Getting Electronic Health Record Standards Right

The following is the text of the Editorial from the latest issue of my eJournal, Standards Today.  You can find the complete issue here, and receive a free subscription here.

On January 20, a new show opened in Washington D.C. After eight years under one administration, the curtain cascaded down on one set of policies, and a moment later rose to unveil a new administration, with new ideas, new priorities, and a new agenda. Included in that agenda is a commitment to embark on a five year quest to dramatically decrease the cost of healthcare — by investing as much as $50 billion dollars of public funds in the design and deployment of something called "electronic health records," or EHRs.

Readers of this Blog, but not the public at large, will be immediately aware that the foundation for the EHR vision is standards.

As of this writing, $20 billion of that amount is included in the current House draft of the Economic Stimulus bill called for by the new administration. The full cost of EHR implementation, including private expenditures, has been estimated to be $156 billion over five years, not including $20 billion in operational costs. With such a price tag, the promise of EHRs had best be realized, or the new administration will have some significant explaining to do.

At its most basic conceptual level, an EHR is to a medical chart what an electronic spreadsheet is to its paper analog. And indeed, the roots of the EHR can be traced back to the concept of "computerized patient record" technology that would allow a doctor to enter notes with a stylus on a tablet PC. But the value of these early records was only realized by the hospital that hosted the proprietary system to which the tablet was linked. When the patient left the hospital, his data was left behind, unavailable even to the physician that had entered the data when she returned to her own off-site office. Nor could the data be accessed by any other physician elsewhere in the future, or by the emergency room staff of any other hospital to which the patient might be taken in the future. Instead, islands of isolated data were created by each physician and facility in technically idiosyncratic fashion, and maintained in proprietary systems, never the twain to meet.

The result is that we are constantly filling out new questionnaires in doctors’ offices and waiting days or weeks for paper copies of records to be printed by one care giver to be mailed, hand delivered or faxed to another. In emergencies, we are apt to be cared for by medical staff that have no access to vital facts relating to our medical history at all, perhaps with unfortunate and avoidable consequences. Meanwhile, our care providers are weighted down with expensive, tedious and duplicative record keeping.

The ultimate goal of health information technology is therefore a medical record in which a patient’s medical information will accumulate over a lifetime as a succession of care givers contribute it. That data will be accessible from anywhere, and at anytime, by those to whom the patient wishes to give access. Because everyone will enter and access the data in the same way, the quality of care should increase, the incidence of avoidable mistakes should decline, data input and storage and other costs will decrease, insurers will be able to verify claims more accurately and make payment more speedily, and patients will have greater control over their own medical information. With appropriate provision for protection of patient privacy, masses of invaluable, comparable data would also become available to researchers to speed the advance of new treatments and medications.

Whether wide uptake of EHR technology and real savings are achieved quickly will in great measure result from how well the standards that enable EHRs are selected, assembled and integrated into actual systems.

But in order for this eHealth nirvana to be attained, millions of hospitals, doctors’ offices, emergency responder units, insurers and others will need to purchase and install the software and other technology needed to create, maintain and exchange EHRs, and their personnel will need to be trained to use them. All of this can only be achieved at great cost of both public and private funds.

Readers of this blog, but not the public at large, will be immediately aware that the foundation for this entire vision is standards — taxonomies to ensure uniformity of data input, identifiers for authentication, security requirements for authorization and maintenance, protocols to enable communication between systems, data formats to ensure long term accessibility, and much more. Upon this foundation must rest other standards tools — frameworks, profiles, reference implementations, and guidance documents. Indeed, the blueprint for a successfully deployed, national EHR infrastructure must by definition be a complex and carefully constructed hierarchy of standards.

Designing and deploying this standards-based infrastructure will be comparable in scope and scale to designing and deploying the Internet, minus the requirement to build the telecommunications backbone that is now already in place. But unlike the "opt in" Internet, to which users gradually migrated in increasing numbers over two decades as the Web’s capabilities grew and its lure became more seductive, EHR technology must be adopted very widely before cost savings begin to outweigh expenditures. Unless that happens quickly, it will be many years before meaningful savings are achieved.

Whether wide uptake of EHR technology and real savings are achieved quickly will in great measure result from how well the standards that enable EHRs are selected, assembled and integrated into actual systems. Unfortunately, the history of ambitious standards projects has not always been a happy one, and for every grand success like the World Wide Web there is a well intended POSIX that fails to achieve its hoped-for destiny. Moreover, the record of EHR deployment success to date, both within individual hospitals as well as in national programs abroad, has been mixed.

The lesson to be learned, then, is that we had better get the standards right, both from a real world as well as a technical perspective. If the standard suites mandated do not solve real problems in ways that work for care givers, vendors and other stakeholders, then this ambitious and worthwhile endeavor will be doomed from the outset, and an enormous amount of money will have been squandered.

Getting the standards right is possible, but will not always be easy. As with any other government initiative involving vast amounts of money, those with the most to gain will have the greatest incentives to steer decisions to their advantage. Those in government who do not have deep expertise in standards development but may find themselves charged with achieving rapid results will be hard pressed to know which recommendations to follow. Finally, until the standards are finalized, the greater part of the funding available cannot be spent. All of these forces will work against making the best decisions in the time necessary to make them.

The Obama administration should therefore pursue its EHR agenda with as much caution as speed, and with deliberation as well as determination. Because once these important infrastructural decisions have been made, it will be difficult indeed to turn back.



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