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H H S Department of Health and Human Services
U.S. Department of Health and Human Services
Health Information Technology and Quality

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How do we ensure that our electronic patient records will satisfy evidentiary requirements?

General Requirements for Admissibility
Generally, the rules of evidence are no different for electronic records than for paper records. Medical records are first subject to the hearsay rule, which says that any statement made out of court by a person not currently testifying is not admissible. However there are a number of exceptions to this rule, one of which is the Business Records Rule.  Medical records are considered business records.
For any business record to be admissible in a legal proceeding, it must be properly authenticated.  In the case of medical records, a "sponsoring witness" must normally testify that the medical record meets certain conditions. Usually the sponsoring witness will be someone who knows enough about your medical record procedures to testify about how they are created and maintained.
Computer print-outs are often used when the evidence is stored electronically. This is typical procedures for producing records from EHR or other electronic data systems.

Evidence in Electronic Form
While the basic rules of evidence are the same for paper and electronic records, there are several important differences. Compared to paper records, most courts consider electronic records to be more voluminous, more difficult to destroy, easily modified, easily duplicated, potentially more expressive, and more readily available. As a consequence, strict new rules were enacted in December 2006 requiring the preservation and disclosure of electronically stored evidence.

Authentication of Electronic Records
Authenticating records means showing they are a reliable representation of the event recorded.  With EHR systems, this means paying special attention to factors such as the reliability of the computer equipment, the manner in which the data was original collected, the measures taken to insure the accuracy of the data when entered, the methods to ensure stored data is not tampered with, changed, or destroyed, and the overall measures to verify the accuracy of the application programming.  With the increased publicity surrounding all types of security breaches, data tampering, and unauthorized access to computer systems, at some point courts wills stop routinely admitting computer print-outs without questions about their overall security and reliability.

  • Legal Medical Record (PDF - 157KB) go to exit disclaimer -- Fact Sheet (2006) from HIMSS that provides high level information on what data in an EHR should be considered part of the "legal record" and thus discoverable.
  • E-discovery and HIM: How Amendments to Federal Rules of Civil Procedure Will Affect HIM go to exit disclaimer (2006) -- Overview of the new Federal Rules for preserving and documenting EHR data used for legal purposes written by AHIMA.  Written more for the records custodian and health care attorney with responsibility for producing admissible records or responding to subpoena, but it does provide good overview of some of the changes and issues surrounding EHR evidentiary data.
  • New Electronic Discovery Rules go to exit disclaimer (2005) -- AHIMA publication summarizing the 2006 Federal Rules for Electronically Stored Information with suggestions for compliance by health care organizations.
  • Maintaining Legally Sound  Healthcare Record go to exit disclaimer (2005) --  AHIMA publication describing the legal requirements for authenticating medical records subpoena's for legal proceedings.
  • The Legal Process and Health Records go to exit disclaimer (2005) -- AHIMA publication that provides general advice on how to understand what aspects of an EHR system should be treated as a legal record with discussion of the implications.  This document is somewhat dated but still relevant to understanding the differences and importance in the types of data maintained by an EHR system.
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