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The FDA’s shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) is often described as a move from “test everything” to “test what matters.”  

For clinical laboratories and blood banks, that is both liberating and unsettling. We work in environments where patient s...

At the recent White House health tech event, CMS and more than 60 organizations—including Amazon, Epic, Apple, Google, and OpenAI—committed to modernizing healthcare with better data infrastructure, interoperability, and patient-facing digital tools.

HHS recently proposed eliminating the“real world testing” (RWT) requirement for certified health IT vendors under the ONC Health IT Certification Program. RWT was originally introduced as part of the 21st Century Cures Act to ensure that certified systems performed safely and effectively in the...

Healthcare systems are under intense pressure—staffing shortages, tighter budgets, rising operational demands—all while navigating the relentless pace of digital transformation.