CICOSAT COLLEGES

LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES

Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

MODULE 5: ETHICAL ISSUES IN HEALTH

INFORMATICS
Human values should govern research and practice in the health professions.
Health care informatics, like other health professions, encompasses issues of appropriate
and inappropriate behavior, of honorable and disreputable actions, and of right and
wrong. Students and practitioners of the health sciences, including informatics, share an
important obligation to explore the moral underpinnings and ethical challenges related
to their research and practice. Informatics now constitutes a source of some of the most
important and interesting ethical debates in all the health professions. People often
assume that the confidentiality of electronically stored patient information is the primary
source of ethical attention in informatics. Although confidentiality and privacy are
indeed of vital importance and significant concern, the field is rich with other ethical
issues, including the appropriate selection and use of informatics tools in clinical settings;
the determination of who should use such tools; the role of system evaluation; the
obligations of system developers, maintainers, and vendors; and the use of computers to
track clinical outcomes. To consider ethical issues in health care informatics is to explore
a significant intersection among several professions’ health care delivery and
administration, applied computing, and ethics each of which is a vast field of inquiry.
Fortunately, growing interest in bioethics and computer-related ethics has produced a
starting point for such exploration. An initial ensemble of guiding principles, or ethical
criteria, has emerged to orient decision making in health care informatics.

LESSON 1: HEALTH INFORMATICS

APPLICATIONS: APPROPRIATE USE, USERS, AND CONTEXTS

Application of computer-based technologies in the health professions can build

on previous experience in adopting other devices, tools, and methods. Before they
perform most health-related interventions (e.g., genetic testing, prescription of
medication, surgical and other therapeutic procedures), clinicians generally evaluate
appropriate evidence, standards, presuppositions, and values. Indeed, the very
evolution of the health professions entails the evolution of evidence, of standards, of
presuppositions, and of values. Similar considerations determine the appropriate use of
informatics tools.

THE STANDARD VIEW OF APPROPRIATE USE

Excitement often accompanies initial use of computer-based tools in clinical

settings. Based on the uncertainties that surround any new technology, however,
scientific evidence counsels caution and prudence. As in other clinical areas, evidence
and reason determine the appropriate level of caution. For instance, there is
considerable evidence that electronic laboratory information systems improve access to

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024
 CICOSAT COLLEGES
LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES
Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

clinical data when compared with manual, paper-based test-result distribution methods.
To the extent that such systems improve care at an acceptable cost in time and money,
there is an obligation to use computers to store and retrieve clinical laboratory results.

Clinical expert systems can improve patient care in typical practice settings at an
acceptable cost in time and money. Clinical expert systems are intended to provide
decision support for diagnosis and therapy in a more detailed and sophisticated manner
than that provided by simple reminder systems. Creation of expert systems and
maintenance of related knowledge bases still involve leading-edge research and
development. It is also important to recognize that humans are still superior to electronic
systems in understanding patients and their problems, in efficient collection of pertinent
data across the spectrum of clinical practice, in the interpretation and representation of
data, and in clinical synthesis. Humans may always be superior at these tasks, although
such a claim must be subjected to empirical testing from time to time. What has been
called the standard view of computer-assisted clinical diagnosis holds in part that human
cognitive processes, being more suited to the complex task of diagnosis than machine
intelligence, should not be overridden or trumped by computers. The standard view
states that when adequate (and even exemplary) decision-support tools are developed,
they should be viewed and used as supplementary and subservient to human clinical
judgment. They should take this role because the clinician caring for the patient knows
and understands the patient’s situation and can make compassionate judgments better
than computer programs; they are also the individuals whom the state licenses, and
specialty boards accredit, to practice medicine, surgery, nursing, pharmacy, or other
health-related activities.

Corollaries of the standard view are that: (1) practitioners have an obligation to
use any computer-based tool responsibly, through adequate user training and by
developing an understanding of the system’s abilities and limitations; and (2) practitioners
must not abrogate their clinical judgment reflexively when using computer-based
decision aids. Because the skills required for diagnosis are in many respects different from
those required for the acquisition, storage, and retrieval of laboratory data, there is no
contradiction in urging extensive use of electronic laboratory information systems, but
cautious or limited use (for the time being) of expert diagnostic decision-support tools.
The standard view addresses one aspect of the question, “How and when should
computers be used in clinical practice?” by capturing important moral intuitions about
error avoidance and evolving standards. Error avoidance and the benefits that follow
from it shape the obligations of practitioners. In computer-software use, as in all other
areas of clinical practice, good intentions alone may be insufficient to insulate
recklessness from culpability. Thus, the standard view may be seen as a tool for both error
avoidance and ethically optimized action.

Ethical software use should be evaluated against a broad background of

evidence for actions that produce favorable outcomes. Because informatics is a science
in extraordinary ferment, system improvements and evidence of such improvements are
constantly emerging. Clinicians have an obligation to be familiar with this evidence after
attaining minimal acceptable levels of familiarity with informatics in general and with the
clinical systems they use in particular.

APPROPRIATE USERS AND EDUCATIONAL STANDARDS

Efficient and effective use of health care informatics systems requires training,
experience, and education. Indeed, such requirements resemble those for other tools
used in health care and in other domains. Inadequate preparation in the use of tools is

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024
 CICOSAT COLLEGES
LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES
Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

an invitation to catastrophe. When the stakes are high and the domain large and
complex as is the case in the health professions education and training take on moral
significance. Suitable use of a software program that helps a user to suggest diagnoses,
to select therapies, or to render prognoses must be plotted against an array of goals and
best practices for achieving those goals, including consideration of the characteristics
and requirements of individual patients. For example, the multiple interconnected
inferential strategies required for arriving at an accurate diagnosis depend on
knowledge of facts; experience with procedures; and familiarity with human behavior,
motivation, and values. Diagnosis is a process rather than an event so even well-
validated diagnostic systems must be used appropriately in the overall context of patient
care. To use a diagnostic decision-support system, the clinician must be able to recognize
when the computer program has erred, and, when it is accurate, what the output means
and how it should be interpreted. This ability requires knowledge of both the diagnostic
sciences and the software applications and their limitations. After assigning a diagnostic
label, the clinician must communicate the diagnosis, prognosis, and implications to a
patient and must do so in ways both appropriate to the patient’s educational
background and conducive to future treatment goals. It is not enough to be able to tell
patients that they have cancer, human immunodeficiency virus (HIV), diabetes, or heart
disease and simply to hand over a number of prescriptions. The care provider must also
offer context when available, comfort when needed, and hope as appropriate. The
reason many jurisdictions require pretest and posttest HIV counseling, for instance, is not
to vex busy health professionals but rather to ensure that comprehensive, high-quality
care rather than just diagnostic labeling has been delivered.

ACTIVITY 1: THE ETHICAL PRINCIPLES FOR APPROPRIATE USE OF DECISION-SUPPORT SYSTEMS

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024
 CICOSAT COLLEGES
LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES
Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

OBLIGATIONS AND STANDARDS FOR SYSTEM DEVELOPERS AND MAINTAINERS

Users of clinical programs must rely on the work of other people who are often far
removed from the context of use. Users depend on the developers and maintainers of a
system and must trust evaluators who have validated a system for clinical use. Health
care software applications are among the most complex tools in the technological
armamentarium. Although this complexity imposes certain obligations on end users, it
also commits a system’s developers, designers, and maintainers to adhere to reasonable
standards and, indeed, to acknowledge their moral responsibility for doing so.

ETHICS, STANDARDS, AND SCIENTIFIC PROGRESS

The very idea of a standard of care embodies a number of complex assumptions

linking ethics, evidence, outcomes, and professional training. To say that a nurse or
physician must adhere to a standard is to say, in part, that they ought not to stray from
procedures that have been shown or are generally believed to work better than other
procedures. Whether a procedure or device “works better” than another can be difficult
to determine such determinations in the health sciences constitute progress and indicate
that we know more than we used to know. Criteria for evidence and proof are applied.
Evidence from randomized controlled trials is preferable to evidence from uncontrolled
retrospective studies, and verification by independent investigators is required before the
most recent reports are put into common practice.

People who develop, maintain, and sell health care computing systems and
components have obligations that parallel those of system users. These obligations
include holding patient care as the leading value. The Hippocratic injunction primum
non nocere (first do no harm) applies to developers as well as to practitioners. Although
this principle is easy to suggest and, generally, to defend it invites subtle, and sometimes
overt, resistance from people who hold profit or fame as primary motivators to be sure,
quests for fame and fortune often produce good outcomes and improved care, at least
eventually. Even so, that approach fails to take into account the role of intention as a
moral criterion.

In medicine, nursing, and psychology, a number of models of the professional–

patient relationship place trust and advocacy at the apex of a hierarchy of values. Such
a stance cannot be maintained if goals and intentions other than patient well-being are
(generally) assigned primacy. The same principles apply to people who produce and
attend to health care information systems. Because these systems are health care
systems and are not devices for accounting, entertainment, real estate, and so on and
because the domain is shaped by pain, vulnerability, illness, and death, it is essential that
the threads of trust run throughout the fabric of clinical system design and maintenance.
System purchasers, users, and patients must trust developers and maintainers to
recognize the potentially grave consequences of errors or carelessness, trust them to
care about the uses to which the systems will be put, and trust them to value the reduced
suffering of other people at least as much as they value their own personal gain. We
emphatically do not mean to suggest that system designers and maintainers are
blameworthy or unethical if they hope and strive to profit from their diligence, creativity,
and effort. Rather, we suggest that no amount of financial benefit for a designer can
counterbalance bad outcomes or ill consequences that result from recklessness, avarice,
or inattention to the needs of clinicians and their patients.

Quality standards should stimulate scientific progress and innovation while

safeguarding against system error and abuse. These goals might seem incompatible, but
they are not. Let us postulate a standard that requires timely updating and testing of

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024
 CICOSAT COLLEGES
LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES
Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

knowledge bases that are used by decision-support systems. To the extent that database
accuracy is needed to maximize the accuracy of inferential engines, it is trivially clear
how such a standard will help to prevent decision-support mistakes. Furthermore, the
standard should be seen to foster progress and innovation in the same way that any
insistence on best possible accuracy helps to protect scientists and clinicians from
pursuing false leads, or wasting time in testing poorly wrought hypotheses. It will not do
for database maintainers to insist that they are busy doing the more productive or
scientifically stimulating work of improving knowledge representation, say, or database
design.

Although such tasks are important, they do not supplant the tasks of updating and
testing tools in their current configuration or structure. Put differently, scientific and
technical standards are perfectly able to stimulate progress while taking a cautious or
even conservative stance toward permissible risk in patient care.

SYSTEM EVALUATION AS AN ETHICAL IMPERATIVE

Any move toward “best practices” in health informatics is shallow and feckless if it
does not include a way to measure whether a system performs as intended. This and
related measurements provide the ground for quality control and, as such, are the
obligations of system developers, maintainers, users, administrators, and perhaps other
players.

ACTIVITY 2: A COMPREHENSIVE EVALUATION PROGRAM CAN ETHICALLY OPTIMIZE

IMPLEMENTATION AND USE OF AN INFORMATICS SYSTEM. ENUMERATE THE TEN CRITERIA
FOR SYSTEM SCRUTINY.

Another way to look at this important point is that people use computer systems.

Even the finest system might be misused, misunderstood, or mistakenly allowed to

alter or erode previously productive human relationships. Evaluation of health information
systems in their contexts of use should be taken as a moral imperative. Such evaluations
require consideration of a broader conceptualization of “what works best” and must look
toward improving the overall health care delivery system rather than only that system’s
technologically based components.

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024
 CICOSAT COLLEGES
LINGSAT, CITY OF SAN FERNANDO, LAUNION, PHILIPPINES
Tel. No. (072) 687-5500 Email Address: cicosatc@yahoo.com

ACTIVITY 3: SECURITY STANDARDS AND LAW

SECURITY STANDARD/LAW BRIEF DESCRIPTION

ISO 20000/27000

COBIT

ITIL

NIST SP 800-53

HIPAA

Meaningful Use (HITECH Act)

PCI-DSS

FISMA

ACTIVITY 4: HEALTHCARE DATA BREACHES HAVE GAINED TRACTION IN THE NEWS DUE TO
THE LARGE NUMBER OF PATIENTS INVOLVED AND THE SENSITIVE NATURE OF HEALTH
RECORDS

TRICARE (2011)

ADVOCATE MEDICAL GROUP

(2013)

AFFINITY HEALTH PLAN, INC. (2010)

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Pharmacy Informatics
Lamirez, Jorelyn M., RPh
nd
2 Semester SY 2023-2024