CDS forms and MDR certification at Duodecim

Joonas Mäkinen shows how Duodecim delivers FHIR SDC forms and calculators inside their real-time clinical decision support tool used by Finnish doctors, nurses, and pharmacists directly in the EHR. The previous custom calculator platform pre-filled basic patient data but forced clinicians to manually write results back to the health record — the move to SDC and Aidbox closes that loop with automatic extraction and storage on the customer's FHIR server, launched through SMART app launch.

Duodecim deliberately does not run a patient data store: every QuestionnaireResponse and every extracted resource is persisted on the customer's system. That design choice keeps Duodecim out of the patient-data business while still delivering a native experience inside the customer's EHR.

The talk covers MDR certification, which is required for any calculator intended for clinical use in the EU. Joonas is candid that even a "simple" calculator is a significant certification process — but because Duodecim already carries the certificate on the CDS platform, new calculators can be added under the existing certificate rather than re-certified from scratch. A live demo of CIWA-Ar (alcohol withdrawal assessment) saves the result to a FHIR server via SMART app launch.

The talk closes on the concrete benefits of moving from custom JSON to FHIR Questionnaire: testability against a standard, consistency across dozens of calculators, and reusability of the data for longitudinal trend tracking.

Shipping FHIR SDC calculators inside an EHR? Formbox provides the SDC authoring, rendering, and extraction pipeline Duodecim relies on, wired directly to Aidbox as the FHIR system of record.