News & Commentary

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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.

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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.

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Technical Due Diligence Checklist for Software Transactions

Technical due diligence is the process to better evaluate software and identify its strengths and weaknesses. TDD is a critical step in any software-centric transaction.

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…”

Causes and Effects of Bias in Computer-Aided Decision Making

Recent advances and increased application of computer-aided decision making, including artificial intelligence (AI) and machine learning (ML), have caught the attention of consumer protection organizations and regulatory agencies.