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U.S. FEDERAL GOVERNMENT RECOGNIZES IEEE 11073™ STANDARDS
FOR MEDICAL-DEVICE COMMUNICATION

Twelve IEEE standards recommended by the Food and Drug Administration for supporting medical-device interoperability and cyber security

Vivian Kelly, For IEEE Standards Association
+1 703 860 0577; viviankelly@interprosepr.com

PISCATAWAY, N.J., USA, 12 November 2013 – IEEE, the world’s largest professional organization dedicated to advancing technology for humanity, today announced that it received a key recommendation from the U.S. Food and Drug Administration (FDA). The FDA recently recognized multiple standards that collectively help support medical-device interoperability and cyber security. Among the 25 standards listed, 12 originate from within the IEEE 11073™ family of standards for medical-device communication.

“The FDA’s recognition of the IEEE 11073 standards recognizes the many years of effort that have been put into the development of these standards by industry experts,” said Todd Cooper, chair of the IEEE 11073 Standards General Committee. “A recent PricewaterhouseCoopers study commissioned by the West Health Institute identified more than $30 billion of annual costs to the U.S. healthcare system because of the lack of medical-device interoperability. If we had open, standards-based medical device interoperability, think of the savings every year. The FDA’s recognition of these 12 standards within the IEEE 11073 family is a big step in that direction.”

IEEE 11073 standards are designed to help healthcare product vendors and integrators create interoperable devices and systems for disease management, health and fitness and independent living that can help save lives and improve quality of life for people worldwide. The growing IEEE 11073 family of standards is intended to enable interoperable communication for traditional medical devices, as well as personal health devices, and convey far-ranging potential benefits, such as reducing clinical decision-making from days to minutes, reducing gaps and errors across the spectrum of healthcare delivery and helping to expand the potential market for the medical devices themselves.

The FDA recognized three categories of standards: risk-management standards for a connected and networked environment; interoperability standards that establish nomenclature, frameworks and medical-device-specific communication (including system and software lifecycle processes); and cyber-security standards from the industrial-control area most relevant to medical devices. The list is intended to assist manufacturers electing to declare conformity with consensus standards to meet specific requirements for the creation of medical devices and other related products.

The 12 IEEE standards recognized by the FDA:

  • IEEE 11073-10101™ "Health informatics—Point-of-care medical device
    communication—Part 10101: Nomenclature"
  • IEEE 11073-10201™ “Health informatics—Point-of-care medical device
    communication—Domain information model”
  • IEEE 11073- 20101™ “Health informatics—Point-of-care medical device
    communication—Application profile—Base standard”
  • IEEE 11073-20601™ “Health informatics—Personal health device
    communication—Part 20601: Application profile—Optimized exchange protocol”
  • IEEE 11073-20601a-2010™ “Health informatics—Personal health device
    communication—Part 20601: Application profile—Optimized exchange protocol”
  • IEEE 11073-10408™ “Health informatics—Personal health device
    communication—Part 10408: Device specialization—Thermometer”
  • IEEE 11073-10415™ “Health informatics—Personal health device
    communication—Part 10415: Device specialization—Weighing scale”
  • IEEE 11073-10404™ “Health informatics—Personal health device
    communication—Part 10404: Device specialization—Pulse oximeter”
  • IEEE 11073-10421-2010™ “Health informatics—Personal health device
    communication Part 10421: Device specialization—Peak expiratory flow monitor (peak flow)”
  • IEEE 11073-10406-2011™ “Health informatics—Personal health device
    communication Part 10406: Device specialization—Basic electrocardiograph (ECG) (1- to 3-lead ECG)”
  • IEEE 11073-10407™ “IEEE ISO/IEEE Health informatics—Personal health device
    communication—Part 10407: Device specialization—Blood pressure monitor”
  • IEEE 11073-10417™ “IEEE ISO/IEEE Health informatics—Personal health device
    communication—Part 10417: Device specialization—Glucose meter”

"I welcome the FDA’s recognition and hope it encourages additional industry conformance to the IEEE 11073 family of standards,” said Ken Fuchs, secretary of the IEEE 11073 Standards General Committee. “When using interfaces based on IEEE 11073, the syntax and semantics are fully defined, thus improving interoperability. This also encourages standardization of tools and testing suites. As a result, you end up with a more consistent and less error-prone process, which helps foster increased patient safety and lower integration costs.”

For more information on the two IEEE working groups that developed the standards recognized by the FDA, please visit the IEEE 11073 Personal Health Device Working Group and the IEEE 11073 Upper Layer Working Group web pages.

For additional information on the IEEE 11073 family of standards visit: http://standards.ieee.org/findstds/standard/healthcare_it.html. IEEE 11073 standards are developed in the spirit of the “OpenStand” paradigm for global, open standards.

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