The Electronic Health Record In Litigation and Oversight Proceedings

KENNETH N. RASHBAUM, ESQ. RASHBAUM ASSOCIATES, LLC

!  Litigation !  DOH !  OPMC !  OIG !  JCAHO !  OCR and CMS (HIPAA Proceedings) !  QA/QC

!  BALKANIZATION OF JURISDICTION: TOO MANY OR TOO FEW RESPONSIBLE FOR EHR; BLURRED LINES OF JURIDICTION (IT? RECORDS? RISK MANAGEMENT? LEGAL?)

!  LACK OF CONSISTENCY BETWEEN AND WITHIN ORGANIZATIONS (Clinical divisions may have different applications)

!  NO DEFINITIVE CENTRALIZED UNDERSTANDING OF DATA CHARACTERS AND REPOSITORIES (What do we have and where is it?)

!  NO CENTRALIZED RESPONSE MECHANISM FOR EXTERNAL DEMANDS !  POTENTIAL FOR LOSS OF DATA DUE TO LACK OF

PRESERVATION PROTOCOL !  HITECH INCENTIVE PAYMENT REQUIREMENTS

(“MEANINGFUL USE) MANDATE CAPABILITY TO TIMELY EXCHANGE KEY CLINICAL DATA WITH CAREGIVERS AND OTHER PATIENT-DESIGNATED ENTITIES (courts, counsel, etc.) AND REPORT TO OVERSIGHT ENTITIES !  RISKS OF EHR IN LITIGATION

!  EPHI PRESERVATION PROCESS (“LEGAL HOLD”) WITH DATA MAP

!  EPHI DEMAND RESPONSE PROTOCOL !  HITECH INCENTIVE PAYMENTS APPLICATION

AS A BUSINESS DRIVER FOR INITIATIVE !  HIPAA SECURITY RULE PROTOCOLS AS

DOCUMENTATION OF CHAIN OF CUSTODY FOR ELECTRONIC EVIDENCE

!  INFORMATION PROTOCOLS LEAD TO EFFICICIENCIES, ENHANCED QUALITY OF CARE

!  Court Rule, effective August, 2010, requires counsel to discuss electronic discovery at Preliminary Conference

!  1st and 2nd Departments of Appellate Division have ruled on e-discovery issues (i.e., cost-shifting)

!  Plaintiffs’ bar is holding e-discovery seminars for malpractice (“Preservation Letters” sent)

!  New England Journal of Medicine article “Medical Malpractice Liability in the Age of Electronic Medical Records” (11/18/10)

!  HITECH Incentive Payment Requirements: “Meaningful Use” mandates demonstrated capability to: !  Exchange key clinical information with caregivers

and other patient-designated entities (emphasis supplied) !  Report electronically on quality of care metrics and

other aspects of care to oversight entities $27 Billion available, up to $10 Million per hospital

(determined by formula), but Meaningful Use criteria must be met

" Adverse Inference Jury Instruction: Jury told it may presume data not produced would reflect negatively on position of producing party. This Instruction was largely responsible for $29.3 Million verdict in Zubulakev. UBS Warburg after only 30 minutes of deliberation

" Loss of the case: Entry of judgment against party unable to produce data. Qualcomm v. Broadcom (Qualcomm patent held unenforceable due, among other things to discovery abuses; $6 Million in sanctions assessed)

!  A Legal Hold Process, more than mere notification of obligation to preserve by a Legal Hold Notice, is required. See Pension Committee of the University of Montreal v. Bank of America Securities, LLC, Case No.: 05-CV-9016 (Jan. 15, S.D.N.Y.)

!  Documented follow-up to show defensibility of process is critical. Cache Le Poudre Feeds, LLC v. Land O’Lakes Farmland Feeds, LLC, 2007 WL 684001 (C. Colo. Mar. 2, 2007)

!  STEP ONE: THE DATA MAP. What types of EPHI do you have ? !  Progress Notes, Nurses Notes, Orders, Medication

Records, etc. !  Labs !  Radiology Images !  Communications (emails and texts between

caregivers and between caregivers and patients) !  Audit Trails and other Metadata (who accessed

patient record? What did he/she do with it?). Increasingly in demand !  Social Media

!  STEP ONE, DATA MAP, cont’d: Where are these data? !  Servers, desktops, laptops !  Smartphones and Portable Media (iPads, USB’s, etc.) !  Home computers !  Backup Media (tapes, etc.) !  Cloud repositories !  Proprietary and legacy systems

!  STEP TWO: HOLD TRIGGERS, DISTRIBUTION AND TRACKING OF HOLD NOTICE, COMPLIANCE AND COLLECTION !  Formation of Legal Hold Team, facilitated by outside

counsel !  Decides when to issue written Legal Hold Notice, and

release Legal Hold !  Oversees, per Procedures, identification of those most

likely to have relevant information beyond the chart !  Determines preservation methods and production of

requested information

!  POTENTIAL BUSINESS DRIVERS: !  Meaningful Use and HIPAA: Capability to

exchange Key clinical information with caregivers and other patient designated entities. Requires demonstrated ability to identify key information, preserve data, collect it, and produce it in a timely and (additional requirement) HIPAA-compliant manner

!  Cost Savings ROI: Central Jurisdiction over EPHI reduces expensive redundancies, enhances quality of care, reduces legal costs in discovery

!  New England Journal of Medicine, Nov. 18, 2010 outlines some risks of EHR in malpractice litigation: !  Defaults in medication application could lead to

injurious doses !  Metadata memorializes any record alterations and

also timing of review of records !  Clinical support system (safety prompts) establishes

standard of care; deviations not adequately explained !  Incorrect or missing entries

!  Transition protocols not clear, resulting in documentation gaps

!  System “bugs” or “glitches” !  Documented failures to respond to patient emails !  Training does not comprise litigation/oversight/

discipline issues, leading to failures to adequately document, or too much (“smoking gun” emails) !  Consider litigators as part of EHR design and training

teams. EHR’S ARE STILL WORKS IN PROGRESS

!  Reliability: “Computerized data . . . raise unique issues concerning the accuracy and authenticity.” Lorraine v. Markel American Insurance Co., 2007 U.S. Dist. LEXIS 33020 (D. Md. May 4, 2007) at *168

!  Authenticity: Is the email what it purports to be, i.e., a chart entry, other business record, etc.? Origins and Chain of Custody must be established. Id. at *68. See also, State of New York v. Microsoft, 2002 U.S. Dist LEXIS 7683 (D.D.C. April 12, 2002

!  Courts are new to this area and need education by counsel who, in turn, require education on the hospitals’ systems from internal resources (IT, Risk Management, Records)

!  Example: People v. Lenihan, NYLJ 11/28/10 (S. Ct., Queens Cty.): Court excludes MySpace photographs because “ability to ‘photo shop’ photographs . . .(means) defendant could not authenticate the photographs). . .” !  Court had no knowledge of proper authentication

procedure (did counsel?) and thus issued “blanket” ruling

!  Foundation for admissibility of EPHI is a degree of difficulty greater than that for paper

!  Security of EPHI, from hospital to technical vendors (for collection and production) to law firm presents Chain of Custody Issues because EPHI is more susceptible to loss or inadvertent alteration, potentially compromising its integrity

!  HIPAA safeguards function as defensible protocols AND assist in admissibility foundations (reliability and authenticity)

" EPHI, poorly explained, leaves an opening for doubt and attacks on credibility of the case as a whole " Prepare witnesses to testify jargon-free (or at

least be prepared to explain it), even on cross-examination

" Focus on reliability (counter the “CSI/24 effect”) " Pictures really do tell a story: visual aids

!  LEGAL HOLD PROCESS PREPARATION, IMPLEMENTATION AND TRAINING

!  DESIGN OR REVIEW OF EHR SYSTEMS AND APPLICATIONS WITH LITIGATION AND OVERSIGHT

!  FORMATION OF INTERDISCPLINARY DISCOVERY/DEMAND REPONSE TEAMS WITH: !  Risk Management !  IT !  Records !  Legal (in-house, facilitated by outside) !  Clinical

" KENNETH N. RASHBAUM, ESQ. " krashbaum@rashbaumassociates.com " 212-421-2823/973-222-1988 " www.rashbaumassociates.com