#HEORInsights

With all stakeholders increasingly realising the value real-world evidence (RWE) studies can bring into the healthcare delivery, newer applications of RWE are being discovered with each passing day. RWE has the potential to tremendously enhance the speed of patient access to new drugs. With this background, it is absolutely essential that the quality of RWE and the real-world data (RWD) that is used to generate RWE, are of high quality. To ensure quality RWD, it is also essential to bring about transparency into the RWD collection process. Unfortunately, this is easier said than done! However, various steps have been devised to improve transparency of RWD.[1] Two most prominent ones of these are pre-registration of RWE study protocol, and tokenization.

The concept of data tokenization is not a new one, but the tokenization of health data is a fairly recent innovation. Tokenization of healthcare data is a process by which patient identifiers are de-identified through generation of a patient-specific ‘token’ that is encrypted.[2] It helps the researchers to link RWD from a patient’s previous medical history from diverse sources, and also aids tracking different active engagement across the healthcare system without any breach in the patient’s privacy.[2] Basically, all the sensitive data that can compromise a patient’s identity are replaced with unique identification symbols (tokens) that retain all the essential information, but without any compromises in the confidentiality. Tokenization can enable the access of health data without the need for decryption and re-encryption. The possibility of linking data with the use of tokens provides a more comprehensive understanding of health and health care.

Since tokens are unique patient identifiers, they can help recognize a patient who appears across multiple sources of RWD. As the tokens created are patient-specific, the nature of token remains the same across different datasets. Since tokens do not contain any protected health information (PHI) of the patient, such as name, date of birth, and social security number, tokenization can protect against patient reidentification and loss of privacy/ confidentiality. Since the tokens are consistent across different formats of RWE, tokenization also helps to prevent duplication of data while collecting for RWE generation. In other words, tokenization acts as a ‘matchmaker’ to link patient data.[3] Since blockchain technology is generally used in creating tokens, the data is secure and free of manipulation.[4]

Healthcare data tokenization has immense value from the viewpoint of all stakeholders in the healthcare industry. For clinical trial professionals, tokenization can improve study protocol design and can help in anticipating resources and support during a clinical trial. Tokenization also helps to expand follow-up data on trial participants and ensures representation of eligible participants. For healthcare providers, tokenization helps to match their patients’ clinical records accurately, enables keeping track of their patient’s clinical progress, and assists to combine healthcare data from different sources to allow new use cases.[5] For the pharmaceutical company and payers, tokenization provides immense value by helping analyse patient behaviour by tracking patient interactions with hospitals, clinics, pharmacies, laboratories, help groups, and other locations, in a completely de-identified manner. Thus, only the data relevant to the patient’s health is shared with the pharma, by keeping the patient’s personal details hidden. For the regulators, tokenization brings in an unmatched level of transparency in data, and the comprehensive data access that comes with healthcare data tokenization enables the regulators to perform appropriate and unbiased data review. Tokenization also helps data aggregators to meet regulatory compliances surrounding patient data confidentiality, such as HIPAA (Health Insurance Portability and Accountability Act) in the US. [6] Finally, patients can also benefit through tokenization of their health records. The confidentiality ensured by tokenization enables patients to securely organize, compile, share, and trade their personal medical records with relevant stakeholders.[7]

The proliferation of tokenization software and other technologies helps in obtaining a more comprehensive approach of data. The USFDA advises using common data elements to provide a standard, consistent and universal data collection format for better results when linking of patient data is done. Maintaining the data integrity is a must as it may impact the overall scenario. The common issues can be redundant data, inconsistencies across data, privacy and data security. The integrity of data should be assessed for the compatibility and interoperability of data systems and the results produced must be consistent and repeatable, so that relevant data is obtained accurately.[8] Tokenization has the potential to improve the data integrity and enhance the quality of RWE studies.

With the increasing stress by multiple stakeholders on data security and patient privacy, and increasing awareness about the importance of RWD transparency, and considering the unique advantages brought about by blockchain technology, healthcare tokenization has the potential to become a multibillion-dollar industry in the near future.

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References

1. Patorno E, Schneeweiss S, Wang SV. Transparency in real-world evidence (RWE) studies to build confidence for decision-making: reporting RWE research in diabetes. Diabetes Obes Metab. 2020 Apr;22 Suppl 3(Suppl 3):45-59.
2. Weng I. Linking RWE to Clinical Trials. 2022. https://www.komodohealth.com/insights/linking-rwe-to-clinical-trials
3. Dagenais S, Russo L, Madsen A, Webster J, Becnel L. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design. Clin Pharmacol Ther. 2022;111(1):77-89.
4. Scheuer E. Blockchain solves healthcare data obstacles. https://healthmanagement.org/c/hospital/issuearticle/blockchain-solves-healthcare-data-obstacles
5. Healthcare Data Tokenization. https://risk.lexisnexis.com/healthcare/healthcare-tokenization
6. Pezold A. HIPAA compliance requirements and tokenization. https://www.tokenex.com/blog/hipaa-compliance-and-tokenization .
7. Dimitrov DV. Blockchain Applications for Healthcare Data Management. Healthc Inform Res. 2019 Jan;25(1):51-56.
8. Trial Tokenization: Building A Bridge Between Clinical Trial Data And Real-World Data. E-Book. July 13, 2021.