Electronic Discovery and Electronic Health Records
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Electronic Discovery and
Electronic Health Records:
The Impact of “e-Discovery” Involving “EHR”
Upon Healthcare Entities
Gerald “Jud” E. DeLoss, Krahmer & Nielsen PA, Fairmont, MN
and Edward F. Shay, Post & Schell PC, Philadelphia, PA
Amendments to the Federal Rules of eral discovery requirements. Safe- The EHR may encompass a wide
Civil Procedure governing electronic guards should be implemented to variety of types of information. ESI
discovery (“e-discovery”) took effect ensure that the EHR information will such as patient vital signs, radiologi-
on December 1, 2006. These amend- not be altered, improperly disclosed cal films and reports, and consulta-
ments have tremendous potential to to third parties, or improperly tion reports, although in different
either simplify litigation or over- destroyed. Healthcare enterprises formats, could be stored side-by-side
whelm litigants not prepared to should not underestimate this chal- in the EHR. The manner or means
address the enormous volume and lenge given the sheer volume of ESI by which this data is stored in the
variety of electronically stored infor- stored in the databases of EHR sys- EHR could also vary. The storage
mation (ESI) subject to production tems. Further, the production of ESI media utilized may be widely dis-
in discovery. This article is the sec- contained within the EHR system persed throughout the organization.
ond part of a two-part series on e-dis- must remain accessible over time It is up to the healthcare entity to be
covery.1 While the first part focused despite the technological advances able to track each of these types of
on the requirements of the amend- and/or obsolescence of the system data and access it within the dead-
ments, this part will attempt to apply on which it is stored. lines imposed under the Rules to
them to e-discovery in healthcare, produce it in discovery.
particularly to the electronic health Healthcare entities may face difficul-
record (EHR) and related health ties attempting to locate every source Storage formats may change over
information technology systems. It is of ESI in order to produce it in litiga- time as technology advances and
further the position of this article, tion. Much will depend upon the changes allowing for more efficient
shared by many observers of e-discov- architecture of the EHR system. The backup and storage media. Tapes,
ery, that the federal model will most ESI itself may be located in one cen- discs, and hard drives may give way to
likely be followed in future litigation tral repository, but it could be the new and exotic storage mechanisms
by the courts of the several states, compilation of several parties’ input. in the future. The organization must
making the observations here useful Furthermore, portions or copies of keep in mind that not only must this
to those who may be engaged in liti- the EHR could have been transmit- information be accessible on a future
gation often brought in state courts ted electronically to other locations. date; it must also be producible to
(e.g., medical malpractice). The EHR could be downloaded or opponents in litigation as well.3
accessed by practitioners or author- Under the amendments, opponents
ESI, and Therefore EHR, Is ized users via the Internet. The may request the ESI in any reason-
Discoverable advent of handheld computers also ably reproducible form, including
means that portions of the EHR native file format. To the extent that
The amendments specifically provide could reside in the memory of a mul- the ESI is reasonably accessible by
that ESI is discoverable.2 And, EHR titude of mobile devices. If ESI is pro- the organization, the same process
content is clearly ESI. Upon receipt duced from multiple sources, the for accessing the information may
of a document hold request, a authenticity and integrity of the need to be provided to its opponent
healthcare entity must review its EHR “original” electronic record will be in litigation in order to review and
system and the internal policies and crucial to deflecting charges of alter- analyze the ESI.
procedures governing EHR to ensure ation of ESI or even spoliation of evi-
that it can comply with the new fed- dence.
MAY 2007 5ing information. However, for many sent functionality not only creates
HEALTH INFORMATION AND TECHNOLOGY
enterprises with home grown, patch- and applies the informed consent
PRACTICE GROUP LEADERSHIP
work, or transitional electronic template, stepping the physician
Edward F. Shay, Chair record systems, this may not be the through the relevant risks and
Post & Schell PC, Philadelphia, PA case and could, for example, compli- advice, but it also may create in
eshay@postschell.com cate a defense based upon demon- parallel a progress note that shad-
strating what was known and when it ows how and when the consent
Gerald “Jud” E. DeLoss, Vice Chair – was known. was obtained—including alter-
Membership ations and modifications. A tradi-
Krahmer & Nielsen PA, Fairmont, MN Production of EHR-based ESI also tional paper form of consent will
gdeloss@fairmontlaw.com brings with it the potential responsi- not show the need to go back
bility to provide opposing counsel and add a new risk or modify the
Phyllis F. Granade, Vice Chair –
with the means to review that infor- consent, but some EHRs will
Educational Programs
Carlton Fields PA, Atlanta, GA
mation in its native electronic format. show this interplay. Enlightened
pgranade@carltonfields.com Ideally, electronic review will take by e-discovery and EHR function-
place off-site without granting oppos- ality, in an informed consent driv-
Becky Williams, Vice Chair – ing counsel real-time access, for en cases, things will not be as
Publications & Editor example, to a medical group’s inter- straight-forward.
Davis Wright Tremaine LLP, Seattle, WA nal computer system. If the organiza-
beckywilliams@dwt.com • Clinical decision support or
tion’s EHR system does not allow for
adverse drug alert tools are dis-
off-site review, then it is faced with a
Robert Q. Wilson, Vice Chair – coverable. When operating, these
dilemma. Can the ESI be translated
Research & Website alerts may be either non-interrup-
into a readable form acceptable to
The Bogatin Law Firm PLC, Memphis, TN tive or interruptive. Interruptive
opposing counsel; or, will opposing
rwilson@bogatin.com alerts will require an override,
counsel and/or their experts want
possibly an explanation to move
access to the organization’s comput-
Thanks go to the Practice Group for forward. That activity will be doc-
ers to review the ESI firsthand, poten-
sponsoring this feature. umented by the EHR system and
tially including metadata as discussed
it will be discovered. In many
below?
Healthcare entities may have to pro- cases due to alert fatigue, the
duce ESI from a record that is con- alert function will be turned off
stantly changing over time. This EHR Discovery Challenges because it gets overridden repeat-
evolving record will be different Healthcare enterprises faced with edly, perhaps more a function of
depending upon the date and possi- requests for production of EHRs the underlying software and
bly even the time of access. In accor- must recognize that EHRs are funda- knowledge base limitations than
dance with long-standing discovery mentally different information sys- clinical disregard. Nonetheless,
rules, a litigant’s discovery responses tems from paper records. In terms of the decision to turn off an alert
must be supplemented to provide for information capture and display, function can be discovered and
additional information.4 Subject to EHRs well exceed a traditional chart. will need to be explained. In con-
objections based upon relevance,5 The key difference is EHR functional- trast, neither the decision nor the
the organization will be required to ity. EHRs are simply far more robust explanation would have arisen
update ESI previously produced to in terms of what they do and what with a paper chart.
comply with these discovery require- they record. Discoverability of this
ments. The difficulty will lie in track- • EHRs have login/logout access
expanded and integrated functionali-
ing how and when the EHR was sup- features that track and time-
ty will make e-discovery a challenge.
plemented with the new or additional stamp access in terms of
For healthcare enterprises producing
information. The organization must create/view/update/delete activi-
a patient electronic medical record
be able to capture the data at each ty by a user. EHR audit logs will
some key aspects of EHRs to watch
moment in time to determine what identify literally everyone who
for are as follows:
information changed and how it looks at patient X’s record. The
• Legibility issues go away and that
changed in order to properly identity of all of these persons
may be the good news.
respond to initial discovery requests will be discovered in a request for
and to supplement or amend existing • Built-in tools tell a more complex production of patient’s EHR. The
responses. New EHR systems with and revealing story. For example, list of persons who accessed the
robust functionality will track evolv- in some EHRs the informed con- EHR will begin to look a lot like
6 HEALTH LAWYERS NEWSthe list of persons who will be more than knowing where the enterprises. For these organizations,
deposed in most cases. When information is and then waiting serious role-playing exercises
persons not authorized to access for a request. It requires fore- through various e-discovery scenarios
the EHR turn up in the mesh of thought about how it will be pre- will be time well spent.
the e-discovery net, look for spin- sented and explained.
off Health Insurance Portability Healthcare enterprises involved in lit-
• Despite some recent efforts at
and Accountability Act workforce igation have long been able to assert
standardization, EHRs are not
sanctions and the predicable certain evidentiary privileges that
one size fits all, may reflect enter-
employment law litigation.6 apply to specific types of health infor-
prise culture, and will require
mation. However, as that privileged
• EHRs have tools and efficiencies extensive policies and proce-
health information migrates onto
that may require new and exten- dures to adapt system features
electronic health information systems
sive explanation once discovered such as: (1) when and by whom
and databases, and it becomes subject
in litigation. Simply put, EHRs modification to the record may
to e-discovery, the old ways of assert-
do not create information in the be made; (2) whether to deploy
ing privilege need to be re-visited.
same manner as a traditional or disable a “break the glass”
chart. EHRs use many of the tool; or, (3) whether the adverse
EHRs typically interface with other
same tools as other software pro- drug alerts system is system-wide,
HIT systems (e.g., patient account-
grams (e.g., copy and paste on or off. All of this is fair game
ing, lab, pharmacy, clinical data
entries, templates). Sometimes for e-discovery and needs to be
repositories). EHRs will likely be orig-
these tools provide efficiencies, considered well before the first
inal source documents; but clinical
but they may lend themselves to hold letter arrives.
data repositories with quality of care
the perception that caretakers
In short, EHR technology is new and benchmarks may or may not be an
are saving time by cutting cor-
rapidly evolving for most healthcare original source. These databases may
ners. If doctor A simply cuts and
enterprises and the e-discovery rules be the repositories where the statuto-
pastes doctor B’s progress note,
are likewise new to most healthcare rily protected deliberations of a
the appearance of an identical
note may require a different
explanation than a handwritten
note. Nonetheless, A’s cut and
paste will be discovered.
Given the robust functionality of
EHRs, healthcare enterprises using
EHRs that are engaged in e-discov-
ery need to know several things in
addition to the legal and practical
requirements of the e-discovery
rules. These enterprises need to:
• Carefully examine and under-
stand the discoverable content of
their EHR systems before discov-
ery is commenced (i.e., what can
the system do?). In light of the e-
discovery rules, it is clear that a
healthcare enterprise cannot sim-
ply print its selection of entries
from an EHR system or database
and send it to court with the
record room custodian to testify
that it is the organization’s stan-
dard business record. Virtually all
of the electronic information
and related metadata is discover-
able. Good preparation requires
MAY 2007 7patient safety committee or a peer requirements of the Security should contain an explanation of the
review committee are stored. The Standards simply hands one’s oppo- litigation or event to provide a con-
ability to assert a healthcare related nents an easy collateral win.7 text for employees to understand the
evidentiary privilege may depend hold. To further assist employees, a
upon who can or cannot access the A legal hold may be implemented quick list of the criteria necessary to
information. E-discovery can test the for a variety of reasons and circum- identify potentially relevant ESI
integrity of the access assumptions stances. The duty may arise if the should be drafted. Finally, the hold
upon which an asserted privilege party suffers from a higher number announcement should describe the
rests to determine whether access to of lawsuits such that the party should process for protecting or preserving
protected information has been lim- more reasonably anticipate legal pro- the ESI. Legal counsel, inside or out-
ited to those involved in the protect- ceedings in which the information side, may serve as contact points for
ed activity. To prepare for e-discovery, may be needed. When implementing questions and to assist in the preser-
healthcare enterprises need to closely a litigation hold, it is extremely vation of the ESI.
examine access/use rights to poten- important to identify custodians and
tially privileged databases. We recom- key employees who hold or access In addition to the internal announce-
mend that healthcare enterprises the EHR and relevant information. ment of a legal hold, the entity
review, map, and audit access to These individuals should be at the should notify external parties of the
potentially privileged databases. top of the list of those to be notified requirements to preserve evidence.
in the event a hold needs to be insti- Counsel should continue to monitor
The “Legal Hold” and EHR tuted. Identifying key individuals the hold throughout the litigation. A
assists not only in understanding the lifting of the hold should be formally
Litigants in any proceeding and location of the ESI, but also the dif- communicated upon the conclusion
potential litigants have a legal duty to ferent ways in which it may be used of the litigation to ensure that the
preserve evidence in the event of liti- and stored. data retention and management poli-
gation or reasonably anticipated liti- cy are reinstituted fully.
gation. Healthcare litigants have an A legal hold announcement or letter
arguably higher duty to preserve
electronic evidence with respect to
should be distributed throughout the “Metadata” and the
organization, but targeting key per- Production of EHR
EHRs. Not only do the e-discovery sonnel. The announcement should
rules carry their own sanctions, but contain the following elements. First, The Rules allow for the requesting
failure to preserve an EHR that it should include a reference to the party to obtain the ESI in any form
meets the authenticity and integrity entity’s retention policy. Further, it that the responding party can reason-
ably produce.8 The production of
ESI in its native file format raises the
UPCOMING HEALTH INFORMATION AND TECHNOLOGY PRACTICE GROUP EVENTS issue of production of the metadata
Health Information and Technology • Security Breach Concerns: Legal and accompanying the data itself. The
Practice Group Annual Luncheon practical considerations with respect Comment to the amendment pro-
“Interactive Dialogue on Current HIT to notification in the wake of a securi- vides:
Legal Issues” ty breach, including state notification
laws, HIPAA mitigation, etc. Computer programs may retain
Monday, June 25, 2007 Discussion Leader: Becky Williams, RN, draft language, editorial com-
12:30–1:45 pm JD, Davis Wright & Tremaine LLP ments, and other deleted matter
• EHR Legal Issues: Legal issues impact- (sometimes referred to as “embed-
The Health Information and Technology ing EHRs, including but not limited to ded data” or “embedded edits”) in
Practice Group will hold a lunch meeting e-Discovery, Stark exceptions, and AKS
at the 2007 Annual Meeting that will an electronic file but not make
safe harbors and liability. them apparent to the reader.
focus on an interactive dialogue on cur- Discussion Leader: Jud DeLoss,
rent HIT legal issues. HIT Practice Group Information describing the history,
Krahmer & Nielsen PA
and other AHLA members are invited and tracking, or management of an
urged to share their views and pool their • A Transactional Look at PHI: Secondary electronic file (sometimes called
experience on leading HIT legal issues. uses of PHI and “ownership”/licensing “metadata”) is usually not appar-
We will explore three issues through a issues between providers and third ent to the reader viewing a hard
structured dialogue involving audience parties relating to PHI, de-identified copy or a screen image.9
participation. information, and what lies in between.
Discussion Leader: Rob Wilson, The EHRs contain a wealth of metadata
Bogatin Law Firm including audit logs of who accessed
the record and when, times and
8 HEALTH LAWYERS NEWSdates when actions were taken and decisions were
made, and many other tracking activities. Courts that
have addressed the issue of the production of metadata
have generally concluded that it should be produced
and not purged from the ESI.10 If the metadata were
somehow purged from the ESI, the question arises
whether it would amount to spoliation of the evidence.
This and other questions relating to metadata produc-
tion remain to be determined. In any event, if the meta-
data contained privileged information there is no ques-
tion it should not be produced.
Counsel should recognize the importance of metadata
and fully utilize it for their own purposes when dealing
with their own client’s ESI. In addition, it may be proper
and ethical to utilize computer forensics to review the
opponent’s ESI for metadata and utilize it for their own
benefit.
Conclusion
The amendments to the Federal Rules governing
discovery will provide for many new opportunities and
problems for healthcare entities utilizing EHR. While
the technology may create greater efficiencies in patient
care and business operations, it can also reduce the
time and expense necessary to comply with discovery
during litigation. However, in order to capitalize on the
opportunities available, healthcare entities and their
legal counsel need to address proactively the burden of
managing the enormous amount, types, and locations
of ESI.
Gerald “Jud” E. DeLoss practices with the law firm of Krahmer
& Nielsen, PA in Fairmont, MN. Jud is Vice Chair of
Membership for the Health Information and Technology
Practice Group. Edward F. Shay is a partner at Post & Schell
PC in Philadelphia, PA, and is chairman of the Health
Information and Technology Practice Group
End Notes
1 John H. Martin, Lori L. Dalton, and Ramsey Lauren Burke,
“How to Get a Clean Bill of Health in the Age of Electronic
Discovery: Recent Developments and the Role of Counsel,”
11 Health Lawyers News at p. 6 (April 2007).
2 FED. R. CIV. P. 26(a)(1).
3 See, e.g., Wild v Alster, 377 F. Supp. 2d 186, (D.D.C. 2005),
for how changing computer systems gives rise to the
appearance of altered electronic evidence.
4 FED. R. CIV. P 26(e).
5 Committee Note to FED. R. CIV. P 26(b)(2).
6 See Petryszak v Kalispell Reg’l Med. Ctr., 2002 Mont. Dist. Lexis 3391.
7 45 C.F.R. § 164.312.
8 FED. R. CIV. P. 34(a).
9 Committee Note to FED. R. CIV. P. 26(f).
10 Williams v. Sprint/United Mgmt. Co., 230 F.R.D. 640 (D. Kan. 2005).
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