A Technical History of the SEI

and Drug Administration issued draft guidance to manufacturers recommending the use of assurance
cases and providing guidance for their use. In response, infusion pump manufacturers are beginning
to use assurance cases. The FDA is the only official agency of the U.S. government that
has formally mandated the use of assurance cases to date. At this time, the DoD has not yet embraced
the use of assurance cases, but continuing work is focused on creating a theory of argumentation
that can be used to reason about the amount of confidence in a claim that is provided by
particular pieces of evidence. The expectation is that this work will lead to the ability to determine
how to more effectively use scarce assurance resources.
As DoD software challenges evolve, the SEI will continue to investigate evolving engineering
methods that offer promise for improving capabilities for the future. Just as assurance cases have
not yet matured to the point where DoD programs are ready to apply them, they offer opportunity
for improved safety. Application of such techniques in non-defense systems that exhibit more
constrained characteristics provide the SEI an opportunity to demonstrate the efficacy of such engineering
approaches and evolve them to be more robust.
References
[Brown 1993] Brown, Alan W.; Carney, David J.; Feiler, Peter H.; Oberndorf, Patricia A.; &
Zelkowitz, Marvin V. “A Project Support Environment Reference Model,” 82-89. Proceedings of
TRI-Ada Conference, Seattle, WA, September 18-23, 1993. ACM 1993.
[Buxton1981] Buxton, John & Druffel, Larry. “Requirements for an Ada Programming Environment:
Rationale for Stoneman.” Proceedings of IEEE COMPSAC. IEEE Annual International
Computer and Software Conference (COMPSAC). San Francisco, CA, October 29-31, 1980. Institute
of Electrical and Electronics Engineers, 1981.
[Druffel 1983] Druffel, Larry; Redwine, Samuel, Jr.; & Riddle, William. “The DoD STARS Program.”
IEEE Computer (November 1983): 21-30.
[DSB 1994] Defense Science Board Task Force (Larry Druffel & George H. Heilmeier, cochairs).
Acquiring Defense Software Commercially. (Report #859), June 1994.
http://www.dod.mil/pubs/foi/logistics_material_readiness/acq_bud_fin/859.pdf
[IBM 2010] IBM. Rational Unified Process ® (RUP ® ) Plug-ins for Rational Method Composer
7.5. http://www-01.ibm.com/support/docview.wss?uid=swg24028579
[Weinstock 2009] Weinstock, Charles & Goodenough, John. Towards an Assurance Case Practice
for Medical Devices (CMU/SEI-2009-TN-018). Software Engineering Institute, Carnegie
Mellon University, 2009. http://resources.sei.cmu.edu/library/asset-view.cfm?AssetID=8999
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