Background: Standardizing and formalizing consent processes and forms can prevent ambiguities, convey a more precise meaning, and support machine interpretation of consent terms.
Objectives: Our goal was to introduce a systematic approach to standardize and digitize pediatric consent forms, which are complex due to legal requirements for child and legal guardian involvement.
Methods: First, we reviewed the consent requirements from the Arizona Department of Health Services (ADHS) and we used 21 Arizona pediatric treatment consents from five healthcare organizations to propose and evaluate an implementation-agnostic Consent for Treatment Framework. Second, we assessed the adequacy of the Fast Healthcare Interoperability Resources (FHIR) to support the proposed framework.
Results: The resulting Consent for Treatment Framework is compliant with the state consent requirements and has been validated with pediatric consent forms. We also demonstrated that the FHIR standard has the required expressiveness to compute the framework's specifications and therefore compute the 21 consent forms.
Conclusions: Healthcare organizations can apply the shared open-source code and FHIR implementation guidelines to standardize the design of machine-interpretable pediatric treatment consent forms. The resulting FHIR-based executable models comply with state law and support interoperability and data sharing.
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