Medical Records Are Just One Form of Healthcare Information.

In just a few years medicine has taken major steps to move from paper records in individual doctor’s offices to electronic medical records that can be shared with patients and their other physicians. The primary point of coordination of care among a patient’s physicians is moving from the patient—I saw Dr. Adams last month and he told me…—to the patient and her team of physicians who share the same records. The good news is each physician now has more information; the bad news is they have no additional time to analyze it. That is the tip of the iceberg.

At the same time, the marketplace has seen the value of health related information and is rapidly creating new ways to collect that information. Sources as diverse at private individuals working on smart phone apps to corporate giants like Ford Motor, Intel and General Electric are creating new ways to capture more and more health related information. Most of this will be routine but some of the haystacks will have needles of data critical to a healthy future for some patients or even life savings requirements.

Physicians can choose what medical information to collect depending on each patient’s specific circumstances; they can decide what is relevant and influence the volume of physician generated medical information. Patients will make the decisions about the information to be collected from many of the marketplace solutions: Here are my vital signs taken during my bicycle ride last week when the temperature was 89 to 95 degrees and I climbed 1321 feet and averaged 13.2 miles per hour. Here is the data from my Ford car last month and the statistics Intel/GE captured with regard to when I took my medication and how I answered the phone. How good is the data? Are there any needles of critical data?

We are rapidly moving from inadequate amounts of data to overwhelming amounts.

Prior solutions are the source of almost all significant problems. There is a problem on the horizon and now is the time to explore ways to manage the growing amount of data being generated and shared within the medical community and the marketplace. The people who are harnessing computers to capture medical data may be the logical ones to develop ways to capture, assess, integrate and analyze the growing amounts of data or the solution may be out in the marketplace. Stay tuned.

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Prediction: Pharmaceutical Litigation

Pharmaceutical litigation is where huge lawsuits are common. I predict that this will change and the change will reduce the damage to the bodies and lives of patients, reduce the cost of healthcare, and speed up the process of moving new medications from the laboratory to patients. What will cause that change?

Historically, the pharmaceutical manufacturers have been responsible for the collection, analysis and distribution of data related to benefits and side effects of new medications. Data collection has been an extra cost of doing business. Like all costs, there is pressure to minimize these costs. If, and when, publicly available data including anecdotal evidence begins to point at a serious problem, the plaintiff’s bar also begins to develop data about risks and damage.

The cost of data collection using today’s methods imposes economic limits on the amount of data gathered by manufacturers. Cost control argues for the smallest amount of data that will likely be required, but how much is that? The smaller the data sample the less likely it is that a risk will be identified early in the life of a new medication. If a risk is limited to just some patients, a small total sample makes it unlikely that a risk to a sub-set will be identified, e.g., males over 70. If the total sample is statistically small, a sub-set will be even smaller and less reliable as an indicator of both the need for action and as a guide to appropriate action.

The push by the federal government for healthcare providers to shift from paper records to electronic healthcare records (EHRs) has been seen as a potentially slow process. The common model assumes EHRs will be implemented first in hospitals and then spread to private practices because of two factors: first, the cost and complexity of the required computer systems, and second, the lack of the standards required to move meaningful data from system-to-system for consolidation and analysis.

The maturation of the Internet in terms of processing and security now means that data can be safely moved and stored. Cloud computing—remote data processing and storage—now allows service providers to grow new services rapidly without large up-front investments. The net result is a dramatic reduction in cost for the service provider and users, e.g. physicians. As an example, one company, Practice Fusion, provides a full function EHR to private practices totally free. Step one in the changes that are occurring is unexpected reductions in cost.

Hospitals generally have short term relationships with patients whereas private practices generally have longer term relationships. Private practices monitor more patients over longer periods of time than hospitals. Step two is a shift from hospitals first to private practices first for widespread implementation of EHRs which will provide better longitudinal data about the effectiveness and risks of new medications.

The original model for EHRs envisioned small libraries of patient data sitting on the hard drives in the offices of thousands of doctors. Solutions for the nightmares associated with moving and consolidating all of that data are still on the drawing boards. Rather than “stand-alone” systems, the Internet and cloud computing allow the use of a common set of databases and a single set of standards. As an example, Practice Fusion now has seven million patient records from 70,000 medical professionals in their database. That is nearly 10% of all of the doctors in the US and growing rapidly. The data from thousands of doctors is being monitored as it is received. The data is all in a common format and is available for analysis and reporting in near-real-time. Step three is the availability of large databases with one set of standards that dramatically reduce the time and cost required to convert data to useful information.

The data that was formerly collected by the manufacturers as an additional cost of doing business is now being collected as a routine part of patients’ visits to their healthcare providers. There is little or no extra cost to track a new medication. The data is being collected by nurses and doctors trained in diagnosis and documentation as a normal part of their medical practice. Step four is further lowering of costs; step five is better quality data.

The availability of more, better, and cheaper data at lower cost offers opportunities to reduce the risks associated with new medications and may allow regulatory agencies to approve new products with less research subject to close tracking and third party analysis of results. Lower cost of research and earlier to market could represent significant cost savings for new medications.

As a new medication enters the market feedback about its effectiveness and risks will begin to flow very shortly thereafter. Manufacturers who chose will be able to measure and document effectiveness and will also be able to identify risks. As the patient population using the medication grows, the sample being tracked will also grow. This means that that as risks become significantly large—however significance is determined—the data base will be growing to support both risk assessment and mitigation. Manufacturers, if they chose, will have new opportunities to minimize damage by providing additional information to the medical community and patients and to develop specific responses to specific problems. Timely action will reduce compensatory damages and responsible action will reduce punitive damages. Timely responsible action will reduce damage to the brand in the marketplace.

Manufacturers who chose not to participate in the analysis and application of this data will probably find that plaintiffs’ attorneys are using the data to find opportunities for litigation. The plaintiffs’ attorneys will probably argue that the reluctance of manufacturers to make effective use of the data justifies demands for increased punitive damages.

My prediction: more, better, faster, and cheaper data will speed up the process of moving new medications from the laboratory to patients, reduce the cost of healthcare, and reduce the damage to the bodies and lives of patients who have adverse reactions to new medications. Changes in the way that healthcare data is being collected, processed and stored will reduce both compensatory and punitive damages related to pharmaceutical litigation.

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EMRs: Increasing Complexity and Capabilities V

Bathroom Scale, Apple ear-buds & 9,000 variables

A video of a direct link from a bathroom scale and from a blood pressure cuff to a patient’s computer and from there to their personal health record (PHR) that is linked to their doctors’ (intentionally plural) records. YouTube

A short video showing Apple ear-buds that can capture body temperature, heart rate, and blood oxygen level plus a number of other small devices to provide real-time and near real-time measurements of body functions including level and amount of sleep.TED

“BodyMedia has been working closely with Apple and Google, to develop its smartphone application. It opens the door to allowing a person to monitor a collection of the 9,000 variables — physical activity, calories burned, body heat, sleep efficiency and others — collected by the sensors in an armband in real-time, as the day goes on. The Bluetooth-enabled armband costs $249 and the BodyMedia data service costs $7 a month, when purchased in an annual subscription. The new offerings go on sale next month [November 2010] at the company’s Web site and at Amazon.” The company claims they have already “helped over 400,000 users monitor 10 million days of activity” using earlier devices.

Potentially massive amounts of additional data that can be captured, stored and analyzed at the level of the patient’s record or the doctors’. Data that can be used to track progress and risks in essentially real-time. Data that can be used to improve healthcare and reduce costs.

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Health Insurance: reform, stimulus & codes

I have been focusing on electronic medical records from the point of view of physicians and hospitals. The impact on insurance companies may be even greater. An article in McKinsey Quarterly: The new IT landscape for health insurers, August 2010 ends with the conclusion: “… CIOs will need to transform more than 90 percent of a typical payer’s IT architecture and help other executives make the corresponding changes in their business processes.”

The article provides a comprehensive analysis supported by two exhibits that define and illustrate the issues. Excerpts:

Periodically, a dramatic change in an industry enables CIOs to step up and play a decisive role in corporate affairs. We see such a seismic shift in the US health insurance industry, which faces the most sweeping changes in its half-century history. The ranks of the health care payers comprise more than 350 companies, with combined revenues of $500 billion and combined IT spending of $13 billion annually. Three principal regulatory currents are producing the impending change:

Health care reform: The legislation anticipates 30 million new individuals will join insurance rolls, while an additional 100 million will be shifting policies. The law will usher in a fundamental change to the industry’s business model. Today: 90 percent of all private policies are paid for by employers that negotiate prices and terms of coverage. The recent legislation mandates new insurance exchanges, subsidies, and tax credits that will lead millions of consumers to contract directly with the health insurance payers.

US stimulus funding: In 2009, the US Congress passed the American Recovery and Reinvestment Act (ARRA), which contains special provisions for health care IT. These reforms will first affect providers, as over the next decade health care will become rooted in readily available, comprehensive medical records and IT-based clinical decisions. …  payers’ will need to build substantial new systems that can readily interface with health information exchanges and analyze electronic health records.

ICD-10: The modern data format documenting diagnosis and procedure codes—ICD-10—was released by the UN World Health Organization in 1994. But it is overdue in the United States, where it will replace ICD-9 and expand the available number of medical codes by a factor of eight [in some cases by a factor of 144.] This change will enable a much more detailed description of diagnoses and treatments. While ICD-10 promises to improve the accuracy of medical management and claims, its adoption will force payers to undertake an effort likely to exceed that of the Y2K campaign. Yet while the costs of adopting ICD-10 are significant, the potential regulatory penalties for failing to adopt will make it a necessity.

There are concerns being expressed in the medical community about the availability of resources to provide the infrastructure required for electronic medical records. Add the demands for resources required by insurance companies and the outlook is even more grim, unless of course, you are one of those needed resources.

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EMRs: Increasing Complexity and Capabilities II

EMRs, Intel, GE and telehealth for seniors

Intel has been studying technical and societal solutions for problems related to care for the aging for more than ten years. On August 2, 2010, Intel and GE announced the formation of a joint venture that will focus on telehealth and independent living to tackle the increasing global burden of chronic disease and age-related conditions. Said simply, using technology at places other than medical facilities to improve senior health.

Some of these technologies, particularly the diagnostics, will be heavily data oriented. As an example, monitoring and tracking the ways a person uses the telephone to detect changes that are predictors of Alzheimer’s and Parkinson’s 5 to 10 years before clinical symptoms appear. The analysis is based on subtle changes over a period of time. For an engaging explanation link to a TED MED presentation at http://goo.gl/vALK

More and more data over an extended period of time. Almost certainly, additional providers serving the same or related areas. The providers will deal with the data collection and analysis and then what happens? It needs to be linked to other medical data, both historic and current, analyzed, and made available to the person being monitored so they can be responsible for their own health to the fullest extent possible, to their doctors – seniors almost always have multiple doctors – and the person’s caregivers, and concerned family members. Different forms and presentations of results based on the same data for different uses and users. Complexity and capabilities way beyond the scope of the systems being installed today.

Intel and GE are preparing to do this now. It will be a few years before the impact becomes a major issue but now is the time to design our EMR systems and networks to deal with the increasing need as the population ages and as the technology to assist them advances.

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Six Tech-Enabled Business Trends to Watch

The August 2010 issue of the McKinsey Quarterly is titled: “Ten tech-enabled business trends to watch.” http://goo.gl/cpqN  Six of the trends are related to EMRs and EHRs. I took advantage of an invitation to be a guest blogger to write about these six trends. The post concludes:

EMRs/EHRs started by addressing a limited opportunity: moving from paper to electronic files and to then sharing the data. The Internet is full of examples that started small and evolved in ways undreamed of. That will happen to EMRs/EHRs and, like all other changes on the Internet, it will happen with increasing speed. The six items above provide an “outside the box” look at some of what is on the horizon.

The post is at: http://goo.gl/bYy0

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EMR Risk & Opportunities Map

Medical information is rapidly moving from paper records to electronic formats and new sources of information are being added. The electronic formats provide opportunities to capture, store, share and use information in new ways. These new ways create risks and opportunities.

Most of the elements identified and discussed here have been identified and discussed by others. What is new, is a broader view of more elements at the same time and their interdependencies.

It is these interdependencies that pose risks and create opportunities.

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THE MAP

EMR: Free? Really!

Free is a marketing term that typically evokes a mixed set of reactions ranging from an optimistic “You have my attention, tell me more,” to a cynical “There’s gotta be a catch,” to a pessimistic “There’s no such thing as a free lunch.” All three of these showed up when I heard about a free electronic medical records system offered by a company called Practice Fusion.

Their Web site referenced the book Free: The Future of a Radical Price, which includes an analysis of “How can healthcare software be free?” So I read the book. The basic theme is that costs of data storage, transmission, and processing are falling so fast—on the order of 50% per year–that the costs associated with “bits” of data (as contrast to “atoms” or physical stuff) are heading for zero. With atoms, revenue usually has to be associated with cost. With bits, revenue can be loosely related to costs or even independent of costs.

At the level of a private or small group medical practice the typical evolutionary path for medical records is from paper to site-specific computer to networked systems. Most of the software being sold today is site specific which means the doctor has to pay the up-front costs and networks will be added on. But, only some of the value accrues to the doctor and there is little or no broad agreement about what the networks will be or how they will be managed.

Practice Fusion sees the value in both the local data and data that is networked. Their basic premise is that by providing an EMR to a doctor the doctor’s data will be in a format consistent with the data of all of the other doctors using their system. With the appropriate consents and controls in place, the data can then be networked among subscribing doctors with full compatibility. Subscribing Doctor A can send a patient’s data to Subscribing Doctor B without translation, formatting or delay. Doctor A can send data to other doctors who do not subscribe to Practice Fusion with a similar level of ease or difficulty as using a site-specific system. Data can also be forwarded to billers and insurers.

With appropriate consents and controls in place, the data from multiple practices can be de-identified, consolidated, and shared with public health agencies and medical researchers to further increase its value at a very small increase in costs. Data can be sold at a higher price because it will be in a standard format and in larger quantities. A researcher, whether a not-for-profit institution or commercial company that needs 1,000 records will be able to go to one place and quickly get records of a known quality. Practice Fusion will recover its investment and cost from advertising (optional to users) and the sale of the data.

Practice Fusion has placed itself in the enviable position of having a cost structure that is getting less expensive and a revenue stream derived from data that is becoming more valuable over time as it gains longitudinal range.

Free presents the following hypothetical model:

Medical associations conducting research on specific conditions require longitudinal health records for a large set of patients. Depending on the focus of a study (think white, middle–aged, obese males suffering from asthma) each patient’s anonymized chart could fetch anywhere from $50 to $500. A physician typically sees about 250 patients, so Practice Fusion’s first 2,000 clients translate to 500,000 records. Each chart can be sold multiple times for any number of studies being conducted by various institutions. If each chart generates $500 over time, that revenue should be greater than if Practice Fusion sold the same 2,000 practices software for a one-time fee of $50,000.

[Practice Fusion is now reporting, “… 30,000 users across all 50 states and US territories.”]

Free is an option worth considering. Does that mean you should sign up? No.

The normal business process for selecting a system is to do a high level search and assessment to narrow the number of candidate systems for further study. The fact that free makes sense just means that a Practice Fusion system, or others like it, qualifies as a first round candidate.

The next step would typically be to prepare a cost/benefit study among the top few candidates. Because one of the systems is no-cost, the focus for the next step should be based largely on benefits.

Moving medical records from paper to a computer system provides opportunities to reduce office costs and improve both administrative and medical services to your patients. Benefits will include those directly related to the creation, storage, use, and networking of records plus those related to administration such as the non-medical part of patient records, appointments, billing interfaces, etc.

If you have already done your homework, now is the time to look at the benefits of a no-cost system. If you haven’t done your homework, check with other doctors and see what systems they recommend—both positive and negative. Get vendor documentation for other systems and acquaint yourself with the benefits those systems offer. Make a list of must have, like to have if cost is reasonable, and nice to have. Also, a list of things to avoid (negative benefits.) Now go look at a no-cost option and compare the benefits.

If a pair of shoes doesn’t fit, they aren’t worth taking home even if they are free. If a system doesn’t provide the benefits you need, don’t waste time considering it further. You do not want to change your practice to save money on a system. You want a system that will allow you to get the benefits at the lowest cost in terms of dollars with no negative impact on performance.

If a no-cost system provides the benefits you need at least as well as a for-cost system you have your answer. If two systems have comparable benefits, the cost/benefit analysis will always be better for a no-cost system than one where you buy it or pay a license fee.

If a no-cost system meets you minimum requirements and a for-cost system provides better benefits, you need to judge whether the better benefits justify the cost. They may. If a free pair of shoes fit but are not your style you will probably get more value out of a pair you like even if you have to pay for them. It is sort of the same thing with a computer system.

As a place to start, free is definitely worth considering. Be certain the vendor has a business model that makes sense. If it does, the next step is to get more information and be certain the system really meets your current and long term needs. But, that’s material for another blog post.

A footnote: On May 14, Chilmark Research, one of the healthcare blogs we follow posted a blog titled Where’s the Beef about another company that is offering a free service. That company claims it will be “generally available” in August. “Imagine our disappointment when we clicked on the [site] to find very few concrete details as to what the platform would offer …” Free is a good place to start but the real test is whether or not the system provides the services, protection, etc., you need. Thanks Chilmark for helping us make the point that it takes more than just free to make a system attractive.

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Cathedral & Bazaar Revisited: Healthcare Information

One of the problems we face when we talk about electronic medical records, personal health records, etc. arises because we think and talk about them as systems. A recent post on LinkedIn says:

What was apparent from the first 23 comments is that opinions and perspectives are all over the place. It’s not clear folks are all of one mind with respect to WHO constitutes the users, WHAT constitutes an EHR, what constitutes usability, and/or HOW one should be assessing usability. Many look at usability only from, ultimately, the safety perspective (decreasing medical errors), but how about efficiency, including impact on overall workflow? User acceptance/satisfaction? What are the appropriate usability measures by which to evaluate EHRs?

These are systems related questions. Systems lend themselves to being defined, developed, deployed and used. That is not the case with healthcare information. The information requirements of healthcare providers, patients, and the supporting infrastructure are evolving rapidly as we learn what works and what doesn’t. Supporting technologies – iPhone and iPad to name just two – are evolving and enabling new cost effective services to be provided. The economics of health care are changing because the current medical business model doesn’t fit any economic model that makes sense and the economics of health care are what will provide much of the funding for information solutions. The problems and opportunities of health care information don’t lend themselves to the discipline required for traditional systems.

In 1997 Eric S. Raymond published an essay called The Cathedral and the Bazaar that described the traditional system development process as centrally managed and built to last like a cathedral as contrast to a bazaar that is constantly being modified by its users to meet their evolving needs—in his essay: Linux. The article was sold and is now copyrighted and available only for a fee.[1]

Eric now points to In Praise of Evolvable Systems by Clay Shirky which points in the same direction. I think Shirky’s definition of Evolvable Systems provides and apt description of what is required to realize the benefits promised by improvements in health information:

THREE RULES FOR EVOLVABLE SYSTEMS

Evolvable systems — those that proceed not under the sole direction of one centralized design authority but by being adapted and extended in a thousand small ways in a thousand places at once — have three main characteristics that are germane to their eventual victories over strong, centrally designed protocols.

  Only solutions that produce partial results when partially implemented can succeed. The network is littered with ideas that would have worked had everybody adopted them. Evolvable systems begin partially working right away and then grow, rather than needing to be perfected and frozen. …

  What is, is wrong. Because evolvable systems have always been adapted to earlier conditions and are always being further adapted to present conditions, they are always behind the times. No evolving protocol is ever perfectly in sync with the challenges it faces.

  Finally, Orgel’s Rule, named for the evolutionary biologist Leslie Orgel — Evolution is cleverer than you are. …  it is easy to point out what is wrong with any evolvable system at any point in its life. … However, the ability to understand what is missing at any given moment does not mean that one person or a small central group can design a better system in the long haul.

Evolution is messy, brilliant ideas don’t work, money is wasted, efforts are duplicated, but the Internet has shown that the process is capable linking growing requirements with expanding capabilities to produce solutions to problems we don’t even know we have. The Internet is a better model than traditional, cathedral like systems for what we are dealing with when we talk about converting and sharing medical information in an electronic format.

It’s dinosaurs vs. mammals, and the mammals win every time. … Infrastructure built on evolvable protocols will always be partially incomplete, partially wrong and ultimately better designed than its competition.

There will be some large systems to deal with complex environments. Small systems to deal with special needs. “Apps” to deal with general needs, and forms we haven’t imagined to deal with opportunities undreamed of. We need to recognize that lack of clarity and structure is just part of the process. We need to learn to live with it and occasionally laugh at it, curse it, and celebrate it

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[1] Eric S. Raymond (1999). The Cathedral & the Bazaar. O’Reilly. ISBN 1-56592-724-9.

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Safe Patients, Smart Hospitals

If you are concerned about the quality of health care and rising costs, read this book.

If you are responsible for change management in a corporation, read this book.

If your are working on an electronic medical records system, read this book.

Peter Pronovost, M.D. and Ph.D. took on change management as a process to reduce the costs, and more important, the risks of serious illness or death associated with the practice of medicine. This book is not just about a good idea. It is about having a good idea and then doing what needs to be done to realize the benefits of that idea.

“We knew our success would depend on three key elements: Developing and unambiguous checklist that would encapsulate as much evidence or knowledge as we could capture on a particular procedure; changing the culture and associated broken systems to remove any barriers to implementing that checklist; and measuring results so we could gauge the checklist’s efficacy and provide feedback to provide whatever changes are necessary to improve it.”

“What was striking was that nobody debated the evidence, nobody challenged the items on the checklist, and nobody questioned whether we should do them. But everyone objected to the change in culture. … Perhaps the most radical step we took was to promote the checklist was we gave it to family members of patients. We explained how it worked and why it worked and encouraged these nonclinicians to observe and ask nurses and doctors if the procedures were not being followed. … Now that family members were aware of the checklist, they were asking useful questions that actually helped the nurses and doctors do their job.”

Great move, but one that requires clear support from the people responsible for performance in accordance with the checklist – doctors and nurses – and senior management. For a number of reasons that are covered in the book Dr. Pronovost and his various teams had outstanding support from the senior management of John Hopkins Hospital.

As a business analyst for process improvement and systems development, I find that good ideas are relatively common. Particularly those that include the results of shared experience and thoughtful consideration. “… changing the culture and associate broken systems. …” is the hard part and the part that is least understood by most champions of change. The way Dr. Pronovost and his various teams dealt with those issues is some of the most interesting material in the book.

By the way, very well written.

Safe Patients, Smart Hospitals
By Peter Pronovost and Eric Vohr
Hudson Street Press, 282 pages, $25.95

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