BioRef Infrastructure
BioRef-TI4Health is a framework that helps doctors and researchers define accurate reference intervals (RIs) in a way that protects patient privacy and ensures results can be reproduced, supporting personalized medicine without transferring raw patient data.
At a glance
Use when
Developing or updating reference intervals in multi-center studies without centralizing sensitive patient data
Avoid when
Raw data sharing is permissible and centralized analysis is preferred for methodological reasons
Inputs
Clinical laboratory data from local institutions (aggregated or anonymized)
Outputs
Precise, population-specific reference intervals (RIs)
How it works
The BioRef-TI4Health infrastructure enables the decentralized, privacy-preserving derivation of reference intervals using standardized methods, allowing clinical researchers to generate precise, reproducible RIs while maintaining compliance with data protection regulations by avoiding the need to share raw patient-level data.
- HTA domains
- Clinical Effectiveness, Organisational aspects, Patient and Social Aspects
- Assumptions
- Local data quality is sufficient for RI derivation; participating institutions follow standardized data collection protocols
- Strengths
- Preserves patient privacy, avoids data transfer, supports reproducibility, aligns with regulatory compliance
- Limitations
- Dependent on local data quality and standardization; requires technical setup at each site
- Also known as
- BioRef-TI4Health
Questions this answers
- › How can reference intervals be defined accurately without sharing raw patient data?
- › What infrastructure supports privacy-preserving derivation of clinical reference intervals?
- › How can reproducibility and compliance be ensured in reference interval development?
- › How does BioRef support precision medicine?
- › What role does BioRef play in improving patient care through personalized reference values?
- › How does the infrastructure integrate into clinical research workflows?
References & sources
- paperDOI: 10.2196/47254 ↗
Related methods
Similar by meaning
- SMART on FHIR Conformant Infrastructure for Recording Patient Reported Outcomes
- Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation
- D2.1 Whitepaper on the platform knowledge base and data standards for in silico drug repurposing
- REPEAT Initiative (Reproducible Evidence: Practices to Enhance and Achieve Transparency)
- TEHAI (Translational Evaluation of Healthcare AI)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.