Consent Management 2.0: Empowering Patient Will in Medical Research and Care.

Introduction: The lawful processing of health data in medical research necessitates robust mechanisms for managing patient consent and objections, aligning with national and european regulations. While the initial version of the HL7 standard Consent Management" primarily focused on opt-in scenarios, evolving legal landscapes and practical implementation challenges highlight the need for comprehensive solutions encompassing both opt-in and opt-out approaches, including withdrawals and objections. This paper details the systematic revision of the latest HL7 FHIR-based "Consent Management 2.0" standard to address these limitations.

Methods: Our methodology involved a critical assessment of the 2021 standard against three years of practical experience and emerging regulatory requirements.

Results: Key improvements include enhanced support for diverse document types (consent, withdrawal, refusal, objection), refined technical specifications for automated conversion of questionnaire responses into machine-readable Consent Resources, and the introduction of a novel "ResultType" category. This new category enables use-case-specific aggregation of consent information, simplifying downstream processing and reducing interpretation ambiguities. Additionally, uniform FHIR search parameters were defined, and comprehensive examples were integrated into the implementation guide. The revised standard successfully underwent the HL7 ballot process in April 2025, with early practical implementations already demonstrating its utility.

Conclusion: This extended standard significantly enhances the interoperability and legal robustness of consent management in complex research infrastructures, fostering improved patient autonomy and trust in digital health data reuse.