A Prescription for Electronic Health Record Problems: Four Remedies Borne of Legal Necessity

No documents are as universally important to people, businesses, agencies, and institutions as health records. Enter a great idea and a monumental task: a national mandate for the universal adoption of Electronic Health Records (EHRs) by the health care industry. This idea is embodied by the inclusion of the Health Information Technology for Economic and Clinical Health Act as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5.

Improving information exchange is one of the key objectives of the EHR mandate. But there are significant differences between mandating and achieving results, especially without meaningful EHR oversight or accepted standards. Despite government urging and incentives to use “certified” EHR technology and enormous additional expense for technology solutions in an already overburdened industry, the health care industry still relies on a patchwork of non-standardized, incompatible proprietary systems that often fail to meet even the lax “fit for use” regulatory requirement.

The situation is challenging for everyone involved—patients, care givers, institutions, insurance companies, and regulatory agencies. Lawyers and judges are particularly challenged by the complexities of locating, preserving, requesting, producing, and authenticating EHRs to meet the demands of civil litigation and regulatory compliance.

A multi-disciplinary team of experts, including a former state court judge, a doctor, a medical records expert, and two practicing lawyers representing both plaintiffs and defendants in health care-related litigation, has published a groundbreaking article exploring solutions to the problems of discovery and admissibility of EHRs. See Artigliere, Brouillard, Gelzer, et al., “Diagnosing and Treating Legal Ailments of the Electronic Health Record: Toward an Efficient and Trustworthy Process for Information Discovery and Release,” 18 The Sedona Conference Journal 209 (2017), available online at https://s3.amazonaws.com/IGG/publications/EHR.TSC.Vol18.rev.pdf.

Ralph Artigliere, one of the five authors, summarized the goals of the project.

“With 30 years as a medical malpractice trial lawyer and Florida circuit judge and 15 years of teaching and writing about electronic discovery and evidence,” he said, “I see the challenges and complexity of creating, storing, preserving, accessing, and producing health care information without violating HIPAA [the Health Insurance Portability and Accountability Act] or compromising patient privacy. Achieving justice day-to-day in courtrooms and hearing rooms calls for reliable, complete, and accurate information from medical records. To help lawyers, judges, and juries find the truth, evidence must meet standards of authenticity, veracity, genuineness, and completeness. Evidence must be available in a timely and economic fashion, lest the process of discovery and disclosure mire cases in cost and delay.”

At a fundamental level, Artigliere said, “accurate and complete medical records assist health care providers and patients in the delivery and recording of proper care; they allow continuity among providers and help avoid conflicts and mistakes in care and medication; they help providers, institutions, and agencies in monitoring and improving care; they document care for billing and insurance; they are essential for uncovering and eliminating fraud; they provide key evidence in personal injury and malpractice suits; and they fuel research, education, and other beneficial purposes. Through all these functions, medical records should be user-friendly, economical, efficient, accurate, complete, and reasonably accessible without jeopardizing security and individual privacy.”

But EHR systems vary substantially from facility to facility and from provider to provider.

“Barriers to efficient and economical use of EHRs,” Artigliere explained, “include such basics as lack of common terminology, absence of enforceable standards for keeping and sharing information, and technical incompatibility of data from system to system. The resulting complexity and confusion inherent in requesting essential information from electronic medical records is potentially harmful and often costly.”

The cost of complex, confounding, and sometimes inaccessible health care records presents problems for the providers as well as the patients.

Co-author Chad P. Brouillard, a medical malpractice defense lawyer in the Cambridge, Mass., firm of Foster & Eldridge LLP noted, “Some of the difficulty comes from the EHR product itself and some of the difficulty comes from the legal community’s approach to that product. Physicians should not be disadvantaged or prejudiced in litigation simply because they have been forced by the federal government to use a software product that does not function like the paper chart that judges and plaintiff’s attorneys have been traditionally used to.”

Broulliard added that education on EHRs as evidence is key on all sides of the legal equation to deal with fundamentals of EHRs and more complicated topics like “export distortion,” which the authors explore in their article. “We could also use some help from the vendor community,” he says, “to make their products more transparent and legal-friendly. I suspect savvy vendors will begin to think of litigation support as less of a nuisance, and more of key component of the service they provide to customers.”

To cope with the imperfect patchwork of a system that exists today with all its complexity and challenges, the five authors propose some practical measures to overcome obstacles in the short run, and make a case for evolution to better EHR system in the long run.

1. Parties must understand the ‘Release of Information’ in the health care system

The authors start with the concept of the “Release of Information” (ROI), a term commonly used throughout the health care system, but with no universally accepted definition. They propose that a “Patients’ Bill of Rights” embodied in law and posted in health care facilities and doctors’ offices around the country proclaim the “right” of patients to a full and clear record for safety, continuity of care, personal well-being, and legal needs. Since EHR systems generally were not designed to support ROI, let alone discovery requests, production from EHR systems may include anomalies and gaps.

Recently announced expectations for EHR systems echo the need for broad accessibility. Co-author Kimberly Reich, a credentialed health care information and eDiscovery specialist, notes that the Health and Human Services (HHS) Office for Civil Rights (OCR) released a new program in July 2017, titled “An Individual’s Right to Access and Obtain Their Health Information Under HIPAA,” in which the patient’s right of access applies to all information in a “designated record set.” The designated record set broadly includes medical payment and other records generated in patient care, “no matter how old the information is, where it is kept, or where it originated.”

In their article, the authors discuss the construct of the HIPAA “designated record set,” the varied use of the term “legal health record,” and how those respective sets of data compare to the benchmark of relevance in discovery and evidence. The authors conclude, as recently proposed by the OCR and the Office of the National Coordinator for Health IT (ONC), that to comply with both HIPAA as well as legal requirements, new processes and systems must provide for better and greater access to health information and associated relevant data in ROI and discovery responses.

The authors stress that parties in a legal proceeding need to attain necessary expertise and engage in early, frequent, and continuing communication to overcome the current anomalies and gaps in ROI. The objective is for the parties to reach compliance with these requirements through iterative communication.

2. Lawyers, judges, and expert witnesses must step up their eDiscovery game and bone up on EHR characteristics and context.

A few years ago, a new Comment 8 to ABA Model Rule of Professional Conduct 1.1 confirmed that keeping abreast of technology is fundamental to requisite professional competence. The rules of professional conduct universally require that a lawyer either have the competence and knowledge to do the work needed on a matter they take on or they need to develop the ability to do so or associate another lawyer who does have the requisite skills, knowledge, and ability.

The authors note that this requirement, by definition, includes facility with eDiscovery and electronic evidence, which encompasses the overwhelming majority of information generated, stored, and communicated today.

“EHRs add a whole new level of complexity and difficulty for discovery and record requests because of their widespread adoption and variance in terminology, methodology, standards, and requirements for creating, storing, and providing information in the records,” Artigliere said. “Dealing with a shortfall in skill and understanding of EHRs is problematic because relatively few cases involving medical records will support staffing the case with multiple professionals and experts capable of understanding what may be available and how to effectively request, verify, and process the information.”

“Lawyers are not the only ones who must acquire sufficient learning and skill about EHR. Judges also need to achieve sufficient knowledge to handle their docket competently, including successfully ruling on discovery and admissibility issues involving this important evidence,” he added.

3. EHR systems must facilitate reliable and accurate production of records for legal purposes as a built-in, normal function.

Clinicians and clinical enterprises rightly complain that current EHRs are burdensome and that they present “usability” challenges, with suboptimal fitness for primary duties to patients and patient care. Co-author Reed Gelzer, M.D., of Trustworthy EHR, LLC, posits that many of these complaints are dwarfed by EHR system deficiencies revealed in the adversary process, particularly authentication of EHRs as evidence.

“For example,” he said, “a recurring issue is the ‘convenience feature’ of copying data within an EHR. The legal concepts of authenticity and attribution, and the adversary system of cross-examination, may complicate efforts to efficiently create and produce a clinical record. But clinicians will recognize the importance of creating original, properly attributed documentation when it is explained as a legal—and often scientific—necessity. The nature of digital records and their metadata can reveal the source, time, and place of language in a patient’s record, which in turn can support or undermine the completeness, authenticity, and validity of records produced for legal purposes. This highlights the need for properly creating a record as well as preserving the information necessary to authenticate it,” he concluded.

4. Parties must test, assess, and explain differentiated ROI processes and products.

Clinicians and clinical enterprises can overcome some of these obstacles with an “ounce of prevention.” Instead of simply producing EHRs in response to a request, the authors suggest that parties include with each ROI production a cover letter or similar means of describing what the ROI is intended to represent.

“In the paper record, a copy of a given page will appear the same no matter who copied it or when, Gelzer said. “However, in an EHR, the ROI generated for a routine patient request for their records will probably appear different from an ROI generated in response to, say, a discovery request from an attorney. These differences in appearance are sometimes interpreted to imply nefarious intent, generating costly debates and delay. Variances and misinterpretations may arise simply because providers did not test ROI procedures, assess the products for legal sufficiency, and recognize that different data processes in their system may substantially vary production outputs. Testing, assessing, and improving ROI based on legal principles of completeness, reliability, and authenticity will improve the value of EHRs and reduce risk.”

Gelzer noted that improvements in EHR systems and their use are inevitable. “Recent actions and reports from the US Department of Justice, the HHS Office of the Inspector General, and the Federal Trade Commission highlight that if users and vendors do not assure fitness of EHR systems, law enforcement and other sanction-bearing oversight agents will arrive in due course,” he said.

CONCLUSION

The authors conclude by arguing that access to uniform, complete, accurate, reliable, and understandable medical records from secure systems is critical to achieving justice as well as good health care. In some cases, it is literally a matter of life and death.

Addressing the legal requirements of accessibility and reliability can force the establishment of standards for EHR systems that meet the needs of all EHR stakeholders, including patients, doctors, lawyers, judges, and technology providers. Technology is the reason we are at this imperfect stage in EHRs, and technology surely can reach a solution. Time will tell if legal requirements become a catalyst for positive change.