Welcome!

News Feed Item

U.S. Federal Government Recognizes IEEE 11073™ Standards for Medical-Device Communication

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 at http://standards.ieee.org/develop/wg/PHD.html and the IEEE 11073 Upper Layer Working Group at http://standards.ieee.org/develop/wg/UL.html.

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.

To learn more about IEEE-SA, visit us on Facebook at http://www.facebook.com/ieeesa, follow us on Twitter at http://www.twitter.com/ieeesa, connect with us on LinkedIn at http://www.linkedin.com/groups?gid=1791118 or on the Standards Insight Blog at http://www.standardsinsight.com.

About the IEEE Standards Association

The IEEE Standards Association, a globally recognized standards-setting body within IEEE, develops consensus standards through an open process that engages industry and brings together a broad stakeholder community. IEEE standards set specifications and best practices based on current scientific and technological knowledge. The IEEE-SA has a portfolio of over 900 active standards and more than 500 standards under development. For more information visit http://standards.ieee.org.

About IEEE

IEEE, a large, global technical professional organization, is dedicated to advancing technology for the benefit of humanity. Through its highly cited publications, conferences, technology standards, and professional and educational activities, IEEE is the trusted voice on a wide variety of areas ranging from aerospace systems, computers and telecommunications to biomedical engineering, electric power and consumer electronics. Learn more at http://www.ieee.org.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will shares the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, will discuss how a cloud designed for production operations not only helps accelerate developer...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, will discuss how leveraging the Industrial Interne...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
The increasing popularity of the Internet of Things necessitates that our physical and cognitive relationship with wearable technology will change rapidly in the near future. This advent means logging has become a thing of the past. Before, it was on us to track our own data, but now that data is automatically available. What does this mean for mHealth and the "connected" body? In her session at @ThingsExpo, Lisa Calkins, CEO and co-founder of Amadeus Consulting, will discuss the impact of wea...