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January 1998
Recommendations for responsible monitoring and regulation of clinical
software systems.
Miller RA and Gardner RM; JAMIA 1997; 4: 442-457.
[ see abstract below ]
In this position paper the authors provide important background by noting
that in the 1960's, the United States FDA began new discussions on the
regulation of stand-alone software programs as "medical devices". In
response, a consortium of organizations has developed recommendations for
public and private actions to accomplish responsible monitoring and
regulation of clinical software systems.
The authors state in their introduction that, "The consortium believes that implementation of any new
procedures for regulation of clinical software systems as medical devices
requires detailed prior analysis of regulatory relevance to, or impact on,
clinical software vendors, health care providers, and patients. Failure
to carry out analyses prior to regulatory actions could halt progress in an
emerging new industry that has substantial potential to improve the quality
of health care delivery. Manufacturers, users, and patients cannot
tolerate the delays in critical software improvements that might result
from excessive governmental review and approval processes." The authors
have provided a consolidated version of the extensive recommendations
resulting from this process.
By way of background, the term clinical software system is defined as
individual computer application programs, or interconnected groups of such
programs that are directly used in providing health care. Despite the wide
range of application and the extensive penetration of this technology into
virtually all aspects of healthcare, there are no generally accepted
standards for the use, evaluation, and monitoring of clinical software
systems. The FDA is only beginning to address appropriate policy in this
regard even though its original perception was FDA that such software
should be the subject of regulatory oversight.
Interestingly, the authors highlight some obstacles to the evaluation and
monitoring of clinical software systems. They note that even the
"simplest" of "turnkey", "as is" programs is difficult to evaluate, given
the fact that individual clinical vendor products number in at least the
thousands. Now with the advent of the world-wide-web, the numbers are
expanding even greater, and typically reflect a greater variability in
quality. The conditions under which such systems are evaluated may differ
dramatically, given the differences in maturity of various systems, the
clinical setting in which they are tested and used, and the relative lack
of information regarding true impact of these systems on patient care.
Although the evaluation of turnkey software products is very difficult, the
chances for evaluating complex, interconnected clinical software systems
are even more remote. The authors offer an example in which a healthcare
institution decides to purchase and connect a series of applications for
their laboratory, pharmacy, admission/discharge/transfer, dietary, and
clerical order processing activities: "If the institution considers ten
different vendors that produce products of the sort begin considered, there
are 100,000 different basic configurations possible. Major referral
centers install dozens of individual software components, each selected
from more than a hundred possible product configurations. One hundred
choices for each of 23 components yields a trillion possible overall
configurations for each large site!"
Additional obstacles to evaluation and monitoring of clinical software
systems include the variability introduced by systems which are changed
over time, and performed in the context of users whose insight, training,
and facility with various systems is highly variable. This variability
depends in part on the life-cycle of such products in various healthcare
facilities.
It is the responsibility of the FDA to regulate medical devices that are:
(a) commercial products used in patient care; (b) devices used in the
preparation or distribution of clinical biological materials; or (c)
experimental devices used in research involving human subjects. The FDA
depends mainly on vendors to submit their products voluntarily for initial
review and post-review revisions. The review process is
additionally varied by the differences among the orientations of different
expert reviewers and consultants.
The resulting consensus process arose from inputs from a variety of
organizations with particular interest and expertise in the area of
clinical software. The five general recommendations of the consortium are
summarized as follows:
(1) Recommend four categories of clinical software system risks and four
classes of measured regulatory actions as a template for clinical
facilities, vendors, and regulatory agencies to use in determining how to
monitor or regulate any given clinical software system.
(2) Recommend local oversight of clinical software systems whenever possible.
(3) Recommend that the FDA focuses its regulatory efforts on those systems
posing highest clinical risk that give limited opportunities for competent
human intervention.
(4) Recommend adoption by vendors and software producers of a code of good
business practices.
(5) Recommend cooperation among health information-related organizations,
clinical professional organizations, vendor organizations, regulatory
agencies, and user communities in advancing knowledge and improved
applications.
We should look forward to more rational approaches to the regulation of
such critical components of contemporary healthcare.
Return to the Current Literature Review Front Page, or read the abstract:
ABSTRACT
In mid-1996, the FDA called for discussions on regulation of clinical
software programs as medical devices. In response, a consortium of
organizations dedicated to improving health care through information
technology has developed recommending for the responsible regulation and
monitoring of clinical software systems by users, vendors, and regulatory
agencies.
Organizations assisting in development of recommendations, or
endorsing the consortium position include the American Medical Informatics
Association, the Computer-based Patient Record Institute, the Medical
Library Association, the Association of Academic Health Sciences Libraries,
the American Health Information Management Association, the American Nurses
Association, the Center for Healthcare Information Management, and the
American College of Physicians.
The consortium proposes four categories of clinical system risks and four
classes of measured monitoring and regulatory actions that can be applied
strategically based on the level of risk in a given setting. The
consortium recommends local oversight of clinical software systems, and
adoption by healthcare information system developers of a code of good
business practices.
Budgetary and other constraints limit the type and
number of systems that the FDA can regulate effectively. FDA regulation
should exempt most clinical software systems and focus on those systems
posing highest clinical risk, with limited opportunities for competent
human intervention.
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