Key Medical Recordkeeping Practices Impacted by the New Federal Rules
There are several key medical recordkeeping practices which will be impacted by the new federal rules, viz. disclosure processes, retention and destruction, litigation hold or preservation orders, spoliation and disaster recovery.
Discovery and Disclosure
Although an EMR may be regarded as a record completed in the “ordinary course of business,” because of the privacy and confidentiality rules also imposed by HIPAA, there are certain parts of records containing “personally identifiable medical information” which physicians and their staff must zealously protect from disclosure. This is especially true concerning content pertaining to HIV infection, mental health, substance abuse, and employee records.
Retention and Destruction
Organizations (including physician practices) must know where information is located (i.e. back-up tapes, instant messages, e-mail, word processing drafts) and establish a routine policy and practice for both retention and destruction which specifically identifies when the information’s useful life is over, resulting in destruction. The new rules provide a safe harbor in circumstances where information cannot be produced because it was destroyed as a result of routine policy and practice.
Litigation Hold or Preservation Order
A litigation hold or preservation order in the context of e-discovery is the same concept as that applied to a paper-based record. It suspends the normal practice or disposition, including destruction, of paper and electronic records. Several courts have held that routine document destruction should be suspended once a party reasonably anticipates litigation - see Heng Chan v. Triple 8 Palace, Inc., 206 U.S., Dist. Lexis 15780 (D.N.Y. 2006); Lewy v. Remington Arms Co., 836 F.2d 1104, 1112 (8th Cir. 1988) and Zubulake v. UBS Warburg LLC, 220 FRD 212 (S.S. N.Y. October 22, 2003).
Spoliation
Spoliation is the legal term for intentional destruction, alteration, or concealment of evidence. Efforts to prevent spoliation should be tightly tied to an organization’s policies and procedures for record retention and destruction, as well as to the policy and procedure for a litigation hold or preservation order.
Disaster Recovery
Disaster recovery seeks to preserve patient records in the event of a disaster (think Hurricane Katrina) and to return the organization to usual operations as quickly as possible. Although back-up processes are important to an organization’s resumption of operations, they may also become a legal liability. Consideration of destruction of back-up tapes once their useful life is over should be addressed in the retention and destruction plan (Cf. Generally: Rebelo, M., above at: http://www.physiciansnews.com/law/207rebelo.html).
Other Risk Management Issues
As covered in the November 2007 issue of Risk Review, along with the risk management benefits of EMRs’ “baked in” clinical alerts, there are also medical legal pitfalls if they are not used (without defensible justification). In an effort to avoid disruption of the regular clinical process workflow, medical legal hazards may arise due to either the turning off, ignoring or active overriding of clinical alerts or practice guidelines. EMRs which require the user to generate an explanation for why an alert or guideline is being overridden are almost always preferred.
However, there is still the possibility that such an explanation could be discovered and used against a defendant physician. To what extent EMR vendors may become involved as co-defendants or even expert witnesses in the future is beyond the scope of this article, but still worth pondering.
An EMR also has the ability to create an electronically traceable path that a patient has followed throughout the care process for an episode of illness. This is especially true to the extent that embedded electronic data that is usually “hidden” from view of computer users (the so-called data about the data or “metadata”) is also discoverable. This “metadata” is discoverable under the new federal rules and might well be in those jurisdictions such as New Jersey which have embraced these rules. Still, the extent of discoverability of “metadata” (which could be used to reconstruct a case’s chronology and produce a record of when everybody may have accessed a particular patient’s record) may ultimately be decided on a case-by-case basis.
Nevertheless, the new discovery rules may require that metadata created by computerized physician order entry (CPOE) systems be produced. This metadata may be discoverable even in situations for which hospital policy does not require the data to be integrated into a patient’s permanent health record (e.g. where pursuant to hospital policy, the EMR system does not integrate clinical overrides made in the CPOE system into the EMR) (Rollins, G. The Prompt, the Alert, and the Legal Record: Documenting Clinical Decision Support Systems, J. AHIMA, 2005; Feb; 76(2):24-8). This discoverability of metadata may apply to physician office-based EMR systems, also.
Summary
All of the above is certainly not intended to provide yet another reason to avoid converting from paper to EMRs. As a matter of professional and economic survival in the next three to five years, physicians will need to undertake that transition in any event—voluntarily or involuntarily.
Rather, this article is intended to alert physicians and their staff of these new e-discovery rules. They need to be kept in mind when installing and using EMRs, to capitalize on their many clinical decision-making and economic benefits for physicians and patients alike, without falling into some of the traps which may prove costly should litigation involving the discovery of those electronic records ever arise.