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Background: For ethical, legal and administrative reasons, patients have to give explicit consent to a medical treatment. Objectives: This paper identifies the design requirements for electronic treatment consent (eConsent) architecture, and subsequently proposes a model for the eConsent architecture based on the HL7 FHIR® standard. Methods: Six requirements for the eConsent architecture were identified. A conceptual model for the system was then developed to address the identified requirements using HL7 FHIR. Results: The proposed concept makes use of the existing consent model of HL7 FHIR, and includes additional resources for presenting the information to the patient. Moreover, it uses the SNOMED CT terminology to enable semantic interoperability with other health information systems. Conclusions: The proposed eConsent architecture meets the identified requirements. That said, the system is limited by the low maturity of the implemented FHIR resources and the fact that the terminology is currently inexhaustive for the use case. Custom extensions of the used FHIR resources must be considered.

A Model for Implementing an Interoperable Electronic Consent Form for Medical Treatment Using HL7 FHIR