TWI845966B - System and method for digital health information verification - Google Patents

Abstract

The present invention provides a digital health information verification system for facilitating a holder to obtain a verification from a verifier, comprising a sever side storing a digital health information or certificate of the holder, and a first software product for the verifier’s use. The server side uses a private key to sign and encrypt the digital health information or certificate and provides it to the holder. The first software product reads the signed and encrypted digital health information or certificate presented by the holder and uses a public key to verify and decrypt said digital health information or certificate.

Description

Digital health information verification system and method

The present invention relates to a digital health information verification system and related operating methods.

Digital innovation and transformation are driving disruptive development in all walks of life with rapid momentum, and the pace of smart healthcare is no less impressive. From the pace of medical innovation in European and American countries, the promotion of digital medical data exchange platforms has always been the focus of attention from all walks of life.

On March 9, 2020, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Health Information Technology Coordinator (ONC), both under the U.S. Department of Health and Human Services (HHS), announced new regulations requiring all health insurance contracted medical institutions in the United States to adopt the next-generation international medical data exchange standard Fast Healthcare Interoperability Resource (Fast Healthcare Interoperability Resource) from January 1, 2021. The FHIR standard will be used to strengthen data interoperability and will be enforced by July 1, 2021 at the latest. The scope not only covers medical institutions, medical records, admission and discharge records, and referral records, but also includes data interoperability between insurance institutions, in order to accelerate the promotion of standard interoperability and data exchange in the entire medical ecosystem.

With the rapid development of foreign regulations, the issue of using FHIR as a medical data exchange platform has gradually been taken seriously by domestic competent authorities and major medical institutions, and they are actively promoting its implementation in collaboration with various industries, governments, and academia.

In particular, in response to the COVID-19 pandemic, Taiwan urgently needs to establish an internationally interactive and authentic information exchange platform for medical treatment, entry and exit control, and epidemic prevention.

In the post-pandemic era, safe travel, dining, and business involve multiple stakeholders in different countries using a range of technologies. The main challenges include: (1) The authenticity of health certificates is unproven: there is no standardized way to receive and verify certificates, especially whether the infected person has returned to a "normal" level; (2) Different technologies and international standards are adopted: a wide range of data formats based on different underlying technologies and standards; and (3) Different epidemic prevention requirements: each country has its own requirements, which change from time to time according to the changes in the epidemic.

On the one hand, the present invention provides a digital health information verification system for facilitating a certificate holder to obtain verification from a verifier, the digital health information verification system comprising: a server side storing a digital health certificate of the certificate holder; and a first software product for use by the verifier; wherein: the server side uses a private key to sign and encrypt the digital health information or certificate, and provides the signed and encrypted digital health information or certificate to the certificate holder via a communication method; the first software product reads the signed and encrypted digital health information or certificate presented by the certificate holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate.

According to some specific embodiments of the present invention, the server is connected to a medical information system, and the digital health information or certificate comes from the medical information system.

According to some specific embodiments of the present invention, the digital health information verification system further includes: a second software product installed on a mobile device held by the certificate holder and used to display the signed and encrypted digital health information or certificate.

According to some specific embodiments of the present invention, the signed and encrypted digital health information or certificate includes a two-dimensional barcode.

According to some specific embodiments of the present invention, the digital health information includes the holder's vaccination record, screening record, medical record, medication record, medical history, or any combination of the foregoing.

On the other hand, the present invention provides a method for facilitating a certificate holder to obtain verification from a verifier, which comprises: providing a server side storing digital health information or certificate of the certificate holder; providing a first software product for use by the verifier; the server side uses a private key to sign and encrypt the digital health information or certificate, and provides the signed and encrypted digital health information or certificate to the certificate holder via a communication method; and the first software product reads the signed and encrypted digital health information or certificate presented by the certificate holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate.

According to some specific embodiments of the present invention, the server is connected to a medical information system, and the digital health information or certificate comes from the medical information system.

According to some specific embodiments of the present invention, the method further includes: providing a second software product, which is installed on a mobile device held by the certificate holder and is used to display the signed and encrypted digital health information or certificate.

According to some specific embodiments of the present invention, the signed and encrypted digital health information or certificate includes a two-dimensional barcode.

According to some specific embodiments of the present invention, the digital health information or certificate includes the holder's vaccination record, screening record, medical record, medication record, medical history, or any combination of the foregoing.

According to a specific embodiment of the present invention, the digital health information or certificate includes a COVID-19 vaccination record, a rapid screening result record, and a polymerase chain reaction (PCR) nucleic acid test result record.

According to a specific embodiment of the present invention, the digital health information includes children's vaccination records, that is, a digital children's health handbook is provided.

Other purposes and advantages of the present invention are partially described in the following description, or can be understood through the embodiments of the present invention. It should be understood that the invention content of the foregoing text and the following embodiments are only exemplary and explanatory descriptions, and do not limit the present invention as the scope of the patent application.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

The terms "a" or "an" as used herein, unless otherwise specified, refer to a quantity of at least one (one or more than one).

As used herein, "comprise" or "comprising" is generally used in the sense of include/including, which indicates that one or more features, ingredients or components are allowed to be present. "Comprise" or "comprising" encompasses the terms "consists of" or "consisting of".

The present invention provides a digital health information verification system for facilitating a certificate holder to obtain verification from a verification party, the digital health information verification system comprising: A server end storing a digital health information or certificate of the certificate holder; and A first software product for use by the verification party; Wherein: The server end uses a private key to sign and encrypt the digital health information, and provides the signed and encrypted digital health information or certificate to the certificate holder through a communication method; and The first software product reads the signed and encrypted digital health information or certificate presented by the certificate holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate.

In addition, the present invention also provides a method for facilitating a certificate holder to obtain verification from a verification party. The method comprises the following steps: Providing a server end storing a digital health information or certificate of the certificate holder; providing a first software product for use by the verification party; The server end uses a private key to sign and encrypt the digital health information or certificate, and provides the signed and encrypted digital health information or certificate to the certificate holder through a communication method; and The first software product reads the signed and encrypted digital health information presented by the certificate holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate.

According to some specific embodiments of the present invention, the server is connected to a medical information system (HIS). The digital health information or relevant data in the certificate may come from the medical information system. Generally speaking, the medical information system stores medical records (structured electronic medical records) and, for example, vaccination records.

According to a specific embodiment of the present invention, the digital health information includes a COVID-19 vaccination record and a polymerase chain reaction (PCR) nucleic acid test result, wherein the vaccination record corresponds to an existing paper yellow card.

According to a specific embodiment of the present invention, the digital health information includes children's vaccination records, wherein the vaccination records correspond to the children's health handbook, that is, a digital children's health handbook is provided.

The "communication connection" mentioned in this article includes but is not limited to connection via the Internet.

The server side may be provided with one or more servers, and generally speaking, the server side is owned by a certificate issuer, which may be a medical institution or a health department. If the server side includes a plurality of servers, the servers may be electrically connected in pairs or to each other. According to the present invention, various records and information on the medical information system may be uploaded to the server side, integrated into the data format of Fast Healthcare Interoperability Resources (FHIR), and stored in one or more servers of the server side.

In the conception of the present invention, a management agency may be responsible for authorizing the issuing party (medical institution or health department) and controlling the presentation of health information or certificate types provided by the system (e.g., the structure of a test certificate, vaccination record or certificate, or other). The management agency may be a country's Ministry of Health and Welfare, a local or national government, or other higher-level medical and health management agency. In some application scenarios, the verifier (e.g., a merchant, an entry-exit management agency, and its verifier) needs to obtain permission from the management agency before using the system.

The issuer may be an entity authorized by a health information or certificate management agency to issue a specific type of health information certificate. The types may include, for example, vaccination certificates, COVID-19 PCR test certificates, COVID-19 recovery certificates, treatment records and sequelae records, etc. The issuer may be a medical representative (e.g., a doctor) of a hospital, screening and vaccination center, pharmacy, and similar healthcare providers.

In some preferred specific embodiments, the digital health information verification system of the present invention may further include a second software product. The second software product is suitable for installation on a mobile device and is used to display the signed and encrypted digital health information or certificate. The holder may install the second software product on his/her mobile device, and when the verifier needs to conduct relevant inspection and verification, the holder may present the digital health information or certificate displayed by the second software product on the screen of the mobile device for the verifier's device/software to read and verify the digital health information or certificate.

Preferably, the signed and encrypted digital health information or certificate as described above may contain a two-dimensional barcode, which includes but is not limited to a QR code.

Non-limiting examples of the mobile device include smart watches, smart phones, and tablet computers.

In one example, the certificate holder presents the QR code displayed by the second software product on the smartphone (the digital health information or certificate that has been signed and encrypted, signed and encrypted by the server with a private key). The verifier can then use the smartphone with the first software product installed to scan the QR code (to read the digital health information or certificate). The first software product then uses the corresponding public key to decrypt and verify its authenticity, and can obtain the digital health information or certificate.

According to some specific embodiments of the present invention, the second software product can provide a user interface through a mobile device for the certificate holder to perform related operations and present digital health information or certificates. The digital health information or certificate displayed on the user interface may include a QR code and an identification color. In one example, green means safe (e.g., complete vaccination or negative screening result), while red means doubtful (e.g., incomplete vaccination or positive screening result).

The first software product and the second software product are preferably mobile software (App), but are not limited thereto. For example, the first software product and/or the second software product may also be software applicable to a desktop computer or a laptop computer.

Preferably, the private key and its corresponding public key are issued by a trusted registry. More specifically, the private key and its corresponding public key are issued by one or more servers of the trusted registry. The trusted registry may be composed of one or more certificate management centers or institutions (certificate authority), whose role is to maintain and provide public key metadata of the issuer (server side) upon request, as well as health information or certificate revocation information that is critical to the secure verification of vaccination certificates. The trusted registry may maintain a trusted registry that stores metadata related to the issuer and digital health information or certificate revocation. A trusted registrar performs the following functions after receiving a request with appropriate authorization: Issuer (server) joins, updates the public information of authorized issuers by creating digital certificates for authorized issuers; provides public information related to issuers; sets and updates the health information or certificate revocation list (CRL) of authorized issuers, provides CRLs for specific issuers, and sets and updates authorized health information certificate types.

In a specific embodiment, the digital health information verification system of the present invention may further include one or more servers of a trusted registrant, which are respectively communicated with the server side of the digital health information verification system and the first software product, for example, via an Internet connection.

The server of the issuing party may use a private key to sign and encrypt the digital health information or certificate, and provide the signed and encrypted digital health information or certificate to the corresponding certificate holder through a communication method. As mentioned above, the private key may be issued by a trusted registrant. The communication method for providing digital health information or certificates includes but is not limited to: email, mobile phone text message or through an App on a mobile device (for example, provided through a second software product).

According to the present invention, the digital health information or certificate may be the holder's vaccination record, screening record for a specific disease (e.g., PCR test record for COVID-19), medical record, medication record, medical history, or any combination of two or more of the aforementioned data.

According to a specific embodiment of the present invention, the digital health information includes a record of vaccination for severe specific pneumonia (Covid-19) issued by a credible medical unit, a record of rapid screening results, and a record of polymerase chain reaction (PCR) nucleic acid test results.

According to a specific embodiment of the present invention, the digital health information or certificate is a record of infant or child vaccination. The vaccination may include hepatitis B vaccine, five-in-one vaccine, BCG vaccine, influenza vaccine, and varicella vaccine, etc. For example, the current child vaccination schedule of the Centers for Disease Control, Ministry of Health and Welfare can be found on the website (https://www.cdc.gov.tw/Category/List/IpWZqtnmkJfQPfgnaP4lnw).

On the other hand, the present invention provides a digital health information verification system, especially for the current severe special pneumonia epidemic prevention needs, which includes the preservation and exchange of digital data such as vaccination records, screening records, and medical records, which can be expanded to various vaccine and user health data exchange platforms, and even connected with the international. Specifically, the present invention provides a digital health information verification system, including user data, medical records, vaccination records, screening records, query modules, data exchange modules, databases, and big data analysis center systems.

On the other hand, the present invention provides a digital health information verification system, comprising a server, a mobile device, a terminal and a database; wherein the terminal uploads user data, medical records, vaccination records, screening records, etc. to the server, which are integrated and stored in the database, and a query request is made through the mobile device interface, and the query module performs the query and the query result is returned to the mobile device, and the uploaded data is exchanged with an international vaccine passport system through the data exchange module, and the data can be analyzed by a big data analysis center.

According to some specific embodiments of the present invention, the digital data of the digital health information verification system can be stored and exchanged. According to some specific embodiments of the present invention, the user (certificate holder) uses the line to download the App interface operation to the device. According to some specific embodiments of the present invention, the result of the vaccination record query can be color-coded to indicate whether it meets the standards. According to some specific embodiments of the present invention, the digital health information verification system can further include screening records of infection, including rapid screening records and polymerase chain reaction (PCR) nucleic acid test result records. According to some specific embodiments of the present invention, the system may include the user's vaccination record, screening record, medical record, medication record and medical history treatment record, medication record or medical history as needed. According to some specific embodiments of the present invention, the system may further include the user's footprint record. According to some specific embodiments of the present invention, the system may further include the user's physical contact record.

According to the present invention, in order to meet the need for Taiwanese to present COVID-19 vaccination record cards when traveling abroad in the future, the existing technical framework is combined with the COVID-19 vaccination record platform in HIS, the international medical data exchange standard FHIR technology and other innovative technologies, and even the use of secure blockchain technology records to establish the first health information verification system for traveling abroad. It can be used as a vaccine passport App, and its application scenarios include three test scenarios such as the hospital side, the user side, and the inspection side. The App can also be integrated into the hospital's appointment registration App to provide citizens with proof of COVID-19 vaccination records. Or it can be combined with various health bureaus, medical institutions and health insurance data to provide a digital child health handbook.

A specific implementation example of the digital health information verification system of the present invention is described below with reference to FIG1 .

As shown in FIG1 , the digital health information verification system for facilitating the holder to obtain verification from the verifier includes: a server 100, a first software product 200, and a second software product 300. The server 100, which belongs to the issuing party, is composed of a plurality of servers electrically connected to each other (directly or indirectly), and stores the digital health information or certificate of the holder, whose data comes from the issuing party (e.g., a medical institution or health department). The first software product 200 is for use by the verifier and is connected to the server 400 of the trusted registrant. The second software product 300 is installed on the mobile device held by the holder (not shown in the figure). The server end 100 is connected to the second software product 300 and the server 400 of the trusted registrant for communication.

The server 100 obtains a private key from a trusted registrant's server 400 and uses the private key to sign and encrypt the digital health information or certificate of the certificate holder. Then, the server 100 provides the signed and encrypted digital health information or certificate to the certificate holder through the second software product 300.

When necessary, the certificate holder can use his mobile device to operate on the user interface of the second software product 300 to show the digital health information or certificate, which includes a QR code, to the verification personnel of the verification party. The verification personnel of the verification party can use a scanning device or a mobile device with a camera function to scan the QR code so that the first software product 200 can read the signed and encrypted digital health information or certificate. In addition, the first software product 200 obtains the public key corresponding to the above-mentioned private key from the server 400 of the trusted registrant, and uses the public key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the digital health information or certificate.

A specific implementation example of the method of the present invention for facilitating a certificate holder to obtain certification by a certifying party is described below with reference to FIG. 2 .

First, a server and a first software product are provided. The server stores the digital health information or certificate of the certificate holder, and the first software product is used by the verification party for verification (step S110).

The server side owned by the certificate issuer may be composed of multiple servers that are electrically connected to each other (directly or indirectly), and the digital health information or certificates stored therein are from the certificate issuer (e.g., a medical institution or health department). The first software product communicates with the server of the trusted registrant. A second software product may also be provided and installed on the mobile device held by the certificate holder. The server side communicates with the second software product and the server of the trusted registrant respectively.

After the server obtains the private key from the trusted registrant's server, it can use the private key to sign and encrypt the digital health information or certificate, and provide the signed and encrypted digital health information or certificate to the certificate holder via a communication method (through the second software product) (step S120).

Next, the verifier may request the certificate holder to provide digital health information or certificate, and use the first software product to read the digital health information or certificate presented by the certificate holder, and use the public key corresponding to the private key (obtained from a trusted registrant) to decrypt it to verify its authenticity and obtain the content of the digital health information or certificate (step S130).

Example 1: COVID-19 digital vaccination record certificate

The roles involved in the digital health information verification system may include the holder, the trusted registrant (e.g., the certification authority (CA)) and the verifier. In this example, the sequence of related operations or actions is as follows: 1.       CA: processes the Issuer's private key and public key and stores the whitelist; 2.       The Verifier requests and updates the public key list from the CA every 24 hours to verify the certificate of the digital vaccination record offline; 3.       The holder presents the certificate of the digital vaccination record for the Verifier to scan and verify the content; 4.       Verifier According to the signature logic of the issuer of the digital vaccination record certificate, the data package (Payload) is identified. If the identification is successful, the basic personal information, injection record, and screening record of the holder of the digital vaccination record (Holder) can be checked; and 5.       For the sake of caution, the holder can be asked to show his personal identity document to double-check the personal information identified by the digital vaccination record certificate.

The holder can download and install the vaccine passport application (App) (second software product). At the same time, the holder's vaccination records will also enter the FHIR server from the HIS system through the data standardization API. At this time, the passport app of the digital health information verification system on the holder's mobile phone will use the FHIR API to present the relevant data on the mobile phone interface. At this time, the digitized COVID-19 vaccination record card data will be presented in the form of a QR code on the mobile app interface. Users can scan and authenticate the QR code to present the vaccination record information and approve entry and exit of controlled places.

As shown in Figure 3A, the Vaccine Passport App (second software product) can display the holder's information and vaccination records, and further click on the record of each vaccination to display detailed information (see Figure 3B). In addition, the Vaccine Passport App (second software product) can also include screening records, as shown in Figure 4.

The digital vaccination record certificate issued by the issuer (Issuer) (medical institution, health department) is stored in the database (server side) in the FHIR data format, and will be integrated and used across medical institutions, international medical information exchange, and medical information application platforms in the future. First, the FHIR file is packaged in concise binary representation (CBOR), and then the CA (PKI) certificate center provides the X509 certificate private key to sign and encrypt the CBOR object (COSE) to generate a COSE file. Use Zlib to compress the COSE file, and then convert the compressed data to Base45 format to generate the QR code of the digital vaccination certificate. The QR code of this digital vaccination certificate cannot be recognized by ordinary QR scanners. You need to use this platform verification application (Verifier App) to identify the authenticity and verify the content. The Verifier App updates the public key list to the CA (PKI) certificate center every day, and can verify the digital vaccination certificate held by the holder offline.

The front end of the Verifier App (the first software product) provides the function of scanning and verifying digital vaccine certificates. It scans the base45-encoded QR code, extracts the COSE signature, and decodes the CBOR back to JSON format. The COSE signature is then verified using the public key provided by the CA (PKI) certificate center, and the CBOR content is verified. All scanned or processed digital vaccine certificates will not be stored on the Verifier device. In the standard verification workflow, only minimal messages will be displayed to users of the Verifier App (the first software product). In the case of successful verification, the message should be limited to indicating that the authenticity and validity have been successfully verified (indicated in green), and displaying the certificate holder's minimal personal information, as well as information on vaccination and testing certificates. If the verification fails (indicated by red), the Verifier App (First Software Product) only displays the reason for the failure.

Digital health information in the system of the present invention can reimagine how health information data is exchanged between people through a decentralized identity architecture based on w3c open standards. Unlike traditional data exchange (individuals provide information that they agree to share, but their personal information is fundamentally excluded from the data exchange), a decentralized identity architecture allows individuals to become active participants, allowing them to control their own data and let the agency choose how the data is exchanged. Decentralized identity allows organizations to issue verifiable data to individuals, who can share that data or a subset, and the validity can be verified by the receiving organization. Trust in the exchanged data can be achieved through a decentralized ledger through strict management practices and signature verification.

With the full implementation of the COVID-19 vaccine in the country, after the phased lifting of lockdowns between countries in the foreseeable future, many people may need to prove their health status or vaccination records, or before going abroad for business or travel, when returning to school, workplace, flying, entering the country, or reducing the need for isolation time, they can use the health passport system of the present invention to present their digital vaccination records or screening results. The health passport system of the present invention can play its role in providing a convenient verification method.

100: Server side 200: First software product 300: Second software product 400: Trusted registrant S110~S130: Steps

FIG1 is a system architecture diagram illustrating a specific implementation example of the digital health information verification system of the present invention.

FIG. 2 is a flow chart showing a specific embodiment of the method for facilitating a certificate holder to obtain certification from a certifying party according to the present invention.

FIG3A is a schematic diagram of the user interface of the second software product, which displays information such as the digital health certificate and the certificate holder's information.

FIG3B is a schematic diagram of the user interface of the second software product, which shows the review of a specific vaccination record.

FIG4 is a schematic diagram of the user interface of the second software product, which displays various screens and records, including vaccination records and screening records.

without

100: Server side

200: First software product

300: Second software product

400: Trusted registrant

S110~S130: Steps

Claims (4)

A digital health information verification system is used to facilitate a certificate holder to obtain verification from a verification party, the digital health information verification system comprising: a medical information system storing the digital health information or certificate of the certificate holder; and a first software product installed on a mobile device held by the verification party and used to read and verify the digital health information or certificate; a second software product installed on a mobile device held by the certificate holder and used to store and display the digital health information or certificate; wherein: the medical information system uses a private key to sign and encrypt the digital health information or certificate , and provide the signed and encrypted digital health information or certificate to the holder through a communication method; the first software product reads the signed and encrypted digital health information or certificate presented by the holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate; the data of the digital health information or certificate comes from the medical information system, including the holder's vaccination record, screening record, medical record, medication record, medical history or any combination of the foregoing. A digital health information verification system as described in claim 1, wherein the signed and encrypted digital health information or certificate includes a two-dimensional barcode. A method for facilitating a certificate holder to obtain a certificate from a verification party, comprising: providing a medical information system storing digital health information or a certificate of the certificate holder; providing a first software product installed on a mobile device held by the verification party and used to read and verify the digital health information or certificate; providing a second software product installed on a mobile device held by the certificate holder and used to store and display the digital health information or certificate; the medical information system uses a private key to sign and encrypt the digital health information or certificate, and uses a communication method to The signed and encrypted digital health information or certificate is provided to the certificate holder; and the first software product reads the signed and encrypted digital health information or certificate presented by the certificate holder, and uses a public key corresponding to the private key to decrypt the signed and encrypted digital health information or certificate to verify its authenticity and obtain the content of the digital health information or certificate; wherein the data of the digital health information or certificate comes from the medical information system, including the certificate holder's vaccination record, screening record, medical record, medication record, medical history or any combination of the foregoing. The method as described in claim 3, wherein the signed and encrypted digital health information or certificate includes a two-dimensional barcode.