FDA Recognizes 12 IEEE Technology Standards For Medtech Communication

IEEE, a professional association for the technology industry, commended the FDA this week for recognizing 12 IEEE 11073 health informatics standards that enable communication between medical, healthcare, and wellness devices and with external computer systems.

The 12 FDA-recognized IEEE 11073 standards are:

• 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”

"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.

IEEE framed the development as a step forward for device interoperability efforts, which aim to ensure devices can share data.

Broader device interoperability would be a huge cost-saver for the healthcare industry, according to Cooper. He cited a PricewaterhouseCoopers showing that the lack of medical-device interoperability costs the U.S. healthcare industry $30 billion annually. "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," he said.

IEEE 11073 standards are designed to "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 group said.

The Standards Medical Staff (SMS) at FDA is oversees this issue. The FDA said this staff facilitates "the recognition of national and international medical device consensus standards. CDRH is invested in the development of medical device standards and participates significantly in the development process."

IEEE also announced this week that it has entered a strategic agreement with the non-profit Continua Health Alliance "to help accelerate and broaden the adoption of standards-based technologies for personal-medical and home-monitoring devices."