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.
