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Hospitals, vendors question FDA's plan to oversee decision-support software

from Modern Healthcare

The U.S. Food and Drug Administration's latest plan for overseeing clinical decision-support software leaves too much room for interpretation over what types of software the agency intends to regulate, according to health systems and software vendors. While stakeholders largely applauded the FDA's vision of a risk-based regulatory approach in theory, a major point of contention involves confusion over the FDA's definition of what software would be included under the FDA's oversight. more

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