Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last ...

BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...

As hospitals and health systems accelerate artificial intelligence adoption, industry leaders warn that inaccurate patient ...

Minor data corruptions can be even more dangerous and costly than a data breach or attack because they often go undetected for long periods. Data corruption is usually caused by incorrect, outdated or ...

In May 2026, Dexcom disclosed FDA-enforced, Class II voluntary recalls of its G7 and ONE/ONE+ iOS and watchOS apps worldwide due to a software defect that can delay or replay glucose readings and ...

AI—both generative and machine learning/statistical—is essentially dead in the water without well-vetted, timely, quality data. This is holding back AI efforts more than anticipated, a recent survey ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...

A new research report from Yale School of Medicine offers an up-close look at how biased artificial intelligence can affect clinical outcomes. The study focuses specifically on the different stages of ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...