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.
A comprehensive technical due diligence checklist for software transactions, covering code quality, scalability, IP, and security evaluations.
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.”
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…”
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.
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.
The FDA has announced updated software guidance for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
The digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. These benefits exist in theory, but not in practice—due to cybersecurity concerns and the associated costs.