This guide provides guidance for representing electronic patient consent directives using Fast Healthcare Interoperability Resources (FHIR) Draft Standard for Trial Use Release 2 (DSTU2). Signed patient consent directives can authorize the disclosure of protected health information according to applicable laws and regulations (e.g. 42 CFR Part 2, state policies), as well as a patient’s preferences. This implementation guide was developed for use in the United States, but may be relevant in other jurisdictions.
A FHIR resource for representing patient consent directives was not available until the Consent resource was added in FHIR Standard for Trial Use Release 3 (STU3). Therefore, in DSTU2, a Consent can be represented using a combination of profiles: the Contract resource with references to the List and Basic resource(s). These DSTU2 profiles can be used to create a FHIR representation of a patient’s consent equivalent to the consent structure described in the Normative CDA R2 specification (HL7 CDA® R2 Implementation Guide: Privacy Consent Directives, Release 1 - product id 280).