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Pediatric Consent on FHIR.

Anton Voronov1, Mohammad Jafari1, Lin Zhao2

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Summary

Standardizing pediatric consent forms with a new framework and Fast Healthcare Interoperability Resources (FHIR) improves machine readability and legal compliance. This approach supports interoperability and data sharing in healthcare.

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Area of Science:

  • Health Informatics
  • Legal Technology
  • Pediatric Healthcare

Background:

  • Standardizing consent processes reduces ambiguity and enables machine interpretation.
  • Digitizing consent forms is crucial for modern healthcare data management.

Purpose of the Study:

  • To develop a systematic approach for standardizing and digitizing pediatric consent forms.
  • To address the complexities of pediatric consent involving legal guardians.

Main Methods:

  • Reviewed Arizona state regulations and 21 pediatric consent forms.
  • Developed and evaluated an implementation-agnostic Consent for Treatment Framework.
  • Assessed the Fast Healthcare Interoperability Resources (FHIR) standard's suitability.

Main Results:

  • The Consent for Treatment Framework aligns with state requirements and is validated for pediatric forms.
  • FHIR demonstrated sufficient expressiveness to implement the framework and represent consent forms.
  • The framework supports compliance and machine interpretability.

Conclusions:

  • Healthcare organizations can use open-source code and FHIR guidelines to standardize pediatric consent forms.
  • FHIR-based executable models enhance legal compliance, interoperability, and data sharing.
  • This standardization facilitates machine-interpretable consent for improved healthcare processes.