News & Expert Insights

Tablet device showing a process of compliance in Health IT regulation, similar to the Civil Cyber-Fraud Initiative.

The DOJ’s Civil Cyber-Fraud Initiative

The most recent Health IT vendor to settle with the government is a direct result of the DOJ’s new Civil Cyber-Fraud Initiative.

Software experts meeting in research laboratory: woman leads presentation using digital whiteboard while colleagues listening

Identifying CyberSecurity Risk as Part of Technical Due Diligence

We use SAST tools during our tech due diligence engagements to provide independent analysis of security risk and to help provide recommendations.

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.

Lighthouse perched on sea cliffs

Technical Due Diligence Checklist for Software Transactions

A comprehensive technical due diligence checklist for software transactions, covering code quality, scalability, IP, and security evaluations.

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…”