Patent Issued for Linking of tokenized trial data to other tokenized data (USPTO 11755779): Datavant Inc.

2023 SEP 29 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Datavant Inc. (San Francisco, California, United States) has been issued patent number 11755779, according to news reporting originating out of Alexandria, Virginia, by NewsRx editors.

The patent’s inventors are Gupta, Serena (Woodside, CA, US), LaBonte, Jason A. (Natick, MA, US), Mucaj, Vera (San Francisco, CA, US), O’brien, James (San Francisco, CA, US), Roosz, Samuel A. (San Francisco, CA, US), Suresh, Anjali (Sunnyvale, CA, US).

This patent was filed on June 25, 2021 and was published online on September 12, 2023.

From the background information supplied by the inventors, news correspondents obtained the following quote: “Generally, regulations and laws protecting the privacy of personal data have created a plethora of strategies for protecting the identity of personal data. For example, it is a potential Health Insurance Portability and Accountability Act (HIPAA) violation to incorporate personal health information (PHI) elements into a healthcare data set. Accordingly, to be compliant with government regulations, all PHI data elements must be removed and/or de-identified before being incorporated into any healthcare data set. Typically, institutions, organizations, and businesses that create personal data have their own methods for complying with identity protection laws. These methods may include in-house developed proprietary methods, or one of many disparate off-the-shelf solutions. The conventional methods utilized for protecting personal data have been responsible for serious identity breaches resulting in the theft of customer and employee personal information. Conventional methods implement processes of de-identification by the use of hashing methods applied to strings of characters generated from private data elements in data records. These conventional processes are built using a single hashing seed or encryption key, which is shared across many disparate target sites. Such systems suffer the risk that the resulting generated values can be mapped back to the original source data. Once a breach has occurred, all the target data sites have exposed values which, in themselves, could become regulated data values. Conventional processes also create problems because once PHI data elements are removed from record, users have no way to understand which individuals in the data set match the de-identified individuals, and so conventional healthcare data systems are limited in their ability to identify the existence of duplicate records or duplicate individuals from individual de-identified records in healthcare data sets.

“Additionally, the personal data records stored by the various entities cannot be shared or aggregated for any meaningful or useful data analysis. Specifically, the personal data cannot be shared between entities where the identity any one particular individual is of no importance. A problem associated with protected personal data is easily recognizable in the industries related to healthcare where each provider or insurer typically employs their own proprietary methods for de-identifying personal data records, making it nearly impossible to do any meaningful aggregations of the data for important clinical research or cost analysis at higher regional, state, or national levels. This problem is compounded by the fact that there are many separate and distinct companies involved with the care of an individual patient, making it difficult to share and or tie the information together for a single patient once the stake holder has applied their own proprietary de-identification process to the patient’s personal data records.

“Standardized solutions, such as Datavant’s de-dentification and linking solutions have been developed to address these issues. However, even with a standardized way of de-identifying and linking data based on tokenizing the personal identifying information (PII) of the individual associated with the data, trials, such as clinical trials, provide additional issues. Typically, each participant in a trial is identified with a subject identifier (Subject ID) rather than their personal identifying information (PII) to maintain anonymity. For example, the subject named “John Smith” might be identified as “Subject 12” for the purposes of the data collected and presented in the trial. This additional layer of abstraction means that data for a subject from the trial cannot be easily linked to other data for the subject that has been de-identified in conventional manner by tokenizing the personal identification information (PII) associated with the data. Since the subject in the trial is identified by a subject ID, there is no personal identification information (PII) associated with the trial data to be encrypted and linked to other data using such standardized solutions. While the trial site might collect the subject’s PII when setting up the trial, the PII never leaves the trial site. The trial originator or sponsor or other entities interested in the data only get the subject ID identification associated with the trial data.”

Supplementing the background information on this patent, NewsRx reporters also obtained the inventors’ summary information for this patent: “Thus, there is a need for a solution that can link data from a trial, where the subject is anonymized with a subject identifier (Subject ID), to other data that has been de-identified by tokenizing the personal identifying information (PII) for the individual associated with the data while maintaining the privacy of the subject. The present invention is directed toward further solutions to address this need, in addition to having other desirable characteristics. Specifically, the present invention creates a link between a subject identifier (or a tokenized subject identifier) for the subject in the trial and the tokenized personal identification information of the subject without revealing the link between the subject identifier and the personal identification information.

“In accordance with example embodiments of the present invention, a method of linking trial data for a subject with other tokenized data for the subject is provided. The method involves receiving an identification of a subject in the trial (subject ID); receiving personal identification information (PII) for the subject; generating multiple tokens from personal identification information (PII) for the subject; generating a bridge file mapping a link between the identification of the subject (subject ID) and the multiple personal identification information tokens; and sending the bridge file to a storage location.

“These steps of the method are performed by trial token generation software on a first client site. The resulting multiple personal identification information tokens are unique to the first client site and the subject. The bridge file links trial data for the subject to other data for the subject tokenized with the multiple personal identification information tokens. Only the first client site has access to the subject identification (subject ID), personal identification information (PII), and the link between the subject identification and personal identification information for the subject.

“In accordance with an aspect of the present invention, the trial token generation software is downloaded from a central management platform (vault).

“In accordance with an aspect of the present invention, the method further includes registering, by a trial originator/sponsor, the trial with a central management platform (vault).”

The claims supplied by the inventors are:

“1. A system for linking trial data for a subject with other tokenized data for the subject, the system comprising: a central management platform comprising a processor and storage; a first client site comprising a processor and storage; a second client site comprising a processor and storage; a trial originator/sponsor comprising a processor and storage; the central management platform, first client site, second client site, and trial originator/sponsor in electronic communication over a network; the central management platform configured to: register a trial from the trial originator/sponsor; register the first client site and the second client site participating in the trial; generate and maintain unique encryption keys and tokenizing and encryption rules for entities participating in the trial; provide trial token generation software to the first client site participating in the trial; provide de-identifying software to the second client site; and provide linking software to the trial originator/sponsor; the first client site configured to: receive and execute trial token generation software from the central management platform; receive, using the trial token generation software, an identification of subject in the trial (subject ID); receive, using the trial token generation software, personal identification information (PII) for the subject; generate, using the trial token generation software, multiple tokens from the personal identification information (PII) for the subject, wherein the multiple personal identification information tokens are unique to the first client site and the subject; generate, using the trial token generation software, a bridge file mapping a link between the identification of the subject in the trial (subject ID) and the multiple personal identification information tokens, wherein the bridge file links trial data for the subject tokenized with the subject identification token to other data for the subject tokenized with the multiple personal identification information tokens; send, using the trial token generation software, the bridge file to a storage location, collect trial data for the subject identified with the subject ID; send the collected trial data identified with the subject ID to the trial originator/sponsor; the second client site configured to: collect other data for the subject including PII; receive and execute de-identifying software from the central management platform; tokenize, using the de-identifying software, the other data; and send the tokenized other data to the trial originator/sponsor; the trial originator/sponsor configured to: register the trial with the central management platform; receive trail data with a subject identifier from the first client site; receive linking software from the central management platform; receive tokenized other data from the second client site; access the bridge file; and link, using the linking software and the bridge file, the trial data with the tokenized other data; wherein, only the first client site has access to the subject identification (subject ID), personal identification information (PII), and the link between the subject identification and personal identification information for the subject.

“2. The system of claim 1, wherein multiple subjects participate in the trial and an identification of the subject in the trial (subject ID) and personal identification information (PII) for each of the multiple participants is provided and multiple personal identification tokens are generated for each of the multiple participants in the trial, and wherein the bridge file links the identification of the subject in the trial (subject ID) and multiple personal identification tokens for each participant in the trial.

“3. The system of claim 1, wherein the storage location is located at a trial originator/sponsor.

“4. The system of claim 1, wherein the first client site is further configured to: assign an identification for a subject (subject ID) in the trial; and collect personal identification information (PII) for the subject in the trial.

“5. The system of claim 1, wherein the first client site is further configured to: obtain the subject’s consent for participation in the trial.

“6. The system of claim 1, wherein the generation of multiple personal identification tokens and generation of a bridge file, are performed as a batch process where the personal identification information is sent to a secure location where an application at the secure location generates the multiple personal identification tokens and returns the personal identification tokens to the trial token generation software.

“7. The system of claim 1, wherein the second client site being configured to tokenize the other data for the subject comprises the second client site being further configured to: generate one or more personal identification information tokens from the personal identification information of the subject; and replace the personal identification information (PII) associated with the subject with one or more personal identification information tokens.

“8. The system of claim 1, wherein the trial originator/sponsor being configured to link the trial data for the subject to the tokenized other data for the subject comprises the trial originator/sponsor being further configured to: replace the one or more identification information tokens associated with the other data with one or more shared encryption format person identification information tokens; replace the one or more personal identification information tokens in the bridge file with one or more shared encryption format personal identification information tokens; and link the trial data of the subject to the other data for the subject based on the shared encryption format tokens.

“9. The system of claim 1, wherein the first client site is further configured to: generate, using trial token generation software, a subject identification token from an identification of subject in the trial (subject ID), wherein the subject identification token is unique to the first client site and the trial; wherein the generated bridge file maps a link between the subject identification token and the multiple personal identification information tokens; and wherein the bridge file links trial data for the subject tokenized with the subject identification token to other data for the subject tokenized with the multiple personal identification information tokens.

“10. The system of claim 9, wherein the central management platform assigns a unique encryption key to the first client site, the unique encryption key used by the trial token generation software to generate the subject identification token and the multiple personal identification information tokens.

“11. The system of claim 9, wherein multiple subjects participate in the trial and a subject identification token and multiple personal identification tokens are generated for each of the multiple participants in the trial, and wherein the bridge file links the subject identification token and multiple personal identification tokens for each participant in the trial.

“12. The system of claim 9, wherein the first client site being configured to generate a subject identification token, generate multiple personal identification tokens, and generate a bridge file, involves a batch process where the subject identification and personal identification information is sent to a secure location where an application at the secure location generates the subject identification token and the multiple personal identification token and returns the subject identification token and the personal identification token to the trial token generation software.

“13. The system of claim 9, wherein the second client site being configured to tokenize other data for the subject comprises the second client site being further configured to: generate one or more personal identification information tokens from the personal identification information of the subject; and replace the personal identification information (PII) associated with the other data with one or more personal identification information tokens.

“14. The system of claim 9, wherein: the central management platform is further configured to: provide de-identifying software to the trial originator/sponsor; the trial originator/sponsor is further configured to: receive and execute the de-identification software; tokenize, with the de-identification software, trial data using a subject identification token; and link, with the linking software, the tokenized trial data for the subject to the tokenized other data for the subject using the bridge file.

“15. The system of claim 14, wherein the trial originator/sponsor being configured to tokenize trial data comprises the trial originator/sponsor further configured to: generate a subject identification token from the identification of the subject in the trial (subject ID); and replace the identification of the subject (subject ID) associated with the trial data with a subject identification token.

“16. The system of claim 15, wherein the central management platform assigns a unique encryption key to the trial originator/sponsor, the unique encryption key used by the de-identification software to generate the subject identification token.”

There are additional claims. Please visit full patent to read further.

For the URL and additional information on this patent, see: Gupta, Serena. Linking of tokenized trial data to other tokenized data. U.S. Patent Number 11755779, filed June 25, 2021, and published online on September 12, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(11755779)&db=USPAT&type=ids

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