Journal of the American Medical Informatics Association : JAMIA
Jun 20, 2024
OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software.
Digital therapeutics (DTx) are a somewhat novel class of US Food and Drug Administration-regulated software that help patients prevent, manage, or treat disease. Here, we use natural language processing to characterise registered DTx clinical trials ...
A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode ...
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equivalent to ...
In a drug formulation (DFM), the major components by mass are not Active Pharmaceutical Ingredient (API) but rather Drug Inactive Ingredients (DIGs). DIGs can reach much higher concentrations than that achieved by API, which raises great concerns abo...
Combinatorial chemistry & high throughput screening
Jan 1, 2022
The modern pharmaceutical industry is transitioning from traditional methods to advanced technologies like artificial intelligence. In the current scenario, continuous efforts are being made to incorporate computational modeling and simulation in dru...
How can an agency like the U.S. Food & Drug Administration ("FDA") effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device ca...
Artificial intelligence technology promises to redefine the practice of radiology. However, it exists in a nascent phase and remains largely untested in the clinical space. This nature is both a cause and consequence of the uncertain legal-regulatory...