Electronic Health Records Pose Several Challenges, as appeared in The National Law JournalDecember 14, 2009
They are not static documents, but abstractions, so proving preservation becomes difficult.
So far, the implementation of EHRs has outpaced traditional litigation collection and production practices, which have focused on producing static pieces of evidence, like paper documents. Unlike paper documents or even many electronic documents, EHRs exist as abstractions composed of thousands of data elements in relational databases that may include data hosted by business associates of the organization or other providers and payors. The defense of a covered entity, if data contained in an EHR are relevant to the case, has become expensive and inefficient. More often than not, opposing counsel, including the government, fails to fully appreciate the fluid nature of the modern data-centric medical record. This often results in health care providers being required to produce physical copies of EHR medical records in response to government oversight and enforcement agencies and during litigation. Since EHRs are not documents but rather abstractions, responding to such a request presents several challenges.
Every EHR system is unique. In fact, EHRs created by the same vendor often do not operate or structure the underlying medical records in the same fashion. EHRs are not like paper-based records; the medical record does not have what can be properly termed as folders, pages or documents. And, unlike e-mail or other electronic text documents, an EHR does not have a universal structure. In addition, EHRs are not required to be maintained or accessed using a specific format. So how should they be produced? Since EHRs by nature are not documents with pages, a request that requires production of a stamped medical record often results in inefficiencies associated with tedious tasks such as printing and producing screen shots of pieces of the EHR.
To further complicate the issue, most organizations view the medical record using multiple data abstractions that may be highly customized by department or user type. For example, the hospital emergency department may view and access the medical record using a different tool than a floor nurse, case manager or treating physician. So, which screen shots should be produced as the official medical record? The answer is not clear but should never obligate a party to produce all data in every redundant viewable format.
Considering the amorphous nature of an EHR, authenticating the underlying data also presents several difficulties. Authentication seeks to confirm that a produced piece of evidence is what the proponent claims it to be and that it has not otherwise been altered since it was collected. As lawyers attempt to establish the authenticity of a dynamically generated electronic document, they often are put in the difficult situation of explaining to opposing counsel, and potentially the trial judge, that an electronic health record is not a static document but rather a living document that is continually changing. Issues are further complicated when one set of medical records data is produced to opposing counsel and a few months later the same set of data is produced again and the data do not match. The failure of a system to produce repeatable, consistent results can turn even the most technologically friendly judge into a skeptic.
Courts have commented on problems associated with authenticating electronic data. The U.S. Court of Appeals for the 9th Circuit in In re Vee Vinhnee, 336 B.R. 437 (B.A.P. 9th Cir. 2005), addressed the authentication of electronically stored "business records" and focused on the effectiveness of the document-preservation process. According to the court, "the record being proffered must be shown to continue to be an accurate representation of the record that originally was created....Hence, the focus is not on the circumstances of the creation of the record, but rather on the circumstances of the preservation of the record during the time it is in the file so as to assure that the document being proffered is the same as the document that originally was created."
The emphasis on proving preservation during authentication requires parties to examine how changes in the database were logged or recorded; the structure of the data; the existence and implementation of backup systems; and audit procedures for assuring the integrity of the record. Consequently, authenticating a data set such as an EHR not only burdens counsel to prove that the evidence is what it purports to be, but also imposes additional burdens to prove that it continues to be as it was. In an EHR context, this is often prohibitively expensive and at times impracticable.
During litigation, health providers issue litigation hold notices that instruct personnel not to change or destroy pieces of evidence. However, by its nature, an EHR is designed to be a fluid data set that changes with each patient encounter to enable more effective health care delivery. So long as the historic data relevant to a given matter are preserved, providers should not be penalized if the patient has another medical event and the EHR changes during litigation.
This is not to suggest that, if historic information is improperly destroyed or altered, the responsible party should not be held accountable. Rather, the legal community should establish clearer guidelines that allow a proponent to preserve and establish the authenticity of a dynamic data set notwithstanding the fact that the data in the data set may have increased in size since litigation was initiated. Otherwise, health care providers will continue to be burdened with the expense of moving large data sets to storage in order to preserve a static copy of a record for litigation rather than simply maintaining the data in an active system.
Unfortunately, in the litigation context, preserving and making data available has become so expensive that winning a discovery request for electronic data has become a significant game-changing strategic advantage. After a long and often fruitless discussion between opposing counsel on which format is most reasonable for producing proprietary EHR, the state-of-the-art procedure is to produce custom reports to opposing counsel using functionality that already exists within the software, i.e., using Crystal Reports, and/or custom SQL (Structured Query Language) queries run against the underlying database. This method preserves the file in a static form for litigation while saving time and money. But lawyers for both sides need to stipulate to the use and authenticity of such reports, which themselves are merely abstractions of the original. The use of these reports offers a more efficient method of production when compared to paper; however, they are merely an intermediate step toward a long-term solution.
The inability of the legal community to reconceptualize the concept of a document has also resulted in some substantial inefficiencies in a nonlitigation context. For example, health information exchanges — networks capable of electronically moving clinical information among disparate health care information systems while preserving the meaning of the information being exchanged — are required to maintain a static copy of any document transmitted to another provider as a PDF or image, or in another immutable form.
Inefficient production of screen shots and unnecessarily expensive electronic preservation will probably have to give way to alternative production methodologies. At some point in the future, EHR systems may be designed with an industry-approved discovery and production tool. Currently, there is no "one size fits all" approach; however, parties can engage in a responsible cooperative approach to discovery of EHR. Under a new legal framework, counsel could, for example, make the active system available to opposing counsel for a supervised review and both parties could stipulate to the information in the record. Or both parties could agree to use a third-party vendor to create an abstraction of the data and stipulate to its authenticity.
Given the compelling public interest furthered by EHRs, it's time to consider alternatives to the use of overly broad production and preservation requests as settlement leverage. In order to facilitate the use and success of EHRs, the legal community should depart from viewing electronic medical records as static documents that can be printed, stamped and produced, and move toward producing or otherwise making available the EHR in a responsible manner that takes into account efficiency, expense and the goals of the proceeding.
Reprinted with permission from the December 14, 2009, edition of The National Law Journal © 2009. ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited. For information, contact 877-257-3382, [email protected] or visit www.almreprints.com.