Data breaches in healthcare are increasing at an alarming rate and must be considered inevitable, but you can limit your exposure to regulatory risk when one occurs.
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 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…”
The FDA has announced updated software guidance for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
In a piecemeal regulatory environment, consumers will bear the brunt of the responsibility for vetting any app they choose to give access to their medical information. How that information is protected will be the province of third parties – until legislated otherwise.
A primary goal of Health IT software is to improve the overall quality, safety, and effective delivery of healthcare. However, despite widespread implementation and use of health IT
software, these safety and quality benefits have not been fully realized, as software vendors and users must balance innovation with the ability to mitigate risk in these highly valuable systems.
Quandary Peak was recently selected by a major EHR vendor to serve as a Software Quality Oversight Organization, charged with evaluating the company’s software and internal processes, and issuing software audit reports to improve the overall quality of their product, especially its ability to keep patients safe.
Brad Ulrich, a senior engineer at Quandary Peak, is working on case about the development of electronic health record (EHR) software and software designed to meet Commission on Accreditation of Rehabilitation Facilities (CARF) compliance standards.
A FoxNews.com story on computer glitches in the HealthCare.gov website features several quotes by Quandary Peak software expert George Edwards.
