Biomedical Engineering Reference
In-Depth Information
forming to specification. By contrast, verification means checking whether
the resource was built to specification. As we introduce evaluation methods
in detail, we will distinguish the study of software functions from the study
of their impact or effects on users and the wider world. Although software
verification is important, this volume will only summarize some of the rel-
evant principles in Chapter 3 and refer the reader to general computer
science and software-engineering texts.
Reasons for Performing Evaluations
Like any complex, time-consuming activity, evaluation can serve multiple
purposes. There are at least five major reasons why we evaluate biomedical
information resources.
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1.
Promotional:
To encourage the use of information resources in bio-
medicine, we must be able to reassure clinicians, patients, researchers, and
educators that these resources are safe and bring benefit to persons, groups,
and institutions through improved cost-effectiveness or safety, or perhaps
by making activities possible that were not possible before.
2.
Scholarly:
If we believe that biomedical informatics exists as a disci-
pline or scientific field, ongoing examination of the structure, function, and
impact of biomedical information resources must be a primary method for
identifying and confirming the principles that lie at the foundation of the
field.
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In addition, some developers of information resources carry out
evaluations from different perspectives out of basic curiosity in order to see
if the resources are able to perform functions that were not in the original
specifications.
3.
Pragmatic:
Without evaluating the resources they create, developers
can never know which techniques or methods are more effective, or why
certain approaches failed. Equally, other developers are not able to learn
from previous mistakes and may reinvent a square wheel.
4.
Ethical:
Before using an information resource, clinicians, researchers,
educators, and administrators must be satisfied that it is functional and be
able to justify its use in preference to alternative information resources and
the many other innovations that compete for the same budget.
5.
Medicolegal:
To reduce the risk of liability, developers of an informa-
tion resource should obtain accurate information to allow them to label it
correctly
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and assure users that it is safe and effective. Users need evalua-
tion results to enable them to exercise their professional judgment before
using these resources, thus helping the law regard each user as a “learned
intermediary.” An information resource that treats the users merely as
automatons, without allowing them to exercise their skills and judgment,
risks being judged by the strict laws of product liability instead of the more
lenient principles applied to provision of professional services.
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