Identifying a Clinical Informatics or Electronic Health Record Expert Witness for Medical Professional Liability Cases

Abstract

Background The health care field is experiencing widespread electronic health record (EHR) adoption. New medical professional liability (i.e., malpractice) cases will likely involve the review of data extracted from EHRs as well as EHR workflows, audit logs, and even the potential role of the EHR in causing harm.

Objectives Reviewing printed versions of a patient's EHRs can be difficult due to differences in printed versus on-screen presentations, redundancies, and the way printouts are often grouped by document or information type rather than chronologically. Simply recreating an accurate timeline often requires experts with training and experience in designing, developing, using, and reviewing EHRs and audit logs. Additional expertise is required if questions arise about data's meaning, completeness, accuracy, and timeliness or ways that the EHR's user interface or automated clinical decision support tools may have contributed to alleged events. Such experts often come from the sociotechnical field of clinical informatics that studies the design, development, implementation, use, and evaluation of information and communications technology, specifically, EHRs. Identifying well-qualified EHR experts to aid a legal team is challenging.

Methods Based on literature review and experience reviewing cases, we identified seven criteria to help in this assessment.

Results The criteria are education in clinical informatics; clinical informatics knowledge; experience with EHR design, development, implementation, and use; communication skills; academic publications on clinical informatics; clinical informatics certification; and membership in informatics-related professional organizations.

Conclusion While none of these criteria are essential, understanding the breadth and depth of an individual's qualifications in each of these areas can help identify a high-quality, clinical informatics expert witness.

Keywords

medical informatics - malpractice - expert testimony - electronic health records - education

Background and Significance

Over the past 15 years, the percentage of hospitals, office-based physicians, and nursing homes using at least a basic electronic health or medical record (EHR or EMR) have increased to the point where in 2023, over 95% of hospitals, 84% of nursing homes,[1] [2] [3] and 80% of office-based physicians rely on EHRs to manage the clinical, administrative, and financial aspects of their work. Most health care organizations now use commercially produced EHRs that meet the Centers for Medicare and Medicaid Services and Office of the National Coordinator for Health Information Technology Certified EHR Technology standards.[4] [5] This widespread EHR adoption means that medical malpractice cases that are filed from now on, will likely involve the review of medical records created by, or at least stored in, EHR systems as well as EHR workflows, audit logs, and even the potential role of the EHR in causing harm.

Reviewing a printed version of a patient's EHR can be difficult to interpret even for the best clinicians with experience using a similar EHR product. Simply recreating an accurate timeline showing which clinician placed a particular order, who administered a medication, who recorded all this information, and when and where this recording took place often requires an expert with specific training and experience in designing, developing, using, and reviewing EHRs and the associated transaction and audit logs. Additional expertise is often required if questions arise about the meaning, completeness, accuracy, or timeliness of data or ways that the EHR's user interface or its automated clinical decision support tools, for example, may have contributed to the alleged events.

Such an expert often comes from the field of clinical informatics which is a small, highly specialized, sociotechnical field that focuses on the use of biomedical data, information, and knowledge and the tools used to manage them for scientific inquiry, problem-solving, and decision-making to improve the health care delivery system and human health.[6] It combines knowledge, skills, experience, training, and education in the methods, techniques, and tools from a variety of scientific fields including computer science, information science, biomedical engineering, human factors, physiology, health care administration, organizational behavior, and clinical medicine. A key component of clinical informatics is the study of the design, development, implementation, use, and evaluation of information and communications technology, including EHRs, in the clinical setting.[7] Identifying a well-qualified EHR expert to aid a legal team can be challenging since this is a relatively new scientific discipline that is rapidly evolving.

Roles for an Expert Witness

In medical malpractice cases, attorneys representing clients (i.e., the plaintiff or defendant) are hired for their legal knowledge, skills, and experience. It is not possible for anyone to be a subject matter expert in all aspects of every case. Therefore, attorneys often work with multiple experts to help them (1) figure out what happened and who knew what and when, (2) develop a strategy for the case, and (3) explain in easily understood terms how a complex series of events led to a particular outcome.

In such cases, clinical informatics experts are often called upon to help answer questions such as:

• Which clinicians were involved in the care of a particular patient?

• When was a particular data entry made?

• Who made a particular data entry?

• Was a particular data element modified?

• How long was the clinician on a particular screen?

• Where was a clinician when a particular EHR action occurred?

• When was a particular result available and/or reviewed?

• Whose record(s) did a user access?

• What did the user do in the patient's record?

• How is the EHR supposed to work?

• Did a specific data transmission reach its intended destination in the correct format?

• Is there an error in the EHR's design, development, or use that led to an adverse event?

Answering these, or related questions, in a clear, accurate, defensible, and easily understood manner requires special expertise. Identifying such an individual can be challenging.

Criteria for Identifying an Expert Witness

It is impossible to identify a single or even a complex set of objective measures to ensure someone has the appropriate knowledge, skill, experience, training, or education required by law,[8] although proxy measures have been identified and used.[9] For this project, we identified seven criteria for identifying such a clinical informatics expert. These criteria were identified through a literature review, coupled with extensive experience reading, writing, challenging, and defending expert witness affidavits, reports, depositions, and court transcripts from legal proceedings.

Education in Clinical Informatics

Formal education is critical in the eyes of the court and jurors.[10] Clinical informatics is most often taught at the graduate level in universities associated with medical and nursing schools.[11] Many universities offer both master's and doctoral degrees in biomedical informatics. A small subset of university-level biomedical informatics programs is funded by the National Library of Medicine (NLM), a part of the U.S. National Institutes of Health.[12] These NLM-funded programs tend to be long-standing, well-established (e.g., at least eight programs have been in existence for over 20 years), and successful (e.g., 40% of NLM-funded informatics trainees had careers in academia; 18% had careers in business/industry; 17% were employed by health care organizations; 10% chose to undertake further training; 1% were government employees, while 14% pursued other opportunities) programs in the country.[13] Recently, the Commission on Accreditation for Health Informatics and Information Management Education began accrediting Health Informatics Master's degree programs which is another indicator of high-quality informatics educational programs.[14] A clinical informatics expert should have at least a master's degree (PhD preferred) in biomedical informatics or a related field.

Clinical Informatics Knowledge

Regardless of the formal educational background of a potential informatics expert, there are many areas of knowledge required to successfully interpret and analyze a patient's EHR. This knowledge needs to include (1) basic knowledge of the hardware, software, and networking infrastructure required to run EHR applications; (2) understanding of the relationship between the clinical content and EHR's user interface; (3) interactions between clinicians' routine work and EHR navigation; (4) understanding of the internal policies, procedures, culture, and physical environment of health care facilities; (5) the rules and regulations that govern the design, development, and implementation of the EHR; and (6) how to use the data, information, and knowledge collected in the EHR to measure and monitor the health care delivery system.[15] [16] Every EHR expert also needs to understand how audit and transaction logs work, what information it is required to have, and what questions it can and cannot answer.[17]

Experience with Electronic Health Record Design, Development, Implementation, and Use

While formal education and textbook knowledge are critically important evaluation criteria for any EHR expert, there is no substitute for long-standing experience (e.g., over 20 years) working on the design, development, implementation, and use of various aspects of the EHR. This experience can be gained working in the information technology department of a large health care organization or as a commercial EHR developer. Experience working as a software developer, software architect, or product designer can be particularly useful in cases involving technical EHR issues. Depending on the specific facts in dispute, experience collaborating with technical experts to design and develop specific EHR features and functions such as user interfaces, order entry, clinical documentation, system-system interfaces, or clinical decision support may also prove useful.[18]

Communication Skills

Good communication follows clear, logical, and disciplined thinking. Clinical informatics is a complex social-technical field that requires knowledge about both clinical medicine and health information technology.[19] As such, many informatics practitioners resort to jargon in an attempt to demonstrate their mastery of the subject. An experienced clinical informatician should be able to clearly and succinctly convey how an EHR works, what clinicians are doing, how specific actions and events in the physical clinic are documented in the EHR, and how the metadata in the audit log are related.

For example, given the following scenario, a good clinical informatics expert should be able to explain succinctly to a judge and jury what information would be recorded in the EHR and in the audit log given the following jargon-filled hypothetical transcript (note: the information in parentheses is an example of the type of knowledge of clinical jargon and abbreviations a clinical informatics expert should have): after the EKG (electrocardiogram), the doctor ordered a D5W IV drip (dextrose 5% in water to be administered via intravenous route). Following administration, it was documented in the MAR (medication administration record) by the APRN (advanced practice registered nurse). The order was transmitted by an HL7 (Health Level 7) interface to the PharmD (pharmacist) who reviewed and approved it, which released the transaction to the Pyxis machine (automated medication dispensing device) on the unit (physical location of the patient) for access by the patient's nurse who retrieved the medication and administered it. Prior experience with public speaking, teaching, or successful testimony at depositions or trials are all good markers of communication skills.

Academic Publications on Clinical Informatics

As a scientific discipline, experts in clinical informatics are usually expected to publish the results of their research and practice. While any scientifically sound, publication related to the case is better than no publication, there is a definite hierarchy in academic publications.[20] [21] The first issue to consider is whether the publication is peer-reviewed. Peer review is the final step in the scientific process and provides an independent review of a publication's methods, results, analysis, interpretations, and conclusions. Therefore, peer-reviewed publications in leading clinical or informatics journals along with other journals indexed in the NLM's Medline database are at the highest level.[22] One should also be wary of individuals with a large number (or percentage) of publications in so-called predatory journals that “publish counterfeit journals to exploit the open-access model in which the author pays.”[23] Another factor to consider is the number of single -, first-, or last-author publications (i.e., based on the order of the authors listed in the publication).[24] In the vast majority of publications, the author listed first is the one who wrote the first draft and often the majority of the manuscript.[25] In many scientific fields, including medicine and medical informatics, the last author position is also important, as it often represents the senior person who oversaw the work. The last factor to consider is the number of citations the author's articles have received over time.[26] Briefly, a citation to an article indicates that another scientist thought the methods, results, or conclusions in the article were worthy of being cited and provided a foundation for their new article. Often experts are compared based on their h-index, which is a single, citation-based measure that attempts to measure one's impact on the field.[26] Publication of books on clinical informatics topics is also an important measure of an expert's expertise and potential influence on the field.[27]

In the general research community, publications and citations are often used to rank researchers.[28] Similar efforts have used citation-based statistics to assess the level of expertise of expert witnesses in the field of anesthesiology. For example, Radvansky et al compared plaintiff and defendant expert anesthesiology witnesses based on their years of experience and “h-index” (i.e., the number of papers coauthored by an individual with at least h citations each).[29] They found that both groups had similar lengths of experience (mean = 33 years) although plaintiff experts had a significantly lower h-index than defendant experts (mean ± standard error of the mean; 4.8 ± 0.5 vs. 8.1 ± 0.8, p = 0.02). They concluded that “defense expert witnesses may have greater expertise than plaintiff expert witnesses.”[30] Studies in other medical specialties using similar measures have been done, some showing differences,[31] [32] [33] ^, others that did not.[34] Similar studies have been done within the field of EHR research.[35]

Clinical Informatics Certification

Certification, by an independent organization, provides an unbiased assessment of one's competency and understanding of the current state-of-the-art in a field. Board certification is highly regarded in the medical profession and is included as a requirement in the guidelines for expert witnesses by many medical societies.[36] [37] [38] [39] The American Board of Medical Specialties provides a periodic, independent certification of specialty clinicians (including clinical informatics[40]) to assure that they are competent, continuing their education, and adhering to standards of care identified by their peers.[41] Similar accreditation organizations exist in other parts of the world.[42]

Two major pathways for certification in clinical informatics are available. The first is for individuals who are not medical board eligible (e.g., PhDs in clinical informatics) or those MDs who are no longer practicing clinical medicine. The second is for current, board-certified clinicians who also practice informatics. The American Medical Informatics Association (AMIA) offers the AMIA Health Informatics Certification to individuals with at least a Master's degree in clinical informatics and 10 years of practical experience.[43] The American Board of Preventive Medicine also offers subspecialty certifications in clinical informatics to physicians with a master's degree in informatics along with an active American Board of Medical Societies-recognized board certification.[44] There is also a practice pathway for board-certified medical specialists to become informatics board-eligible, which only requires informatics practice for 25% full-time effort for 3 years. Continuation of this practice pathway is currently under discussion[45] since there are already 58 Accreditation Council for Graduate Medical Education postdoctoral level clinical informatics training programs that offer 2-year fellowships for trainees with MD-level degrees that are filled.[46] [47] While board certification does not guarantee an expert's knowledge or ability, it does provide another unbiased, independent assessment of an individual's knowledge and experience within the broad field of clinical informatics.

Membership in Informatics-Related Professional Organizations

Membership in prestigious professional organizations adds credibility to a witness and shows a commitment to keeping up-to-date with the latest developments in the field by learning from one's peers.[48] There are also honorary organizations that rely on existing members to nominate potential new members who are then elected by a majority of the voting members.[49] In these organizations, membership can also be viewed as an acknowledgment by one's peers of substantial contributions to the field. These honorary, elected, professional societies represent the pinnacle of professional accomplishment (e.g., International Academy of Health Sciences Informatics[50] or American College of Medical Informatics[51]). Slightly below this honorary level are organizations that have predefined criteria that a potential member must meet before they can become a member of the organization (e.g., Fellow of the American Medical Informatics Association[52] or Fellow of Healthcare Information and Management Systems Society).[53] The lowest level of professional organizations are those that only require a person to pay their dues to become and continue being a member (e.g., membership in the American Medical Informatics Association[54] or Healthcare Information and Management Systems Society.[55] It may be necessary for Clinical Informatics Professional Organizations to clarify the necessary qualifications and ethical responsibilities of those who choose to testify.

Conclusion

Identifying an EHR or clinical informatics expert witness can be a daunting challenge since this is a relatively new and small scientific specialty. While none of the seven criteria listed above is essential for being considered an expert, understanding the breadth and depth of an individual's qualifications in each of these areas, can help identify a high-quality, clinical informatics expert witness.

Clinical Relevance

Following the passage of the American Recovery and Reinvestment Act in 2009, the use of electronic health records (EHRs) is becoming widespread in health care settings. From now on, one should expect practically all medical professional liability cases to involve the review of patient records produced by an EHR along with the associated audit logs. Identifying an EHR or applied clinical informatics expert witness can be a daunting challenge, but using the seven criteria described in this article, it is more likely that you can identify a high-quality, applied clinical informatics expert witness.

Multiple-Choice Questions

1. Which of the following types of experience would be the most beneficial for an applied clinical informatics expert witness in a medical professional liability case involving an allegation of a missed abnormal laboratory test result?

   • Working as a database administrator on an internet search engine project.

   • Working on the design, development, implementation, and use of EHRs.

   • Working for a medical malpractice claims adjuster.

   • Working as an emergency medical technician (EMT) in an ambulance.

   Correct Answer: The correct answer is option b. While experience as a database administrator might be applicable in some particular aspect of the case, a sound background as an EHR developer or even EHR product manager would provide much more insight into how the EHR works, how to interpret the audit log entries, and how EHRs are commonly configured within a health care setting. Similarly, experience as either a medical malpractice claims adjuster or EMT would not provide the depth of knowledge or experience required to serve as an applied clinical informatics expert witness.

2. Which of the following types of clinical informatics knowledge would be most useful for an applied clinical informatics expert witness in a case involving allegations of unauthorized access to a patient's medical record?

   • Understanding of the hardware, software, and networking infrastructure required to run EHR applications.

   • Understanding of the relationship between the clinical content and EHR's user interface.

   • Understanding of the regulations governing how an audit log works.

   • Understanding of the Systematized Nomenclature of Medicine—Clinical Terms, International Classification of Diseases 10th Revision, and Logical Observation Identifiers Names and Codes vocabularies

   Correct Answer: The correct answer is option c. User access to a patient's medical record is governed in the United States by the Health Insurance Portability and Accountability Act (HIPAA). Knowledge of this regulation, its history, and modifications over the years, especially how it relates to the EHR audit log would be essential for an expert involved in investigating allegations of unauthorized access to a patient's medical record. While a basic understanding of the hardware, software, and networking infrastructure might be helpful, without in-depth knowledge of the HIPAA regulations, an expert would be at a loss to help the attorneys involved. In addition, knowledge of the user interface and clinical vocabularies, while important in other applied clinical informatics cases, would not be of much use in a case of unauthorized access to a record.

Conflict of Interest

None declared.

Protection of Human and Animal Subjects

None.

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Publication History

Received: 20 October 2022

Accepted: 21 January 2023

Accepted Manuscript online:
27 January 2023

Article published online:
22 March 2023