The DOJ’s Civil Cyber-Fraud Initiative
December 19, 2022
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The most recent Health IT vendor to settle with the government is a direct result of the DOJ’s new Civil Cyber-Fraud Initiative.
Expert Insights
Identifying CyberSecurity Risk as Part of Technical Due Diligence
December 12, 2022
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We use SAST tools during our tech due diligence engagements to provide independent analysis of security risk and to help provide recommendations.
FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device
December 8, 2022
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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.
Technical Due Diligence Checklist for Software Transactions
September 12, 2022
A comprehensive technical due diligence checklist for software transactions, covering code quality, scalability, IP, and security evaluations.
How Project US@ Fits into the U.S.’s Developing Health IT Infrastructure
May 20, 2022
Quandary Peak Research
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.”
Understanding Medical Device Cybersecurity & the FDA’s Role
April 25, 2022
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
January 7, 2022
Quandary Peak Research
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.
Clinical Decision Support (CDS) Software to Become an FDA Priority in 2022
December 16, 2021
Quandary Peak Research
The FDA first drafted guidance on CDS software in 2017, but finalizing it has not been a priority for the agency since. That’s set to change next year.