A Non-Custodial Architecture for Persistent Biological Identity and Enforceable Genomic Consent
Description
This paper addresses the growing need for persistent biological identity and enforceable genomic consent in an era of expanding genomic data use. Current models rely heavily on custodial storage and fragmented consent mechanisms, limiting long-term continuity, transparency, and participant control. We introduce a non-custodial architectural framework that enables durable biological identity linkage while preserving individual authority over genomic access and authorization. The proposed system combines cryptographic verification, consent-aware data routing, and longitudinal identity anchoring to support secure interoperability across research and clinical environments. This architecture establishes a foundation for scalable genomic stewardship, enabling trustworthy data sharing, repeatable verification, and participant-aligned governance in precision medicine ecosystems.
Files
enigma_WP.pdf
Additional details
Software
- Development Status
- Concept
References
- 1. Gymrek M., McGuire A. L., Golan D., Halperin E., & Erlich Y. (2013). Identifying personal genomes by surname inference. Science 339(6117): 321–324.
- 2. Erlich Y., & Narayanan A. (2014). Routes for breaching and protecting genetic privacy. Nature Reviews Genetics 15(6): 409–421.
- 3. Kaye J., Whitley E. A., Lund D., Morrison M., Teare H., & Melham K. (2015). Dynamic consent: a patient interface for twenty first century research networks. European Journal of Human Genetics 23(2): 141–146.
- 4. Budin-Ljøsne I., et al. (2017). Dynamic consent in the CHRIS study: improving informed consent for large scale cohort research. European Journal of Human Genetics 25(3): 447–452.
- 5. Albalwy M., et al. (2021). ConsentChain: a blockchain-based dynamic consent architecture to support clinical genomic data sharing. JMIR Medical Informatics 9(11): e28046.
- 6. Moreau L., & Groth P. (2013). Provenance: an introduction to PROV. Synthesis Lectures on the Semantic Web: Theory and Technology 3(4): 1–129.
- 7. European Parliament and Council. (2016). Regulation (EU) 2016/679 – General Data Protection Regulation (GDPR).
- 8. U.S. Department of Health and Human Services. (2013). Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules. Federal Register Vol. 78, No. 17.
- 9. Global Alliance for Genomics and Health (GA4GH). (2014). Framework for responsible sharing of genomic and health-related data.
- 10. World Health Organization. (2024). Guidance for human genome data collection, access, use and sharing.