Scot M.

Silverstein, MD

Drexel University, College of Information Science and Technology, Philadelphia, PA

sms88@drexel.edu

Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on

Unintended Consequences of Healthcare IT

Abstract:

Background: Case reports, systematic statistical data and other information on unintended
consequences (UC’s) of healthcare information technology (HIT) is relatively scarce despite
ample literature on potential HIT benefits. This impedes optimal efforts at computerization of
healthcare, and can and should be remediated.

Objectives: To illustrate the relative scarcity of information on HIT UC’s, suggest contributing
factors, and recommend tactical measures for improvement such as better user reporting of HIT
UC’s and better diffusion of existing literature on the phenomenon.

Methods: A number of recent indicators for scarcity of UC information were compiled and
possible reasons described. Examples of suboptimal adverse results disclosures in related
domains (e.g., the pharmaceutical industry) that may hold lessons for HIT were included.

Results: UC information on HIT is relatively scarce likely due to a variety of influences and
complex interactions among and between medicine, informatics, government and industry that,
left unaddressed, may lead to delays or other harm to good faith efforts to computerize
informational aspects of healthcare delivery and research.

Conclusions: The relative scarcity of definitive information on the extent of HIT UC’s should be
addressed in a responsible and ethical manner by clinicians, regulators and other stakeholders if
this technology is to be successfully rolled out nationally.

Keywords:

Medical Records Systems, Computerized

Computer Systems Evaluation

Medical Errors

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“Most especially must I tread with care in matters of life and death.” Hippocratic Oath, Modern
Version [1]

“ICT (Information and communications technology) use leads to multiple, and often
paradoxical, effects.” Kling, Sawyer and Rosenbaum, Understanding Social Informatics [2]

1. Background

Medical error reduction is an international issue, as is the implementation of healthcare

information technology (HIT) as a potential means of achieving it. Biomedical informatics
researchers have encountered numerous instances in which HIT applications such as EHR,
CPOE and CDSS seem to facilitate errors rather than reduce their likelihood. With a heightened
awareness of these issues, informaticians can facilitate better system design, implementation, and
research in such a way that might help avoid or minimize avoid unintended consequences of
these errors. [3]

Unintended consequences (UC’s) are outcomes of actions that are not originally intended in a
particular situation. In the clinical domain, UC’s, including those related to the use of healthcare
IT (HIT) are usually equated with clinical side effects or adverse medical events and poor
outcomes. [4]

Information systems are not intended to disrupt clinicians’ workflow, cognitive processes or
actions, so HIT-related “close calls” or “near misses” might also be considered as HIT UC’s.
These are clinician errors of commission or omission related to unintended HIT malfunction,
cognitive or work disruption, and other issues that do not result in patient harm due to
redundancies and human checks and balances in the healthcare delivery process that correct for
the error before harm occurs.

UC case reports, rates, statistics and other information (henceforth “UC information”) are
systematically reported by manufacturer and specific product, and are available in many domains
such as drug adverse events and automobile defects. When, however, information is needed on
the incidence of UC’s related to HIT applications such as electronic health record (EHR) systems
or computerized order entry (CPOE) systems, buyers largely need to rely on the vendors
themselves with their inherent conflict of interest, on word of mouth, anecdote, and perhaps
scant peer reviewed literature. There is no systematic, comprehensive, trustworthy source of UC
information, especially if the information is sought about a specific HIT product version or use
of a product in specialized clinical settings such as subspecialty units. UC’s could be minor and
limited, or could be widespread and clinically significant. It is difficult for applied informatics
personnel and others involved in HIT selection and implementation to ascertain the overall UC
incidence nationwide – or worldwide - without good data.

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While there is an abundance of literature on the positive attributes of HIT towards improving
healthcare quality, efficiency, cost effectiveness and other issues in specific clinical settings,
there is an apparent scarcity of data on in situ UC’s related to HIT. Safety is unproven by
impartial, methodological study and the true risk/benefit ratio is unknown.

2. Methods

A number of recent indicators for scarcity of UC information were compiled and possible
reasons described. Examples of suboptimal adverse results disclosures in related domains (e.g.,
the pharmaceutical industry) that may hold lessons for HIT were included. A number of tactics
for remediation of HIT UC information scarcity are suggested that are practicable at the level of
the individual researcher and clinician, as well as at the policy-making level.

3. Results

3.1 Recent indicators of scarcity of detailed, comprehensive UC information in HIT

UC information diffusion (as well as other information that could place HIT in a negative light
such as implementation conflicts and failures) seems muted. Published information appears
spotty compared to other technological domains and detailed, comprehensive statistics and case
detail appear uncommon.

HIT is an unregulated industry. There are no federal databases to turn to regarding HIT UC’s,
nor is there a commercial source of comprehensive information.

The Joint Commission recently reported in a Sentinel Events Alert [5] that “as health
information technology (HIT) and converging technologies—the interrelationship between
medical devices and HIT—are increasingly adopted by health care organizations, users must be
mindful of the safety risks and preventable adverse events that these implementations can create
or perpetuate … There is a dearth of data on the incidence of adverse events directly caused
by HIT overall (emphasis mine).

The Joint Commission did state that there was some known data on HIT adverse events related
specifically to pharmaceuticals. The JC reported that the United States Pharmacopeia
MEDMARX database [6] included 176,409 medication error records for 2006, of which 1.25
percent resulted in harm. Of those medication error records, 43,372, or approximately 25 percent,
involved some aspect of computer technology such as information management systems,
confusing displays and software. Lack of other sources of HIT UC information, however, led to
the overall statement about a dearth of data.

A longitudinal citation analysis conducted across a significant portion of the Medical Informatics
periodical literature from 1994-2005, focusing on the identification of strings (linear citation
patterns) and networks (multi- branched citation patterns) of highly cited MI-related articles
indexed in the Web of Science, demonstrated an interesting pattern. The temporal strings are

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representative of persistent, highly visible research themes in MI. Themes found not well-
represented included sociotechnical issues such as IT difficulties and UC’s, and ethics and legal
issues in medical informatics. These were felt to represent a gap in research and authorship. The
gaps suggested that medical informatics research and training, while facilitating the improvement
of healthcare, may itself benefit from an evaluation of these themes. [9] These gaps are likely in
part due to unpopularity of subjects that could place HIT in a negative light.

Another illustration of an apparent lack of enthusiasm for publication on clinical IT difficulties

including UC’s is a 2006 study that was conducted of access characteristics to a first-of-its-kind
HIT difficulties web resource placed online in the late 1990’s [7]. The web site explicitly
addressed issues of health IT implementation difficulties, usage problems and failures via
detailed case accounts in a de-identified format. It was found in the study that the website was
one of few relevant sites retrieved via major search engine queries on “healthcare IT failure” or
related concepts, usually at a very high ranking.

With that observation in mind, it was hypothesized that accesses (“hits”) upon the website might
reflect a significant portion of the demand for information on this issue, the site serving as a de
facto gauge or “barometer” of interest in the topic. Interest in reading about healthcare IT
difficulty and UC’s via the Web appeared ongoing by searchers of a variety of demographics in
numerous countries. [8] Yet, the website remained nearly unique after nearly a decade online and
is rarely cited or described in the HIT literature.

A search of a major FDA data resource, the Manufacturer and User Facility Device Experience
(MAUDE) database [10], showed little data on HIT. MAUDE is a national biomedical database
containing reports of adverse events involving medical devices. The data consists of voluntary
reports since June 1993, user facility reports since 1991, distributor reports since 1993, and
manufacturer reports since August 1996. While MAUDE contains many thousands of adverse
events reports on medical devices (reporting of which is largely mandatory), it contains a mere
handful (approximately two dozen) voluntary case reports of HIT malfunctions and UC’ over t
least the past decade. Most MAUDE HIT adverse events reports are, in fact, from a single
vendor. Many of these malfunctions were potentially clinically significant and easily could
have, or did, lead to clinical UC’s [Table 1].

Another aspect of the scarcity of HIT UC data in MAUDE is notable. Reports from many other
vendors were absent altogether in the MAUDE database. For many HIT vendors the MAUDE
database reported no records at all over the past decade. It is unlikely that UC’s do not occur
with other HIT vendor products. It is more likely that they were simply not reported, although
such reporting would have been of benefit to system designers, implementers and purchasers.

A 2009 AMIA research report based on a workshop at the 2006 national meeting, attended by
over fifty informatics specialists across ten AMIA working groups, observed that there have been
few systematic and thoughtful publications describing lessons learned from IT interventions that

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had null, negative, or disappointing outcomes. [14] Workshop attendees also observed that IT-
related failures in health care often are covered up, ignored, or rationalized, so mistakes are
repeated. Noted were a small number of high-profile health IT failures that adversely affected
patient care and well known institutions suspending their systems or halting their development
due to physician protest, extreme overspending, errors, and delays. However, the true extent of
these issues domestically and internationally is not robustly known due to a scarcity of literature
and trustworthy data sources.

The Washington Post reported that more than two dozen doctors, academics, patients and
computer programmers when interviewed opined that HIT can increase errors, add hours to
doctors' workloads and compromise patient care. [15] Since the literature does not support
knowing whether these problems are widespread or not, such reports have led to a Senate
Finance Committee investigation.

The United States Senate Committee on Finance has jurisdiction over the Medicare and
Medicaid programs. The Ranking Member of the Committee Senator Charles Grassley, over the
past year, has received unsolicited HIT complaints similar to those received by the Washington
Post from numerous patients, medical practitioners and technologies engineers, who felt strongly
enough to report these issues to the Senator. These complaints include, for example, faulty
software that miscalculated intracranial pressures and interchanged kilograms and pounds,
resulting in incorrect medication dosages. Since the true extent of the UC’s is unknown, and
since Sen. Grassley has a fiduciary and ethical responsibility to investigate, an investigation has
commenced. A letter of inquiry was sent to ten major HIT vendor and consulting firms,
requesting an extensive variety of documents related to industry practices, including handling of
HIT defects and UC’s. [16]

On occasion, explicit case reports of HIT UC’s do appear, usually in the news and only after
events of high visibility. For example, a report from the Veterans Administration about
problems with VistA appeared in early 2009. After an upgrade, 41 of the 153 VA medical
centers reported information displayed under the wrong name, and failure to display “stop”
orders at 9 VA center resulting in infusion of drugs such as heparin for up to 11 unordered hours.
The authors concluded that although many advocates of electronic medical records systems
promote them as a means to reduce mistakes affecting patient care, the problems in the VA
system suggest that malfunctions of these systems or problems with the way they are
implemented have the potential to lead to medical errors. No patients were injured on this
occasion. Yet, this was only by serendipity, not by design. [17]

The true extent of HIT implementation and usage difficulties, UC’s and “close calls” such as the
VistA malfunction are unknown.

Quality studies of UC’s that do appear in the literature are uncommon. A literature search shows
they largely appear confined to the low circulation informatics journals, not general medicine

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journals or journals likely to be read by policy makers, and appear to be authored by a relatively
small set of informatics researchers. The studies, using various methods including empirical
observation, user surveys and intra-expert discussions, indicate that UC’s are common, for
example with CPOE, but detail is lacking that would be useful to HIT decision makers on
product differentiation by vendor, version etc. [18, 19] A systemic literature review also found
wide variance in study quality including validity measures and measurement issues. [20]

In all, the available UC information seems underwhelming considering the size and budget of the
healthcare and HIT industries and the age of the latter, even at the relatively low adoption rates
of HIT in 2009.

4. Discussion

4.1 A reminder that HIT is an experimental technology

The UC’s related to HIT are not entirely avoidable. It is possible, however, to avoid or minimize
studying them, reporting them, and revealing their occurrence to the research community,
purchasers, and to the public whose medical care increasingly depends on HIT. This results in a
scarcity of UC information.

The term “experiment” comes from 14th century Middle English, from the Anglo-French
esperiment, from Latin experimentum, from experiri: an operation or procedure carried out
under controlled conditions in order to discover an unknown effect or law, to test or establish a
hypothesis, or to illustrate a known law. [21]

It must be remembered that HIT is an experimental technology, not a technology proven to be

safe and efficacious in the complex environments of healthcare delivery. Its use is an
experiment, an operation or procedure carried out under controlled conditions in order to
discover an effect. Profound alterations in the provision of medical care mediated by HIT may
occur as a result of the experiment.

It is perhaps not unreasonable to lightly study the UC’s of long-proven technologies. HIT,
however, while having the potential for many benefits, is also capable of facilitating known and
unknown, predictable and unpredictable UC’s that can result in undesired or adverse clinical
outcomes. Many unintended and undesired consequences of Healthcare Information
Technologies (HIT) flow from interactions between the HIT and the healthcare organization’s
sociotechnical system—its workflows, culture, social interactions, and technologies. [22]

A January 2009 National Research Council report notes that HIT at present does not adequately
support clinician cognitive processes, will not be sufficient to achieve medical leaders' vision of
health care in the 21st century and may even set back the cause [23]. The report concedes that
success of HIT will “depend upon accelerating interdisciplinary research in biomedical
informatics, computer science, social science, and health care engineering.” [24] A technology

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that does not support critical aspects of the work of its users, and whose success depends on
further intensive multidisciplinary research across disparate disciplines, cannot reasonably be
considered a proven technology.

It therefore does not seem reasonable to commit low levels of attention to study of HIT UC’s.
Experimental technologies need to be treated as such in terms of researcher and user obligations
to report potentially adverse effects. We need to better understand the incidence of UC’s and
how to prevent them before a national rollout of HIT gets underway, if such a rollout is to be
conducted to the highest scientific and ethical standards of medicine.

4.2 UC information scarcity as an unintended consequence of HIT

The intended consequences of HIT R&D and implementation should include an increase in the
knowledge of both HIT benefits and possible drawbacks, for protection of patient safety. This
seems a reasonable and ethical position.

Evaluation methods in biomedical informatics must address not only a range of different types of
information resources (Including HIT), but also a range of questions about them, from the
technical characteristics of specific systems to their effects on people and organizations. The
reasons for performing evaluation studies include promotional, scholarly, pragmatic (to help
developers know what is most effective, and what does not work), ethical, and medicolegal (to
assure users that an information resource is safe and effective). The methodologies and
expertise exist to conduct both objectivist and subjectivist studies of health IT that could reveal
the incidence of UC’s in greater detail. [25]

Thus, the scarcity of studies and data on UC’s could itself be considered an unintended
consequence of HIT research and efforts to diffuse this technology throughout the healthcare
system.

4.3 Proposed reasons for scarcity of comprehensive UC data:

4.3.1 Loss of scientific skepticism

In Dr. Octo Barnett’s Ten Commandments (1970), the tenth commandment was perhaps the
most important. Dr. Barnett wrote “Be optimistic about the future, supportive of good work that
is being done, passionate in your commitment, but always guided by a fundamental skepticism.”
[26] Fundamental skepticism must promote consideration of UC’s and caution about claims of
the absolute benevolence of HIT.

Loss of fundamental skepticism may be one factor that has contributed to a relative scarcity of
knowledge of HIT UC’s. Instead, a marketing-driven atmosphere of exuberance seem to
prevail, to the extent that billions of dollars have been earmarked in the American Recovery and
Reinvestment Act (ARRA) of 2009 for a national rollout of HIT in five years, with penalties then
accruing to non-adopters.

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4.3.2 Adverse consequences of challenging the HIT industry status quo, real and perceived

Another likely reason for the scarcity is unpopularity (due to opposition or “pushback”) of
writing about UC’s and other aspects of HIT that may put the technology in an unflattering light.
Such material and opinions are contrary to the current popular culture about computers in
general, and about HIT specifically. A marketing mindset-based environment openly promotes
HIT as a highly benign and extremely beneficial technology.

A very large industry stands to benefit from increasing sales of HIT, recently amplified further
by the recent Electronic Health Records provisions in the ARRA. Researchers in the field stand
to benefit from both government and industry largesse if they propose research or publish results
on the positive side of the spectrum. Research and results that could potentially tarnish HIT’s
reputation or injure the market for robust HIT sales would not surprisingly be unpopular among
the HIT industry and government stakeholders and consultants who serve this industry.

HIT evaluation studies, with some notable exceptions, tend to emphasize the benefits and
downplay or ignore the problems and UC’s. They often fail to take into account workflow
disruptions, distracting workarounds and improvisations, communication failures, decreased
productivity, treatment delays, incorrect tests, close calls, and other adverse incidents.

Several notable exceptions by authors such as Han et al. [27] , Koppel et al. [28, 29] and others
did indeed receive “pushback”, sometimes in the form of notably harsh criticism. Examples
include published JAMA letters calling Koppel’s research “disingenuous at best“ due to
versioning issues [30] or “misleading and inaccurate” [31], an accusation that Han’s conclusion
of an unintended increase in pediatric mortality due to a new CPOE is not at all supported by his
team’s analysis [32], and the involuntary (but fortunately temporary) pulling of Dr. Jon Patrick’s
essay on major EMR problems and physician dissatisfaction in the ED’s of the Australian state
of New South Wales [33] apparently due to governmental intervention or pressure. (Dr.
Patrick’s essay reappeared in a revised form under the rubric of an Opinion Editorial.) [34]
Such pushback, especially when governmental officials may be involved, can potentially be
career damaging.

4.3.3 Contractual nondisclosure clauses

When a UC or “close call” (an HIT-related event caught early by clinicians before patient harm
accrues) does not result in patient harm, and in the absence of reporting requirements, such
incidents will most likely not appear in the literature.

In fact, even if harm occurs, contractual clauses agreed to by hospital governance that hold the
HIT vendor harmless for any HIT UC-related injuries and prohibit clinicians from divulging the
problems outside of their organization (“gag clauses”) may prevent reporting, in a manner
distinctly different than reporting of drug adverse events such as through MedWatch, the FDA
Safety Information and Adverse Event Reporting Program. [35]

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HIT contracts may permit vendors to retain company confidential knowledge about designs,
faults, software operations, and glitches. Their counsel have crafted contractual terms that
absolve them of liability and other punitive strictures, while compelling users’ nondisclosure of
their systems’ problematic, even disastrous, software faults. This may create a culture of
enforced nonsharing of HIT problems. [36]

4.3.4 Lack of HIT regulation

Unlike the pharmaceutical industry where FDA regulates research IT used in clinical trials and
data management, and may inspect and validate the IT for robust and secure operation, there is
no such regulation of HIT. This is despite the fact that pharmaceutical research IT does not have
a potential for short term or immediate patient harm as does HIT, and that unregulated HIT may
be of similar complexity to regulated pharmaceutical research IT. The paradoxical lack of
regulation of HIT may lead to systems more prone to cause UC’s, and may decrease stakeholder
motivations to report these problems.

It should be noted that HIT other than the simplest of systems will likely soon be subjected to
regulation as medical devices in a number of countries, including Sweden and other members of
the EU [37], Canada [38], the United States [39] and other countries as well. Considering the
advances in HIT in the past decade or two and the increasingly deep penetration of this
technology into the complex ”metabolic-pathways-like” complexity of healthcare delivery and
the increasing chances for clinically significant UC’s, this redefinition and regulatory oversight
is probably well past due.

4.3.5 Bypassing oversight review

Implementations in hospitals and physicians’ offices of new HIT systems, or revisions and
customizations of existing HIT may bypass ordinary patient and clinician protections. There is
no requirement that institutional research governance officials review HIT projects, although as
pointed out earlier these systems are probably best thought of as still experimental in nature. The
implementation is generally led by IT personnel, often lacking biomedical backgrounds, and/or
multidisciplinary steering and operations oversight committees where power structures may
impede optimal clinician and clinician/informaticist decision making.

It is the committee that thus holds the responsibility to report adverse events, and if dominated
by hospital executives with a career advancement stake in HIT implementation, UC’s might not
be reported, or differing accounts of system problems that may minimize the downsides can arise
between the IT steering/operations committees and senior executives. [40]

4.3.6 Bypassing traditional patient protections

Lack of informed consent provisions and procedures for patients may mute another possible
source of UC reports (the patients themselves) by leaving patients in the dark about mediation of

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their care by a new and/or modified HIT system. The lack of awareness might prevent a patient
from even recognizing that an adverse outcome may be related to an UC of HIT, if this
information is not explicitly revealed to them. There is strong motivation not to reveal such
information, or to settle off the record if injuries occurred, in that such revelations could lead to
litigation and publicity that could place HIT in a negative light.

Interestingly, NIH requires that research on new biomedical tools and technologies be conducted
will full patient informed consent, attention to patient protections, and protection of researchers
as well. For example, federal regulations for protection of human research subjects mandate that
NIH grant proposals (including those that might involve new, novel or altered HIT such as CDSS
algorithms, IT-mediated real time home health care data transmission, IT-mediated interventions,
and other uses of HIT) undergo a review process under guidelines that call for explicit
consideration of informed consent and protections. Failure to provide for this consent and
protections can lead to a poor score or rejection of the proposal [Table 2]. The lack of informed
consent processes in HIT may not only may reduce UC information, but is also a significant
incongruity with potential liability implications.

4.3.6 Market and regulatory capture

The Washington Post reported that the influential HIT trade group, the Healthcare Information
and Management Systems Society (HIMSS), had worked closely with technology vendors,
researchers and other allies in a sophisticated, decade-long campaign to shape public opinion and
win over Washington's political machinery. HIMSS represents 350 companies and about 20,000
members. Corporate members include massive government contractors such as Lockheed
Martin and Northrop Grumman, health-care technology giants such as McKesson, Ingenix and
GE Healthcare, and drug industry leaders, including the Pharmaceutical Research and
Manufacturers of America (PhRMA). [42] This is a wealthy and powerful organization.

Large scale lobbying can lead to a trade association’s domination of a product market over
neutral, objective observers. It may also lead to “regulatory capture”, where powerful
organizations with private interests may “capture” the government regulators through well
placed influencers and functionaries in order to foster regulations (or lack thereof) supporting
their private goals. [43]

HIMSS and other large IT trade organizations have a fiduciary responsibility to represent their
constituent vendor and consulting companies to improve their reputation, sales and financial
positions. This is manifested by lobbying activities on government and press/public relations
and marketing activities. The natural tendency of such a responsibility is to de-emphasize UC’s
that could inhibit sales or tarnish a company’s products and market reputation. A similar
inhibitory effect on third parties’ (e.g., researchers, clinicians) propensity to potentially tarnish
the image of health IT may also occur, since speaking and research fees from the trade

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organizations are dependent on the loyalty of the third party to presenting HIT as safe and
effective.

4.3.7 Failure to report safety issues in a study

In the conduct of research, there is a tendency to minimize reporting of UC’s such as adverse
clinical events while reporting positives. Reports of clinical trials usually emphasize efficacy
results, especially when results are statistically significant. Poor safety reporting can lead to
misinterpretation and inadequate conclusions about the interventions assessed.

For example, in a recent study investigators at Paris Diderot University in France assessed 133
articles reporting the results of randomized controlled trials published in 2006 in six prestigious
English language journals with high impact factors, including the New England Journal of
Medicine, Lancet, JAMA, British Medical Journal, and Annals of Internal Medicine. The
review revealed important heterogeneity and variability in the reporting of harm-related results.

Adverse events were mentioned in some manner 88.7% of the 133 trials reports. However, no
information on severe adverse events was given in 27.1% of the articles. No information on
withdrawal of patients owing to an adverse event was given in 47.4% of the articles. Restrictions
in the reporting of harm-related data were noted in 43 articles (32.3%), with a description of the
most common adverse events only (n=17), severe adverse events only (n=16), statistically
significant events only (n=5), and a combination of restrictions (n=5). The authors concluded,
"the reporting of harm remains inadequate." [44]

An accompanying editorial raised concerns about why the reporting of adverse events is so
heterogeneous, again with possible applicability to many areas in biomedicine including HIT:

Perhaps conflicts of interest and marketing rather than science have shaped even the often
accepted standard that randomized trials study primarily effectiveness, whereas
information on harms from medical interventions can wait for case reports and
nonrandomized studies. Nonrandomized data are very helpful, but they have limitations,
and much harm will remain long undetected if we just wait for spontaneous reporting and
other nonrandomized research to reveal them. In an environment where effectiveness
benefits are small and shrinking, the randomized trials agenda may need to reprogram its
whole mission, including its reporting, toward better understanding of harms. [45]

Similar issues may prevail in evaluation studies of HIT.

4.3.8 Suppression of negative studies Related to the above, health care corporations may
regard clinical trials more as marketing tools than as science. Clinical research studies that failed
to provide results favorable to a sponsor's product may be simply suppressed due to the profit
motive. [46] Recent examples include the suppression of negative studies on acute migraine
headache medication sumatriptan in favor of studies with positive results. [47] Information on

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defective non-IT-related medical devices may also be suppressed. In another recent example, a
company will plead guilty to two criminal misdemeanors for failing to properly alert the U.S.
Food and Drug Administration about problems with some of its implantable defibrillators. [48]

Many other examples have been documented in the pharma and medical device sectors [49], and
a similar tactic may occur in the highly profitable HIT sector as well.

5. Recommendations for remediation of scarcity of UC information

5.1 Scientific rigor and candor

Broadly speaking, in a field with downsides, it has been said that there are: 1) those who know
about the problems but fail to speak, 2) those who see the problems but fail to act, and 3) those
who see, know and speak out. The field of HIT needs more of the third group.

5.2 Nondisclosure clause elimination

Nondisclosure clauses in HIT contracts should be dropped or refused. This measure is needed to
increase transparency and data sharing, along with regulatory requirements that UC data be
recorded, reported without fear of adverse consequence, and shared and diffused transparently
across institutions, medical societies, and geographic boundaries.

5.3 Reporting of HIT UC’s

Clinicians should manage HIT UC’s as they manage drug adverse events, and be educated to do
so. As an example, a clinician could report UC’s as they occur via the FDA MedWatch system.

5.4 Standardized service level agreements

SLA’s from HIT vendors calling for rapid remediation of serious HIT defects, especially those
that could result in patient harm in the short or medium term, should be a sine qua non of the
HIT market, and at reasonable costs.

5.5 Sharing of liability as appropriate to the circumstance.

Koppel and Kreda had suggested some reasonable compromises on this issue in their JAMA
“Hold Harmless clause” article. [36]

5.6 Increased cross disciplinary research focused on HIT UC’s

The National Research Council recommendations on accelerating interdisciplinary research in

biomedical informatics, computer science, social science, and health care engineering should be
strongly supported by all HIT research funding agencies and stakeholders.

5.7 Rigorous evaluation and validation of HIT pre- and post-sales

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Evaluation of health IT, both pre- and post-sales, that consider both the benefits and the
downsides, and that accurately records and reports UC’s, should become a formally mandated
process as in drug clinical trials. A post marketing surveillance system and registry analogous to
FDA MedWatch, which allows individuals and organizations to report UC’s to an agency with
authority to act upon the data, must also be developed if we are to successfully achieve national
HIT. The methods and studies are best developed by neutral organizations and personnel
without conflict of interest where possible, and with full disclosure of possible conflicts if they
exist.

5.8 Informed Consent

An informed consent process for patients, making them fully aware of the mediation of their care
by HIT devices, should be developed and implemented.

5.9 Wider dissemination of recent reports on HIT

2009 is proving to be a pivotal year in healthcare IT. Authoritative articles and reports on health
IT problems and UC’s have appeared at an accelerated pace. It is apparent that the HIT industry
is coming under increased scrutiny, perhaps a necessary requirement for the IT reform needed to
decrease UC’s. Dissemination of the most authoritative examples such as the Joint Commission
Sentinel Events Alert, National Research Council report, JAMA and JAMIA articles, major
newspaper reports, letters, and others [e.g., 5, 14, 15, 24, 50-55] might serve to return the HIT
marketplace from a pseudoscientific, marketing-influenced exuberance to a condition of
“sobriety” and scientific rigor.

5.10 Support of ongoing governmental investigations

On Oct. 16, 2009 a letter was sent to major healthcare IT vendors and management consulting
firms by Senator Charles E. Grassley initiating a Senate investigation of HIT and of HIT
corporate practices. [16] This investigation should be supported and relevant information
forwarded by involved stakeholders.

6. Conclusion

UC information on HIT is relatively scarce likely due to a variety of influences and complex
interactions among and between medicine, informatics, government and industry that, left
unaddressed, may lead to delays or other harm to good faith efforts to computerize informational
aspects of healthcare delivery and research. A computer-related, highly visible “Libby Zion”
analog, for example, could cause a severe setback to the cause of healthcare automation.

HIT should not challenge the resilience of the healthcare delivery system through engendering
“near misses”, since eventually actual patient harm is likely to result. Such challenges must be
prevented to the greatest extent practicable.

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The scarcity of definitive information on the extent of HIT UC’s should be addressed in a
responsible and ethical manner if this technology is to be successfully rolled out nationally over
the next five to ten years, and internationally as well. This includes measures practicable at the
level of the individual (e.g., improved reporting of UCs via existing resources such as FDA
MedWatch, improved dissemination of UC literature to organizational HIT leadership) and at the
level of policy-making (e.g., HIT regulation, requirements for patient informed consent).

The appearance of this new journal Applied Clinical Informatics itself is a hopeful sign that these
issues will receive the critical attention they merit.

Finally, medical innovation that does not properly account for patient rights, provide robust and
good faith research on UC’s, and patient protection from UC’s is not true innovation, but taking
advantage of patients seeking care. Greater transparency and reporting about HIT UC’s, along
with appropriate levels of validation and regulation of HIT, will benefit patients in the highest
traditions of medicine.

Clinical Relevance Statement:

The implications for practitioners of these results and recommendations are improvement of the
quality of care they provide and the protection from HIT defects and liability for events that
might be beyond their control. For consumers the implications are also improvement of care
quality, reduction of error, and enhanced informed consent rights related to the conduct of care
provision.

14
Table 1: Example cases of HIT issues in the MAUDE database that could have or did cause
UC’s:

Example 1: The issue involves powerchart local access medication

administration task, used when certain cerner millennium solutions are not
available. At powerchart local access sites that utilize coordinated universal time
(utc) functionality, medication administration tasks might be displayed with
incorrect times. When a pt download occurs from cerner millennium servers to
powerchart local access, and there is no cerner millennium application session
active, powerchart local access adds or subtracts the number of hours equal to
the time zone difference from greenwich mean time. Scheduled medication
administration tasks may show an incorrect administration time and the
possibility exists for a pt to receive medications earlier or later than intended.
[11]
Example 2: Patient care delay. The issue involves functionality in cerner
millennium powerchart office and powerchart core and affects users that utilize
the powerchart inbox and message center inbox. In results to endorse or sign and
review, if the user clicks ok and next multiple times in quick succession while
attempting to sign a result or a document, the display could lag behind the
system's processing of the action, and multiple results or documents could be
signed without the user's review. In message center, when clicking ok and next
or accept and next, or when deleting or completing messages and moving to the
next task, a document could be signed or a message could be deleted without the
user's review. Results could be endorsed or documents could be signed without
physician review, which could impact patient care. Cerner received
communication that a patient's follow-up care was delayed as a result of this
issue. [12]
Example 3: Microbiology set up a program within the cerner computer system
to automate the reporting system for hsv testing. The system was tested with the
assistance of cerner and found to be working appropriately. The new system was
operational for approximately 3 weeks when it was determined that the first
word of the sentence, "no" was inappropriately dropping off of the following
sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2
detected by dna amplification. " as such, two of five patients were incorrectly
informed that they had hsv before the error was detected. One had started an
antiviral creme treatment. The other three did not have follow-up visits until
after the correct results were determined. Cerner has looked at the program and
has not provided an answer for the system issue. In the interim, the previous
manual review and entry process is being used. [13]

15
Table 2: NIH Human Subjects Protection Requirements for Grant Review

Human Subjects Protection and Inclusion of Women, Minorities, and Children

Guidelines for Review of NIH Applications

Requirements for Review

Federal regulations for the protection of human research subjects (45 CFR 46),
require that the evaluation of research applications that involve human subjects
take into consideration the risk to subjects, the adequacy of protections against
risk, potential benefits of the research to subjects and others, and the
importance of the knowledge to be gained.

The NIH Peer Review regulations (42 C.F.R. 52h) specify that reviewers will
take into account, in determining overall impact that the project in the
application could have on the research field involved, the adequacy of the
proposed protection for humans. Therefore, reviewers must evaluate the
proposed plans to protect human subjects from research risks, as appropriate
for the research proposed, as appropriate for the research proposed, as one of
the review criteria that factor into the evaluation of scientific and technical
merit. [41]

16
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