Consent Management System on Patient-Generated Health Data.

Area of Science:

• Health Informatics
• Data Privacy
• Digital Health

Background:

• Informed consent is crucial for sensitive health data protection under regulations like GDPR.
• Patients often lack sufficient information to make informed decisions about their data.
• Patient-generated health data requires robust consent mechanisms.

Purpose of the Study:

• To present a novel consent management system for patient-generated health data.
• To ensure informed consent by providing necessary information upfront.
• To facilitate secure data exchange and reuse across borders.

Main Methods:

• Developed a consent management system architecture.
• Utilized HL7 FHIR (Fast Healthcare Interoperability Resources) as the data exchange format.
• Tested the system using synthetic data for Type 1 diabetes.

Main Results:

• The system enables patients to manage consent for their health data effectively.
• HL7 FHIR proved to be an effective format for unambiguous data exchange.
• Demonstrated the potential for cross-border health data sharing.

Conclusions:

• The proposed system enhances patient control over their health data.
• It supports informed consent and facilitates the European Health Data Space initiative.
• This approach promotes secure and ethical health data reuse.