1. High Confidence Medical Device Software and Systems Workshop Planning Meeting Government Introduction November 16, 2004 Sally E. Howe, Ph.D. Associate Director National Coordination Office for Information Technology Research and Development (NCO/ITRD)

2. November 16, 2004 2 Overview of the NITRD Program The Networking and Information Technology Research and Development Program –High-Performance Computing Act of 1991 –Next Generation Internet Act of 1998 Interagency Working Group on IT R&D –Representatives from 11 agencies + OMB + OSTP + NCO/ITRD –Has six Coordinating Groups NCO/ITRD –Planning, budget, and assessment for the $2 billion invested by 11 agencies in the NITRD Program –Produce reports — http://www.nitrd.gov/pubs/ Annual Supplement to the President’s Budget Research needs

3. November 16, 2004 3 NITRD Program Coordination WHITE HOUSE Executive Office of the President Office of Science and Technology Policy National Science and Technology Council National Coordination Office (NCO) for Information Technology Research and Development High End Computing Coordinating Group (HEC) Large Scale Networking Coordinating Group (LSN) High Confidence Software and Systems Coordinating Group (HCSS) Human Computer Interaction & Information Management Coordinating Group (HCI & IM) Software Design and Productivity Coordinating Group (SDP) President ’ s Information Technology Advisory Committee (PITAC) Interagency Working Group (IWG) on Information Technology R&D Social, Economic and Workforce Implications of IT and IT Workforce Development Coordinating Group (SEW) Participating Agencies: AHRQ, DARPA, DOE/NNSA, DOE/SC, EPA, NASA, NIH, NIST, NOAA, NSA, NSF, ODDR&E U.S. Congress NITRD Authorization and Appropriations Legislation

4. November 16, 2004 4 Why is the NCO here today? The NCO helps the IWG and the Coordinating Groups identify their research needs and then plan, budget, and assess progress in addressing those needs Per its name, the domain of the NITRD Program is networking and information technology research and development The Program and the NCO do their best work in the context of real, important, hard problems –High confidence medical device software and systems provide such problems Our method is meetings, workshops, conferences Our medium is the written word, especially reports

5. November 16, 2004 5 Workshop Report Will identify and describe HCMDSS research needs –Will probably be structured like the workshop structure, which will be determined largely by the outcome from this planning meeting –Will probably not be just proceedings –Will describe the process by which the report was produced, including this meeting Audiences –OSTP, OMB, and Congress –Federal agencies — both NITRD and others –University research community –Medical device hardware, software, and systems manufacturers –General public

6. November 16, 2004 6 For more information about the NITRD Program and the NCO … Visit http://www.nitrd.gov/ Send e-mail to nco@nitrd.gov Call or write us: –Frankie King at (703) 292-7920 or king@nitrd.gov –Sally Howe at (703) 292-7923 or howe@nitrd.gov

7. November 16, 2004 7 Government Speakers Paul Jones, Senior Systems/Software Engineer, FDA Paul Black, Computer Scientist, Information Technology Lab — NIST Brad Martin, Senior Computer Scientist — NSA Helen Gill, Program Director, Computer and Network Systems Division, Directorate for Computer and Information Science and Engineering — NSF

8. November 16, 2004 8 Food and Drug Administration 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. The planning meeting and workshop are expected to 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

9. November 16, 2004 9 National Institute of Standards and Technology 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/.

10. November 16, 2004 10 National Security Agency 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/

11. November 16, 2004 11 National Science Foundation (1) 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.

12. November 16, 2004 12 National Science Foundation (2) NSF sees this workshop planning meeting as a key step toward identifying and exploring ambitious national challenges for future IT-enabled medical devices and systems. NSF hopes this planning 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/

13. November 16, 2004 13 High Confidence Software and Systems Coordinating Group (HCSS CG) The activities funded under the NITRD Program’s HCSS PCA focus on the basic science and information technologies necessary to achieve affordable and predictable high levels of safety, security, reliability, and survivability in U.S. national security- and safety-critical systems realized in critical domains such as aviation, healthcare, national defense, and infrastructure. NITRD Agencies: –NSF, NASA, NSA, NIH, DARPA, NIST Other Participating Agencies: –AFRL, ARO, DHS, FAA, FDA, and ONR Activities include: –Sufficient Evidence? Building Certifiably Dependable Systems being conducted by the Computer Science and Telecommunications Board of the National Academies to assess current practices for developing and evaluating mission-critical software, with an emphasis on dependability objectives.

14. High Confidence Medical Device Software and Systems Workshop Planning Meeting November 16 and 17, 2004 Arlington, Virginia

15. November 16, 2004 15 Bio Sally E. Howe is Associate Director of the National Coordination Office (NCO) for Information Technology Research and Development (IT R&D), and has been at the NCO since it was established in 1992, serving first as Assistant Director for Technology and then as Chief of Staff. The NCO’s activities include: coordinating the Federal government's $2 billion per year Networking and Information Technology Research and Development (NITRD) Program; supporting the Interagency Working Group (IWG) on ITR&D under the National Science and Technology Council, Office of Science and Technology Policy, Executive Office of the President; coordinating the preparation of documents including the NITRD Program's annual report to Congress (commonly known as the Blue Book); and supporting the President's Information Technology Advisory Committee (PITAC). Dr. Howe’s duties at the NCO include: coordinating the activities of the NCO's technical staff, including their support for the six Coordinating Groups that report to the IWG/ITR&D; serving as Executive Editor for the Blue Book; coordinating the NCO's technical support for the PITAC and preparing and overseeing the NCO budget. Prior to working at the NCO, she spent 12 years at the National Institute of Standards and Technology, including serving as Chief of the Scientific Computing Environments Division within the Center for Applied Mathematics. Before joining the Federal government, she was an Assistant Professor of Statistics at Carnegie Mellon University and an Instructor in Mathematics at Keystone Junior College. She holds a B.A. in Mathematics from William Smith College, an M.A. in Mathematics from the University of Virginia, and a Ph.D. in Applied Mathematics from Brown University.