High Confidence Medical Device Software and Systems Workshop Planning Meeting Government Introduction November 16, 2004

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High Confidence Medical Device Software and
Systems Workshop Planning Meeting Government
IntroductionNovember 16, 2004

• Sally E. Howe, Ph.D.
• Associate Director
• National Coordination Office for Information
  Technology Research and Development (NCO/ITRD)

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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 RD
• 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 Presidents Budget
• Research needs

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

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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

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For more information about the NITRD Program and
the NCO

• Visit http//www.nitrd.gov/
• Send e-mail to nco_at_nitrd.gov
• Call or write us
• Frankie King at [phone] or king_at_nitrd.gov
• Sally Howe at [phone] or howe_at_nitrd.gov

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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

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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

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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/.

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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/

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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.

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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/

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High Confidence Software and Systems Coordinating
Group (HCSS CG)

• The activities funded under the NITRD Programs
  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.

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High Confidence Medical Device Software and
Systems Workshop Planning Meeting

• November 16 and 17, 2004
• Arlington, Virginia

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Bio
Sally E. Howe is Associate Director of the
National Coordination Office (NCO) for
Information Technology Research and Development
(IT RD), 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 NCOs 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 ITRD 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. Howes 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/ITRD 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.