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PathData Use and Sharing Agreement to Support the United States Government’s COVID-19 Emergency Response Jurisdiction Immunization and Vaccine Administration Data Agreement This Data Use and Sharing Agreement (“DUA”) is made between U.S. Virgin Islands Department of Health, Immunization Division (“Data Source” or “Jurisdiction”) and the Centers for Disease Control and Prevention (CDC), an agency of the Department of Health and Human Services (“HHS”), to describe the data use and sharing parameters for certain immunization and vaccine administration data, as further described herein. This DUA: 1) describes platforms for the rapid collection, transmission, use, storage, and maintenance of these data available to data sources, CDC, and other users; 2) establishes the terms and conditions for the sharing, protection, and use of these with CDC, HHS and other federal partners; and 3) sets forth the roles and responsibilities of each party. The DUA is effective as of__________________________________________ (“Effective Date”) Background and Purpose Access to immunization and vaccine administration data is critical to the whole of government response to the Coronavirus Disease 2019 (COVID- 19) public health emergency. In furtherance of federal government response efforts, HHS and CDC seek to obtain and utilize these data from various immunization and vaccine data sources, including a jurisdiction’s immunization information system (uS), pharmacies, federal Provider Organizations, and other relevant parties for a range ofpurposes, including but not limited to rapidly assessing patterns of vaccination among the population; identifying pockets of under vaccination ; assisting in determining vaccine resource allocation to address the needs of jurisdictions; monitoring vaccine effectiveness and safety; assessing spectrum of illness, disease burden, risk factors for severe disease and outcomes; and helping to understand the impact of COVID- 19 on the healthcare system and communities. To support these purposes, HHS and CDC: 1) have made available a platform for use by data sources to manage, share, and store their immunization data; 2) have developed platforms for use by HHS, CDC, and other federal partners to extract, accept, manage, share, and store relevant immunization data in furtherance of the response; 3) will, consistent with applicable law, enable the secure transmission of extracted data from and across these platforms for further use by a jurisdiction, CDC, HHS, and other federal partners in furtherance of the response; 4) as applicable, will assure compliance of these platforms with the Federal Information Security Management Act (FISMA) and other federal data security policies; and 5) will provide operational support to the data sources and other authorized users of the various platforms, as appropriate. Authority HHS and CDC are authorized by Sections 301 and 319D of the Public Health Service Act [42 U.S.C. § 241 and 247d-4), as amended, to maintain active surveillance of diseases through epidemiologic and laboratory investigations and data collection, analysis, and distribution. The Jurisdiction entering this DUA agrees that it is authorized to send the Covered Data to and through the COVID- 19 Clearinghouse, the Immunization (IZ) Data Lake, the Vaccine Administration Management System (yAMS), and HHS Protect/Tiberius, as those platforms and systems are further defined herein, 1 Page DUAJMOU: 20th Day of November, 2020 G004DOHT21 and/or will obtain consent from any external entities or individuals from whom it collects data to allow for such sharing and use. In addition. HHS and CDC each is a “public health authority” as defined at45 C.F.R. §164.501 and as used in 45 C.F.R. § 164.5 12(b), Standards for Privacy of Individually Identifiable Health Information, promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and, as such, are authorized by 45 CFR 164.512(b) to receive Protected Health Information (“PHI”). As applicable, the Parties acknowledge that Jurisdiction may be a hybrid entity for purposes of HIPAA. Jurisdiction’s healthcare component is neither involved nor implicated in this DUA. For purposes of this DUA. Jurisdiction is a public health authority under 45 CFR § 164.5 12 and is neither a covered entity nor a business associate, as defined under 45 C’FR §160.103. The Parties expressly do not intend to create a HIPAA business associate relationship, and nothing in this DUA may be construed to make Jurisdiction a covered entity or business associate for purposes of this agreement. Data Use and Sharing Terms 1. Platforms In furtherance of the activities set out in this DUA, HHS and CDC. either directly or by and through a service provider, have stood up. are supporting, and’or are expanding the capacity of the following secure, certified, cloud-based data management platforms: a. Immunization (IZ) Gateway: The IZ Gateway is a cloud-hosted message routing service offered by the Association for Public Health Laboratories (API-IL) and is intended to enable data exchange across lISs, other provider systems, the COVID-19 Clearinghouse, and the IZ Data Lake. A jurisdiction may enter into appropriate agreements with APHL to enable its IIS to update, query, and report immunization data to and through the IZ Gateway. The IZ Gateway is intended to allow a jurisdiction to connect its ITS and other provider systems to the COVID-19 Clearinghouse and the IZ Data Lake; connect its uS to VAMS data, where applicable; enable queries and route messages to/from its uS; and route secured, standardized HL7 messages from its us, yAMS, or other provider organizations to the COVID-l9 Clearinghouse and the IZ Data Lake. A jurisdiction choosing to use the IZ Gateway will enter into relevant agreements with APHL with respect to use of the IZ Gateway. b. COVID-l9 Clearinghouse: The COVID-19 Clearinghouse is a cloud-hosted data repository provided and managed by HHS that, as a functional tool, provides a secure space for a jurisdiction to upload and store COVID-19 vaccination data collected from provider organizations via electronic health records (EHRs) and from pharmacy systems. The COVID-19 Clearinghouse is intended to allow a jurisdiction to upload, store, reconcile, and manage data for general COVID 19 vaccine administration, to meet reporting requirements and needs, and to allow providers to search for a patient, see what brand of COVID-19 vaccine they received, and when they received their first dose of COVID-19 vaccine to ensure dose matching to complete the vaccine series (see Appendix A). The COVID-19 Clearinghouse will be able to receive data from VAMS and other vaccination sources not already onboarded as providers to an immunization registry and will allow the data to 21 Page DUA/MOU: G004DOHT21 be shared across relevant jurisdictions for reconciliation of patient registry records. Neither CDC nor HHS. either directly or by and through the cloud service provider, will have access to personally identifiable vaccination data submitted by a jurisdiction’s uS, yAMS, or other vaccine source record system during transport or record processing or while in storage without the express consent of the jurisdiction. HHS and CDC. either directly or by and through the service provider, will take all reasonable measures to secure the data residing in the COVID-19 Clearinghouse and. except as may be required by applicable federal law, will not. without the prior written authorization from the jurisdiction, further use. disclose, or transmit the data beyond what is described within this DUA. Should disclosure or transmission of ajurisdiction’s data be required by federal law. HHS and/or CDC will promptly notify the jurisdiction in writing of the required release. c. Immunization (IZ) Data Lake: The IZ Data Lake is a CDC secure, cloud-hosted data repository created to receive and store redacted COVID-l9 vaccination data for doses administered, coverage, inventory, and distribution. The lZ Data Lake will receive the data from various data flows, including internal CDC sources (VTrckS). Provider Agreement data via an upload portal, VaccineFinder, and the COVID-19 Clearinghouse. These data will be used by CDC to provide aggregate-level reports for COVID-19 vaccine administration, ordering, Inventory, and provider information. The IZ Data Lake will also aggregate and analyze data and provide data summaries and analytics via platforms such as the Data Storefront HHS Protect, and HHS Tiberius. d. VaccineFinder: The VaccineFinder website helps people find providers who offer specific vaccines. VaccineFinder will serve two roles during the COVID-l 9 Vaccination Program: 1. Inventors’ reporting: Approved COVID-19 vaccination providers will report on-hand COVI[)-l9 vaccine inventory daily. 2. Increase access to CO’ID-19 vaccines: COVID-l9 vaccination providers may choose to make their location(s) visible on VaccineFinder to increase access to COVID-l9 vaccines once supply is available for the general population. VaccineFinder will exchange data with the IZ Data Lake for the purposes of provider pre-enrollment, data analysis, and summaries via platforms such as the Data Storefront, HHS Protect, and HHS Tiberius. e. VTrckS: CDC’s Vaccine Tracking System is the platform for ordering all COVID-19 vaccines. VTrckS users will use the system to: • View vaccine allocations allotted to each program. • Place andlor manage vaccine orders for their providers. • Generate reports throughout the vaccine distribution process, from placing vaccine orders through distribution. VTrckS receives data from jurisdiction immunization registries and transmits data to these registries, VaccineFinder, and the IZ Data Lake. f. Provider system: A provider system is any platform used by a vaccination provider to track the administration and uptake of vaccine among their patient populations. Vaccination providers generally utilize an Electronic Health Record (EHR) to connect directly to lISs for vaccine uptake tracking. In some instances, vaccination providers will utilize a direct user interface (UI) to enter vaccination information directly into an uS UI portal. g. Other vaccine source: These are alternative sources (in addition to lISs and ERRs) that may store vaccination information about an individual. Examples include travel vaccination records, passports, vital records/birth records, Medicaid records, insurance claim information, etc. and their corresponding systems. 31 Page DUA/MOU: G004DOHT21 h. HHS Tiberius: Tiberius provides a COVID-19 vaccine distribution planning, tracking, modeling, and analysis ecosystem. Tiberius leverages the same technologies as the HHS Protect Platform (“HHS Protect”) and integrates data sources from federal agencies. state and local partners. private sector partners, and open data providers to create a comprehensive common operating picture for tlie COVID-19 vaccine planning, distribution, and administration effort. 2. Definitions: For pui-poses of this Agreement, the following definitions shall apply and may be used in the main body of the DUA and/or in relevant appendices: “Authorized User,” for purposes of this DUA, means an individual who, as part of directly supporting the whole of government response efforts, has a need for data stored in the COVID-19 Clearinghouse, the IZ Data Lake and/or the Tiberius platforms in furtherance of the purposes and uses set forth herein. Authorized Users will generally be employees, contractors, and/or other agents specified by Jurisdiction or federal agencies engaged in the response for purposes of addressing critical public health and emergency response activities, including assessing infrastructure needs and resource allocation. Authorized Users must adhere to applicable federal law and, as consistent and applicable the provisions set out in this DUA with respect to the data stored in the respective platforms. “Data Source,” for purposes of this DUA, is a Jurisdiction which, by and through an lIS and/or similar system(s) created to serve a range of administrative functions related to vaccines, provides Covered Data as set forth herein. Generally, the JIS or related system(s) will collect data from public and private health care provider organization e.g. EHRs, health information systems, (e.g., vital statistics, state Medicaid agencies. etc.), and pharmacies. “Covered Data” means the information that is being shared by the Data Source with each relevant platform as further described in Appendices A-D, but that is generally categorized into four primary datasets: the VAMS data, the COVID-19 Clearinghouse Data, the IZ Data Lake Data, and the Tiberius Data. HHS and CDC acknowledge that the Covered Data to which each agency will have access is the minimum amount of information necessary to accomplish public health or emergency response needs. A list of Covered Data elements for each dataset is provided in Appendices A-D. Covered Data may be used by Authorized Users within the parameters set forth in this DUA. The data elements listed in Appendices A-D will be updated periodically as more information on COVID-19 immunization is available. The overall DUA will remain unaffected by subsequent updates. Appendices A-D also provide the mode and method of secure transmission of the data from the Jurisdiction’s ITS or similar system(s) directly to the COVID-19 Clearinghouse from the COVID-l9 Clearinghouse to the IZ Data Lake and from the IZ Data Lake to Tiberius. This infonnation includes the potential availability and use of a privacy-preserving record linkage (PPRL) tool, which may be made available by HHS or C’DC, either directly or by and through a contractor (Appendix E). Of note, data entering the COVID-19 Clearinghouse through the IZ Gateway will be governed by agreements between the ITS jurisdiction and APHL. “Jurisdiction” means the state, territorial or local health jurisdiction operating under either statutory or regulatory authority to obtain and use health-related data for population health protection. For the purposes of this document, Jurisdictions are funded under CDC-RFA-IP 19-1901 317 Notice of Funding Opportunity. 4Page DUAIMOU: G004DOHT21 “Immunization Information System” or “uS are confidential, population-based, computerized databases that record all immunization doses administered by participating providers to persons residing within a given geopolitical area. “Deidentified Data” means data that do not identif’ an individual and there is no reasonable basis to believe the information can be used to identify an individual because the data have been rendered not identifiable in accordance with the HIPAA standards set forth in 45 CFR §164.514. “Party” means a state, territorial or local jurisdiction or CDC: “Parties” means state, territorial, or local jurisdiction and CDC. “Privacy—Preserving Record Linkage (PPRL)” means the process whereby personally identifiable information (P11) is rcdacted from a patient/customer record using a one—way, irreversible encryption algorithm to create one or more unique tokens that replace PIT elements and allow data systems to match patient/customer records. PPRL is an industry standard that has been implemented and integrated across several data collection sectors where an individual’s privacy must be maintained (e.g.. health care, biomedical research, payment and claims, retail, intelligence, social research, and public health). For COVID- 19 immunization reporting, PPR F offers jurisdictions a mechanism to meet applicable jurisdiction regulations where data sharing with partners such as HHS and CDC may be limited. “Vaccine Administration Management System” or “yAMS” means the CDC-provided and supported web-based application that provides an option for a jurisdiction to plan and execute COVID-l9 vaccine administration in a mass vaccination setting. VAMS has four users with multiple roles within each user module: I) jurisdictions can provide end-to-end mass vaccination capability and manage mass vaccination clinics: 2) healthcare providers can manage patient scheduling, vaccine administration workflow. and patient monitoring, support social distancing requirements with a scheduling feature, track vaccine inventory and usage, and include warnings when inventory is low: 3) employers/organizations can bulk input employees who will receive an email to register in VAMS: and 4) vaccine recipients can schedule vaccination appointments and receive appointment reminders. For purposes of this DUA, VAMS may be used to send data directly to the COVID-19 Clearinghouse or through the lZ Gateway either back to the Jurisdiction IlS and/or to the COVTD-19 Clearinghouse. The Jurisdiction uS may choose to use VAMS or an alternate mechanism (e.g., state- based vaccination clinic solution) to transmit the data to the TZ Gateway and/or the COVID-19 Clearinghouse. 3. Description of Data Requested and Transmission Data Source agrees to provide data as described in Appendices A-D to and through platforms as indicated therein, subject to the terms and conditions included in this DUA and applicable to that option. 4. Data Use Terms The Data Source acknowledges and agrees that HHS, CDC, and Authorized Users may use the Covered Data transmitted to the various platforms as described in this DUA and Appendices A-D in furtherance of response activities related to the COVID-19 pandemic. This includes, at a minimum, the following activities: a. Analyze and visualize the Covered Data to which they have access to improve the monitoring of vaccine and vaccine-related activities related to the COVID-19 pandemic response including vaccine safety and assessment of vaccine effectiveness; 51 Page DUAJMOU: G004DOHT21 b. Analyze and visualize the Covered Data to improve the monitoring of vaccine safety and assessment of vaccine effectiveness; c. As applicable to the platforn, share the Covered Data and analyses thereof with official federal, state, local, tribal, and territorial government health agencies or other agencies and entities conducting their public health and vaccine response responsibilities consistent with applicable federal law and the terms of this DUA; d. Develop analytic methods using the Covered Data to identify immediate public health events or concerns at the federal, state, territorial and local level that warrant further public health investigation or immediate public health intervention actions; e. Enable Authorized Users, including public health and emergency response officials, to query the Covered Data within the HHS and CDC-provided data platforms as may be necessary to carry out critical public health functions; f. Share specified data elements with HHS Tiberius for the visualization of Vaccine Administration Data; and g. Publish findings and conclusions related to their analyses of the data provided. As appropriate, publications will acknowledge Data Source as the source of the data in any such publication. Given the emergent nature of the response, HHS and CDC may not be able to inform or seek approval from Data Source for such publications but will coordinate as soon as possible and practicable. 5. Data Confidentiality and Security As applicable to the platform, HI-IS and CDC will establish appropriate administrative, technical, procedural. and physical safeguards to assure the confidentiality and security of Covered Data in their custody and control, consistent with federal requirements under the FISMA) and other applicable federal laws. The safeguards shall provide a level and scope of security that is not less than the level and scope of security established by applicable law for the type of data provided under this DUA. Where Covered Data provided pursuant to this DUA are identifiable or potentially identifiable, CDC agrees to maintain the confidentiality of the Covered Data to the fullest extent required by applicable law, which includes, as applicable, the Privacy Act of 1974; standards promulgated pursuant to), and the Freedom of Information Act (FOIA), including exemptions provided thereunder. Where required by law andor where practicable, HHS and CDC agree to noti’ Data Source before releasing Covered Data to a third party pursuant to a judicial, governmental, or other request under law, to allow Data Source the opportunity to state any objection to the disclosure of the Covered Data. Transmission of the Covered Data by and through the various platforms in the control of HFIS and CDC shall be done in accordance with acceptable practices for ensuring the protection, confidentiality, and integrity of the contents. Covered Data will be maintained and stored in compliance with CDC’s security policies and procedures and consistent with applicable law. Miscellaneous 1. Data Disposition: Data that have been provided to HHS and CDC under this DUA will be archived, stored, protected, or disposed of in accordance with relevant federal records retention requirements. 2. Funding: This DUA is not an obligation or a commitment of funds, or a basis for a transfer of funds, and does not create an obligation or commitment to transfer data, but rather is a statement of understanding between the parties concerning the sharing and use of covered data. Expenditures by 61 Page DUAJMOU: G004DOHT21 each party are subject to its budgetary processes and to the availability of funds and resources pursuant to applicable laws, regulations, and policies. 3. Settlement of Disputes: Disagreements between the parties arising under or relating to this DUA will be resolved by consultation between the parties and refeiTal of the dispute to appropriate management officials of the parties whenever possible. 4. Applicable Laws: U.S. federal law shall govern the construction, interpretation, and performance of this Agreement. Term of Agreement, Amendment, and Termination: I. The term of this DUA shall be one year commencing from the date of the final signature or the duration of the national emergency. The DUA may be renewed upon mutual written consent of the parties. 2. Except as otherwise expressly provided herein, this DUA may be amended only by the mutual written consent of the authorized representatives for each party. 3. This DU.A may otherwise be terminated with ninety days’ advance notice upon written notice by either party. 4. Any notice required under this DUA must be in writing and sent by electronic mail with written acknowledgement of receipt to the email address for each party provided below. 5. Each party represents that the individual signing below on behalf of the party has the authorization to bind the party indicated to this DUA. This DUA may be signed in counterparts and signatures provided electronically will be deemed originals. CENTERS FOR DISEASE CONTROL AND PREVENTION AND DATA SOURCE By: Name: _Megan C. Lindley Title: Acting Associate Director for Science, CDC!NCIRD!ISD Date: 11/06/2020 ______________ Email: MLindlcycdc.gov_____ WITNESSES / 11/12/2020 tcu A -1Ite ______ Jtista E. Encamacion, Commissioner Date Department of Health Anthony D. Thomas, Commissioner Date Department of Property and Procurement APPROVED AS TO LEGAL SUFFICIENCY DEPARTMENT OF USTICE BY: ____________________________ Pate 1 1 / 20 / 2020 7 Page DUAJMOU: 11/20/2020 G004DOHT21 Appendix A: Covered Data—CDC uS Data Elements for COVID-19 Vaccine Monitoring A strong, nationally coordinated approach is critical to collecting, tracking, and analyzing vaccination data, especially in early phases of vaccine administration, which is expected to occur in nontraditional settings during this COVID—l 9 response. This document outlines the anticipated data elements that will be reported to various platforms supported by HHS and CDC. ultimately with certain elements being shared with HHS and CDC. The required data elements in this document represent demographic and vaccination information routinely captured by an uS during a vaccination event. Discrete Data Elements In order to ensure appropriate vaccine administration and distribution by HHS and CDC to jurisdictions and, ultimately. to providers, certain data elements must be provided to HHS and CDC. Table I includes each data element a Jurisdiction will report to VAMS (if applicable), to the IZ Clearinghouse, and to the CDC IL Data Lake. Table 2 includes each data element that will be optional for submission to each platfom. Optional data requirements will support additional national coverage analysis and vaccination monitoring efforts. Any identifiable data elements will be used to facilitate deduplication of data within the COVID-19 Clearinghouse, an analytic environment that will be used to consolidate. deduplicate. and reconcile vaccine administration information from multiple sources (e.g., jurisdictional immunization programs, pharmacies, Department of Defense, Veterans Affairs, Bureau of Prisons. Indian Health Service). Directly identifiable elements will not be sent or stored in the CDC IZ Data Lake environment. The IZ Data Lake will aggregate and analyze data and will provide data summaries and analytics via platforms such as the Data Storefront, HHS Protect, and the HHS Tiberius systems. Data flowing from the IZ Data Lake to Tiberius will be used by Operation Warp Speed members to track progress of vaccine distribution, provider inventory, and administration. Table 1. Required Data Elements Required Data Element VAMS COVID-19 Immunization Data Lake Clearinghouse Data elements requiredfor reporting by uS Administered at location: s”. V. V facility name/ID Administered at location: type Administration address (including county) Administration date V CVX (product) Dose number V. V lIS recipient ID* V V Recipient race 81 Page DUA/MOU: G004DOHT21 G004DOHT21 G Recipient ethnicity V 115 vaccination event ID V Lot number: unit of use V and/or unit of sale MVX (manufacturer) Recipient address* V. Recipient date of birth* V. Recipient name* Recipient sex V V Sending organization V Vaccine administering V provider suffix Vaccine administering . site (on the body) Vaccine expiration date Vaccine route of . administration Vaccination series V. complete Optional Data Elements Optional Data Element VAMS COVID-19 Immunization Data Lake Clearinghouse Comorbidity status Recipient missed . V vaccination Appointment (Y/N) Serology results (Y/N) V V. V. Vaccination refusal (Y/N) V. V. V. *Identifiable Information 9Page DUA/MOU: G004DOHT21 G004DOHT21 Appendix B: Vaccine Administration Data Workflow Primary Path: uS Connected to IZ Gateway and Data Lake 5Iü ‘ieir Idd .,j ad 1aOdr . Description of Data Workflow and Transmission Data Source will provide vaccine administration data (Appendix A) to the COVID-19 Clearinghouse as described in Appendix D, in part. for purposes ofdeduplication, record matching, and reconciliation. The COVID- 19 Clearinghouse vi1l encrypt and store personally identifiable vaccine administration data, allowing secure, role-based access for authorized data users/systems. It will also support multijurisdictional lookup/queries by vaccination providers for validating vaccine type and manufacturer for administration of a second dose. Once processed in the COVID 19 Clearinghouse, certain data elements (see Appendices A and C) from the COVID-19 Clearinghouse Data will be transmitted to the CDC IZ Data Lake platform for additional analyses by CDC and HHS. Data may be transmitted to the COVID-19 Clearinghouse through the following applications and technology solutions: • Option 1: Directly, via a Jurisdiction uS or Mass Vaccination Clinic Application (e.g., VAMS or a state-based vaccination clinic solution) • Option 2: Via a Jurisdiction uS or vaccination clinic application through the IZ Gateway provided by APHL • Option 3: Submission of record-level vaccination and demographic data to the COVID-19 Clearinghouse through a data extract (see Appendix D) For Data Sources using the IZ Gateway, data from a vaccination clinic application are submitted to the IZ Gateway through a Simple Object Access Protocol (SOAP) Transport in the form 10 I P a g e g3[fJ 4. Nn-flS CDnneted EntIties (Nring nd Pdscn Piti) Federbl Apnde (VA. tHS, DoD, BoP) LI . StoeFront DUAJMOU: __________ G004DOHT21 G004G004DOHT21 of vaccine record updates (VXU) and acknowledgment (ACK) messages. A similar mechanism is used for the submission from the IZ Gateway into the IZ Data Clearinghouse. Data from both technical solutions will be submitted directly to the COVID-l9 Clearinghouse through functionality existing within the technology and will not require direct action on the part of the Data Source. If the Data Source is unable to submit data through the aforementioned technical solutions, Data Source may transmit Covered Data directly in the form of a data extract to the COVID-19 Clearinghouse. The COVID-19 Clearinghouse will then deliver certain data to the IZ Data Lake. The Data Source will submit information about COVID-19 vaccinations only. The Data Source agrees to provide all required data elements described in Appendix A unless prohibited by state law. Written documentation of these legal restrictions must be provided. Data from the TZ Data Lake will transmit into HHS Tiberius. The IZ Data Lake connects to Tiberius by using the lZ Data Lake Azure Synapse component. The Tiberius IP addresses are white-listed, and credentials are exchanged over a secure channel. Tiberius credentials in TZ Data Lake Synapse are only provided access to the data approved by CDC programs. Tiberius pulls the data from IZ Data Lake Synapse when it needs to refresh. Appendix C: Data Dictionary for CDC Vaccine Administration Requirements for COVID-19 Vaccine Monitoring (attached) Appendix D: COVID-19 Vaccination Reporting Specifications Document (CRVS) (attached) 11 I P a g e DUAJMOU: G004DOHT21 APPENDIX E: PRIvAcY-PREsERvING RECORD LINKAGE Currently, there is no consistent way for public health jurisdictions to share vaccine administration data with each other, due to two major constraints. First, these data are considered personally identifiable information (PIT) and/or protected health information (PHI) and may be subject to a jurisdiction’s laws and regulations that may prohibit or limit the sharing of such information outside the jurisdiction. Second, though most people will complete their dose series in the same jurisdiction, some individuals may cross jurisdictions before completion of the series. There are currently no optimal technical solutions to link vaccine administration data electronically across jurisdictional boundaries. Privacy preserving record linkage (PPRL) provides a practical way for jurisdictions to exchange information on vaccine administration with federal agencies, while preserving and protecting PIT and PHI. By creating tokenized. deduplicated data. PPRL can link an individual’s COVID-l9 vaccination records to inform booster dose delivery decisions without sharing PIT across jurisdiction boundaries. PPRL has the potential to optimize vaccination administration efforts by streamlining processes and resolving orphaned data issues within the uS by providing record linking without the need to exchange P11. Beyond the dose series look-up use case, PPRL can also enable CDC to associate vaccine administration data fioni multiple sources (e.g., epidemiologic, laboratory and immunization data) to a specific individual without receiving any P11 that might compromise the privacy of that individual. In the PPRL process, P11 is hashed using a one—way, irreversible encryption algorithm to create one or more tokens in a series of prescribed steps prior to transmission beyond an organizational boundary for matching. Hashing works by passing a piece of data through a mathematical function to convert the data into a multi-character code that can be used by computers to match records in the same way that personally identifiable data would be used the code(s) act as new record identifiers that are used to match with other records similarly converted to codes. The process of hashing results in the creation of unique information based on the P11 data of interest that prevents an outside party from recovering the P11, while allowing for the establishment of links across organizations in order to share P11 when necessary. PPRL offers more than one protocol for establishing links. In a “direct” protocol, each party hashes and encrypts their PH and shares the hashed tokens directly with the other party to compare matches. In a “blind” protocol, a third party known as a “linkage agent” is provided access to the hashed data but is unable to view P11. The linkage agent then compares the obfuscated information to establish linkages using the tokens (see Figure below). Commercial implementations of PPRL services operating in the health domain need to demonstrate that the tokens created are deidentified per the HIPAA standard. This includes demonstrating ability to resist cryptanalytic attacks, dictionary attacks, and statistical attacks (e.g., frequency attacks, collusion attacks). 12 I P a g e DUAJMOU: G004DOHT21 Figure 1. Tokenization/Unique ID Creation Apply Configuration First Narn John & Encryption Last Nane Smith , Gnrder Mate Key Escrow Hash Code Combinations Sate r Bitt 01/31/1970 I1 — I Hash 1 = iName + 3 Zip + GOB First Narre Redacted Address 123 Main St. NY L.EJ Hash 2 = LName * Friame ZipCode * Gender Last Na,e Redacted Zp Ccde 10001 Hash 3 INarne t 008* Geisder Gender Male VaxType Moderna c. ; DateofBirt’ 01/31/1870 Acmin Da:e 01/28/2021 Address Redacted Hash Zp Code 10001 USG ______________________________________ Vax Type Moderna 3rd Party Linkage Agent Acrntn Date 01/28/2021 0 tirin ;Dnsa4kjfesairsdaisndeikbdsshbdra 4 Matching Service Link Table 13 I P a g e DUA/MOU: G004DOHT21