Methods and systems for obtaining, controlling, accessing, and / or displaying personal genetic identification information.

The integration of STR analysis and blockchain technology enables secure and efficient genetic identification management, addressing the challenges of rapid personal identification in emergencies and respecting religious customs.

JP7848808B2Active Publication Date: 2026-04-21STR ID INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
STR ID INC
Filing Date
2021-12-21
Publication Date
2026-04-21

AI Technical Summary

Technical Problem

Existing methods for personal identification, particularly in emergency situations, are time-consuming, unreliable, and lack the ability to securely and efficiently manage genetic identification information, often requiring family member involvement and being incompatible with religious customs.

Method used

A method and system utilizing short tandem repeat (STR) analysis and blockchain technology to securely store and manage genetic identification information, allowing individuals to register their genetic data and access it through a blockchain ledger, enabling rapid and reliable personal identification.

Benefits of technology

Facilitates fast, secure, and reliable personal identification, reducing the need for family involvement and respecting religious customs, while providing a tamper-proof and universally accessible genetic identity management system.

✦ Generated by Eureka AI based on patent content.

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Abstract

Methods and systems for obtaining and controlling genetic identity information are disclosed. The method includes providing personal information of a registrant to a secure website using an electronic communication device, obtaining a genetic material-containing sample from the registrant, providing the sample to a genetic material analysis facility, analyzing short tandem repeat (STR) regions of the genetic material at a plurality of loci to generate a genetic identity for the registrant, recording the personal information and the genetic identity on a blockchain ledger, and enabling the registrant to display a code corresponding to the genetic identity on another electronic communication device. The system includes a genetic material sampling kit, a short tandem repeat (STR) analysis kit, and an electronic communication device configured to input personal information of the registrant, record the personal information and the genetic identity on a blockchain ledger, and display the code corresponding to the genetic identity.
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Description

Technical Field

[0001] [Related Application] This application claims priority to U.S. Provisional Patent Application No. 63 / 131,626, filed Dec. 29, 2020, which is incorporated herein by reference.

[0002] The present invention generally relates to the field of obtaining, controlling, and accessing genetic identification information. More particularly, embodiments of the present invention relate to novel methods and systems for obtaining, storing, controlling, and accessing genetic identification information, particularly using short tandem repeat analysis and blockchain data / transaction storage and retrieval, and methods of creating and using the same.

Background Art

[0003] Short tandem repeat (STR) analysis is a useful technique for genetic identification and is commonly associated with DNA testing in forensic laboratories, paternity disputes, or missing person cases. Of the approximately three million DNA bases that do not encode proteins, there are regions that have multiple copies of short repeat sequences of these bases, which make up the DNA backbone (e.g., TATT). These sequences are repeated a variable number of times in different individuals. Such regions are called "variable number short tandem repeats," and they form the basis of STR analysis. The collection of these repeat sequences at different loci in the genome can statistically provide almost irrefutable evidence of a person's identity because the probability that two unrelated individuals have the same number of repeat sequences at these loci becomes extremely small as more loci are analyzed.

[0004] Currently, consumers generally lack the ability to readily participate in managing their own identity before, during, and even after emergency events. To the best of our knowledge, there is no “pre-event” preparation for personal injury using a pre-analysis DNA identification system. For example, traditional forms of identification (ID), such as driver’s licenses, passports, and birth certificates, can be tampered with or stolen and are often simply obsolete (for digital purposes, for example). Therefore, there is a need to be able to identify a person confirmatory, highly reliable, securely (e.g., using any necessary or desired cybersecurity and / or digital traceability), verifiable, and easily during emergency or catastrophic events (e.g., accident or crime scene, natural disaster, during war / conflict, after acts of terrorism, etc.), while still protecting the privacy of that person.

[0005] For example, one report indicates that more than 800,000 children go missing in the United States each year (Goldberg, B. "Missing Children in US Nearly Always Make It Home Alive," Reuters News Service, April 26, 2012). That corresponds to one child going missing every 40 seconds. Major disasters, both natural and man-made, are now commonplace. Injuries and deaths are unfortunate consequences of military, defense, law enforcement, and other first-response activities, and often it is undesirable to ask close relatives to identify a person who recently died while serving their country or community.

[0006] The time required to identify individuals adversely affected by accidents or catastrophic events is often unacceptably long. Furthermore, historically, the process of identification using genetic information has generally been time-consuming due to the need to locate family members for proper sampling. If family members do not live in the immediate vicinity, multiple agencies are generally involved in locating them and obtaining samples. If family members live in another country, the time and the number of agencies involved increase significantly. For example, the California Office of Emergency Services (OES) took approximately 10 days to identify 34 victims after the September 2, 2019, fire on the USS Conception during a planned three-day diving trip, even though all victims' names were known and recorded prior to the trip. This effort also involved multiple agencies (the FBI, the Los Angeles County Medical Examiner, the Santa Barbara County Sheriff's Office, and the Sacramento County Coroner) and benefited from the limited opportunities presented by mobile, rapid DNA technology at the scene. It is not always possible to involve a large number of agencies or make such valuable resources available in every major accident or incident resulting in numerous injuries.

[0007] The relatively lengthy identification procedure is also incompatible with several religious customs and / or practices regarding the treatment of recently deceased persons. Many religious groups around the world believe in the sanctity of the human body after death. Some religious practices do not approve of autopsies because they consider them to be desecration of the sacred body. Identification via DNA (even when expedited DNA testing is used) is still hindered by the process of locating a suitable family member for a reference sample. If the location of a family member cannot be quickly identified or if they are no longer alive, the time required for identification increases, and an autopsy may be deemed necessary, regardless of the religious beliefs of the deceased or the family.

[0008] Despite millions of dollars being poured into person identification efforts, families often have to wait days, months, or even years to confirm the identity of their loved ones. A movement to cut off aid to law enforcement, if successful, may have negatively impacted person identification efforts, slowing down the process and making it more difficult for everyone involved.

[0009] Contracts, transactions, and associated records are fundamental constructs in our economic, legal, and political systems. They protect assets and define organizational boundaries. They establish and verify identities and record events chronologically. They govern interactions between nations, organizations, communities, and individuals. They guide administrative and social actions, yet these critical tools (and the bureaucracies formed to manage them) seem to be struggling to keep pace with the digital transformation of the modern economy.

[0010] Blockchain is expected to solve at least some of the problems in managing contracts, transactions, and the information associated with them. Blockchain, the core technology of Bitcoin and other cryptocurrencies, is a data structure that enables the creation of an open, distributed digital ledger that can efficiently, verifiable, and permanently record transactions between two parties. The ledger can be shared among a network of independent parties and can be programmed to automatically trigger further transactions.

[0011] This “Background Art” section is provided for background information only. The statements in this “Background Art” section are not intended to be approvals that constitute prior art of this disclosure, and no part of this “Background Art” section can be used as an approval that constitutes prior art of this disclosure, nor can any part of this application, including this “Background Art” section, constitute prior art of this disclosure. [Overview of the project]

[0012] In one embodiment, the present invention relates to a method for acquiring and controlling genetic identification information, comprising the steps of: providing a registrant's personal information to a secure website using a first electronic communication device; collecting a sample containing genetic material from the registrant; providing the sample containing genetic material to a genetic material analysis facility; analyzing short tandem repeat (STR) regions of the genetic material at multiple loci to generate the registrant's genetic identity; recording the personal information and the genetic identity in a blockchain ledger; and enabling the registrant to display a code corresponding to the genetic identity on a second electronic communication device. The first and second electronic communication devices may be the same device or different devices. In various embodiments, the first and second electronic communication devices may be independently selected from smartphones, personal computers, tablet computers, and workstations.

[0013] The aforementioned personal information may include at least two of the following: the registrant's name, address, government-issued identification number, and photograph. For example, the government-issued identification number may include a social security number, driver's license number, or passport number.

[0014] In some embodiments, the method may further comprise the steps of (i) encrypting the registrant's personal information and genetic identity before recording the personal information and genetic identity in the blockchain ledger, and / or (ii) registering the registrant for services including STR area analysis, personal information / genetic identity recording, and genetic identity code visualization. In further embodiments, the method may further comprise the step of ordering a home genetic material sampling kit on a website. The home genetic material sampling kit may comprise a vial or tube, instructions for collecting the sample, and / or a pre-addressed envelope or box for sending the genetic material-containing sample to the genetic material analysis facility. In yet further embodiments of the method, the step of collecting the genetic material-containing sample may comprise the steps of placing the genetic material-containing sample in the vial or tube, and then placing the vial or tube containing the genetic material-containing sample in the pre-addressed envelope or box.

[0015] In various embodiments, the step of obtaining the gene material-containing sample from the registrant includes the steps of collecting the registrant's saliva into the vial or tube, collecting it with a cotton swab from the inside of the registrant's mouth or nose, or puncturing the registrant's skin and collecting one or more droplets of the registrant's blood on a cotton swab or absorbent paper. In some such embodiments, the method further includes the steps of (i) the registrant certifying or confirming that the registrant has collected the DNA sample, or (ii) the third party certifying or confirming that the third party (who is registered or who can collect samples from one or more other individuals, such as a minor, a person with a disability, an employee, or a beneficiary of public services) is authorized to collect the registrant's DNA sample. In other or further embodiments, the step of providing the gene material-containing sample to the gene material analysis facility includes the step of shipping the gene material-containing sample to the gene material analysis facility in an envelope, sleeve, tube, or box.

[0016] In some embodiments, the step of analyzing the STR region of the gene material includes the steps of extracting DNA from the gene material, optionally quantifying the DNA, amplifying the DNA at multiple STR loci, isolating and sizing the amplified STR alleles, and interpreting the profiles of the isolated and sized STR alleles. The method may further include the step of labeling the amplified STR alleles during or after amplification. In some cases, the DNA is amplified at 20 or more STR loci, and the step of isolating and sizing the amplified STR alleles may include (i) isolating the labeled, amplified STR alleles by gel electrophoresis or capillary electrophoresis, (ii) irradiating the labeled, amplified STR alleles with light that causes them to fluoresce or emit cold light, and (iii) measuring the fluorescence or luminescence of the irradiated, labeled, amplified STR alleles.

[0017] In various embodiments, the method may further include the steps of enabling the registrant to access entries in the blockchain ledger, including the personal information and the genetic identity; authenticating the registrant's identity or personal information using the registrant's genetic identity; and / or enabling the registrant to authorize a third party to access the code on a third electronic communication device. In the latter embodiment, the method may further include the step of accessing the code using one of the first, second, and third electronic communication devices. The third electronic communication device may be identical, the same as, or different from one or both of the first and second electronic communication devices. However, generally, the method may further include the step of accessing the code using one of the first and second electronic communication devices.

[0018] Another aspect of the present invention relates to a system for acquiring and controlling genetic identification information, comprising a gene material sampling kit, a short tandem repeat (STR) analysis kit, a first electronic communication device configured to input the registrant's personal information into a secure website, a second electronic communication device configured to record the personal information and the genetic identity in a blockchain ledger, and a third electronic communication device configured to display a code corresponding to the genetic identity. The gene material sampling kit comprises a sealable container configured to resealably store a sample containing the registrant's gene material, instructions for taking the sample from the registrant and placing the sample in the sealable container, and a pre-addressed envelope or box for sending the sample in the sealable container to a genetic material analysis facility. The STR analysis kit comprises a plurality of primers for copying the STR region of the gene material at a plurality of loci, and a mixture containing gene material polymerase, buffer, and dNTPs necessary for amplifying the STR region, comparing the amplified STR region with similar genetic identification information, and generating the registrant's genetic identity. The second electronic communication device differs from the first and third electronic communication devices, and the first and third electronic communication devices may be the same electronic communication device or different electronic communication devices.

[0019] The first electronic communication device may include a personal computer or smartphone, which may be configured to input at least two of the following as personal information: the registrant's name, address, government-issued identification number, and photograph (for example, using an app). In some embodiments, the first electronic communication device may be further configured to enable the registrant to (i) register for services including STR analysis and recording of the personal information and genetic identity, and / or (ii) access and / or display a code corresponding to the genetic identity. The second electronic communication device may include, for example, a personal computer, workstation, or server, which may be configured to (a) provide services including STR analysis of the genetic material, recording of the personal information and genetic identity, and / or creation of a code corresponding to the registrant's genetic identity, and / or (b) present the registrant with a genetic material sampling kit. The second and / or third electronic communication device may be further configured to authenticate the registrant's identity or personal information using the registrant's genetic identity, and the third electronic communication device may be further configured to access the code from the blockchain ledger.

[0020] In various embodiments, the sealable container comprises a sealable plastic bag, or a vial or tube, wherein a cap or lid is configured to seal an opening in the vial or tube, and the STR analysis kit further comprises (i) a gel electrophoresis cassette / tray and gel, or (ii) a capillary electrophoresis capillary, wherein the primers include fluorescent or luminescent labeling, and / or the system further comprises a gene analyzer. The gel electrophoresis cassette / tray and gel or the capillary electrophoresis capillary is configured to separate the amplified STR regions by size. In the latter embodiment, the STR analysis kit may further comprise a plurality of allelic ladders for a gene locus, each of which has a predetermined size, and the allelic ladder is configured to calibrate the size of the amplified STR regions to the number of STR repeats.

[0021] The present invention presents a novel digital genetic (e.g., DNA-based) identity management system and method in which users have control over their identification information at substantially any location and / or at substantially any time in many cases. In many embodiments, the present invention is human-centered, easily and directly connecting to consumers / users and their electronic communication devices (e.g., smartphones), and leverages advanced privacy-preserving, genetic identification technology and tamper-proof blockchain technology to generate and / or authenticate an individual's "permanent identification." For example, the present invention can use the same person identification technology (e.g., STR) used and accepted by the U.S. Federal Bureau of Investigation (FBI) and law enforcement agencies worldwide.

[0022] The present invention uses non-coding regions of an individual's DNA to distinguish a person's identity with substantial non-disprovable accuracy, while protecting the individual's genetic privacy. The system and method also enable compatibility with post-mortem religious procedures and / or customs. The system and method eliminate the need to find family members for positive genetic identification, thereby saving the time, money, and resources of government agencies, as well as the family itself (in addition to reducing stress on the family) in identifying and verifying the identity of their loved ones. This is particularly important when resources are scarce, especially in the case of disasters that result in a large number of casualties.

Brief Description of the Drawings

[0023] [Figure 1] It is a flowchart of an exemplary method for obtaining and providing genetic identification information according to one or more embodiments of the present invention.

[0024] [Figure 2] It is a diagram showing a color separation panel for an allelic ladder from a commercially available STR analysis kit used for STR test calibration.

[0025] [Figure 3] It is a block diagram showing the components of an overall system for obtaining and accessing / providing genetic identification information according to one or more embodiments of the present invention.

[0026] [Figure 4] It is a diagram of an exemplary blockchain according to one or more embodiments of the present invention.

[0027] [Figure 5] It is a flowchart showing an exemplary method for managing genetic identification information according to one or more embodiments of the present invention.

[0028] [Figure 6]This is a flowchart illustrating an exemplary genetic information recording process and an exemplary ledger transaction using a public permission blockchain and blockchain network, according to one or more embodiments of the present invention.

[0029] [Figure 7] This block diagram shows an exemplary personal and genetic information privacy protection system according to one or more embodiments of the present invention.

[0030] [Figure 8] This block diagram shows an exemplary blockchain having a distributed ledger for recording personal and genetic identification information and related transactions, according to one or more embodiments of the present invention.

[0031] [Figure 9] This figure shows a smartphone displaying an exemplary personal and genetic identification data retrieval page according to one or more embodiments of the present invention.

[0032] [Figure 10] This block diagram shows exemplary PC / computer system components suitable for use in this system and method. [Modes for carrying out the invention]

[0033] Various embodiments of the present invention are described in detail here, examples of which are shown in the accompanying drawings. The present invention will be described in combination with the following embodiments, but it should be understood that these descriptions are not intended to limit the present invention to these embodiments. On the contrary, the present invention is intended to encompass alternatives, modifications, and equivalents that may fall within the spirit and scope of the present invention. Furthermore, the following detailed description includes many specific details in order to provide a full understanding of the present invention. However, it will be readily apparent to those skilled in the art that the present invention can be carried out without these specific details. In other cases, well-known methods, procedures, and components are not described in detail so as not to unnecessarily obscure aspects of the present invention. Furthermore, it should be understood that possible permutations and combinations described herein are not intended to limit the present invention. Specifically, inconsistent variations may be mixed and matched as desired.

[0034] For convenience and brevity, the terms “user,” “consumer,” and “registrant” may be used interchangeably herein, but generally given in their respective industry-recognized meanings. Generally, whenever one such term is used, it also encompasses the other terms. Similarly, for convenience and brevity, the terms “party” and “entity,” and separately, the terms “individual” and “person,” and the terms “information” and “data,” are generally interchangeable and may be used interchangeably herein, but generally given in their respective industry-recognized meanings, and whenever one such term is used, it also encompasses the other terms. In addition, for convenience and brevity, the terms “part,” “section,” and “part,” may be used interchangeably, but these terms are also generally given in their respective industry-recognized meanings. Furthermore, unless otherwise indicated by the context of their use in this specification, the terms “known,” “fixed,” “given,” “specific,” and “predetermined” generally refer to values, quantities, parameters, constraints, conditions, states, processes, procedures, methods, implementations, or combinations thereof, which are theoretically variable but are generally predetermined and do not change thereafter once used.

[0035] One ultimate goal of this invention is to facilitate preparation among and / or among the general public regarding emergency identification, while simultaneously directly supporting the efforts of law enforcement agencies, making the identification process faster, easier, and cheaper for society as a whole. Other goals include enabling the fast and easy identification of individuals and / or the ownership and traceability of digital assets (such as personal information in electronic form) in a safe and secure manner. This invention aims to reduce the pressure, stress, and / or dependence on limited public and private resources, particularly during disaster events (natural or man-made) resulting in a large number of casualties, and, perhaps most importantly, to bring about a more efficient and / or less disruptive conclusion for grieving families. This invention presents a novel solution for many religious groups to identify a recently deceased person without autopsy, because such groups may value the freedom to honor the deceased based on their religious beliefs and practices.

[0036] In some aspects of the present invention, a user can save the life of another by a timely identification process of a deceased person or a person connected to life support. Many individuals and their families believe in and propose post-mortem organ donation. The organ donation process is hindered if an individual is connected to life support or has recently died but is not properly identified. Many organ procurement agencies require explicit and / or written consent (e.g., through a donation list) or permission from the family of the donor before death for organ donation. If the person's identity is unknown or the agency cannot locate the family, this prolongs the time before the donation can be completed. Organ donation is a time-sensitive process, and the viability of organs decreases significantly with time. The present invention provides an advanced method for identifying individuals, saving time, and potentially saving the life of another if the individual authorizes organ donation. In some aspects of the present invention, a registrant may use a digital genetic (e.g., DNA-based) identity management system and method to verify their identity in order to access certain electronic systems such as corporate computing, intranets, bank accounts, or online database storage, but not limited to these.

[0037] Identity is an important part of society, but it is even more critical in urgent situations. In some aspects of the present invention, users and / or consumers own their own identifying information and control the authorization of access to and release of it when needed. The system and method can completely avoid privacy surveillance and infringement.

[0038] This system and method, which can be considered a form of "DNA digitization," has a global, interconnected security application because law enforcement agencies worldwide use the same scientific basis for genetic identification. An individual's ID in this system and method is a kind of "eternal identification" that remains valid and relevant from the individual's birth through to the end of their life. Recognizing that public security is, to some extent, a public responsibility, this system and method can make the world safer for everyone, especially those most vulnerable. Exemplary Method

[0039] This method can be divided into two processes: a testing process and a digital identification management process. An exemplary process for this method is shown in flowchart 100 in Figure 1.

[0040] In the first stage, an individual or user may register with the blockchain registry administrator by entering personally identifiable information on a secure website in 110. The individual or user may be a person who registers on their own behalf, on behalf of a minor or other person under their guardianship or representation, or on behalf of another person who has authorized the individual or user. In the case of a child or another relative who does not have the capacity (for example, to enter into a contract), the individual or user may register on behalf of such "family-registered" user and act on behalf of such "family-registered" user. The user may further register others who authorize them to register on their behalf (for example, members of the same organization such as a military unit, police or fire department, government agency, relief organization, church or religious organization, hospital, corporation, etc.).

[0041] Personally identifiable information entered on the secure website may include the registrant's name (real name and, if different, birth name), birth information (e.g., date and / or place of birth), biometric information (e.g., height, weight, eye and / or hair color), home address, mailing address, citizenship, driver's license information (e.g., driver's license number), passport or national identification information (e.g., passport number, issuing country, expiration date, etc.), marital status, "multiple birth" status (i.e., whether the registrant is one of a set of twins, triplets, or other multiple birth groups), or a combination thereof. Optionally, individuals may enter their race, religious affiliation, political affiliation, employment status, employer, health information (e.g., known chronic conditions such as disabilities, chronic diseases such as diabetes and hypertension, presence of internal health support devices such as pacemakers, known adverse drug reactions, etc.), close relatives, emergency contact information, educational history and information (e.g., high school and university attended, dates of enrollment, degrees obtained, etc.). In addition, individuals may upload a photograph of the registrant or other facial recognition information about the registrant, one or more fingerprints of the registrant, etc.

[0042] Individuals may complete registration by ordering a DNA home testing kit at 110. The database / registry administrator will generally verify that no entries for registrant verification exist (e.g., in the blockchain register, other genetic identity databases, etc.) before the entry into the blockchain ledger at 120, and will eliminate any potential duplication of PII or genetic identification information to prevent any single individual from having more than one genetic identity, if necessary or desired. The database / registry administrator may also charge a fee for the kit and shipping, and collect any applicable taxes. Next, at 120, an entry is created in the blockchain ledger. Entries into the blockchain ledger will be described in more detail with respect to Figures 3 and 4. Ledger entries are accessible to the registrant and any person authorized to access the ledger (e.g., on behalf of the registrant).

[0043] Alternatively, registrants could simply enter their identification information without ordering a DNA home testing kit, provided their non-DNA identification information is maintained in a database / registry, but they would lose the benefit of access to encrypted genetic identification information. However, there may still be some benefits to storing non-DNA-based identification information in a blockchain registry.

[0044] The DNA home testing kit is then shipped to the registrant or the registrant's guardian or authorized agent (e.g., caretaker). Once the kit is received by the registrant (or the registrant's guardian or authorized agent), a DNA sample is collected from the registrant in accordance with the instructions in the kit, and an entry is optionally recorded in the blockchain ledger with a timestamp of sample collection and / or confirmation that the sample was collected from the individual whose information was entered into the secure website in 110. For example, the confirmation may include a certificate or other document from the registrant confirming that the registrant collected the DNA sample, or alternatively, from a third party confirming that the third party is authorized to collect the registrant's DNA sample. The third party may register (or collect samples from) one or more other individuals, such as a minor, a person with a disability, an employee of the third party's employer, or a beneficiary of a particular administrative service. In an alternative embodiment, limited PII (e.g., name, email address, date of birth, and optionally other basic identifying information sufficient to create a unique identifier about the registrant) is collected at 110, and the remainder of the PII is collected at 130.

[0045] The samples are then shipped to an analysis lab in 140 for analysis. Typically, the kit will include a pre-addressed, postage-paid envelope or container for shipping the samples to the lab. In a further option, the entry is recorded in a blockchain ledger along with a timestamp or date stamp of the shipment of the samples to the analysis lab. For example, an entry may be made by a registrant or a third party (i.e., a user registering or entering information on behalf of another person) who can generate one or more documentation photos, such as a barcode on the kit or sample holder, or the person holding the sample ready for shipment, using a camera on the registrant's or user's communication device. Such photo entries may be useful, at least in part, for validating the identity of the registrant or user.

[0046] At 150, the analysis laboratory performs STR testing. Kits and equipment for performing STR testing are widely available. For example, STR testing kits are available under the trademark of Applied Biosystems from Thermo Fisher Scientific Corporation (Waltham, Massachusetts), Promega Corporation (Madison, Wisconsin), Qiagen (Germantown, Maryland), and others. Gene analyzers and other equipment are available from Thermo Fisher Scientific and others.

[0047] Commercially available kits, typically providing a standard master mixture containing pre-mixed primers and the polymerase, enzyme buffer, and dNTPs necessary for amplifying STRs, simplify the generation of STR profiles and provide results for a uniform set of core STR loci, enabling the sharing of genetic identification information and comparison with similar genetic identification information obtained from different samples. In fact, commercially available kits are preferred by most analytical laboratories over in-house assays, even though the kits are more expensive. Commercially available kits help simplify and standardize procedures and remove the burden of PCR component quality control from analytical laboratories. In addition, STR kits supply allelic ladders containing common STR alleles that have been previously characterized for the number of repeat units via DNA sequencing. These allelic ladders are used to calibrate PCR product sizes to STR repeat numbers for genotyping purposes. Genotyping in samples to be processed is performed by comparing the allele sizes (relative to an internal size standard) to commercially available STR kit allelic ladders that are calibrated for repeat numbers and sized according to the same internal size standard.

[0048] The process for STR testing includes sample collection, DNA extraction, DNA quantification, PCR amplification of multiple STR loci, STR allele separation and sizing, STR typing and profile interpretation, and reporting of the statistical significance of agreement (if observed). Following PCR amplification, the total length of the STR amplicons is measured to determine the number of repeats present in each allele found in the DNA profile. This length measurement is performed via size-based separation using gel electrophoresis or capillary electrophoresis (CE). Each STR amplicon may be fluorescently labeled during PCR if either the forward or reverse locus-specific primers contain a fluorescent dye. The size of each STR allele may be determined after its separation from other STR alleles by recording the dye color and migration time of each DNA fragment relative to an internal size standard. Commonly used instruments for STR allele separation and sizing include the ABI PRISM 3100 and ABI PRISM 3500 gene analyzers (available from Thermo Fisher Scientific Corporation under the trademark of Applied Biosystems).

[0049] The results of an STR test are a series or multiple graphs or plots of the sizes of repeat DNA segments at a given number of loci, as determined by gel electrophoresis or capillary electrophoresis. Typically, the number of loci is 11 to 25 (higher numbers of loci increase the reliability of the results; currently, the FBI requires at least 20 loci, and at least one commercial process [GlobalFiler from Thermo Fisher] includes 24 loci). The number of graphs or plots is based on the number of electrophoretic separation runs in the test / analysis. For example, Figure 2 shows five (5) color separation panels for an allelic ladder from an AmpF / STR Globalfiler kit (available from Thermo Fisher) used for DNA size / short tandem repeat (STR) calibration. Genotype determination in the sample being processed is performed by comparing the allele sizes (relative to an internal size standard) in the sample being processed to a repeat-count calibrated STR allelic ladder (e.g., Figure 2) that is sized according to the same internal size standard as the sample being processed.

[0050] Referring back to Figure 1, the digitized format of the registered user's DNA analysis results (i.e., genetic identification information) is reported directly to the registered user (e.g., consumer) and entered into the blockchain ledger at 160. Simultaneously, the genetic identification information and / or blockchain ledger entry is associated with the registration entry in the blockchain ledger. In some embodiments, the analysis lab encrypts the DNA analysis results before uploading them (e.g., to the database / registry administrator or directly to the blockchain ledger) so that the genetic identification information is encrypted before it is entered into the blockchain ledger. In one variation of these embodiments, only the registrant (or user, if authorized) can decrypt the genetic identification information. This variation is somewhat critical to enabling self-sovereign identification (SSI) in this methodology, protecting the data from access by third parties and unauthorized entities, which may do so unintentionally (e.g., using a law enforcement warrant) or with malicious intent. Upon receiving the DNA analysis results, the registrant or authorized user can decrypt them using a decryption key (which may be a public key generated by the registrant, or an encryption key [or its complement] programmed into a secure application provided by the database / registry administrator). In some examples, the DNA analysis results may be further encrypted using the registrant's PII and / or DNA sequence combination before being entered into the blockchain ledger. In further embodiments, the registrant's identity may be validated using family genetic information (e.g., the registrant's genetic identification information compared to that of one or more members of the registrant's family).

[0051] In 170, the digital DNA analysis results (which may be previously encrypted) are embedded as a unique machine-readable icon or other symbol, such as a QR code®, barcode, etc. For example, the machine-readable symbol may be a digital representation of the digital DNA analysis results and may include locus, allele, and STR copy number information converted into a digital format. In various embodiments, the digital format may include p characters, where p is (2 q +2 r ) is an integer, where q is 5 or an integer greater than 5, and r is 0 or 1 or an integer greater than 1. In one example, p is 196. In further embodiments, the digital format may be condensed or compressed (e.g., to a smaller number of characters) using conventional algorithms. The options for taking and testing samples, and for recording, reporting, displaying and otherwise using the test results are substantially unlimited.

[0052] For example, a registered user may share their genetic identification information with a pre-approved individual or entity, or provide such information to government authorities in an emergency (e.g., by providing a decryption key to such individual, entity, or authority). For example, genetic identification information may be provided to government authorities by showing a QR code® or similar information displayed on the electronic communication device of the registrant or pre-approved individual or entity in 180. Once the genetic identification information in the blockchain ledger is encrypted, the QR code® or similar information is provided after decryption. Alternatively or in addition, genetic identification information may be shared with a pre-approved individual or entity (e.g., the registrant's emergency contact or medical representative) by sharing access information and a decryption key with that pre-approved individual or entity in 185. Typically, government authorities (e.g., police, FBI, coroner's office, etc.) would not receive authorization to use the registrant's genetic identification information for purposes unrelated to identification (e.g., in criminal investigations).

[0053] In a further example, an optional location service (which may be available at no cost to individual users or consumers) could allow registrants (e.g., users or consumers) to decide whether or not they want their location to be tracked. This can be done conventionally by apps on smartphones or similar electronic communication devices with geolocation tracking hardware and software. Many currently available apps track the device's geolocation with or without the user's permission. Combined with required and / or appropriate authorizations and / or permissions (e.g., from the registrant, optionally recorded in a blockchain entry) to share the registrant's location or enable location tracking, location tracking could allow law enforcement and / or others to determine the registrant's "last known location" if the registrant goes missing (in some cases, this could be a child).

[0054] Genetic identification information may be managed in different ways. In one example, a private authorization identification information management system can be implemented as a blockchain network that can accept and hold personal identification information and genetic identification information. Personal identification information (which can be entered by the registrant or authorized user at the time of registration in Figure 110 or 130) may include name, date of birth, place of birth, "refusal of resuscitation" instructions, organ donor information, burial or cremation instructions, etc. Therefore, the registrant's genetic identification in this invention can be used to authenticate the registrant and / or the registrant's personal identification information. Other documents such as copies of a person's birth certificate, marriage certificate, will, etc. may also be stored (for example, as one or more additional blockchain entries). After a person's death, the person's death certificate may be associated with the registration in the blockchain ledger. Stored and / or associated documents may be authenticated using the registrant's genetic identification.

[0055] In another example, a public permission identification management system (which can also be implemented as a blockchain network) may include citizen registration. Participation in the public permission identification management system is voluntary but may be encouraged through the offer of dividends or other benefits (see, for example, Figure 6 and its discussion herein). Citizen registration may include, for the purpose of facilitating statistical analysis or other further data analysis, an individual's political affiliation (e.g., voter identification), religious affiliation, one or more results of asking for a vote or an individual's opinion (e.g., voter integrity assurance, opinion voting results, etc.).

[0056] A key advantage of the present invention is that the legality of the voting rights of forensically identified individuals (e.g., via STR-ID analysis) can be easily verified. Furthermore, the authentication aspects of the present invention ensure that any opinion polls and votes conducted using genetic identification from blockchain registers to identify survey participants are unbiased and 100% certain that participants are the people they describe and are in the locations they claim to be at of their own choice. In recent years, the results of certain political votes have raised questions regarding their accuracy and the possibility of false claims.

[0057] Using blockchain-based transactions, contracts may be embedded in digital code and stored in a transparent, shared database, where they are protected from deletion, tampering, and revision. As a result, substantially all consents, processes, tasks, and payments can have digital records and signatures that can be identified, validated, stored, and shared. One aspect of the present invention involves encrypting the validation of digital code against a unique genetic DNA record that cannot be altered or replaced. Intermediaries such as lawyers, brokers, and bankers may not be required for such activities. Thus, individuals, organizations, machines, and algorithms can interact freely with each other and conduct transactions with little to no friction. These are some of the many advantages of blockchain.

[0058] Figure 3 shows a block diagram of a system and / or hardware 200 that implements a method for acquiring and providing genetic identification information according to an embodiment of the present invention. The system and / or hardware 200 comprises a DNA test kit 210, a genetic information digitization system 220, a web portal 230, and a mobile application 240.

[0059] The DNA test kit 210 may include a home test kit as described herein. Alternatively, the test kit may be a sample collection kit for commercial use (e.g., in a clinic or other healthcare service provider facility, a testing service provider facility, a forensic laboratory, etc.).

[0060] The genetic information digitization system 220 is largely conventional. An example of personal genetic identification management is shown in Figure 4, which shows a blockchain distributed ledger 329 that stores encoded data relating to the genetic identification of a registrant. The ledger 329 may be an immutable distributed ledger, and the blockchain may include, for example, a public blockchain and / or a private blockchain. In some embodiments, the storage 312 may be the same as the ledger 329. The system 220 in Figure 3 provides security and integrity for multiple records and events within the system 220, all within the parameters of a single-ledger transaction 326 on the ledger 329.

[0061] Each new record (or combination of records) of a transaction in the storage medium 312 generates a ledger transaction 326 into the ledger 329, which allows anyone to verify and validate the existence and accuracy of the data entries. One embodiment of verification includes parsing the cryptographic data 310 in combination with a digital signature for the ledger transaction 326 provided to the ledger 329. Advantageously, anyone can use the storage 312 and the ledger 329 to validate the existence of information in the ledger transaction 326 based on the cryptographic data 310. As shown in Figure 3, the identification data 310 is stored in the storage 312 and, in the meantime, divided into core data 323 and metadata 324. The metadata 324 is generally (but not always) not present in the cryptographic data 310, so the core data 323 may be equal to the cryptographic data 310. The metadata 324 may be derived from an external source (not shown) and / or determined from other variables (e.g., a timestamp). Both the core data 323 and the metadata 324 can be processed using the cryptographic function 316.

[0062] A record hash 325 is generated from the metadata 324 and core data 323. The record hash 325 is distributed to the ledger transaction 326 as additional information. In the case of a blockchain transaction, the record hash 325 is written to the "OP_RETURN" field of the ledger transaction 326. The ledger transaction 326 is broadcast across the ledger network 328. As soon as a new block (reflecting the transaction) is generated on the ledger 329, the record placed by system 220 in the ledger transaction 326 is secured within the ledger 329 itself. In other words, while the ledger transaction 326 is in a block, it is difficult or impossible to change or tamper with it, and therefore difficult or impossible to change its history. Anyone who possesses the corresponding raw data can generate the cryptographic data 310, check its existence in storage 312, and validate / verify the information using the ledger 329.

[0063] Furthermore, in some embodiments, the storage medium 312 does not maintain the data in its original or open form. In contrast, the raw data can first be processed through a cryptographic function 316, as shown in Figure 3. This is advantageous in that hashed stored data cannot be reverse-engineered back to its original form, even if a hacker gains access to the hashed data. In some embodiments, the personal genetic identification management system 220 may have at least one processor (e.g., within the registrant's electronic communication device) configured to perform cryptographic primitives on the identification information / dataset (e.g., raw data and / or cryptographic data 310).

[0064] Any input to storage 312 as described herein may be followed by the generation of one or more ledger transactions 326 created in ledger 329 as shown in Figure 4, in order to provide a fully secure and trusted method for the storage, validation and / or verification and authentication of immutable data. As used herein, the term “immutable data” refers to data that, once it occurs, can never be changed (e.g., names of biological parents, date of birth, biological sex, birth name, multiple birth status, place of birth), or data that, for example, is difficult to manipulate even for a system administrator after the data has been written to the blockchain.

[0065] Each individual user of system 220, such as a registered or authorized user, can issue a cryptographic secret key (private key, etc.), which is relatively long in some embodiments. In some embodiments, the cryptographic secret key may include Rivest-Sharmir-Adleman (RSA) keys, elliptic curve cryptography (ECC) keys, etc. A known feature of ECC is that this type of key can be divided into multiple independent parts (factors). These factors can be of any nature, such as tokens, passwords, biometric data, PIN codes, etc., but are not limited to these examples.

[0066] One common model of how blockchain works involves five fundamental principles that underpin blockchain technology. First, a distributed database is used. Each party on the blockchain has access to the entire database and its complete history. No single party controls the internal data or information. All parties can directly verify the records of their trading partners without intermediaries.

[0067] Secondly, transactions and communications are conducted via peer-to-peer transmission. In other words, communications occur directly between peers, rather than through a central node. Each node in a transaction or communication stores information and forwards it to all other nodes in that transaction or communication.

[0068] Thirdly, while transactions on the blockchain are transparent, participants are not easily identifiable (i.e., the use of pseudonyms exists). All blockchain transactions and their associated values ​​are visible to anyone with access to the system, including the blockchain. Each node or user on the blockchain has a unique 30+ alphanumeric address that identifies that node / user. Users can, at their discretion, choose to maintain anonymity or provide proof of their identity to others. Transactions occur between blockchain addresses.

[0069] Fourth, records on the blockchain are irreversible. Once a transaction is entered into the database and the account is updated, the record cannot be changed because it is linked to all transaction records that came before it (hence the term "chain"). Various computational algorithms and techniques are employed to ensure that the records in the database are permanent, chronologically ordered, and available to everyone on the network.

[0070] Fifth, blockchains utilize computational logic available within the network / system they comprise. The digital nature of a blockchain ledger means that the transactions recorded within it can be linked to computational logic and are essentially programmable. As a result, users can set up algorithms and rules that automatically trigger transactions between nodes.

[0071] Figure 5 shows a flowchart 400 of another exemplary method according to an embodiment of the present invention. Flowchart 400 is consistent with flowchart 100 in Figure 1, but may include several variations and / or details that are not present in or discussed in relation to Figure 1.

[0072] The method shown in Figure 5 begins in 410 when a user signs up, for example, on a website or using an app. Typically, signing up involves the user entering their email address or other personal communication information (e.g., mobile phone number, social media handle, or username) and optionally requesting information about the services related to the method.

[0073] In step 420, the user's basic personal information is entered (for example, in a field on a secure page of a website or in a field within an app). The entered personal information is generally a subset of the personally identifiable information (PII) in flowchart 100 of Figure 1, and may include the registrant's name, birth information, home address, mailing address, citizenship, etc., and optionally, the user's employer or affiliation with another organization. The user's basic information is then temporarily stored in a cloud data storage system in step 422.

[0074] In 430, the user decides whether or not to purchase a kit (e.g., a home test or sample collection kit) as described herein. If the user decides not to purchase a kit, in 432, the data temporarily stored in cloud storage is deleted. On the other hand, if the user purchases a kit, in 434, the kit (e.g., its serial number or other unique identifier) ​​is recorded on the blockchain register, and the user's PII and Personal Identification Number (PIN) are collected (e.g., by entering a field on a website or app). The user's PII may be selected from the Personal Identification Information in the flowchart 100 of Figure 1, other than the basic information entered in 420. The user also selects and enters a PIN, which may be n characters long, where n is 6 or a larger integer (e.g., 6, 8, etc., with the option up to 12, 16, 20, or 24). The characters may be numbers, phonetic letters, or a combination thereof, and may optionally include one or more special characters such as @, #, $, ^, &, *, punctuation marks, etc. Furthermore, after purchasing the kit, users may be reclassified as "members" or registered users.

[0075] In step 440, the member's PII and PIN are encrypted on the device on which the PII and PIN are entered. Data entered into this gene identification management system (including data entered on a user device) is encrypted using a local application on a local device (in this case, the user device) before being uploaded to the system. The algorithm used to encrypt the PII and PIN may include one or more conventional algorithms (e.g., industry standards, current best practices, etc.) such as asymmetric encryption (AE), advanced encryption standards (AES), or Blowfish, or public-key cryptography algorithms such as RSA. The encryption key is generated using symmetric encryption techniques, where the sender (e.g., user or member) creates the key and shares it with entities that need to upload data on their behalf (e.g., DNA testing facilities, individuals whose gene identification is entered and managed, etc.). For example, if a member submits their DNA sample along with the key to a lab or other testing facility in step 450, the lab / testing facility uses the key to encrypt and upload the data in step 454. In another example, when a government agency or other organization (e.g., a legal entity) uses a key to set up an account for an individual within the organization, login information is sent to the individual (member) along with the key as access. The individual (member) then uses their own original key (e.g., PIN) to accept the data into the account associated with the individual (member) at the genetic identification management service provider (i.e., at 456) (i.e., after the upload at 454 and before storage in the private blockchain ledger at 460). After acceptance at 458 (described in more detail below), the encrypted data is stored in the private blockchain register at 460. In one embodiment, the member is permitted to use the PIN only once to decrypt, and therefore accept, the DNA test data (e.g., a given one-time use of the PIN).When uploading information to an account in 460 and / or storing it in a private blockchain data storage system, the information undergoes further encryption using one or more standard blockchain hashtag algorithms.

[0076] More specifically, in 450, the user / member collects a DNA sample using the kit as described herein and sends the sample, along with their PIN, to a DNA testing facility (e.g., a laboratory). Alternatively, the kit (sample) may be physically shipped to the DNA testing facility, and the PIN may be electronically (and optionally securely) transmitted to the DNA testing facility. In 452, the DNA sample is processed in the laboratory (e.g., STR tested) as described herein to obtain a digitized version of the registered user's genetic identification information (i.e., a code based on a graph or plot of the user's repeat [STR]DNA segments at several predetermined loci). This digitized DNA data is encrypted in the laboratory in 454 using the user / member's PIN as the encryption key (e.g., using one or more AE, AES and / or RSA encryption algorithms), and then in 460, it is uploaded to a private blockchain register in a private cloud storage system. For even higher security, upon data acceptance (for example, in a private blockchain register in 460), all data may be decrypted and then re-encrypted using one or more AE or RSA algorithms.

[0077] Simultaneously or approximately simultaneously with the uploading of encrypted genetic identification information to the private blockchain register, it is also presented to members at 456 for acceptance (e.g., by sending, becoming available through a secure website or app, etc.). Members may accept the genetic identification information at 458 by decrypting the genetic identification information (e.g., using a PIN as the decryption key), viewing and confirming the acceptability of the decrypted genetic identification information (e.g., by checking a box on a secure website or app, by sending a message to a genetic identity information service provider or administrator, etc.), and re-encrypting the decrypted genetic identification information (e.g., using one or more standard and optionally embedded encryption algorithms on a secure website or app), and upload the encrypted genetic identification information to the private blockchain register at 460.

[0078] In 470, a member may share the encrypted PII data stored in 460 with a trusted individual, group, or entity, and a public key is generated on the member's device as needed (e.g., to be provided to the trusted individual, group, or entity for either single use or multiple or recursive use). In some embodiments, a user / member authorizes a specific device to receive the key (e.g., based on a random sequence of the user / member's PII / DNA). The trusted individual, group, or entity then uses the authorized device to enter a secure website (which may be the same as or different from the one used by the user to register the member) or application programmed to allow the trusted individual, group, or entity to access (e.g., decrypt) the encrypted data.

[0079] In 470, the assignment and distribution of public keys (such as those selected by the member) to trusted individuals, groups, or entities is managed, for example, using a secure website (which may be the same as or different from the one used by the user to register a member) or application. The information that the member or user uses to access the system (typically a combination of email, password, and PII multifactor authentication data determined by the system from the registrant's PII entry) is used to validate the entry to the secure website or application and authorize the generation of the public key. In one embodiment, the decryption key is generated as a seed from a unique combination of the user / member's PII and a fragment or sequence of the member's DNA (e.g., an n-character sequence generated using a random sequence of the member's DNA). One advantage of this DNA-as-seed method is that, unlike a driver's license number or passport number, the member's DNA cannot be altered. This decryption key may be similar to an authorization code sent by the owner or administrator of the secure website to authorized individuals accessing the secure website. Random sequences can be six or more bases long (e.g., eight or more, ten or more, twelve or more, etc.), and up to approximately 100 bases long. There is no technical upper limit on the number of bases in a random sequence, but typically, 50 to 60 bases or less are required or desired in the sequence.

[0080] A member or trusted individual, group, or entity then decrypts and accesses the encrypted PII (e.g., using a secure website or application and a public key) in 475. Decryption of the PII and DNA may be performed at a later date, unless trust is revoked by the registrant, and may be used to assist in establishing the deceased's identity after the registrant's death. Generally, the key for decryption is associated with the authority controlling the genetic identification information (e.g., the individual member if the individual member registers themselves, or the legal entity, government agency, bureau, or other entity if the legal entity or governmental entity registers the member). Method 400 then terminates in 480, or may return to 470 if the member wishes to generate and / or distribute another public key and authorize another trusted individual, group, or entity.

[0081] Returning to 460, the member's encrypted PII data may be segmented into a private blockchain storage system such that only a specific subset of the member's data (e.g., member's name, photograph, social security number or copy of member's social security card, completed W2 forms, signed non-disclosed and / or employment contracts, emergency contact information, shareable and / or confidential documents, e.g., intellectual property documents or trade secret information [e.g., customer lists, sales strategies, etc.], security information, e.g., permission to access specific systems, etc.) is available to a designated one of trusted individuals, groups, or entities. More sensitive data, e.g., a member's genetic identification information, may be subject to additional protection, including converting an industry-standard DNA information exchange format into a proprietary format representing the member's raw or native DNA (e.g., in a format not generally recognizable by others, such as an n-digit numeric string encoding DNA information by digits and / or positions in a string), optionally compressing the converted information, and then applying one or more industry-standard encryption algorithms to the compressed or uncompressed converted information. In some embodiments, the multilevel protection possible in Method 400 enables the generation of individualized, unique identification numbers, member QR codes®, or other identification methodologies that do not expose the actual DNA information of the members, which may be used in genetic identification information management applications.

[0082] Further embodiments of the present invention relate to a unique architecture for managing self-sovereign identity (SSI) information (e.g., when the user / registrant is an individual) and PII (e.g., when the user / registrant is an organization). As described above with respect to Method / Flow 400 in Figure 5, PII data and transaction data (e.g., relating to registration) are encrypted and stored in blocks of a private blockchain data repository. In this architecture, PII may (typically) include DNA information. Endpoint encryption (e.g., on the user's electronic communication device) may be based on a system-generated encryption key, which is generated from a unique combination of the user / member's PII and fragments or sequences of the member's DNA (e.g., n-character sequences generated as described herein), using a random sequence of the member's DNA as a seed. The system-generated encryption key may function as the member's private key.

[0083] As described above, members generate private / public security keys when creating a PII profile. These private / public security keys are used for encrypting and decrypting data in the system after the initial data upload. In some embodiments, only members may have access to the private key and use it to decrypt data stored in the blockchain ledger (e.g., through system login validation). In such embodiments, the genetic identification information management service provider does not process, hold, or have access to any unencrypted data. In other or further embodiments, members may share their public key with one or more trusted individuals (e.g., family, one or more friends) or organizations through the genetic identification information management system. The public key provides the trusted individuals or organizations with the ability to decrypt the member's genetic identification data and / or other PIIs when necessary.

[0084] To enable distinct access to general or basic PII, secure documents, and / or genetic identification information, several levels of decryption may be available in the genetic identification information management system. For example, all such information may be encrypted using conventional encryption algorithms, thus providing a first level of decryption. Certain information (e.g., secure documents and / or genetic identification information) may be compressed (e.g., before encryption), thus providing a second level of decryption to enable distinct access to such information. Furthermore, member genetic identification information may first be converted to a digital (e.g., p-character) format, as described herein, before compression and / or encryption, thus providing a third level of decryption to enable distinct access to member genetic identification information.

[0085] Real-time validation challenge tokens may be generated using decryption algorithms and segments of an encrypted DNA sequence (i.e., "seed"). The challenge tokens may include codes such as QR codes®, barcodes, or authorization codes. These tokens may be programmed to exchange, scan, type, or verbally to validate the user / member's identity based on the user / member's DNA sequence. This validation may be part of a multi-factor identification solution, as described herein.

[0086] In this way, encrypted DNA information cannot be matched against family DNA that may be accessible to others or in the public domain. Therefore, it is not possible to obtain user / member DNA information or genetic identity from information available to others.

[0087] The PII management system may allow members or users who do not provide DNA samples to replace the DNA sequence encryption / decryption seed with a numerical string representation from a facial ID scan, fingerprint scan, or other digital representation of a unique personal identifier.

[0088] In some cases, genetic identity will be requested by third-party authorities such as government agencies, corporations, or social groups. A genetic identification information management system or architecture may isolate data repositories (e.g., blockchain registers) so that individuals can hold SSIs across data that they designate as SSIs (e.g., stored in one repository or an SSI segment of a repository), and so that third-party authorities can access certain information that is shared (e.g., stored in a separate repository or a “shareable” segment of one repository).

[0089] Authorized device data and genetic identification codes (e.g., QR codes® or barcodes) may also be modified by the authorities on a real-time basis to provide validation keys that authenticate the dissemination (e.g., the "latest" status of the data) and / or validity of the genetic identification codes at the time of use. Implementations include placing or embedding genetic identification codes or other information that will be presented using electronic communication devices or on physical items such as ID badges, wallet cards, RFID tags, or wearables. Such physical items may include authorization validation codes placed on or embedded within them.

[0090] A genetic identification information management system or architecture may include an application programming interface (API) that enables the bidirectional exchange of genetic identification and other information within the management system or architecture, and available to the Authority, with the Authority's or other established information systems controlled by the Authority. The API adheres to encryption / decryption algorithms (e.g., cannot be circumvented) and allows access to and exchange of information only that the individual member / registrant is permitted to share with the Authority. In some embodiments of the bidirectional API, the Authority may have the ability to push encrypted security keys to the genetic identification information management system or architecture. This would allow the Authority to include software keys for an individual's genetic identification code (e.g., QR code®) or underlying genetic identification data, data controlled by the Authority such as stored documents, or other data that the individual does not have access to. This would be used in cases of suspected breach of login validation, such as lost / stolen devices / IDs, suspected extortion, or separation from the Authority.

[0091] A reward and data sharing process may be used to encourage participation in a public permissioned genetic identification information blockchain network. Figure 6 shows an exemplary flowchart of a reward and data sharing process 500, which begins with entering personal data at 502 and setting sharing controls for personal data at 504. These actions may also be performed during user registration 110 (Figure 1).

[0092] The reward and data sharing process 500 may share some or all of the personal data with authorized entities such as government authorities, healthcare providers, security service providers, and insurance companies in 506. The specific parties or types of parties with which the information may be shared are also defined in 506. In 520, authorization and / or permission to share personal information with other parties and / or entities is written to the blockchain ledger. Once a user / registrant provides at least some of the personal information, process 500 provides the user / registrant with a reward in 508 via the digital wallet 518. The reward may be proportional to the amount and / or type of information shared and / or the number and / or type of third parties granted access to the information.

[0093] At various points in time, process 500 may initiate a user participation event, such as a survey, shopping, or travel opportunity, in 514. When a user / registrant participates in a user participation event, process 500 provides another reward in 516. The reward may be in proportion to the amount spent and / or the total number of user participation events in which the user participated.

[0094] Rewards may be deposited into digital wallet 518 as crypto tokens, other electronic currencies, or as discounts on products or services offered by participating sellers or providers. Transactions in 506, 508, 514, and 516 are recorded on blockchain ledger 520.

[0095] Referring to Figure 7, the genetic information privacy system 600 may include an electronic communication device 602, a personal / genetic information privacy settings ledger 604, a personal / genetic information privacy regulation ledger 606, a privacy auditor 608, a website 610, an improvement action 612, a privacy remediator 614, and a browser 616. The web portal 230 (Figure 3) may include an electronic communication device 602 and a browser 616.

[0096] The Universal Privacy Settings / Opt-in / Opt-out Client ("Universal Client") enables a user to connect to an Application Programming Interface (API) for one or more different sites that hold the user's data. The Universal Client allows the user to curate the privacy settings and overall opt-in or opt-out for any site selected by the user or provided by default. This allows the user to choose to opt in or opt out entirely or partially, where the user has granular control if they wish to allow the use of some of their data and access to others, while restricting others. If a user has calibrated their privacy and data settings, the enterprise, site, or distributed application may offer incentives and motivations for the user to allow access to certain data (see the discussion in Figure 6 above). This allows the user to have simultaneous global control over their personal data, while at the same time allowing the user to receive compensation and / or services for the use of their personal data, thus enabling enterprises to have better access to data.

[0097] Users may retain global control over their personal data, while others may allow access to and / or use certain personal data of theirs by maintaining a universal profile in their personal privacy policy, which may apply to corporate privacy policies. In some cases, the system may automatically resolve inconsistencies between personal privacy policies and one or more corporate privacy policies. Common settings across sites may have a unified view, and site-specific settings may be labeled with site identifiers. This allows user data and privacy settings to maintain consistency across sites, where common data and settings are used and uniquely required by individual sites.

[0098] A user may authenticate the privacy system 600 to websites and decentralized services and authorize its access to the sites using the user's credentials. If a blockchain ID is used, the privacy system may operate similarly with respect to the user's behavior. For example, after a user installs the user portion of the system (e.g., using an electronic communication device 602), the user may use a mobile device or computer (e.g., similar to or identical to device 602) to access sites 610 or decentralized services, such as Facebook®, Steemit, or STR-ID (located in Lewis, Delaware). When a user does this for the first time, the system 600 may automatically generate a pop-up window or notification prompting the user for their settings, and the system may be automatically configured based on the user's online behavior. This allows for greater freedom of the user to use the software that is most efficient for their purposes, as the user is not forced to access sites 610 through the system 600, and the system 600 runs in parallel with or within the user's browser 616. System 600 runs in the background (like a daemon) and may discreetly monitor Site 610.

[0099] System 600 may then verify that the user has previously accessed Site 610 or a decentralized service containing the user's personal data. System 600 may query how the user wishes to have their data managed on Site 610. System 600 may also allow the user to configure while System 600 is running. For example, System 600 may allow the user to toggle the system off and on, or allow the user to configure specific instances or sites that should be explicitly included or excluded (i.e., “whitelisted” or “blacklisted”), or allow the user to “defer” protection if desired.

[0100] If Site 610 or a decentralized service is accessed in the future, System 600 will enforce the privacy settings in Ledger 604 through the browser 616 or interface used to access Site 610. Otherwise, Site 610 may automatically (re)configure the user's profile. For example, a user's Facebook® profile may be automatically configured to reflect the user's preferences regarding the Facebook® website (or decentralized service).

[0101] System 600 may synchronize with privacy settings in the Personal / Genetic Information Privacy Settings Ledger 604 that users have manually modified to resolve inconsistencies and / or approve. When System 600 connects to the privacy settings or opt-in / opt-out settings of Site 610 or a decentralized service, System 600 may evaluate such settings to see if any changes have been made. System 600 may access Site 610 or a decentralized service through an API or more directly through “web scraping,” and may use the user’s ID and other personal information (e.g., in Ledger 604) to gain access. System 600 may use intermediaries to parse the settings and perform manual translations until System 600 can gain access to Site 610. System 600 may be configured in accordance with national privacy laws (e.g., recorded in Personal / Genetic Information Privacy Regulations Ledger 606) and may monitor information on websites and decentralized services to comply with both the user’s settings and the privacy laws of their jurisdiction.

[0102] In system 600, the privacy auditor 608 may scan the website 610 for the user's personal information. For example, the privacy auditor 608 may configure the browser 616 using a concept filter (not shown), and the browser 616 may then analyze data on site 610. The browser 616 may then detect information on site 610 that does not match the personal privacy settings ledger 616 and / or the personal privacy regulation ledger 606. The browser 616 may then notify the privacy auditor 608, and the privacy auditor 608 may then notify the privacy remediator 614. An alert generator (e.g., in device 602 and / or browser 616) receives the notification and generates an improvement action 612. The improvement action 612 may include, for example, accessing and correcting inconsistent data on site 610 (e.g., via an API), or completing a suspension notice form and submitting it to site 610 or the host and / or owner of the decentralized service. Browser 616 may monitor and “crawl” websites for registrants’ personal information and may access and monitor personal information on decentralized applications such as blockchain-based decentralized services, sites, and applications.

[0103] Figure 8 shows an exemplary distributed blockchain storage network 700 comprising a computing device 710 that stores a personal / genetic information ledger 704 (e.g., similar to or identical to ledger 520 in Figure 6), a computing device 712 that stores blockchain smart contracts 708, a computing device 714 that stores regulations 706 (e.g., in the form of a personal / genetic information privacy regulation ledger), a computing device 716 that stores one or more licenses 702, an authenticator 730, and multiple transactions 718, 720, 722, and 724 in blockchain 726. Computing device 710 transmits the personal information ledger 704 to blockchain 726 (if necessary) and vice versa. Computing device 712 transmits the blockchain smart contract 708 to blockchain 726 (if necessary) via authenticator 730 and vice versa.

[0104] Computing device 714 records regulation 706 on blockchain 726, and computing device 716 records license 702 on blockchain 726. License 702 may include any licenses or third-party permissions necessary to share certain personal information, such as driver's license information, passport information, professional licenses, etc., and / or the registrant's genetic identification information and / or other personal information with others. License 702, regulation 706, blockchain smart contract 708, and personal information ledger 704 may be recorded on blockchain 726 as transactions 718, 720, 722, and 724, respectively. Blockchain 726 may be distributed on or among computing devices 710, 712, 714, and 716. Exemplary System

[0105] Similar to this method, the system may be divided into two parts or sections: a gene testing part or section and a digitization / identification information management part or section. Referring back to Figure 3, as described herein, the gene testing part or section of the exemplary system 200 comprises one or more DNA (e.g., STR) test kits 210, and the digitization / identification information management part or section of the exemplary system 200 comprises a DNA or gene information digitization system 220, a web portal 230, and a mobile application 240.

[0106] In one example, DNA testing kit 210 may include a DNA home sample collection kit. DNA home sample collection kits may be commercially available from companies that manufacture STR analysis kits, such as Thermo Fisher, Promega, and Qiagen, but can also be easily assembled. A typical kit 210 includes a tube or sample cup with a cap or lid for collecting DNA samples, and detailed instructions for the user to properly collect the samples and return them to a testing facility (e.g., an analysis lab). Detailed procedures for forensic DNA sample collection are well known and widely available (see, for example, Tan, E. "Sample Collection System for DNA Analysis of Forensic Evidence: Towards Practical, Fully-Integrated STR Analysis," NIJ Award 2008-DN-BX-K010, Document No. 236826, December 2011, National Criminal Justice Reference Service, Rockville, MD; http: / / www.geneticprofiles.com / procedure / ; and https: / / blog.puritanmedproducts.com / how-to-collect-dna-evidence). Optionally, Kit 210 includes cotton swabs (e.g., for obtaining saliva samples from inside the registrant's mouth or mucus samples from inside the registrant's nose) or absorbent paper or cotton pads (e.g., for absorbing blood samples after pricking the registrant's fingertip, heel, etc. with a pin or needle). Kit 210 typically includes an envelope or box for shipping samples to a laboratory or testing facility for analysis, and a container (e.g., a box or envelope) in which all kit components are placed.

[0107] Alternatively or in addition, the test kit 210 may include commercially available STR analysis kits for use in a testing facility or analytical laboratory, such as those available from Thermo Fisher, Promega Corporation, Qiagen, etc., as described herein with respect to the STR analysis 150 in Figure 1. However, STR analysis kits are not intended for home use and typically do not include components for sample collection.

[0108] The mobile application 240 may be installed on an electronic communication device 800 (Figure 9), such as a smartphone 810. In Figure 9, the smartphone 810 displays personal information 830 and a genetic identifier 824 on its screen 820, which are accessed through a secure application or website 822. The personal information 830 is the personal information of the registrant and may include, among other things, the registrant's name, residential address, date of birth, social security number or other government-issued identifier, driver's license number and other information associated with the registrant's driver's license, and / or passport number and other information associated with the registrant's passport, as described herein. The genetic identifier 824 may be in the form of a QR code (registered trademark) (as shown), but may take other electronically readable or scannable forms as described herein. In some embodiments, to further facilitate the identification of the registrant, the genetic identifier 824 (or, if desired, the personal information 830) may further include a photograph 826 of the registrant. The smartphone 810 may further include features such as an on / off button or switch 812 and an application close / switch and / or screen change button 814.

[0109] The web portal 230 may be included on a web page (e.g., 610, Figure 7) accessible through a browser (e.g., 616). For example, registration may be performed using the web portal 230, which can be accessed by a smartphone 810 or on an alternative electronic communication device 900 as shown in Figure 10. The electronic communication device 900 may take the form of a personal computer, workstation, tablet computer, personal digital assistant, etc.

[0110] Figure 10 shows the basic architecture of an electronic communication device 900 comprising components such as one or more human input devices 910, a central processing unit (CPU) 920, a network interface 930, an output and / or display device 940, main memory 950, cache memory and / or random access memory (RAM) 955, one or more peripheral devices 960, and read-only memory (ROM) 970. These components communicate with each other via one or more buses 905. The architecture of the electronic communication device 900 is largely conventional.

[0111] For example, the human input device 910 may include a keyboard (e.g., a standalone or virtual keyboard), a mouse, a microphone (stored in main memory 950 and functioning with speech recognition software executed by the CPU 920), a fingerprint reader, a facial recognition system, etc. The network interface 930 may enable communication between the electronic communication device 900 and a home network, intranet, data and / or voice network and / or the internet, and may be wired or wireless. The output and / or display device 940 may include a monitor, a display screen, a television, one or more speakers, etc. The main memory 950 may include a magnetic or non-volatile (e.g., flash) hard drive configured to store software programs, data, user preferences, etc. The cache memory and / or random access memory (RAM) 955 may temporarily store recently used programs, program routines or subroutines, data, etc., for easier use of such data, programs and (sub)routines. Peripheral devices 960 may include devices such as printers, external memory, speakers, wireless receivers (from other devices such as keyboards, mice, etc.), cameras, smartphones, or tablet computers. Read-only memory (ROM) 970 may store information and programs that are generally not erasable or reprogrammable, such as device booting or startup information, disk operating system (DOS) software, and device configuration settings.

[0112] The present invention may be implemented in any of the various different types of blockchain networks. In particular, the system may be implemented using public blockchain networks, private blockchain networks, permissioned blockchain networks, consortium blockchains, or a combination thereof. Examples of such blockchain networks and the functions and transactions they perform are shown in Figures 5 to 8 and discussed in some detail above.

[0113] A private blockchain network, like a public blockchain network, is a decentralized peer-to-peer network, except that one organization controls the network. (In a public blockchain network, no single organization or entity controls the network.) The organization controlling the private blockchain network controls who receives permission to join the network, runs the consensus protocol, and maintains the shared ledger. Alternatively, the organization controlling the private blockchain network may also control who runs the consensus protocol and maintains the shared ledger. Depending on the use case, this can significantly increase trust and confidence among participants. A private blockchain can run behind a firewall and be hosted on-premises.

[0114] Businesses that set up private blockchains often set up permissioned blockchain networks. Public blockchain networks can also be permissioned blockchain networks. This can impose restrictions on (1) who can participate in the network and (2) which transactions certain participants can participate in. Participants need to obtain an invitation or permission to participate in the permissioned blockchain network.

[0115] Multiple organizations can share the role of maintaining the blockchain. These organizations (which may be pre-selected) determine who can submit transactions or access data stored in the ledger. A consortium blockchain network is ideal when all participants need to be authorized and have a shared role in the blockchain.

[0116] The above description of specific embodiments of the present invention is presented for illustrative and explanatory purposes only. It is not intended to be exhaustive or to limit the invention to any specific form disclosed, and many modifications and variations are clearly possible in light of the above teachings. The embodiments have been selected and described in order to best illustrate the principles and practical applications of the present invention, thereby enabling those skilled in the art to best utilize the invention and its various embodiments, along with various modifications suitable for a particular intended use. The scope of the present invention is intended to be defined by the claims and equivalents appended herein.

Claims

1. a) The computer receives the registered user's personal information provided to the secure website by the first electronic communication device; b) A step in which a computer analyzes the short tandem repeat (STR) regions of the gene material at multiple loci in a gene material-containing sample taken from the registrant and provided to a gene material analysis facility, thereby generating the registrant's genetic identity; c) The computer encrypts the personal information and the genetic identity; d) The computer records the encrypted personal information and the encrypted genetic identity in a blockchain ledger; e) The computer enables the registrant to display a code corresponding to the encrypted genetic identity on a second electronic communication device, wherein the first electronic communication device and the second electronic communication device are the same device or different devices; and f) A computer uses the code to authenticate the personal information or the identity of the registrant on a third electronic communication device, wherein the third electronic communication device is configured to access the code from the blockchain ledger. A method for acquiring and controlling genetic identification information, comprising:

2. The method according to claim 1, wherein the personal information includes at least two of the following: the name of the registrant, the address, an identification number issued by the government, and a photograph.

3. The method according to claim 1 or 2, further comprising the step of a computer registering the registrant for a service including STR region analysis, recording of personal information and genetic identity, and making the genetic identity code displayable.

4. The method according to any one of claims 1 to 3, wherein the first electronic communication device and the second electronic communication device are independently selected from a smartphone, a personal computer, a tablet computer, and a workstation.

5. The collection of the gene material-containing sample from the registrant comprises collecting the registrant's saliva in a vial or tube, collecting it with a cotton swab from the inside of the registrant's mouth or nose, or puncturing the registrant's skin and collecting one or more droplets of the registrant's blood on a cotton swab or absorbent paper. The method according to any one of claims 1 to 4, further comprising the steps of (i) the registrant certifying or confirming that the registrant has collected the sample containing the gene material, or (ii) the third party certifying or confirming that the third party has the authority to collect the sample containing the gene material from the registrant.

6. The method according to any one of claims 1 to 5, wherein the sample containing the gene material is provided to the gene material analysis facility using an envelope, sleeve, tube, or box.

7. The method according to any one of claims 1 to 6, wherein the analysis of the STR region of the gene material comprises the steps of extracting DNA from the gene material, amplifying the DNA at a plurality of STR loci, isolating and sizing the amplified STR alleles, and interpreting the profiles of the isolated and sized STR alleles.

8. The method according to any one of claims 1 to 7, further comprising the step of enabling the registrant to access entries in the blockchain ledger, including the encrypted personal information and the encrypted genetic identity.

9. The method according to any one of claims 1 to 8, further comprising the step of enabling the registrant to authorize a third party to access the code on the third electronic communication device, wherein the third electronic communication device is identical, the same as, or different from one or both of the first electronic communication device and the second electronic communication device.

10. The method according to any one of claims 1 to 9, further comprising the step of a computer accessing the code using one of the first electronic communication device and the second electronic communication device.

11. The method according to any one of claims 1 to 10, wherein only the registrant and users authorized by the registrant can decrypt the encrypted genetic identity.

12. The method according to any one of claims 1 to 11, wherein the personal information includes at least one item of immutable data selected from the names of the registrant's biological parents, the registrant's date of birth, the registrant's biological sex, the registrant's birth name, the registrant's status as a multiple birth, and the registrant's place of birth.

13. a) Genetic material sampling kit, the genetic material sampling kit is: i) A sealable container configured to resealably store a sample containing the registrant's genetic material, ii) Instructions for taking the sample from the registered person and placing the sample in the sealable container, and iii) A pre-addressed envelope or box for sending the sample in the sealable container to a genetic material analysis facility. Yes: b) Short Tandem Repeat (STR) analysis kit, the STR analysis kit is: i) Multiple primers for copying the STR region of the gene material at multiple gene loci, and ii) A mixture containing gene polymerase, buffer, and dNTPs necessary for amplifying the STR region, comparing the amplified STR region with similar gene identification information, and generating the registrant's genetic identity. Having; c) A first electronic communication device configured to input the personal information of the registered person into a secure website; and d) A second electronic communication device configured to record the personal information and the genetic identity on a blockchain ledger; and e) A third electronic communication device configured to access and display the code corresponding to the genetic identity. A system comprising, wherein the second electronic communication device is different from the first electronic communication device and the third electronic communication device, the first electronic communication device and the third electronic communication device are the same electronic communication device or different electronic communication devices, the personal information and the genetic identity are encrypted before being registered in the blockchain ledger, and the code is a system for acquiring and controlling genetic identification information that authenticates the personal information or the identity of the registrant.

14. The system according to claim 13, wherein the sealable container includes a sealable plastic bag, or a vial or tube, and a cap or lid is configured to seal an opening in the vial or tube.

15. The system according to claim 13 or 14, wherein the STR analysis kit further comprises a gel electrophoresis cassette or tray and gel, or a capillary electrophoresis capillary, configured to separate the amplified STR regions by size.

16. The system according to any one of claims 13 to 15, wherein the primer includes a fluorescent or luminescent label.

17. The system according to any one of claims 13 to 16, further comprising a gene analyzer.

18. The system according to any one of claims 13 to 17, wherein the first electronic communication device includes a personal computer or a smartphone.

19. The system according to any one of claims 13 to 18, wherein the second electronic communication device includes a personal computer, a workstation, or a server.

20. The system according to any one of claims 13 to 19, wherein the personal information includes at least one item of immutable data selected from the names of the registrant's biological parents, the registrant's date of birth, the registrant's biological sex, the registrant's birth name, the registrant's status as a multiple birth, and the registrant's place of birth.

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