FDA recognizes med device interoperability standards

Voluntary medical device standards for interoperability were recognized this week by the U.S. Food and Drug Administration, as outlined in an Aug. 6 post in the Federal Register. The recognition, according to Bakul Patel (pictured), senior policy advisor to the director of the Center for Devices and Radiological Health at FDA, is a "first step" toward helping manufacturers to create medical devices that can "work well" with each other.

"As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable--and that the data they transmit will be secure," Patel said in an FDA Voice blog post this week. "Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can 'plug and play.'"

The 25 standards recognized can be divided into three categories:

  • Applications of risk management for IT networks
  • Health informatics dealing with point-of-care and personal device communication
  • System security for industrial communication networks

"We hope this first set of voluntary standards will encourage further efforts to identify standards and create new ones for our review, because improving the care of patients through medical devices increasingly depends on those devices and information systems being 'interoperable,'" Patel said.

Continua Health Alliance Executive Director Chuck Parker called the FDA's recognition of the standards "a significant step forward for interoperability," in a statement released this week.

"Federal initiatives to address interoperability standards in healthcare are among the more sweeping changes we have seen since Continua was founded in 2006," Parker said.

Improved medical device interoperability, combined with the adoption of commonly accepted standards for that interoperability, could save the U.S. more than $30 billion annually in healthcare costs, according to an analysis published in March by the San Diego-based West Health Institute.

Additionally, a report published last fall by the ECRI Institute identified interoperability failures with medical devices and health IT systems as one of the top 10 health technology hazards for 2013.

To learn more:
- here's the Federal Register post (.pdf)
- read the FDA Voice post
- check out the Continua statement

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