Articles about News

Close up of hand touching smartwatch with health app on the screen, gadget for fitness active lifestyle.

FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device

Quandary Peak’s review of FDA’s final guidance leads us to believe we could see meaningful expansion of the amount of CDSS qualifying as a medical device, which could subject many current and future CDS software applications to FDA oversight.

Doctor hand writing notes in patient medical record

How Project US@ Fits into the U.S.’s Developing Health IT Infrastructure

A standard approach for representing patient addresses across all health IT systems was needed to improve patient matching using accurate address information. Enter Project US@, the “Unified Specification for Address in Health Care.”

Medical devices hanging on wall

Understanding Medical Device Cybersecurity & the FDA’s Role

As medical devices evolve to better treat and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility…”

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Inside T-Mobile’s Massive Security Failure

Around the middle of August, a security research firm named Unit221B reached out to T-Mobile with some really, really bad news.

Woman operating bio tech equipment in a cancer testing laboratory

This Summer’s Highest Profile Lawsuit

In this post, we breakdown the most high-profile lawsuit taking place in the United States this summer: the prosecution of Elizabeth Holmes and Theranos.

Person holding up mobile phone, playing Fortnite game

Apple vs. Epic Games: Awaiting a Critical Verdict

After a three-week trial, the yearlong legal affair between technology giant Apple and Fortnite developer, Epic Games, is nearing its end.