1. High Confidence Medical Device Software and Systems Workshop: Government Participants and their Expectations June 2 – 3, 2005 Sally E. Howe, Ph.D. Associate Director NCO/NITRD

2. 2 Government Speakers Simon Szykman –Director, National Coordination Office for Networking and Information Technology Research and Development (NCO/NITRD) Sally E. Howe –Associate Director, NCO/NITRD Wei Zhao –Director, Computer and Network Systems (CNS) Division, Computer and Information Science and Engineering Directorate (CISE), National Science Foundation (NSF) Helen Gill –Program Director for Computer Systems Research, CNS, CISE, NSF –High Confidence Software and Systems (HCSS) Coordinating Group (CG) Co-Chair Brad Martin –Chief, High Confidence Software and Systems Division, National Security Agency –HCSS CG Co-Chair Paul Jones –Senior Systems Software Engineer, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration Dave Hislop –Program Manager, Software and Knowledge-Based Systems, Army Research Office Their perspectives: –Address individual agency mission needs –Coordinate with other agencies on areas of overlapping interest Two types of agencies: –Part of NITRD Program’s budget crosscut (NSF, NSA, NIST, …) –Participate in NITRD Program activities (FDA, ARO, Services, …)

3. 3 This Workshop vs. November 2004 Workshop Planning Meeting November 2004 Workshop Planning Meeting –Initial invitational meeting of a variety of communities These communities had not known about one another HCSS CG agencies and NCO identified the communities and community representatives –Sponsored by HCSS CG, funded by NCO, chaired by UPenn –Received input from the communities about topics to be addressed in this Workshop and recommendations about other communities to invite to the Workshop June 2005 –Open solicitation for participants –Sponsored and funded by several agencies, organized by Upenn and Vanderbilt –Made such substantial progress in November that this Workshop now can address two major tasks: Report (more on next slide) PLUS a roadmap (more on another slide)

4. 4 Anticipated Report Organizers and breakout chairs will prepare report required by NSF grant –Report is to be balanced and unbiased –All voices at breakouts to be reflected in the report –Report expected to organize the topic well and add value beyond what is said at the Workshop –“Court reporters” in plenary sessions and either court reporters at or taping of breakouts will be used to produce transcripts for use in preparing the report –Report shall include a roadmap (next slide) — though that roadmap is to be a living document Report should communicate the views of a community that understands and agrees about its research needs, present a plan, and show that it has the leadership and organization to implement the plan –This is a highly diverse community, and each individual and group plays a necessary role Once the content is finalized, the sponsoring agencies and HCSS CG will accept the report and turn it over to the NCO for final copyediting, etc. Report will be an NCO publication Model for process and report –Software Design and Productivity workshop held December 2001 at Vanderbilt and report entitled Workshop on New Visions for Software Design and Productivity: Research and Applications

5. 5 Roadmap Identify major areas –Break down major areas as appropriate Include academia, industry, and Government in an open process of creating, implementing, and periodically assessing progress Include timelines, milestones, and metrics Identify needs, gaps, trends, interdependencies, and technology challenges Identify performers and processes by which the roadmap will be implemented Be enthusiastically embraced and responsibly implemented by all communities involved in developing and deploying high confidence medical device software and systems

6. 6 Questions? Visit http://www.nitrd.gov/ Send e-mail to nco@nitrd.gov Call us at (703) 292-4873