04 May Virginia: Medical Malpractice – a Lawyer’s Trails
In Temple v. Mary Washington Hosp., Inc., No. 131754 of the Virginia Supreme Court, Mr. Waterman authored the Virginia Trial Lawyers Association’s Reply Brief Amicus Curiae in Support of the Appellant, the deceased patient’s widow. The second major issue in that wrongful death case rebutted by him is the discoverability of metadata in patient’s electronic medical record, including particularly audit trails, an excerpt of which follows.
Under records statutes and in discovery, hospitals undisputably cannot withhold the “paper” records, so too cannot withhold the “electronic” records. Audit trails may impeach defense doctors.
A. Metadata is unique, prevalent, critical, and reasonable.
In 2000, a Virginia scholar attested the uniqueness of electronic discovery:
Electronic discovery has become a ‘mini-industry’ in the legal field, with that aspect of the discovery process having a significant impact on the results of numerous cases. Electronically stored data has become a prime source of evidence in litigation because of the increasing use of computer technology. Recent industry surveys reveal that approximately thirty percent of all current discovery requests involve electronically stored data. * * * Discovery of electronically stored data is essential because litigants would not find much of this information through traditional paper discovery processes.* * * * [T]he electronic version of a document may provide an individual with much more information than its paper counterpart.
Giacobbe, C.L., Allocating Discovery Costs in the Computer Age, 57 Wash. & Lee L. Rev. 257, 259-60 (2000). In 2003, “only 0.01 percent of newly created information was stored in paper format, with the remainder being stored in electronic formats;” and since at least 2009, “the federal government’s intent [has been] to practically mandate provider conversion to an electronic health record format.” Bryan, A.M., et al., Electronic Discovery and Healthcare Litigation, 23 Health Lawyer 1, 1-3 (2010).
“Metadata is particularly important in [healthcare] litigation…it firmly establishes who, what and when”. Id. at 76. “[P]rintouts of computer data […are] fundamentally different from the electronic record on the computer;” and “relevant metadata sources include audit trails, [warning] pop-ups, and preliminary questions and checkboxes”. Masor, J.L., Electronic Medical Records & E-Discovery, 5 Hastings Sci. & Tech. L. J. 245, 251-53 (2013).
Surgeon-lawyer healthcare insider McLean calls it for what it is:
[M]etadata can be evidence of physicians and other healthcare providers’ conduct and credibility. Metadata can create reasonable inferences concerning what physicians knew and when they acquired this knowledge.* * * *
Misleading statements…are common in the healthcare field as doctors often describe in the medical record the care they should have given, rather than the care they actually gave.* * * *
All too often, physicians memorialize the care that they should have given, rather than the care they actually gave. This characteristic of physicians’ documentation helps to explain why medical records often read as if the physician did everything correctly, even though the patient died. EMR [electronic medical records] metadata changes the nature of a medical record because it allows inferences about actual care given to a patient. Accordingly, when a physician’s note states that he or she reviewed a radiographic examination and the physician’s metadata fingerprint is not linked to that radiograph, then the physician’s credibility will be tarnished. Thus, EMR metadata is like an Orwellian Big Brother who silently records the actual care given to patients.* * * *
PMR [paper medical record] and an image file version of an EMR [electronic medical record, without metadata] reflect only a certain point of view.* * * Unfortunately, the evidentiary quality of a PMR or image file version of the EMR also is undermined since physicians feel encouraged to exaggerate and prevaricate in these unaudited business records [lacking metadata].
McLean, T.R., EMR Metadata Uses and E-Discovery, 18 Ann. Health L. 75, 76, 82 n.54, 116-17 (2009)(emphasis added). “Out of fairness to patients and [Medical Examiner Boards], attorneys should anticipate more production orders for EMR metadata in healthcare litigation.” Id. at 118.
One party’s routine “discovery of electronically stored information (‘ESI’) which has become an integral part of the discovery process in commercial litigation” can exceed 40 gigabytes, despite uncomplicated factual and legal issues. Hanwha Azdel, Inc. v. C&D Zodiac, Inc., 2012 WL 6726412, *1 (W.D. Va. Dec. 27, 2012). Yet “in a medical malpractice action … ESI at issue would likely be limited to the EMR of a single patient [and] may not be significantly larger than the amount of documents subjected to traditional paper discovery.” McLean, 18 Ann. Health L. at 109.
Since the cost of the attorney’s time most significantly impacts the overall cost of e-discovery, the production of an EMR native file is unlikely to have a negative impact on the cost of litigation. After all, it usually does not take an attorney much longer to review an e-document that contains ‘track change’ annotations than it does to review a clean copy of the same document.
Id. at 110 (emphasis added). Metadata production simply is not undue burden.
Nonetheless, despite medical records statutes, healthcare providers fight and limit patients’ entitlement to audit trails. E.g., Harris v. EVMS Academic Physicians and Surgeons Health Servs. Found., No. CL12-194, Order (Norfolk Jul. 19, 2012)(Motion to Quash denied, but audit trails limited to “what [three defendants] accessed, authored, and reviewed”). However, McLean details how electronic record printouts – even metadata limited to defendants – obfuscates and misleads. McLean, 18 Ann. Health L. at 116-17 (electronic printout indicated defendant surgeon culpability, but metadata revealed true fault of non-party anesthesiologist).
B. Fed. R. Civ. P. 26 is a red herring.
Appellant’s Amicus VTLA cited Fed. R. Civ. P. 34(b)(2)(E) and jurisprudence as persuasive authority for expansive metadata discovery. Companion Fed. R. Civ. P. 26, cited by Appellees’ Amicus Curiae, Virginia Hospital and Healthcare Association (“VHHA”), in a vacuum, is consistent with Rule 34(b)(2)(E).
Rule 26(a)(1)(A)(ii) requires automatic disclosure of certain “electronically stored information”. Also, Rule 26(b)(2)(B) has a party bear the burden of proving electronically stored information is “not reasonably accessible because of undue burden or cost” – yet still be subject to producing it for “good cause” under specified conditions.
Hence Appellant’s Amicus wrote the Federal issue is more one of who pays for metadata, not its discoverability. Yet the massive expensive metadata discovery of commercial litigation in Federal Court contemplated by Rule 26(b)(2)(B) does not even apply to patient metadata in medical malpractice cases. McLean, 18 Ann. Health L. at 109-10.
Moreover, McLean and co-authors note in a medicolegal research article that then-“new FRCP e-discovery rules….make clear that health-care providers cannot stonewall [‘medical malpractice’] plaintiffs”:
In the past, defense attorneys would attempt to frustrate a plaintiff’s EMR discovery by providing a paper copy of the EMR, complete with all of the usually unprinted symbols (like the symbol for the return key). When an EMR is printed on paper in such a fashion, it contains sections of readable textual information interspersed with sections of incomprehensible strings of letters, numbers, and symbols. Overall, these paper printouts of EMR are unintelligible because it is unclear where, for example, a laboratory value ends and a string of numbers that are normally invisible begins. Under new discovery rules, a Plaintiff needs to be able to view a patient’s EMR to the same extent as the patient’s physician.
McLean, T.R., et al., Electronic Medical Record Metadata: Uses and Liability, 206 J. Am. Coll. Surg. 405, 409 (2008)(emphasis added). Finally, unlike business records in commercial litigation, medical records in malpractice litigation are subject to State and Federal medical record statutes for preservation and provision, independent of Rule 26.
C. HIPAA, HITECH, and CFR cover audit trails.
VHHA claims VTLA glosses over “definitional quandary” in stating HIPAA, HITECH, and CFR disclosure covers audit trails of patients’ electronic medical records. Yet VTLA asserts VHHA actually attempts to create “definitional quandary”.
VHHA does not dispute “an individual has a right of access to inspect and obtain a copy of protected health information about the individual in a designated record set”. 45 C.F.R. §164.524(a)(1)(emphasis added). Indeed, VHHA concedes as it must that “protected health information” is “subject to the [HIPAA] requirement that it be provided on demand” (emphasis added).
1. Protected Health Information.
“Protected health information means individually identifiable health information” maintained in “electronic media”. 45 C.F.R. §160.103. Obviously, MWH’s electronic audit trails are “electronic media”.
“Individually identifiable health information is information that is a subset of health information…and:
(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and
(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and
(i) That identifies the individual; or
(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.
45 C.F.R. §160.103. Obviously, electronic patient medical record of Mary Washington Hospital (“MWH”), including its audit trial, is “individually identifiable health information”.
2. Designated Record Set.
“Designated record set means:
(1) A group of records maintained by or for a covered entity that is:
(i) The medical records and billing records about individuals maintained by or for a covered health care provider;
(ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for health plan; or
(iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals.
(2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.
45 C.F.R. §164.501 (italics in original)(underlining added). “Designated record set” is broader than individual “protected health information”.
D. Va. Code §8.01-413 must cover metadata.
Practically and equitably, it is important that the Virginia Supreme Court declare Va. Code §8.01-413 covers audit trails and other metadata. The millions of VHHA patients should not be provided – ostensibly as their entire “medical record” – only an incomplete sanitized “final chart” that does not show everyone who accessed and inputted, and especially who changed, data and when.
Virginians are entitled a level playing field, which as bedrock includes all factual information of patient care, not simply partial laundered printouts. Patients deserve and their reviewing experts need to know – not to be kept ignorant by industry-wide electronic hide-the-ball – about the basic truth of all that happened at the hands of healthcare providers.
Oral argument in the Temple wrongful death appeal is expected during June 2-6, 2014. Assuming that scheduling, the Virginia Supreme Court likely will issue its opinion during its September Term, 2014.