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Background
The rapidly increasing software complexity of medical devices makes the
development of high integrity software a crucial issue. Several Federal
agencies are interested in identifying the research needs required to
improve the design, certification, and operation (by both health care
professionals and consumers) of medical device software and systems that
will result in better and more cost-effective medical care.
The November 2004 planning meeting assembled a select group of leaders and
visionaries in the medical device industry, research laboratories,
academia, and government who helped identify short-term and long-term
technological challenges faced by medical device manufacturers and
regulators.
Information gathered from this planning meeting is being used
to establish the full scope and agenda for a larger national-level
research workshop slated for June 2005. The objective of the
workshop will be to identify and discuss potential approaches
that can help answer the challenges.
WORKSHOP ORGANIZERS
Insup Lee | | University of Pennsylvania (Chair) |
George J. Pappas | | University of Pennsylvania |
Janos Sztipanovits | | Vanderbilt University |
Shankar Sastry | | University of California-Berkeley |
Program Committee
- Tarek Abdelzaher, Unviersity of Virginia
- Rance Cleaveland, Reactive Systems, Inc.
- Helen Gill, National Science Foundation
- Julian M. Goldman, Massachusetts General Hospital/Harvard
Medical School
- John Hatcliff, Kansas State University
- Paul L. Jones, Food and Drug Administration
- Bruce Krogh, Carnegie Mellon Universit
- Insup Lee, University of Pennsylvania
- Peter Lee, Carnegie Mellon Universit
- Brian Litt, Hospital of University of Pennsylvania
- Jane Liu, IIS, Academia Sinica, Taiwan
- William Bradley Martin, National Security Agency
- George J. Pappas, University of Pennsylvania
- Raj Rajkumar, Carnegie Mellon University
- Victoria L. Rich, Hospital of University of Pennsylvania/School
of Nursing
- Douglas Rosendale, Veterans Affairs Office of Information
and Surgery
- Harvey Rubin, University of Pennsylvania School of Medicine
- Doug Schmidt, Vanderbilt University
- Janos Sztipanovits, Vanderbilt University
Goals of Sponsoring Agencies
The goals of the individual Federal agencies sponsoring the Planning Meeting
and Workshop are as follows:
Food and Drug Administration (FDA)
Paul Jones, Senior Systems/Software Engineer, writes that "the FDA's Center
for Devices and Radiological Health (CDRH) is tasked by Congress to promote
and protect the public health. CDRH works to ensure that medical devices
placed on the market are safe and effective. CDRH needs scientific and
engineering based methods for assessing that increasingly complex and
ubiquitous software perform as intended, safely, and effectively, prior to
being approved for the market. Similarly, medical device manufacturers need
the tools and methods for developing cost-effective high-integrity software to
sustain their competitiveness in a global market." Jones desires that the
Planning Meeting and Workshop identify short-term and long-term technological
challenges faced by medical device manufacturers and their regulators in order
to meet these objectives.
For more information please visit
http://www.fda.gov/cdrh.
National Institute of Standards and Technology (NIST)
Paul E. Black, Computer Scientist, Information Technology Laboratory (ITL),
writes that "NIST is a non-regulatory Federal agency with a mission to develop
and promote measurement, standards, and technology. NIST works with a broad
range of industries and research laboratories. Some of NIST/ITL's projects
touching medical software and systems include security and certification, user
interfaces, software diagnostics and conformance testing, network research,
and pervasive computing. We come to this Planning Meeting and Workshop to help
determine where new software measurement and assessment methods, standards,
and software engineering and computer technologies are crucial and, in the
future, to help develop those capabilities."
For more information please visit
http://www.nist.gov/, particularly
http://www.itl.nist.gov/
National Security Agency (NSA)
Brad Martin, Senior Computer Scientist, writes that "while the Planning
Meeting and Workshop will focus on medical devices, the general goal of
identifying crucial issues for the design, certification, and operation of
high integrity software and systems is of overwhelming interest to
participants affiliated with NSA. In a wide variety of domains, software and
systems face many of the same issues as medical devices. These include the
increasing complexity of these critical systems, the accelerating product
development cycles due to market pressures, and the effort, time, and cost of
certification processes for critical systems."
For more information please
visit http://www.nsa.gov/.
National Science Foundation (NSF)
Helen Gill, Program Director, Computer and Network Systems Division,
Directorate for Computer and Information Science and Engineering, notes
that "NSF is responsible for far-reaching, long-term research that
promotes progress in science; advances national health, prosperity, and
welfare; and secures the national defense. Information technology and
networking research is rapidly changing the face of all engineered
systems, including medical devices and systems. In support of building
systems that are inherently dependable, there is growing emphasis
on security, safety, and assurance in real-time embedded systems and in
architectures and system technologies for sensor and control systems. NSF
seeks to advance knowledge in foundations, computational models, and
systems technologies for future IT-intensive engineered devices and
systems with the goal of improving the safety and security of systems we
already know how to build and building systems with entirely new
capabilities. We see this workshop as a key step toward
identifying and exploring ambitious national challenges for future
IT-enabled medical devices and systems. We hope this meeting can
set in motion a process to chart the systems technologies and
assurance methods needed to reliably develop and certify a new generation
of increasingly capable, complex, and inherently dependable medical
devices and systems."
For more information please
visit http://www.nsf.gov/.
National Coordination Office for Information Technology Research and
Development (NCO/ITRD)
Sally E. Howe, Associate Director, and Frankie King, Special Projects
Coordinator, write that "in its role of coordinating the $2 billion 11-agency
Federal Networking and IT R&D (NITRD) Program, the NCO supports six
Coordinating Groups (CGs), including the High Confidence Software and Systems
CG by supporting meetings, workshops, and the preparation of Government
reports."
For more information about the NCO please visit
http://www.nitrd.gov.
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