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Digital Health Consent - for Better Interoperability and Consumer Control.

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We developed a digital health consent framework for secure consumer data sharing, using computable medico-legal policies. This approach ensures compliance and facilitates data exchange across healthcare providers.

Keywords:
FHIRInteroperabilityclinical trialcomputable policyconsent

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Area of Science:

  • Digital Health
  • Health Informatics
  • Health Law

Background:

  • Healthcare data sharing is complex, governed by medico-legal policies.
  • Existing consent mechanisms lack computable and standardized approaches.
  • Need for interoperable frameworks for managing consumer data access.

Purpose of the Study:

  • To present a novel framework for digital health consent.
  • To enable computable expression of medico-legal policies for data sharing.
  • To align with HL7 FHIR standard for interoperability.

Main Methods:

  • Developed a generic formalism for policy modeling.
  • Utilized normative systems and deontic logic for policy representation.
  • Integrated the framework with the HL7 FHIR standard.

Main Results:

  • Demonstrated a framework for computable digital health consent.
  • Successfully modeled medico-legal policies for consumer data sharing.
  • Showcased applicability in a clinical research scenario.

Conclusions:

  • The proposed framework supports standardized and computable health consent.
  • It enhances secure data sharing across providers.
  • Facilitates compliance with medico-legal policies in digital health.