The Food and Drug Administration Changes Course toward Healthcare Communications

EDITOR'S NOTE: Special thanks to Cynthia Bradford Lencioni for writing today's blog post. You can connect with her on LinkedIn. 

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In a stunning development leaked this week to the media, a senior Food and Drug Administration source told journalists that the FDA plans to begin regulating as medical devices certain mobile phones, fax machines, pagers, and some models of egg timers used by healthcare providers for communication and care coordination within the next year. 

………… Fake News!!

The truth is that over the past 5 years, there has been a deregulatory trend in the US with regard to low-risk healthcare software, and the 21st-Century Cures Act (2016) is the latest in that trend. Specifically, the Cures Act provides that software for healthcare communication and logistics does not meet the FDA’s “medical device” definition, or classification, and is therefore not subject to FDA regulation.  The FDA classifications for software as a medical device are based on the intended use of the application and the risk it presents to patient safety.  

As a healthcare communications platform enabling providers to accelerate lifesaving care, Pulsara has always been outside the definition of a medical device and unregulated by the FDA. Pulsara helps the care team be prepared to receive all patients with time-sensitive emergencies, syncing prehospital, hospital, and interhospital teams within regional systems of care.

Even though Pulsara is not a medical device, quality, effectiveness, and security are of utmost concern to us and we are committed to providing the best solution in the industry. Built on the latest mobile and cloud technology, Pulsara blends clinical and technical expertise into our product design and professional services offerings. Our experienced development team has over 30 years of combined experience, and our code undergoes multiple levels of rigorous automated and manual testing protocols. All Pulsara releases are deployed to internal clinical demonstration teams for testing prior to general release, and we regularly undergo external security audits by industry experts. Combine our minimum 99.95% uptime statistics with published peer-reviewed research demonstrating the effectiveness of our solutions, and you can see why we believe Pulsara is best-in-breed.

And now for the moral of the story: don’t be fooled by anyone claiming to know which software solutions are medical devices or telling you that only FDA-regulated devices deliver quality and security for your mission-critical communications.