{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T08:08:12Z","timestamp":1793261292493,"version":"4.5.0"},"reference-count":18,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T00:00:00Z","timestamp":1766016000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Drug Saf. Regul."],"abstract":"<jats:p>Tokenization is a crucial technology for ensuring the security and privacy of patient data in clinical research, pharmacovigilance, and drug safety monitoring. As healthcare increasingly integrates diverse data sources-ranging from clinical records to non-clinical data such as social determinants of health (SDOH)-it is essential to protect sensitive patient information while improving data quality and analysis (National Institutes of Health, 2006). This article emphasizes tokenization\u2019s critical role in safeguarding privacy, particularly in pharmacovigilance activities including safety monitoring, risk assessment, and post-market surveillance. Beyond security, tokenization enriches research datasets by enabling integration of external information, thereby enhancing the rigor and reliability of pharmacovigilance outcomes. With effective tokenization, researchers can better protect patients while gaining deeper insights into clinical and pharmacological research (Cruz et al., 2024). Recent global applications validate tokenization as a foundational privacy-preserving technology in pharmacovigilance. An applied example from a psoriasis clinical trial demonstrated referential tokenization\u2019s capacity to securely link electronic health records (EHRs) and claims data across systems with greater than 99% linkage precision while maintaining privacy standards (D'Andrea et al., 2024). These capabilities align with emerging international frameworks, including the European Health Data Space (2025), reinforcing tokenization\u2019s value in generating regulatory-grade evidence for pharmacovigilance across national and multinational research environments. In many jurisdictions, tokenization that meets de-identification or pseudonymization standards may not require individual patient consent, though this varies based on data sensitivity, jurisdictional law, and the study\u2019s intent (Office for Civil Rights, 2023; EDPB, 2021).<\/jats:p>","DOI":"10.3389\/fdsfr.2025.1599217","type":"journal-article","created":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T06:44:58Z","timestamp":1766040298000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts"],"prefix":"10.3389","volume":"5","author":[{"given":"Camille V.","family":"Cook","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,12,18]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"58","DOI":"10.1016\/j.cell.2019.02.039","article-title":"Personalized medicine and the power of electronic health records","volume":"177","author":"Abul-Husn","year":"2019","journal-title":"Cell"},{"key":"B2","volume-title":"Real-world matching performance of de-identified record-linking tokens","author":"Bernstam","year":"2023"},{"key":"B3","doi-asserted-by":"publisher","first-page":"439","DOI":"10.1016\/j.procs.2023.12.231","article-title":"Decentralize healthcare marketplace","volume":"231","author":"Cruz","year":"2024","journal-title":"Procedia Comput. Sci."},{"key":"B4","article-title":"How to transition RWE studies to non-clinical regulatory grade","author":"Dunne","year":"2023","journal-title":"Appl. Clin. Trials"},{"key":"B5","article-title":"Unlocking insights: lessons learned from the tokenization of a psoriasis trial","volume-title":"International conference on pharmacoepidemiology (ICPE)","author":"D\u2019Andrea","year":"2024"},{"key":"B6","doi-asserted-by":"publisher","first-page":"101354","DOI":"10.1016\/j.conctc.2024.101354","article-title":"Linking clinical trial participants to their U.S. real-world data through tokenization: a practical guide","volume":"41","author":"Eckrote","year":"2024","journal-title":"Contemp. Clin. Trials Commun."},{"key":"B7","doi-asserted-by":"publisher","first-page":"3578","DOI":"10.1038\/s41591-024-03239-5","article-title":"A framework for sharing of clinical and genetic data for precision medicine applications","volume":"30","author":"Elhussein","year":"2024","journal-title":"Nat. Med."},{"key":"B8","article-title":"Regulation (EU) 2025\/327 of the European parliament and of the council on the European health data space","year":"2025","journal-title":"Official J. Eur. Union"},{"key":"B9","unstructured":"Guidelines on pseudonymisation under GDPR\n          \n          \n          2021"},{"key":"B10","volume-title":"ENCePP methodological guide (Version 5)","year":"2020"},{"key":"B11","volume-title":"Registries for evaluating patient outcomes: a user\u2019s guide","author":"Gliklich","year":"2014"},{"key":"B12","doi-asserted-by":"publisher","first-page":"e147","DOI":"10.1017\/cts.2024.571","article-title":"Realizing the potential of social determinants data in EHR systems: a scoping review of approaches for screening, linkage, extraction, analysis, and interventions","volume":"8","author":"Li","year":"2024","journal-title":"J. Clin. Transl. Sci."},{"key":"B13","article-title":"\u201cTokenization\u201d: privacy-Preserving data integration to enhance clinical trials and real-world evidence studies","volume-title":"DIA real-world evidence conference","author":"Liede","year":"2023"},{"key":"B14","volume-title":"MedlinePlus medical encyclopedia","year":"2006"},{"key":"B15","volume-title":"HIPAA compliance and tokenization: enhancing patient privacy","year":"2023"},{"key":"B16","doi-asserted-by":"publisher","first-page":"105191","DOI":"10.1016\/j.ijmedinf.2023.105191","article-title":"Privacy-preserving record linkage: a scoping review","volume":"169","author":"Velummailum","year":"2023","journal-title":"Int. J. Med. Inf."},{"key":"B17","first-page":"34","article-title":"Improving data security in healthcare: practical approaches to tokenization and encryption","volume":"39","author":"Walters","year":"2025","journal-title":"J. Healthc. Inf. Manag."},{"key":"B18","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1016\/j.hdsj.2022.01.005","article-title":"Privacy-preserving methods for medical data sharing: tokenization and beyond","volume":"6","author":"Yue","year":"2022","journal-title":"Health Data Sci. J."}],"container-title":["Frontiers in Drug Safety and Regulation"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdsfr.2025.1599217\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T06:45:01Z","timestamp":1766040301000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdsfr.2025.1599217\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,18]]},"references-count":18,"alternative-id":["10.3389\/fdsfr.2025.1599217"],"URL":"https:\/\/doi.org\/10.3389\/fdsfr.2025.1599217","relation":{},"ISSN":["2674-0869"],"issn-type":[{"value":"2674-0869","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,18]]},"article-number":"1599217"}}