Clinical decision support encompasses a wide variety of software tools used to support decision-making by doctors, nurses and other healthcare providers. They include alerts to flag potential cases of sepsis, medication interactions and care reminders.
Under the 21st Century Cures Act, some of these systems had been exempted from FDA regulation if healthcare providers could independently review the basis of the recommendations, and don’t rely on them to make a diagnostic or treatment decision. Under the regulator’s final guidance in September, more predictive tools would now be regulated as medical devices, including software that analyzes patient information to detect potential stroke or sepsis, and alerts a healthcare provider.
