What is patient tokenization?

Patient tokenization is a privacy-preserving method used in healthcare to replace personally identifiable information (PII) with unique, encrypted identifiers known as tokens. This process enables the secure linkage of patient data across disparate sources such as electronic health records (EHRs), claims data, and clinical trial information, without exposing sensitive information. By facilitating data integration and maintaining patient confidentiality, tokenization supports comprehensive patient journey analyses, enhances real-world evidence generation, and ensures compliance with regulations like HIPAA.

HealthVerity's synchronized tokenization approach is superior to legacy tokenization because it assigns a universal HealthVerity ID (HVID) to each patient that remains synchronized with the patient journey across any dataset, ensuring consistent and accurate data linkage and better data interoperability.

Synchronizing patient journeys from registries and clinical trials to launch and beyond

The pharmaceutical industry is moving beyond clinical trial data to incorporate real-world evidence (RWE) from real-world data (RWD) in regulatory submissions. Life science tokenization enables seamless linkage between clinical and real-world sources, enriching RWE with deeper patient context. From 2019 to 2021, 116 FDA approvals cited RWE for therapeutic or safety support, and the trend is only accelerating as data teams embrace more robust, multi-source strategies.¹

With the advantages that RWD can provide, pharma companies are shifting to patient-centric RWD strategies. There are; however, challenges and concerns to consider on a number of fronts and you have to be cognizant of patient consent, regulatory compliance, and a patient opting out or being lost to follow up. 

Benefits of synchronized tokenization in clinical trials

For an ideal RWE strategy, pharma companies want to know and trust third-party data sources, ensure data has rich attributes, and that there is a continuous record-level data to follow the patient journey. Implementing synchronized tokenization in clinical trials offers several advantages:

• Enhanced Data Accuracy: Consistent patient identifiers reduce errors in data linkage, ensuring reliable analyses.
  
  
• Improved Patient Privacy: By replacing PII with tokens, patient confidentiality is maintained throughout data integration processes.
  
  
• Regulatory Compliance: Synchronized tokenization aligns with HIPAA and other regulations, facilitating smoother regulatory submissions.
  
  
• Comprehensive Insights: Linking trial data with real-world evidence provides a holistic view of patient outcomes and treatment effectiveness.

Achieving these objectives requires moving beyond traditional healthcare tokenization methods to a synchronized approach that ensures accurate, privacy-compliant data integration. HealthVerity recently hosted a webinar that discussed how a synchronized approach can help you realize the true potential from RWD. If you missed the webinar, here’s a brief recap:

Six fundamental factors for successfully incorporating RWD:

1. Accurate patient identity resolution
   Accurate life science tokenization enables seamless data linkage across clinical and real-world sources, making it imperative to ensure patient identity resolution is both precise and privacy-preserving. Traditional healthcare tokenization methods have an average false negative rate of 15% (where the same person is tokenized as multiple individuals), and that can climb to 40% with noisy data. False positive rates (where different people are assigned the same token) are typically 2% or higher.
   
   
2. Data provenance for greater transparency
   You want to know where your data comes from, who’s providing it and how it’s generated — not just for your own peace of mind, but to meet FDA guidance. When asked about the value of clinical data provenance and how much it matters, an industry leaders told us:
   
   

   “The short answer: A LOT. If companies can show the FDA that their data is clean and robust, it’s a plus. The value of data provenance to the FDA is huge.”

3. A broad data ecosystem
   To unlock more of the patient journey, you need a variety of data sources, including open and closed medical claims, pharmacy claims, lab results, EMRs, biomarkers, chargemaster data, and consumer data.
   
   
4. Open access to data versus a walled garden platform
   You want the flexibility to import first-party or third-party data, even pre-tokenized, to ensure the most comprehensive view of the patient journey.
   
   
5. Built-in HIPAA compliance for complex cohorts
   You want data that’s already certified HIPAA-compliant so you can begin analysis without delay. Relying on internal, vendor-controlled certification introduces conflicts of interest.
   
   
6. Single contract for speed to market
   Rather than sourcing datasets and managing multiple vendors, a single contract gives you faster access to insights.

Go with the FLOW

With our IPGE approach, we are able to offer HealthVerity FLOW, a 21 CFR Part 11-compliant solution for synchronizing patient journeys from clinical trials to launch and beyond, including building registries to recruit patients for research studies, conducting safety/phase 4 studies, or for post-launch activities where a patient enrolls through a website or digital outreach. 

As life science tokenization enables seamless data linkage across clinical and real-world sources, HealthVerity FLOW provides the infrastructure to support that connection with speed, accuracy, and compliance:

• Identity Manager - When a patient is enrolled in a trial, a study, a registry or engages through digital outreach, HealthVerity Identity Manager creates a universal HVID, creating a source of truth that allows you to easily discover their RWD.
  
  
• Governance Manager - HealthVerity provides governance of engaged patients’ consent and data rights, informing you of what’s allowed and what isn’t with regards to their data.
  
  
• HealthVerity Marketplace de-identified RWD exchange - With the source of truth, for patient identity and data permissions, rights and usage, you can discover and exchange broad-scale de-identified data for patients of interest. 

This solution enables you to source, retrieve and deliver data into data stores, either you’re own data stores or those hosted by us, with identifiable data being kept separate from de-identified data and the ability to synchronize your first-party data, while maintaining a HIPAA-compliant firewall between the two. 

Beyond tokenization, HealthVerity FLOW allows the data to flow where you need it, when you need it, how you need it, and flows throughout the product lifecycle.

1. Pupura, Christina A., et al (2022). The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications. Clinical Pharmacology & Therapeutics, 2022 Jan; 111(1): 135-144. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299054/