that products be purchased which have markings and documentation in their national language – this is for ease of use as well as cultural preservation goals).
5. Another big issue is system ergonomics with respect to patient cohort.  Mobile phones with small screens and small input interfaces (small mobile phone keyboards) don’t work well with more elderly patients.

This project will be ongoing until 2013 and at the end the results are hoped to strengthen the hypothesis that well designed remote monitoring programs for chronic disease management is as or more effective than care delivered in the traditional manner.  There should also be some interesting results from a technical perspective.  The market is slowly moving towards providing more standards-based products, however, for the purposes of this project, timing did not allow more adoption of those types of products.

So, with all of the activity described above what should healthcare providers do?  I suggest the following:

1. Keep current on the mobile telecommunications arena both in product offerings and regulatory oversight.  With the MDDS and the draft mobile medical apps guidance, the FDA has signaled they will be interested in regulating some aspects of healthcare delivery.   If you as a healthcare provider adopt mHealth solutions, this will increase the complexity of providing and servicing/maintaining healthcare products from the provider.  You control your enterprise, but as the information goes outside the enterprise to the shared infrastructures, you lose that control.  Therefore, you may not be able to guarantee the types of performance or response that may be the norm within your enterprise.  Agreements with the third party infrastructure entities will become paramount to ensure good performance and in the end good relationships with your customers:  the patients and clinicians.  Moreover, in light of the recent FDA guidance, understanding the infrastructure path of your mHealth solutions so that you meet any regulatory burden will become even more important as you embark outside of your enterprise.
2. Consider specifying standards for data and communication across each interface (example: Continua Guidelines, IHE-PCD) in your acquisition documents.  As with traditional medical device connectivity in your enterprise, the more you can decouple the medical device choice from the other parts of a connectivity solution, the more flexibility you have to make decisions based on the quality of the different parts of the system.  In the future, this may avert having to redesign, augment and/or replace the whole system from medical device to electronic medical record application due to a technology refresh of one of the manufacturers in the system.
3. Providers are under a lot of pressure to control healthcare costs in all parts of the world.  As remote monitoring pilot results become more prevalent, it will be expected that providers adopt some of these mobile health solutions.  Timing of your adoption will become very important as this is a fast moving train.  The product cycles for mHealth can be 6 months to 1 year.  This is much faster than your usual IT infrastructure refresh cycle which is already faster than your medical device/technology refresh cycle.  Although many of the traditional medical device companies are migrating to a software based solution and a refresh cycle similar to that in the IT industry, they may not be as ready for the mHealth refresh frequency cycle.  This may slow down in the US and Europe due to more regulatory oversight, however, the development outside those areas of the world does not have as much regulatory oversight, so some of the more interesting products may be developed outside of the geographical areas we’ve become accustomed to in the US and Europe.  If you have a ‘wandering clinician’ or patient, they may be the one who introduces or demands a specific functionality to your enterprise from their wanderings.
4. If your mHealth solution implementation is successful, be prepared to expand.  It is estimated that 80% of healthcare costs are borne by 20% of the population and most of this is due to the management of chronic diseases.    Remember, as with most endeavors, more is demanded of you once you succeed.

So is 2012 the year of mHealth?  Perhaps.  If anything, it will be another exciting year for mobile technology and the convergence of the consumer and healthcare industries.  It will be bumpy, but in the end, it should be better for the consumer who usually also happens to be the patient.

Bridget A. Moorman, CCE, is president of BMoorman Consulting, LLC, providing consulting to healthcare providers, standards promulgation organizations and medical device and information technology companies regarding their medical device integration strategies.  She can be reached via email  or at her website.

During breakfast, I chatted with Michael Kurgan, CEO of start-up Service Wing Healthcare. They’re targeting the wireless gateway market to support body area networks. I mentioned a company I heard about yesterday, GainSpan and Michael had some great perspective on the challenges picking tech winners in immature markets. GainSpan has an ultra low power wireless SOC (system-on-chip) that includes an 802.11b radio and two ARM processors, one for the radio and one to drive whatever device the chip is enabling. In an immature market, just because a component comes from a big company does not mean that their component will have long term success. A much smaller competitor with a better solution may win, or the big company may acquire a better solution in order to be a big player in that market segment.

Rob McCray, chair of the Wireless-Life Sciences Alliance, kicked things off. Camille Sobrian was up next, touting San Diego as the biggest wireless hot spot in the world (perhaps for cellular wireless). She also mentioned the West Wireless Health Institute, and the upcoming TEDMED event. Dr. Paul Jacobs, CEO and chair of Qualcomm passed on introductory remarks and jumped right into things wireless.

Paul noted that what’s going on right now is convergence, and it’s those who understand both industries that can lead that convergence. He described the new mobile internet experience: networks, devices and applications in the cloud. Multiple air interfaces are a key enabling component. The newest radios are only a few percent more efficient, but they tend to support broader bandwidth to improve network performance. He mentioned a mobile WAN, and various wireless LANs and BANs. A future trend is where applications control the radio to optimize performance for that application.

In Europe, mobile broadband radio dongles for connecting laptops outsell all the 3G phones sold there. Paul defined convergence as the overlapping of computing devices, consumer electronics and wireless tech. Paul alluded to the Amazon Kindle, as a prototypical device for the future, where an embedded system includes a cell phone built in for connectivity. He also highlighted Snapdragon as a platform for mobile data processing, multimedia performance, 3G wireless connectivity and the low power consumption.

Another Qualcomm solution, eZone universal wireless charging tech, an induction-like recharging solution was touted. Something like this is the future of charging for reusable wireless sensors or patient worn gateways.

Paul wrapped things up by announcing Qualcomm’s contribution to a wireless innovation challenge for universities in southern California.  He equated this effort to past market development efforts of Qualcomm’s. Their approach to collaborate with wireless network operators (carriers), cell phone manufacturers, media/services and application providers, and web companies like eBay, Amazon and others.

Next up was Katherine Kalin, vice president of strategy, J&J Corporate Development. She bragged on her company (120k employees, $60 billion revenue, 250 operating companies, etc.) emphasizing their decentralized management structure. This allows each operating unit to get closer to their customers and better bend their operations to their specific market segment.

Katherine talked about how J&J is targeting what they call “white spaces” for new business opportunities. Wellness and prevention was designated a business platform, including two new acquisitions: HealthMedia and Human Performance Institute.

Part of the disruptive solution evolution she mentioned includes unusual partnerships: Intel/GE Healthcare, Walmart/Dell, and other cross-market alliances.

The first panel was up next: Dr. Eric Topol, Philip Low, MD, Jeff Augenstein, MD, and Stan Kachnowski, MD, moderated by David Gruber, MD.

Jeff started things off. He contrasted the promise of health care IT (HIT) and the reality. He noted a litany of very expensive, high profile HIT failures. He presented a scenario — a strawman of a sort — centered on trauma. Trauma is the most expensive disease, and it is almost always preventable.  This trauma example, self inflicted by the victim, offers examples of how current and soon to be available tech is applied to the situation.

In response to Jeff’s scenario, Stan Kachnowski noted that the type of innovation that is required must be low cost, small and easy to use. Stan went on to describe research he’s done looking at clinician workflows and how various communications methods impact workflow. His research has shown that workflow problems like process interruptions, can result in patient injury or death.

Philip Low described technology to provide feedback to the patient about their neurological state, whether they are intoxicated or falling asleep behind the wheel. He also suggested that we not confuse wellness with health care. Health care is delivered to patients by providers; wellness is a physiological condition attained by individuals.

Topol stated the health care delivery system in the US has already crashed. Anything you do can only improve the situation. He was not optimistic about EMR interoperability. Jeff’s genomic component of his trauma scenario was of interest. One fifth of the population has a gene that makes them more susceptible to brain swelling from head trauma. If you’ve not had your genome sequenced, you don’t know if you have that risk.

Dave asked the group about the current paradigm of research, randomized double-blind trials, and how that applies to evaluating software and other tech that impacts care delivery. Great question; manufacturers and physicians perennially tussle over this issue. The conventional scientific method is great for drugs and some devices like stents, pacemakers and heart valves, but worthless in evaluating workflow automation.

Jeff noted that the focus in this event is about how care is delivered rather than the basic science of diagnosis and therapy. The implication being that conventional randomized trials are not appropriate to evaluate improved workflows resulting from improved communications or software applications. Stan argued for a lower hurdle for the regulatory approval for new and innovative technologies to get them to market more often and in a shorter period of time. He suggested that post market surveillance might be a way to do that without compromising safety.

Jeff noted that we need to overcome the poor adoption of many purported trends in health care: he noted EMRs and patient self management as two examples. Stan observed that physician technology adoption can be very rapid — pagers, fax machines, new diagnostic technologies, etc. — if it works and delivers value, they will adopt. Philip noted that some physician resistance is the concern that new technologies will replace them rather than just make them more efficient. Eric noted that the administration of TPA (tissue plasminogen activator) for heart attacks and stroke took almost 10 years to become a standard of care, and a trial with 40,000 patients, suggesting that this is too long.

Wrap up comments captured an interesting dog/cat perspective: health care delivery (and providers) is transaction oriented, while patients look to form relationships with providers.

After the break, Andy Thompson, founder and CEO of Proteus Biomedical, talked about How can Wireless-Life Sciences Transform the (Broken) Economics of Global Healthcare? He suggested the acute care hospital is the “epicenter of economic distortion.” In the UK, they’ve built up a primary care network and moved the “becoming acutely sick” and the “chronically sick” patients out of the hospital. The promise of wireless convergence is to move the chronically sick out to “community and family care networks.” He defined the family care whole product solution to include therapy, monitoring, applications and community, and incentives. His company, Proteus, can deliver a highly profitable solution for $2 per day. Andy’s message was that the technology exists, what’s missing is the whole product solution combined with an alignment of incentives.

The next panel included Agnes Brzsenyi, general manager of GE’s home health business, Terry Hinsey, vice chair at Deloitte, and Jeff Goldsmith, blogger and president of Health Futures. Jeff Belk, principal of ITC 168 Capital moderated. Terry sees many companies focused on finishing a product, and missing things in regulatory and the “whole product solution” that will drive adoption. Agnes talked about recent CMS studies that showed cost increases or no meaningful cost savings using remote monitoring or Healthcare Unbound technologies. GE is heavily focused on value, which is what people require before they buy. Another issue was product design: usability and good workflow automation. She contrasted the group here lobbying for e-health with a conference she attended in Prague last week was attended by the ministers of health from many of the members of the European Union — who described how they’re adopting e-health. This contrasted with this conference where a bunch of providers and entrepreneurs are trying to drive adoption.

Jeff asked the question, how many of these products are we welling to adopt ourselves? He noted that he’s 60 and has no interest in going to a  retirement home and living with a bunch of other old people. Nor is he looking forward to getting calls from his daughter to put his smart shirt back on. He referenced Clint Eastwood’s character in Gran Torino as a model for the soon to be elderly. He suggested that the paternalistic bent of many of these solutions was a huge barrier to adoption.

Regarding reimbursement, Jeff noted that that really went out the window with capitated care. The trend is to disperse risk across the care delivery system. For example, CHF readmissions: a hospital that knows they won’t be reimbursed for the next frequent flyer admission will be motivated to manage that patient to avoid that readmission. Terry noted the list of CPT codes that vendors used to promote how providers could generate revenue with their products. Now cost avoidance and improved outcomes are an increasing factor due to shifts in incentives and reimbursement. Terry sees market incentives aligned to foster cross party interoperability — across providers, payors, technology solutions.

Jeff sees the hospital as a huge market for the technologies represented at this meeting. He noted the need to greatly increase productivity to enable the growing shortage of health care workers to serve the soon to explode number of elderly. Jeff Belk suggested that disruptive technologies will just as likely to come from developing country markets, and not necessarily the developed world as most people seem to expect. One of the factors here is that many emerging markets can’t afford the same technology adoption path followed by developed markets. Consequently, these emerging markets try completely different things by necessity, some of which will have applicability world wide. Agnes: technology itself is just technology, it is the people, workflow and importance of the information that comes out of it that is key. The secret sauce is figuring out how to leverage this to change behavior — especially important with chronic disease management.

There is a strong idealistic theme in wireless health care that we can save people from themselves. This seems true especially of the obese, smokers, substance abusers, and extends even to chronic diseases like diabetes, CHF, and COPD. A question from the audience asked about personal responsibility on the part of the patient. She suggested financial responsibility (i.e., consequences) are necessary.Terry agreed that, “stick beats carrot every time.”

Next up: part one of award finalist presentations. Presenters include GreatCall/Jitterbug, MedApps, CellTrak Technologies, BeWell Mobile, Diversinet/AllOne Mobile, and Epocrates. Each company CEO had 2 minutes each to tell their story. They failed miserably.

Lunch saw a presentation from Jay Parkinson, MD, founder of HelloHealth. HelloHealth supports a direct pay (cash) business model for patients and physicians. Like Amazon for resellers, HelloHeath handles payment transactions. Like Facebook, there is a rich environment for scheduling appointments (in office, text or video), rating providers, tracking health care information and supports messaging and activity feeds for patients and physicians. The software is effectively an electronic medical record and billing/payment system for both providers and patients. There’s also a social networking angle amongst physicians and patients. Potentially a game changing platform for health care. According to Jay, HelloHealth is ideal many relatively healthy people when combined with a high deductable health plan and health savings account. Jay pointed out that many people in the US are actually over insured.

After lunch Clint McClellan, Qualcomm, moderated a panel looking at international wireless health initiatives. Panel members included Karl Brown, Rockefeller Foundation, David Edelstein, Grameen Foundation, and Mitul Shah, United Nations Foundation. These groups are looking to leverage the low cost disruptive capabilities of wireless health to improve health care in developing countries.

Grameen is using a simple Java app deployed on a low cost cell phone to replace most of the current log books and statistics worksheets in clinics.  Mitul noted that many undeveloped markets have an advantage in that they don’t have the health care system baggage that countries like the US have. This could allow these countries to leapfrog developed countries in their utilization of wireless health and other technologies. The lack of legacy systems is a real advantage.

The agenda broke into two tracks, continuing the international focus and another applying Gameboy/Xbox like consumer electronics to wireless health. I picked the international track. The previous panel was expanded to include Shawn Covell, Qualcomm, Yuri Ostrovsky, Click Diagnostics, and Dr. Krishnan Ganapathy, Apollo Telemedicine Networking Foundation. Ashok Kual of ARCS Global moderated.

In environments where the population is uneducated, i.e., illiterate, an effective solution is to use a local proxy (who can at least read at a grade school level) to operate the technology and mediate the communications between the physician and patient. The general population in developing markets, while not formally educated, are intelligent. Properly designed products have been very successfully adopted in these markets. Shawn noted that, regardless of education, users need to be trained.

Cultural issues equates to local needs and how to address those needs in the local community. There’s a tension between the need for scalability and high-touch capabilities. The basic economics of wireless health technologies are of much greater importance — to the foundations and those in underdeveloped markets — are much more important than cultural issues.  A common mistake is to “dumb down” a product for developed markets, when you need to know what the market requirements are for those international markets. In every market the users are different, and this must be taken into account.

Karl noted that historically on a world wide basis the cost of health care always grows substantially faster than growth in GDP. For example, over the past 20 years, health care costs in China have grown 50 times — several times faster than their GDP. To a great extent, this makes sense to me — as a society gets more affluent, what better to spend your money on than health care? From a market opportunity perspective, diabetes represents a huge target market for developing countries.

In summary, developing countries represent a great opportunity to test products. Their receptivity to technological innovation, low regulatory hurdles, and the potential for demonstrating benefits makes them a great target for initial product releases.

Aaron Goldmuntz provided an update on CardioNet, the first wireless health application using a carrier network for communications. A big part of CardioNet’s success is based on research done to validate the clincal benefits of CardioNet over loop event cardiac monitoring. CardioNet is looking to extend their franchise to grow the business. They plan to leverage their service model, build share within their current market, and expand current technology to adjacent cardiac segments. Their new atrial fibrillation monitoring is both a diagnostic and management tool. They’re also getting in to the clinical trails business. CardioNet is also looking to expand outside the US to international markets. Finally, they’re looking beyond ECG and cardiac monitoring to look at new therapeutic and diagnostic modalities. Neurology (strokes, sleep disorders) are recent targets for CardioNet.

Part two of award finalist presentations include: IntelliDot, Triage Wireless, Tagnos, MicroCHIPS, PhiloMetron, and Proteus (which Andy talked about earlier today). Jim Sweeney with IntelliDot, noted that CMS’ list of never events, the adverse events that should never happen — which they won’t reimburse hospitals for — is now up to 27 items. This group of CEOs did worse than the previous one at limiting their comments to 2 minutes each.

Now for the Triple Tree aware in three categories: clinical applications using wireless tech, consumer oriented solution, operational effectiveness solution. (Oops, the actual award trophies are a few days late and will be sent to the winners.)

Proteus Biomedical wins the clincial applications using wireless technology solution.  Best consumer experience goes to Great Call/Jitterbug. Best operational effectiveness is IntelliDot. And thus ends the first day’s sessions.

Photo at top: Computational modules for wearable health monitors from Nyx. Very cool stuff.

The following are some notes from some of the more interesting presentations – be sure to keep scrolling, this is a long post! I’ll follow this up with a post on my presentation at this year’s conference, “How the Network Effect Impacts Adoption of Healthcare Unbound Technologies,” and a wrap-up post.

At 8 am Monday morning, Teri Louden kicked things off. She started her career at Baxter Travenol in the 1970s. Referring to The Graduate, Baxter’s innovative technology of the day was plastic IV bags. Today, things have come a long way from plastics to Healthcare Unbound.

There have been few breakthrough industry segments over time – disease management, home infusion therapy, outpatient surgery – and Healthcare Unbound (HU) is an important pioneering new industry segment.

Teri prognosticated that many of the really breakthrough solutions in health care will come from companies outside of health care – mentioning Intel, Qualcomm, and other electronics and communications companies.

Using CardioNet as an example, Teri described how a new type of solution presents substantive challenges for adoption and effective use. The CardioNet value proposition was unique and required new ways of selling, patient use, and reimbursement.

She introduced Vince Kuraitis and David Kibble, and their topic: The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound

The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound

Vince introduced the topic with a classic example of the network effect, phones. He asked, what is the value of a single phone? The health care industry is currently the equivalent of two phones representing one to one solutions. The real value comes to the fore when many phones are interconnected, allowing users to contact many other users whenever they want.

Today personal health information is scattered and static. It is not accessible using computing and Internet standards. That data is frozen.

Using a prototypical patient as an example, he introduced the following concepts:

• Portability (can I take my data with me),
• Interoperability (can different applications exchange information – can Cerner’s EMR exchange data with Google Health?), and
• Data liquidity (the degree of freedom with which data from difference sources are permitted to move over networks).

Possible routs to portability/interoper/data liquidity (which can be complementary):

• Maintain the status quo
• Legislative mandates
• NHIN+RHIOs
• PHIN

The PHIN platform companies include Microsoft HealthVault, Google Health, Dossia, and others to follow. Future platform vendors could be affinity ogranizations like AARP, banks, health insurers, large provider organizations and others.

The PHIN could be made up of multiple interoperable platforms. One one side are patients with intermediary applications or direct access to what Vince called “consumer access services.” These “middle” services are currently HealthVault, Google Health and Dossia. Interoperability is assumed between these various middle services (but by no means assured). Without interoperability it is like trying to use your Visa card at a retailer that only takes American Express. Interoperability would be like the phone system, where calls go across all carriers. On the other side are all the various providers in health care: payors, hospitals, physicians, labs, pharmacies, etc.

There are several challenges that PHINs must overcome. These are described as “conventional wisdom” or the status quo, and potential market responses.

Conventional wisdom #1: “It’s our data” where players in health care (payors, providers, etc.) consider their patient’s data as their data. Certainly patients can have a paper copy of data (for a charge), but the liquid flow of that data is purposely restricted. The emerging reality is that patients say, “Its my data, hand it over, now!” This means personally controlled health records. This transformation has no real legal changes. What’s missing is the ability to get that data electronicallly in an interoperable form.

Conventional wisdom #2: Proprietary IT and business models are sources of competitive advantage. This is the traditional proprietary product strategy. Market pressures are causing a small but growing number of vendors to move to common platforms to take advantage of a network effect.

Conventional wisdom #3: Building  NHIN/RHIOs with a “big bang” approach where an entire community or region ties everthing together in one big move. In reality, interoperability and data liquidity can be achieved incrementally, obviating the need for the perfect soluition in a single step. Vince sees business models being built around high value incremental applications.

Conventional wisdom #4: Personal health records (PHRs) done by patients won’t work; patients don’t understand, don’t care. Vince suggested that in fact, patients are getting it. More importantly,  PHR applications can be enabled for patients provided you have the data liquidity, automation and patient permissions.

Conventional wisdom #5, where the media positions this as a zero-sum battle between Google and Microsoft. The reality is that the competition is between electronic means versus the persistence of paper records where competitors like Google and Microsoft cooperate enough to grow the market.

At this point, David Kibbe took over to ask, “How is all this disruptive?”

If you were interested in being a participatnt in health care over the next 10 or 20 years, what would you need to be thinking about? Here are some key issues:

•  Health is personal, healthcare is not
• The PHIN-empowered patient is no longer simply an object for institutional medical process, but the locus of change
• We can’t expect government to “fix” healthcare (they haven’t fixed much of anything else)
• Consider the power of Wikinomics, community, collaboration, soelf-organization of health information
• “We’ve tried the experts, and it’s not working. Let’s try the wisdom of crowds.”

Transparency and openness will be key. Most of health care is closed. All along the supply chain, health care is made up of oligopolies and alliances. Outright secrecy about methods, pricing and data is used to gain competitive advantage.

The PHIN creates new opportunities for non-experts to access health data and knowledge, and to use it without (as much) need for experts.

Continuity is control. The patient needs to be the integrating agent in the system, and not the other way around.

We are at the dawn of an era of new tools and capabilities that can link a person’s health experience in time and space.

Coaches, caches, continuity, control are the watchwords. These tools will be expert systems for use by non-experts, and therefore must be designed to be used by patients.

The public benefit matters. There is a common interest, a public interest, in improving the health status of Americans. Kebbe promotes socialized health care.

Vince wrapped things up talking about the migration of multi parameter remote patient monitoring. This transition will be from high costs and proprietary systems (bound by low volumes and unnecessary duplication of capabilities that adds little or no value) to openness that provides the free flow of patient data throughout the health care system.

Next up was Liz Boehm, principal analysist Forrester Research. Her topic, creating a culture of wellness rather than illness.

Healthcare Everywhere – How the New Culture of Wellness Is Opening the Door for Healthcare Unbound

In 2002 Forrester was defining the HU market with focus on technology. In 2004 they sized the market and came up with growth projections. (She noted we’re getting uncomforably close to that hockey stick with little uptick in growth rate.) In 2005 they identified early adopters of HU. The “network” was the focus in 2006 – the ecosystem with Continua, HealthVault and Google. In 2007 Forrester looked at design elements and market requirements for seniors. Today we’re looking at culture versus biology.

We’re up against a culture that in some ways is antithetical to what we’re trying to achieve, i.e., wellness. Boehm went on to paint a pretty negative picture of society in the U.S. today.

In the U.S. our culture is about the here and now. We’re about profits rather than ethics, about near term costs versus long term costs – destroying our environment rather than hair shirt environmentalism. Simplicity (e.g., feedlots) compared to the complex (polycomplexity farming). Convenience (food that’s easy to find, tastes good) rather than health (foods that are more challenging to put together). Today’s pressure versus tomorrows consequences – smoking, sedentary lifestyles, etc. Her conclusion: Healthcare Unbound is antithetical to U.S. culture.

If were relying on consumers to suddenly gain an interest in health and wellness, we’re in for a long slog. HU is about prevention, management, outcomes and consequences.

Are there signs that times are changing? Perhaps.

Priorities are shifting in increased consumer interest in whole foods, and hybrid cars (although I would argue that’s only because of short term pain – $4 a gallon gas). In health care, consumers are bombarded with choices – type of coverage, primary care physician or specialist, community or teaching hospital, hospital ED or walk-in clinic, etc. Consumers also wonder if a PHR is safe, and is it worth the effort?
Patients are struggling with what they don’t know. Awareness of the actual impact of behavior is low. Perception: is healthy behavior worth the trade off? Psychology of loss versus gain: why does gaining a pound feel so much worse than losing a pound feels good?

Culture changes occurs at all levels, nationally, ethnic culture, at the family level, and at the corporate level.

Forrester surveyed corporations about HU. The top interests were preventive health, cost sharing with employees and wellness management. Wellness prevention investments have grown the most within corporations. But employers are still struggling with how to measure the impact of their efforts in this area. Employers want to measure things like drug compliance, health outcomes and wellness participation.

Employers are looking for one stop shopping, or to put it another way, they want whole product solutions rather than a few tools.

Consumers are looking for convenience.

HU vendors need to provide solutions rather than tools, and build on existing tech infrastructure (rather than waiting for PHRs). Boehm suggested using Boomers to get to their parents, i.e., drive adoption among seniors.

Behavioral Economics Goes Pop

Mike Barrett’s talk was, Behavioral Economics Goes Pop, is based on research that goes in sharply divergent directions. Behavioral economics was founded by psychologists and is now dominated by economists. Current research continues to use insights from psychology to challenge traditional “rational actor” assumptions. Two years ago, Mike introduced behavioral economics to HU. Last year, Mike dug into loss-aversion and associated negative information, with heightened risk of loss.

In the last 12 months, behavioral economists have pushed for a popular audience. Two books have come out, Predictably Irrational and Nudge, targeting the mass audience. Both books have done well. These behavioral economists are also getting proscriptive, suggesting solutions to the problems they’ve identified.

The focus of behavioral economics looks at the decision-making that departs from rational actor expectations. The focus is on heuristics and biases: framing effects, excessive optimism, status quo bias, lose aversion, anchoring, conformity effects, etc.

“Dual personality” conflicts like the id versus the super ego, becomes an exploration of the doer versus the planner, the human versus the economist and reflexive responses versus reflective responses.

Incentive effects are being explored, focused on monetary versus non monetary incentives.

The bottom line is that we are far less rational than standard economic theory assumes. The good news is that the irrational behaviors are predictable.

In the book Nudge, the author developes a construct called “choice architectures.” Anyone responsible for organizing the context in which people make decisions are “choice architects.” And this context is never neutral.

These behavior economists have developed a political frame work and justification for consciously creating choice architectures that they call “libertarian paternalism.” The libertarian part is leaving the ultimate choice up to the individual. The paternalism comes in how the economist creates the choice architecture.

A key concept in choice architectures how the question is framed. Humans are wired for context and this is where choices are framed.

Behavior economists recommend “social engineering” to correct for the distortions caused by heuristics and biases by putting those heuristics and biases to work in a good cause. Because there is no such thing as neutral design, defaults need to be tweaked to produce better choice architectures and outcomes.

Some interesting questions:

• Can payors be trusted as choice architects? Can politicians?
• Who plays the role of choice architect in social networks and patient communities?
• What is the right role for financial incentives?
• Who organizes the context in which people make decisions at home?

Mike provided the example of personal care robots and their ability to greatly influence choice architectures.

The notion of a PHIN is based on the assumption that patients reliably do the right thing – something that behavior economists show does not happen.

How Can Healthcare Unbound Avoid the “DM ROI Trap”

After the break, Gordon Norman of Alere Medical, presented “How Can HU Avoid the “DM ROI Trap.” Gordon admitted that he came today, not with answers, but with a series of questions.

The DM (disease management) ROI trap refers to the question, “does DM work?” Proving the value of DM once it is generally accepted and nearly ubiquitous becomes very challenging. And proof hurdles differ between academics, government and corporations.

In the early days, DM referred to the minority of the population that drives the highest levels of health expenditures. Employers who come into DM on the buyer side have an additional issue, presenteeism – employees who are present but not fully productive. Many employers are looking for someone to effectively address this much larger segment of the population. This extension of DM now includes wellness programs and health coaching, in addition to the traditional acute chronic disease management.

Now, DM means population health improvement to virtually the entire population.

The implied question is, does DM always work for every condition in every population? “Working” typically means short term savings and ROI. This assumes that DM is some monolithic invention, unlike the specific medical interventions applied to more acute chronic disease management.

Some better questions to ask:

• Does DM ever work for any condition in any population?
• Which outcomes are impact and in what sequence, over what time frame?
• How important is personalization of DM?

Due to different apporaches, policy wonks reach the conclusion that there is no proof that DM works, while employers and the health care industry concludes that DM does indeed have compelling justification.

In spite of this “absence of proof” DM is used in over 90% of health plans. Yet CMS remains skeptical. This issue continues to be worked out between CMS, industry and the DMAA.

Gordon ask if the medical home model and DM will converge. He suggested that the two are very complimentary. Since three fourths of patient practices have inadequate resources to implement the medical home model, DM firms could compliment those smaller practices.

Researcher Don Berwick once observed that, “the RCT is an impoverished way to learn.” A better model might be the CMO model (context + mechanism = outcome).

From Mainframe to Personal Healthcare:  A Progress Report on Addressing Technology, Policy, and Cultural Challenges

Eric Dishman, of Intel Digital Health, talked about the transition from mainframe to personal health care. The medical mainframe borrows from the concept of the mainframe computer. This highly centralized form of computing shifted to personal computers and smart phones.

Eric drew the analogy to health care, and posited that the current acute care delivery system – the mainframe – can’t effectively provide things like chronic disease management, wellness and prevention. Demographics and a constrained acute care delivery system will force the adoption of personal health care.

How do we create a vibrant personal health industry in response to and in order to prepare for the age wave? His solutions:

• Look beyond the acute care setting
• Enable care networks to drive healthy life styles, improved detection, etc.
• Focus on behavior markers (diet, exercise, weight, etc.)

The medical mainframe is all about biology, but behavior and how care is delivered are just as important.

His case study, fall detection, was based on the 3 Es: ethnography, evidence, and ecosystem.

• Ethnographic – Understanding falls, fall risks, and fear of falls in elderly homes;
• Evidence – capture baseline of falls and movement data; deploy to in-home pilots to prove prevention;
• Ecosystem – share common research platform of hardware, software, and data; collaborate to build 10,000 home testbed.

The emerging competition, oriented towards proprietary solutions, frightens Eric because without a certain common ecosystem underpinning the market, there will be no market for anyone.

Intel is working through the Technology Research for Independent Living to create a broad platform for research. The goal is to take university research to large population studies. Software is made available to researchers for free to facilitate research.

Real Time Incorporated is now the commercial provider for a common platform for wireless sensors called Shimmer.

Another missing piece is the R&D ecosystem for HU.

He asked, “Have you regularly used a PHR for more than 6 months and gotten medical/personal value from it?” Very few in the audience had. Eric’s conclusion: there is no market place. You’d have to hire a systems integrator to put all this together.

The good news:

• Products based on the Continua spec v 1.0 will be released soon
• More universities are doing work on personal health
• Conferences are abounding
• Press coverage is growing
• The CAST congressional vision video is increasing interest
• Early products are arriving
• Bits and pieces of legislation are popping up
• Some coalitions/non-profits are banding together

The downside:

• Very few products so far
• There is no channel or shelf space for these products
• Not enough value to warrant making a lot of money (and thus motivating entrepreneurs or corporations)
• Many corporate labs are small, barely hanging on
• Academic labs at risk; no publications, reviewers, tenure or scale
• Very little progress on prevention, behavior change
• Advocacy groups fighting for small bills and members
• The health care mainframe is fighting back

His advice for the industry:

• Get real – get out of denial about the thinking there’s no market
• Get large – create the ecosystem to drive sufficient value to grow the market
• Get loud – stop battling one another, join voices and work together

Q: How do we get through the mire in methods patents. A: Eric noted this as a huge issue with no obvious or short term solution. It’s gotten so bad that he’s finding it harder to negotiate with universities than companies like Microsoft.

The Internet of Bodies

Don Jones with QualComm, presented “the Internet of Bodies,” where he explored potential and actual successful wireless Healthcare Unbound applications.

Don started his talk with an overview of the wireless industry. There are now more than 625 million 3G subscribers world wide. Mobile services are becoming central to modern lives. Don’s group at QualComm is focused heavily on the body area network (BAN).

Don mentioned the Amazon Kindle as a device that’s really a cell phone that’s positioned as something completely different. The potential for non-cell phone looking HU technologies based on cell phone technology is considerable.

His summary of sensor platform requirements:

• Ultra low power
• Security
• Integration with sensors – prcoessing, essy configuration
• Smart nodes

Once the sensors capture the data and it is sent on by a gateway, you have to have data management.
A discussion of remarkably successful health and wellness products included the Wii Fit and Nike Plus described as the two most successful digital health products. The Wii Fit sold over 1 million units in a month – in Japan alone.

The challenge is the decentralized patient view and the standards for interoperability so products from different vendors all work together in support of the patient.

The Wireless-Life Sciences Alliance was noted as a forum for vendors to come together to build market awareness and create platforms for HU solutions.

The health care market is a very big – wide and deep – black hole. They see  very select rifle shots as having the best chance of success.

When asked about the patent situation, Don noted that the cell phone industry works on a “patent pool” approach to grow the market.

There was also a question about research on running life critical applications on cellular networks. Don’s response was that any product’s design must identify and mitigate all communications risks.

Google Health Overview

Jerry Lin, product manager at Google, presented Google’s perspective on personal health technologies. He suggested that the patient may be in the best position to manage information on things like redundant lab test results – or actually pointing to the previous lab test, precluding the need to have that duplicative test.

Semantic interoperability was noted as a major requirement. Alignment of incentives has a big impact on the adoption of semantic standards.

Jerry noted “long tail” applications, and providing their service for free (foregoing transaction fees) to drive adoption. They do see opportunities for third parties to provide valuable services from which they could generate revenue.

He went on to demo Google Health, showing the importation of data from third parties (Beth Israel Deaconness) and how patients could view and manage that data.

Q: What’s your strategy for driving adoption? A: By creating more value for the user.

Q: Issues were raised regarding Google’s current business model and whether that’s a fit for a service like this. Specifically, an account break in to Gmail and Google’s lack of the means to respond to individual situations, security, and normalizing data in the front end. A: Jerry had a rather unfulfilling boiler plate answer for this question.

Q: What’s Google Health revenue model? A: There is no revenue right now. They have yet to figure out how to monitize it.

Q: How doe they limit access to the data from internal Google employees. A: Patient data is encrypted and a limited number of employees have access.

Continua Health Alliance Update

Next up, Dave Whitlinger, director of healthcare device standards at Intel, with an update on Continua’s activities. Dave is also the president and board chair of the Continua Health Alliance.

Continua’s mission is to establish an ecosystem of interoperable personal health systems – as opposed to the usual proprietary end-to-end solutions. The three categories of personal tele health targeted by Continua are health and wellness, disease management, and aging independently. Continua aims to provide interoperability between sensors, gateway devices and the back end information systems. He noted the WiFi Alliance as an example of the desired cooperation between competitors with the goal of increasing market growth.

Version one of Continua’s device connectivity standards includes 11073 standards (just finishing up) running on Bluetooth and USB. The standard for connectivity to providers is HL7. Starting late this year and early next year, we’ll start to see new products with Continua logos.

Continua has about 500 modules of member written source code that can be downloaded by member companies. They’re paying contractors almost $1 million to finish up a common software library for connectivity. The code is “reference” only, and written for a generic reference platform, rather than optimized for a specific device. The reference is Windows XP, X86-based hardware, written in C/C++. The library will implement all the mandated features. The library modules include a common API. They estimate member companies can save $500k to $600k in R&D costs.

Use case voting for version 2 occurred earlier this year – a total of 16 use cases. It takes roughly 18 months to 2 years to go from use case selection to commercially available product.

Work is progressing on a project plan for companies to use Continua certified solutions in trials of remote monitoring products. There is also a global policy working group and regulatory user group working in their respective areas.

Continua has also pushed strong internal involvement, with meetings in Europe, Asia and elsewhere.

Dave sees the IHE as the key entity focused on interoperability in acute care.

Emerging Technologies Help Consumers Enjoy Higher Healthcare Standards

David Cerino is general manager, consumer engineering, health solutions group, at Microsoft. His presentation was titled, “Emerging Technologies Help Consumers Enjoy Higher Healthcare Standards.” David applied his experience in the market’s adoption of electronic banking and travel. He had some great suggestions about how consumers will shape HU, and similarities with electronic baking and travel.

He showed geographically based health care communities calling them silos, where providers take their best educated guess based on the knowledge they have. They want to put the patient in the middle to connect all their information together.

Microsoft took the platform approach. Health care is so big and complex, automating this industry is beyond any one vendor – collaboration is a requirement. Health care is always changing as science advances.

Microsoft’s position is that HealthVault is not a competitor to Google Health’s PHR, and that they should be interoperable.

A key differentiator of HealthVault is the Connection Center where device vendors can create interfaces so data from their devices automatically flows into HealthVault.

David compared and contrasted HealthVault with PayPal to illustrate how HealthVault is a platform. Both are data exchange platforms where the user experience is driven by partners. (The HealthVault team is not even marketing to consumers yet.)

HealthVault is not a PHR. A PHR’s end point is to store data. HealthVault stores data so that it can be shared with other entities in the health care delivery system.

The revenue model for HealthVault is based on search engine ads and lifting other Microsoft business.

Disruptive Healthcare Innovation – Changing the Rules of Diabetes Management by Marrying Wireless and Clinical Innovation in the Healthcare Ecosystem

Anand Iyer, president and COO of WellDoc, presented on “Diabetes Management and Emergin Wireless Solutions.” Technology as an enabler can make two key contributions in improved outcomes and lower costs.

Anand used an imaginary diabetic, Frank, to illustrate how WellDoc’s technologies can improve chronic disease management.

Traditional healthcare levels include disease management, pharma innovation, device innovation, and healthcare plan design. These levers have resulted in the status quo. Emerging innovation levers include health and wellness management, pharmokinetic innovation, solution innovation, and value chain design. The heart of this innovation is real time information distributed across a common network.

WellDoc’s solution is chronic disease management and welness coaching over cell phones using simple text messages. How interactions are designed and implemented has allowed a ubiquitous technology – cell phones and text messaging – to be used in a new and very effective manner.

How Health Plans Leveraging Active Biometrics Can Drive Member and Provider Engagement to Help Improve Health Outcomes and Lower Costs

Larry Leisure, North American president for iMetrikus talked about “How Health Plans Leveraging Active Biometrics Can Drive Member and Provider Engagement to Help Improve Health Outcomes and Lower Costs.” Employers impact plan design and health plans influence behavior.

Larry did a great job of laying out an approach to improving HU’s traction in the market to grow the industry.

Anand Iyer asked a question that showed a clear understanding for MVAs (multi vendor alliances, like Continua). Larry thinks the best trends will be driven by large employers.

Wireless Technology – Direct Connect to Influencing Consumer Behavior

Sherri Dorfman with Stepping Stone Parnters chaired this panel discussion. Richard Adler, Institute for the Future, lead things off starting with key mobile health trends:

• Evolution of wireless networks (3G networks currently, WiMax coming)
• More powerful handsets (multi modal radios)
• Smaller, more capable sensors
• Longer lasting batteries/lower power consumption
• Eventual adoption of EHR/PHR
• Development of effective behavior change algorithms.

Vince McNeil, Product Line Manager, Wireless Connectivity, Medical Business Unit, Texas Instruments, reviewed the “usual subjects” in wireless HU technologies – Zigbee, Bluetooth, GSM/GPRS, etc. The first proposed TI corporate pilot is a weight management wellness project. They’re going to use Body Media to monitor activity to track effectiveness in behavior modification. Next they will do a chronic disease pilot.

Aaron Goldmuntz, director of business development at Cardionet, described their mobile cardiac outpatient telemetry. Beyond their existing diagnostic service, Cardionet presented a atrial fibrillation disease and therapy management application. This would include correlation of HR trend and AF burden graph. This application can also be used to evaluate AF therapy efficacy by monitoring the patient be fore and after ablation.

Beyond patient management and self care, Cardionet has been successful in providing tools to cardiologists.

Silviu Chiricescu, principal engineer at Motorola Labs, talked about a planned trial. Targeting an independent living facility, a variety of sensors (glucometer, weight scales, NOBP, SpO2) will be used to manage a variety of chronic diseases. The study will have use a control group and will last a total of 2 years.

Paul Hedtke, from QualComm, talked about consumer perceptions on a diabetic self-management application. The solution aimed to be convenient (data logging, data capture), personalized (data driven, tailored assistance) and persistent (always there, integrated with phone). Solutions from t+Medical and WellDoc have shown to be effective – if you can get patients to use them.

Half of diabetics in the study expressed significant interest in a personal diabetics management service delivered via their cell phone. Interest levels were higher among newly diagnosed and those newly on insulin therapy.

Key features by level of interest:

• Converged devices (phone and measurement device)
• Auto logging of measurements
• On demand emergency assistance
• On demand live diabetes management advice
• Automatic medication management
• Automatic electronic diabetes management advice
• Integrated PHR
• Physician access to measurement data (QualComm was surprised that consumers ranked this so low)

Q: Wireless sensor band-aids, are those real today? A: Vincent noted that there are presently no released product like this. Paul suggested that adhesives may be the biggest R&D challenge to this application.

Q: Cellphones are quickly becoming the de facto ambulatory gateway; what do you see as the standard gateway for home use – will it also be the cell phone?  A: Aaron notes that cell phone coverage, especially in the home is still problematic. Cardionet has a home based gateway that plugs into the land line to complement wireless carrier networks. Silviu suggested that WiFi and set top boxes provide alternative gateways at home.

Q: Silviu was asked what vendors offer standards protocols for their wireless sensors. A: Silviu noted that the protocols are standard transport protocols, but they are going to be using products coming out of Continua’s version 1 work.

Doug McClure, transtioned the panel to consider business models.

Paul Hedtke noted that chronic conditions require a continuum of care that cannot be cost effectively delivered by the taditional health care delivery model. Potential models include:

• Provide tools that allow traditional health care providers to extend the “point of care”
• Provide tools that allow traditional disease management providers to provide more robust services
• Leverage technology to provide chronic condition management tools and services directly to consumers at consumer price points

The business model has to be more than instrumenting patients, with data now flowing into the physician’s office. For example, Cardionet built the platform to sell a service in order to relieve the cardiologist with a burden that they really weren’t able to cover.

LifeCOMM (QualComm’s announced MVNO) is a direct to consumer model experiment. They plan to bundle health services with typical cell phone services, employing a subscription business model. These services will be tailored for specific chronic diseases. They will build these services through collaboration with “brand authority” partners and market direct to consumers. They plan to sell through health product and services relevant channel partners

Richard explored the pros and cons of mobile as a health platform. It’s personal, portable, ubiquitous, connected and intelligent. The downside is that it is a heterogeneous environment (multiple operating systems), networks operate as walled gardens, its a rapidly changing environment, there appears to be a mismatch between the mobile and health care industry.

The most promising applications include: remote monitoring, reminders (appointments and medications), clinical trial communications, patient behavior change, and remote consultations.

In the long run, a very interesting HU platform is SMS texting. Over 95% of phones are text-capable. More than 100 million of 253 million U.S. subs use SMS. 41 mil Americans text “almost every day,” generating about 1 billion text messages are sent daily. At least 3 of the above 5 applications are well supported by SMS texting. There are even some provocative trials showing the ability to change behavior using texting. An evolution in the technology is MMS, multi media messaging service, for texting messages with still and motion pictures. (Richard also mentioned a low cost SMS application intended for NGOs.)

The future of mobile health care 5 key trends:

• Continuous monitoring (MD Keeper, RFID band-aid with temp, Body Bug, free swimming nano tech sensor)
• Continuous support – personal coaches for asthma, I Buy Right that reads packaged goods barcodes that provides additional neutritional and ecological footprint data, and an advanced pattern matching application that identifies your location and provides warnings.
• Remote consultations – the service shown is in the UK; patient competes an intake form on the Internet and then
• Mobile personal health record
• Merging of mobile and social media – Qwitter instead of Twitter to help stop smoking, Daily Strength and Patients Like Me patient support web sites.

Nowadays, patients show up for an office visit with research from the Internet, in the future they may come with their own support group with whom they will filter physician therapies.

Silviu is confident appropriate models will emerge – there is no one single model for everything.

Vince sees consumer electronics and preferences having a growing influence. The key will be not the what, but how best to use it.

Aaron noted that there’s tremendous enthusiasm about the consumer electronics market, but we’re in an environment where patients aren’t used to paying for health care and business models that better fit into the current health care market will be more successful in the near term. While some potential business models have huge long term potential, fitting them into the current health care industry is important.

Paul believes that new technologies will drive new business models. He suggested that if we let the health care providers dictate how to use new technology, only a small fraction of the potential of this new tech will be realized. Doug, who works for a large provider organization, agreed.

Twenty years ago, the thought of doing all your banking without ever facing a bank teller was inconceivable. Today most bank customers rarely interact with tellers.

Q: Is any one working on the meta analysis medical device? A: Aaron reported that there’s lots of interest, but there is an incremental approach being taken.  Paul referred to advances in automobiles; 10 to 15 years ago RPM was about the only thing continuously sensed on your car, now there are many parameters being continuously monitored and recorded. HU technologies are moving in the same direction. Vince sees the same requirements, but because these capabilities are new the market’s working out to use the new data (e.g., combining ECG and auscultatory data or gait data).

Q: What about the challenge in getting buy-in from physicians? For Cardionet, what challenges and success have you had in that area? A: Aaron noted that there are several things. First, they offer a service that takes a lot of the load off the physician. In terms of convincing payors, there is some intuitive persuasion but the heavy lifting comes from clinical trials.

The project was lead by Stephen Matchett, MD, Chair, and Project Sponsor, and included the following team members:

• I/S Applications and Administration
• Clinical Services Administration and leadership
• Respiratory Therapy
• Administrative Planning
• Pharmacy
• Clinical Engineering
• Others invited on as needed basis

The Lehigh Valley system is based on an application from iMDsoft. Device drivers for legacy devices (or devices that do not include connectivity) use serial device drivers written by iMDsoft. Patient context for devices with serial interfaces was done by bed location. [This works fine for an ICU implementation where patients rarely move - connectivity on devices connected to lower acuity patients should establish patient context in the device.] Data was received from devices with built in connectivity (via integrated network support) via HL7 from the device vendor’s HL7 server.

They use HP OpenView to monitor device connectivity as far as the Lantronix terminal server for serial-based devices. Devices with network connections can be monitored by OpenView up to the medical device vendor’s server. The links between the device and the next step (term server or device vendor’s server) is not visible to IT for monitoring. They usually get warning from biomedical engineering when new devices or firm ware upgrades, and test in advance of deployment.

An interesting part of their description of the project includes a test environment. During deployment, this environment was a “simulated ICU” that includes back to back TNICU/MICU beds in test, and four additional beds at remote ends of the ICU. Beds were added until the first twenty eight ICU beds were online. This required continuous coordination with Facilities and Bed Management. As the first 28 bed unit prepared to go live, additional units were subsequently wired & placed in test. This approach offered the following advantages: facilitation of training by department prior to “go live,” and identification and correction of system, device and workflow issues. Once fully deployed, they use spare devices (they’re usually available) to create a test environment as needed.

Surprisingly, they’ve had problems with some vendors getting the data required to develop a serial port device driver.

Christina Roberts, on the IT side, talked about the nursing and clinical engineering relationship. At Lehigh Valley, the IT department facilitates the coordination between nursing and biomedical engineering. The IT department takes calls 24×7 and provides tier 1 support for the aICU (and other clinical information systems). Depending on the problem, they will call biomedical engineering.

According to this story in the New York Times, “More than half the doctors from New York State, New Jersey and
Connecticut who responded to a survey conducted in April by the
American College of Emergency Physicians said that boarding had
increased significantly in recent years.” Boarding is the practice of treating patients in hallways of busy Emergency Departments, frequently while waiting for an in-patient bed to become available.

You can chalk up this survey as another example of the increase in reporting of patient safety and outcomes:

Ms. [Julie] Lloyd [a spokeswoman for the American College of Emergency Physicians] said the survey was the first by her group, or any other she
knew of, to try to assess the number of deaths resulting from boarding.
She said in an e-mail message that a key point in legislation before
Congress “is to collect boarding statistics, which heretofore have
remained the province of the hospitals.”

Public reporting of boarding seems to be in our future, nation wide.

Don't kid yourself, boarded patients have died, in New Jersey and beyond. There are no statistics on this because hospitals don't code the cause of death to reflect the preventable adverse event that killed them like, “death from inattention due to boarding.” Harsh? Perhaps, but this is a long standing problem in which most hospitals still wring their hands and ask, “what can we do?” Here's what they did at Stony Brook hospital:

[Hat tip: FierceHealthcare]

After spending nearly $500,000, a year to implement the system, and training 1,600 employees, the hospital went live.

[Hat tip: iHealthBeat]

Tony Chen at the Hospital Impact blog has a great post on the tsunami of recent deals in health care. These deals are changing the health care industry. Outsiders in the form of private equity investors and insider hospital M&A are gobbling up failing organizations or those weakened by market changes for which they have ineffective responses. Newly recast ventures that are successful will reward effective change which will drive additional change.

The change required is not the simple head count reduction, and trying to figure out how to do the same old thing with fewer people. What is needed are fundamental changes to the way that care is delivered. These are the changes that will reduce length of stay and improve both patient safety and outcomes. Hospitals today are stuck between a rock and hard place – the rock is the inexorable reduction in reimbursement, and the hard place is the increased visibility and transparency surrounding patient safety and outcomes.

Here are a couple quick examples of the change I'm referring to. Almost every hospital boards patients in the emergency department (ED) to a greater or lesser degree. These patients, shuffled off to out of the way halls awaiting admission, are cared for by off-service nurses (ED nurses) at ever worsening – and sometimes hair raising – nurse to patient ratios. A few heretical hospitals have started boarding those patients awaiting beds up on the floors, on their service. Consequently, each nursing unit could have 1 or 2 extra patients – receiving appropriate care (because they're in the appropriate unit) and at a nurse to patient ratio that is only slightly impacted by a couple extra patients. To someone from another industry this makes admirable sense. From my peers, I've heard excuses ranging from “it's jut not done” to “we can't do it because of fire codes (or department of health regs, etc.)”.

The other example is variable acuity care delivery. Hospitals are organized into units that are specialized based on the level of care, nursing vigilance, therapies that can be delivered, and staff training. This regimented organization was used in manufacturing 20 years ago. Like manufacturing in general, manufacturing healthy patients is not a steady state process. Consequently, census in units varies wildly from unit to unit and day to day. Some units are habitually over capacity, and represent the most common patient flow bottleneck found in hospitals – those over capacity units are critical care units with patient monitoring. Variable acuity units are an analog to manufacturing clusters or pods where the physical environment is quickly modified to adjust to new requirements. Rather than transferring patients because of needed patient monitoring, or a more sophisticated therapy, those patients are kept in their unit and those resources are brought to them. Monitoring patients outside traditional monitored units is a growing trend – half of the telemetry transmitters in hospitals are used on non-cardiology patients. Implementing variable acuity care units is not easy; it requires some pretty fundamental changes.

So, how do you accommodate falling reimbursement and demands to improve patient safety and outcomes? The opportunities to improve operations are many, almost as many as the excuses used to avoid substantive change. As private equity and M&A roils the health care industry, smart people will ask the hard questions with increasing fequency, and change will come.

Pictured right, “resistance is futile.”

The California Healthcare Foundation has underwritten a study looking at ambulance diversions across the state. Findings in this phase 1 report showed that state wide emergency departments (EDs) were on divert an average of 10% in 2005. Emergency department closings to ambulances continue to confound hospital administrators. You can read about a recent survey showing patient flow as an increasing problem here.

ED diversions also frustrate policy wonks and consultants due to the almost total absence of public reporting. Certainly hospitals (and their state associations), emergency response districts, along with some local and state governments, know their emergency room diversion statistics – they just aren't publicly available. Even though access to data is improving, organizations like the CHF have to pay to collect much of their data.

As expected, the study finds that ED diversions occur mostly in urban areas. Increasingly districts and hospitals are implementing “no diversion” policies – in other words they simply take the patients that they used to refuse – even though in most cases little or nothing has been done to improve emergency department overcrowding or patient flow.

You can download your version of the first report here.

Since patient flow interests me, all of the patient flow and bed management vendors are on my list to visit. I started with StatCom who officially introduced their new product at this year's show. Their new release is a combination of new architecture upon which they're running current and new applications. According to StatCom CEO Eric Morgan and EVP Ben Sawyer, the new release takes StatCom from a departmental orientation to supporting patient flow and the delivery of care on a new enterprise-level scope. Automation in support of the efficient movement of patients through the care delivery process is the health care equivalent of industrial logistics management – health care may lag 10-15 years in this area, but we can take advantage of concepts, software application design and architecture that have been refined over many years. Obviously, we can't just apply industrial management techniques to health care, but the concepts and processes are readily transferable to the delivery of care. StatCom is keenly aware of this and is drawing heavily on industrial logistics to guide and inform their approach to automating the care delivery process to increase patient velocity through the hospital.

Ken Kiser MD, CEO of MedSphere, is probably the most visible proponent for bringing the open source software model to health care. MedSphere is using the VA's VISTA EMR as the code base for their EMR. Last week MedSphere had two big open source releases. They released server and clinical information system services under a GPL license and another release under a Mozilla variation that they call an MPL license. This is their first big contribution of new features to the code base, that's available to the public. They've reserved some rights like attribution, but there are no license fees. Their business model is based on providing implementation services and ongoing software support and enhancement around their code base.

Ken believes the open source business model is well suited for health care. There are many applications and capabilities that providers would like to have. In a market dominated by large health care IT vendors, new software (what little they actually develop rather than acquire) must be justified by large market opportunities, leaving many market requirements unmet. Open source efforts can fill this gap by providing complete applications or software components that meet those needs that lack the big market potential conventional vendors need to justify new product development. The challenge for the open source business model is to come together into an effective organizing structure to facilitate interoperability, consistency and quality. With this most recent code release, MedSphere hopes to contribute to advancing the open source model. Rusty Lewis, MedSphere's CTO, is leading this effort and MedSphere plans to add dedicated resources to advancing open source software in health care.

Later I came across an RFID vendor I'd never heard of called RadiantWave. Business models in the RTLS space are presently going through considerable transition. Some vendors are moving to become enterprise infrastructure providers, others are moving into the application space. Some RTLS vendors have developed their own technology, while others have OEM'd their technology. RadiantWave is an unusual chimera – they are tag agnostic through an “edgeware” positioning engine that they developed and an enterprise mobile resource management system licensed from Red Prairie. RadiantWave has been working with large health care delivery providers (multi site providers is their sweet spot) by providing an enterprise logistics system and configuring specific applications for providers on top of that enterprise architecture. The result strikes me of an enterprise oriented custom application development business model. I can't decide whether this is an oxymoron or a brilliant business strategy.

Regardless of the motivation driving observation unit creation in a hospital, every hospital has observation patients. Because of their undeniable presence among your patient population, they cannot be avoided. Certainly improved management of observation patients has the potential to improve patient flow. But regardless of this potential, observation patients must be managed properly to ensure good outcomes – both clinically for the patient, and financially for the hospital. Recent reimbursement changes have increased the potential for negative financial outcomes with observation patients. A consensus among presenters was that observation patients managed in a dedicated obs unit were significantly better managed than observation patients placed in on-service care units throughout the hospital. Another key learning was that appropriate case management staffing levels are essential (and easily justified if you dig for the data) to avoid loosing your shirt with observation patients.

The practice of emergency medicine, for physicians and nurses, has changed over the past 10 years. The role of observation medicine has grown considerably – many ER docs and nurses still find observation medicine boring and look to swap assignments with others in triage or more acute care areas – but there is a growing acceptance and understanding of the observation role. At the same time, a growing number of hospitals are committed to getting observation right.

It struck me that the level of care delivered (not patient status) in most observation units is very similar to variable acuity units. Obs units tend to have a higher nurse to patient ratio than med surg, but less than the ratio in the ED. These specialized units also include patient monitoring capabilities and the observation of some pretty complex therapies like chemotherapy. Many of the same management and implementation challenges exist for both obs and variable acuity units – staffing skill mix, admissions requirements, and policies and procedures that are unique in the hospital. Many hospitals feel they lack the patient volumes to clearly justify dedicated obs units, despite patient flow problems. Why not create a unit that provides both observation care and variable acuity nursing?

Another topic that came up at the conference was the discharge lounge. The group reported, “I've never heard of a discharge lounge that worked.” And yet, the reasons described for past failures seemed, to this observer, to be implementation failures rather than an indictment of the concept itself. Creating new types of care delivery units of any kind in hospitals is hard - hence the value of a conference on observation units.

I also noticed at this conference a keen interest in other institution's policies, procedures, templates and guidelines – particularly as it relates to implementing a new policy or procedure at the requesting hospital. This is also a common request on the listservs that I subscribe to, the NPSF and biomed listservs. The delivery of health care is incredibly complex and highly variable from provider to provider. Other institutions' protocols, order sheets, policies and procedures are an interesting read, but their value is directly related to how closely your hospital's operations and environment (including providers and patient population) match those of the other hospital's – an unlikely coincidence in my experience.

There is no substitute for good needs assessment, planning, execution and ongoing active management; there is no “instant” observation unit kit to which a hospital can just add staff and a few hundred square feet to create an effective and profitable observation unit that will run itself. To me this is healthcare's greatest frustration and attraction – it's not easy playing Sherlock Holmes and helping solve Important Problems in the delivery of care, but it is what makes getting up the morning worthwhile.

Oh, by the way, you can buy a CD of all the presentations (except the pre-conference workshops like mine – those were charged for separately) from this conference. Go to this page, and select conference “HW707-01/22/2007 Optimizing Observation Pa, $150.00″ from the drop down.