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

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.