Clinical Decision Support Template

Passive CDS presents information without interrupting the provider's workflow. Examples include order sets, documentation templates, and reference links. Active CDS interrupts the workflow with alerts that require acknowledgment. Most CDS failures stem from making everything active. Default to passive presentation and reserve active alerts for situations where the clinical risk justifies the interruption.

If your product integrates with multiple EHR systems, abstract your CDS logic into a rules engine that is EHR-agnostic. Use FHIR CDS Hooks (an HL7 standard) as the integration layer. Each EHR calls your rules engine at defined workflow touchpoints, and your engine returns cards with recommendations. This avoids rebuilding logic per EHR.

CDS that meets all four criteria in the 21st Century Cures Act exemption is not considered a medical device: (1) it is not intended to acquire or analyze medical images or signals, (2) it is intended for a healthcare professional, (3) it is intended for the purpose of enabling that professional to independently review the basis for the recommendation, and (4) it is intended for the purpose of not replacing the clinical judgment of a healthcare professional. If your CDS meets all four criteria, it is likely exempt. If it does not meet all four, consult your regulatory team.

Run a retrospective validation against 6-12 months of historical patient data. Count how many times each rule would have fired, what the provider actually did, and whether the alert would have changed the outcome. This gives you a baseline override rate estimate and helps you tune triggering conditions before providers ever see the alerts.

Research consistently shows that provider attention drops sharply after 3-5 alerts per encounter. Above 10, providers adopt "alert dismissal autopilot" and stop reading entirely. Aim for fewer than 5 unique alerts per encounter. If your system generates more, re-evaluate rule specificity and severity classification. ---