Monthly Archives: September 2010

EMRs: Increasing Complexity and Capabilities IV

EMRs as networks of networks

The Internet is sometimes described as a network of networks. Electronic Health Records (EHR or EMR), like the Internet, are becoming a network of networks. Just three examples: Practice Fusion provides cloud based EHRs for physicians that facilitate the exchange of information between practitioners and patients, the later in the form of personal health records (PHRs). OmniPACS provides cloud based bio-imaging data services that facilitate sharing of information between bio-imaging service providers, doctors and patients, the later in the form of, you guessed it, PHRs. Surescripts provides e-prescribing software so a doctor can accesses the patient’s prescription benefits and medication history from all of their doctors (including patient visits to in-store clinics)   and route prescriptions to a patient’s pharmacy of choice.

A friend of mine describes it as, “the systems are transparent to the data.” What is important is the ability of the systems to capture the data, store it, protect its privacy, and make it available in various forms to meet the needs of the people who “own it” or the needs of people who are authorized by an owner to access the data. Systems will come and go and others will evolve to meet the needs of the owners and users of the data.

The growth of EMRs began with stand-alone systems and is evolving by adding network capabilities. The simplest level is the exchange of data located on a single computer between two doctors or a doctor and patient. We are rapidly moving to an environment in which the data–wherever it is located–can be shared. Specific patient data can be shared to meet the needs of the patient. De-identified general data about a patient population can be shared for research and public health.  The data can be delivered in multiple formats to meet the needs of a broad variety of users while protecting patient privacy.

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EMRs: Increasing Complexity and Capabilities III

Change-over-time rather than point-in-time

There is an evolving body of services that gather health related data beyond the scope of traditional healthcare and then deliver the data and analysis to your personal health record. They provide a form of diagnosis based on measurement-of-change-over-time rather than the point-in-time-assessment made at your doctor’s office or a hospital in response to an incident. The enabling technology records information about what you are doing or how your body is reacting as it as it happens and then transmits the data to a central computer for analysis.

The data and the analysis are then sent to you and your doctor. Not necessarily better information but additional information for preventative medicine or to supplement the assessment of a medical incident.

The Internet has a history of beginning simple and then adding new capabilities. It is not clear whether need leads to the creation of these new capabilities or the new capabilities awaken unfelt needs. Either way the scope of the information that is available continues to grow and systems become more robust. That kind of future evolution must be built in to each step forward if progress is to continue. Two recent examples:

US Preventive Medicine is offering a preventive “program and it sounds pretty cool: you pay $229 for the first year, complete an online health risk questionnaire, and then go to a local lab to have a panel of blood tests. The company sends your lab results to a PHR, you and your doctor get a custom prevention plan, you gain access to online dashboards and action programs, and a nurse advocate is available to help with health maintenance. Since it’s not tied to insurance or employment, nobody sees the information without your approval.”
DirectLife, a subsidiary of Phillips, provides a, “program designed to help you become more active by setting goals based on your current activity levels. The monitor tracks your movements and, when plugged into the computer, transmits your data to the website where you can track your progress.”

I would be surprised if there are not similar services already available on your iPhone or Android based phone that will expand the amount of data available for diagnosis.

I’ve written on this topic before. The first dealt with the Johns Hopkins University depression mood tracking SMS technology. The second dealt with Intel’s ten year old program studying technical and societal solutions for problems related to care for the aging. On August 2, 2010, Intel and GE announced the formation of a joint venture that will focus on telehealth and independent living which suggests further expansion of these and related programs.

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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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Health Insurance, Y2K & a PMO

The impact of the change from IDC-9 to IDC-10 for health insurance companies has been characterized as comparable to or larger than Y2K. The linked PowerPoint deck provides background on the issues and a starting point for the development of a Project Management Office for health reform including the change in coding. Health Insurance & Health Reform

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