EMRs as Part of Larger Networks

Electronic medical records provide an alternative to paper based records. They are also a source of information that can be used as part of other processes to address a wide range of healthcare issues. Here’s one example:

Congress has passed a bill requiring food processors to implement systems to track cases of food that may be related to outbreaks of food-borne illness.

An estimated 76 million people contract food-borne illnesses in the U.S. each year, with 325,000 hospitalizations and 5,000 deaths, according to the Centers for Disease Control and Prevention in Atlanta. Those illnesses cost the U.S. economy $152 billion a year in health care and related expenses. Rapid identification of the source of these illnesses and their removal from the market is critical.

Under the required tracking system, farmers would scan individual cases of produce, keeping records of where they are shipped. If a recall is ordered by the FDA, the records would be quickly disseminated to trace the current location of the recalled produce.

Once specific cases have been identified as carrying a food-borne illness, the new system will allow those cases to be removed from the market; however this is only part of a complete system. How can the illness be linked to specific cases of food? Here’s where an EMR system can help.

Most EMR systems provide for reporting of food-borne illnesses. By adding a few additional elements of information, the search for the source can be narrowed very quickly. When a doctor enters a diagnosis of food-borne illness, the system can ask for the type of food that is suspect, i.e., eggs, fish, spinach, etc., and the name of the market where the suspected food was purchased. The EMR can track doctors’ reports and when a target number of similar reports is reached an analysis can be launched. A single answer will not be helpful, but if the answers from several cases list the same food and the same market or chain, that provides a place to start. Appropriate information can be forwarded to a public agency.

Samples can be acquired, tests run, and the investigation focused on just a few likely sources. Once a case of food carrying an illness is found, the food processors’ system can be used to find all of the cases from a specific producer and they can be remove from the market.

There is one other piece to the complete solution and that is rapid access to a large enough number of records to find what may be an isolated set of incidents. There are a number of organizations including the VA, Kaiser, and vendors of hospital systems that have large databases and could report to public health agencies or the FDA. There are also physician office systems like Practice Fusion that are database driven and can quickly draw information from more than five million patient records today.

The tracking process from identification of a problem to a solution would look like this:

This provides an illustration of the way an EMR can also be linked to other tracking systems to identify and facilitate the search for health issues such as some common types of sports injuries or automobile accident injuries. EMRs are clearly more than just systems to replace doctors’ paper records.

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The Promise of EHRs for Pharmaceutical Companies

Today pharmaceutical companies conduct extensive research to obtain Food & Drug Administration (FDA) approval of a new medication. Typically this pre-approval research is structured in three phases: Phase I, a small (20-100) group of healthy volunteers to assess safety; Phase II, larger groups (20-300) to assess how well the drug works; and, Phase III, randomized controlled trials on large patient groups (300–3,000 or more ) to assess effectiveness vis-à-vis with the current ‘gold standard’ treatment.

Phase IV trials involve the safety surveillance of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than is possible during the Phase I-III clinical trials.

There are opportunities to use data from Electronic Health Records (EHR) for Phases II and III, but the larger opportunity, and the one addressed here, is Phase IV, post approval surveillance.

Theoretically it should be possible to use the growing body of data in EHRs to track patients for whom a new medicine is prescribed. However, EHR adoption is still very limited; almost all reports show adoption rates less than 10%. More important, there are more than 200 vendors providing EHRs, all of which are built using limited standards for the information to be acquired, the coding for diagnosis and treatment, and for the exchange of information.

Historically, it has proven very difficult to exchange information among multiple systems within a single organization. The generally accepted solution is an enterprise resources program (ERP) which is complex, costly, and difficult to implement.

The collection and exchange of medical information is simpler in some ways and more difficult in others. The efforts of the Federal Government to develop and implement EHR standards will help but there is a great deal to do and the final definition and implementation of standards will take time—probably several years. Even with standards, there will be minor differences among systems developed independently by a large number of vendors that will limit the industry’s ability to exchange information and will raise questions about the quality of the data.

When a significant body of common data becomes available, pharmaceutical companies should be able to use that data to track a sample of patients using a new medication in “near real time,” perhaps within a week after a doctor sees a patient. This could provide four major benefits.

• First, regulatory agencies may give earlier approval subject to effective ongoing sampling and reporting of any adverse reactions—earlier to market.
• Second, any adverse reactions could be found early and evaluated to minimize damage to patients—minimize patient harm.
• Third, early warning could lead to examination of additional data from existing medical records of patients receiving the medication relatively quickly and at relatively low cost. This will further define the risk and whether or not there are patient, disease, or treatment conditions that create or reduce risk. It may be possible to eliminate a risk just by restricting use based on definable conditions—protection for both the patient and market value of the medication.
• Fourth, timely responses to an identified risk will make it difficult for plaintiff’s attorneys to successively demand punitive damages. Compensatory damages will be smaller and punitive damages will be smaller or non-existent—reduced legal costs.

There is enough information about current and near term EHR systems for pharmaceutical companies to develop strategies to use more and better data they will offer. The time to begin the development of those strategies is now.

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Hospitals: reform, stimulus & codes

This month, August 2010, McKinsey has published several articles about the impact of changing regulations and other market dynamics on healthcare costs, investments and benefits. Earlier I summarized and provided a link to one of their articles: Health Insurance: reform, stimulus & codes That post addressed insurance companies; this one provides the save service for hospitals.

New regulations that require US health care providers to use electronic health records (EHR) and adhere to strict data-coding standards will force hospitals to spend billions of dollars over the next decade to upgrade their IT systems. The spending requirements risk squeezing hospital capital budgets already under strain from steadily rising costs. With government incentives covering only a small portion of the total, providers will be forced to recover quickly their investment dollars from operating changes.

… Our research shows that automating and standardizing health care information can bring benefits that extend beyond meeting demands for compliance. A provider that creates a best-practice IT platform to house and share medical records, to manage hospital resources more transparently, and to define precise guidelines for medically authorized tests and procedures can generate significant operating efficiencies. Such a platform minimizes paperwork, reduces the number of unnecessary treatments, and lowers the risk of drug and medical error.

The productivity and resource savings often pay back the initial IT investment within two to four years while also producing better health outcomes for patients. We estimate that total savings across the US provider landscape could be on the order of $40 billion annually. Achieving such a positive return on investment (ROI), however, requires distinctive change-management skills among hospital leaders, better governance, and sustained engagement from key clinicians.

Estimates suggest that a wave of US legislation and regulatory changes will affect up to 80 percent of the existing hospital IT applications. Among the most far-reaching of these developments are provisions, laid down by the American Reinvestment and Recovery Act (ARRA), requiring health care providers to implement IT capabilities such as electronic health records and computerized-physician-order-entry (CPOE) systems. While some providers use electronic health records on a limited basis, the new regulations standardize what is expected from them and make their use mandatory.

An accelerated timetable means that US health care providers have until the end of 2015 to make the investments or face fines starting at $2,000 a bed in the first year and up to $35,000 a bed by 2019.¹ In addition, both revisions to the Health Insurance Portability and Accountability Act (HIPAA) 5010 and the switch to ICD-10 require providers to apply strict new data-coding standards—no small task given the number of databases, hospital systems, and clinicians affected.

…US hospitals will need to spend approximately … $80,000 to $100,000 per bed, for the required project planning, software, hardware, implementation, and training.

Our research shows that optimizing the use of labor, reducing the number of adverse drug events and duplicate tests, and instituting revenue cycle management can help typical hospitals generate savings of some $25,000 to $44,000 per bed a year. … The realization of the benefits from health care IT investments will require a radically new approach to IT on the part of the CIOs of health care providers, as well as the business leaders and clinicians those CIOs serve. Health care providers will need to use new approaches to achieve an inclusive governance process with streamlined decision-making authority, a radically simplified IT architecture, and a megaproject-management capability.

Many of the changes that are facing healthcare require new systems, new delivery processes, and new management strategies. In short: new ways of doing business. The sheer volume of work to be done and the need for new thinking suggest a need to bring in new talent to assist those already in healthcare meet the wide ranging challenges of the next few years.

The complete report is at: https://www.mckinseyquarterly.com/Health_Care/Strategy_Analysis/Reforming_hospitals_with_IT_investment_2653#

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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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EMRs: Increasing Complexity and Capabilities

EMRs and the Internet: evolutionary processes

The Internet is a place where a good idea are expanded and enhanced to make them more and more useful to more and more people. Early email often included links to “cool” sites and then we got Web crawlers that gave us access to more site and then there was Google. Email with lists of recipients grew into social networks that are still expanding.

Tomorrows medical records will be electronic, have formats that include today’s standard codes plus further refinements that make the sharing of existing and new information available for uses we have not even dreamed of.

A recent example: “Many in the medical community believe that those who treat depression would be able to dramatically reduce suicide or medication related problems if the doctors had access to daily mood diary data. Pilot data from John’s Hopkins has confirmed that. … We will use the Johns Hopkins University depression mood tracking SMS technology [the technology of Twitter] and adapt it to connect to the Practice Fusion EHR instead of the current physician standalone system [which will make it available to additional doctors and bring all relevant data to a single patient record.]” http://goo.gl/3R6v

Simply using today’s paper based formats and codes for the creation of medical records does not provide for “daily mood diary data” from cell phones and other SMS devices and the integration of the additional data with traditional medical data.

The history of the Internet argues that whatever is built today must allow for future flexibility for new uses and new technologies. Simply providing faster ways to replicate the faxing of standard code-based-forms will not provide access to the benefits that can be achieved.

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Electronic Tower of Babel II

“Friday, July 30, 2010: When the Veterans Affairs and Defense departments began testing health information sharing for their joint virtual lifetime electronic record (VLER) project, they could not initially exchange patient data successfully using the very standards specified by the Office of the National Coordinator for health record formatting. …

“Dr. Doug Fridsma, acting director of ONC’s standards and interoperability office, used the experience of VA and DOD as an example of the trickiness of getting standards right so healthcare providers can exchange health information properly. C32 is among the requirements of ONC’s recent final rule on standards and certification of electronic health records (EHRs).” Government Health IT http://govhealthit.com/newsitem.aspx?nid=74346

Two agencies of the Federal Government encounter the electronic Tower of Babel. Can 200+ vendors who are focused on individual healthcare providers with little or no financial incentive to deal with the networking of data beyond insurance do it better?

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EMRs: An Electronic Tower of Babel?

When you mix 200+ EMR vendors with $19 billion dollars of federal funding and send them out to chase 700,000 doctors and 5,000 hospitals what do you get? We are about to find out.

Years ago the commercial world learned that it is almost impossible to network and share date between computer systems sponsored by siloed organizations within a single company: marketing, production, distribution, HR, etc. The solution was enterprise systems (ERPs) from a limited number of vendors that cost millions and take years to fully implement.

Now we are looking to independent medical providers to acquire systems from a very large number of vendors driven by pressure to implement quickly with only limited standardization of some data and expecting to reap the full benefits of networked data.

It sounds more like a recipe for an electronic Tower of Babel than a solution for the 21^st century. Am I missing something?

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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