Notice F1: Implementation of the WHO digital documentation of COVID-19 certificates: vaccination status (DDCC:VS) technical specifications

SantéIMS Immunization Management System WHO DDCC:VS Alignment

Two Sentence Overview: 
SanteSuite Inc. (SSI) will contribute to accelerating the global adoption of the WHO global vaccination certificate standard by implementing the WHO DDCC:VS specifications in SantéSuite’s Immunization Management System and EIR, SantéIMS, a DPGA nominated “global good”. SantéIMS is the only proven, person-centered, national scale immunization management system, designed and purpose-built to overcome the full range of barriers and challenges national vaccination programs face, in LIMIC settings and beyond. To achieve this goal, SanteSuite Inc. and its collaborating partners will apply and leverage our extensive frontline expertise as well as lessons learned developing and implementing national immunization management systems for Tanzania and Myanmar, our work on the WHO Digital Accelerator Kit for implementing immunization computable care guidelines (CCG), and our significant contributions to international standards development and implementation, including our early contributions to the HL7 FHIR standard.
Executive Summary: 
The goal of this project is to dramatically accelerate the adoption and success of the WHO DDCC:VS specification in the real world. PATH Digital Square is advancing digital health immunization management solutions by investing in existing approved global goods to align with and implement the WHO’s published Digital documentation of COVID-19 certificates vaccination status (DDCC:VS) technical specifications and implementation guidance. A key output of this project is showcasing an advanced, field proven, national-scale immunization management system, SantéIMS, as a reference implementation of WHO’s DDCC:VS technical guidance. SanteSuite Inc. (SSI) will help implement and align the community to the WHO DDCC:VS technical specifications in two significant ways. Firstly, by implementing the DDCC:VS specifications in the SanteSuite Immunization Management System (SantéIMS), a national-scale immunization management solution global good designed specifically for use in low- and middle-income countries. Secondly, SSI will identify and resolve gaps in the DDCC:VS artefacts with respect to implementation considerations and share these findings with the DDCC community of practice and contribute to the development of a free and open online conformance testing environment. Digital Square’s investment will be used to implement the DDCC:VS artefacts in the SantéIMS platform, including software design, development, testing and documentation, with all deliverables to become freely available and open source. In addition to our team’s deep expertise in developing and implementing digital health immunization management solutions, the SanteSuite team brings decades-long history of contributing to international health standards development, including being early significant contributions to development of the FHIR standard, and as lead authors of the original IHE profiles for mobile patient identity (PIXm and PDQm). Interoperability and standards compliance is engineered into all components of SantéSuite’s platform, which supports a variety of standards-based health records exchange including HL7 Version 2, FHIR, IHE profiles and is fully compatible with OpenHIE. SantéIMS and it’s sister modules are field proven and “interoperability ready” for national scale implementation.
Consortium Team: 
SanteSuite Inc. is a Canadian social benefits enterprise, whose founders have extensive, award-winning international experience developing and implementing national digital health strategies and solutions in LMICs and beyond. Our skillset and track record includes leading the development and implementation of: immunization management systems and registries (SantéIMS, OpenIZ, TImR); master patient index/client registry systems (SantéMPI is a PATH Global Good, MEDIC CR); primary care and hospital electronic medical record systems (OSCAR EMR, WorldVistA EHR); Digital health certification including US Meaningful Use, ISO 13485, and IHE Conformance; PMI, PMP, TOGAF and Agile practitioner certifications; and establishing and coordinating international open source community ecosystems. SSI’s collaborating partner, Hamilton Health Sciences/McMaster University Medical Centre CREATE team, adds deep data sciences and innovation expertise, experience with immunization management systems and is the lead organization for the WHO immunization computable care guidelines (CCGs) initiative. The SanteSuite consortium partners will leverage the synergy between the DDCC initiative and their work developing the WHO’s (Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable) SMART Guidelines for Immunizations Digital Accelerator Kit (DAK). The DAK will include documentation, procedures, and digital health components to support guideline adaptation and implementation through digital systems. WHO SMART Guidelines will help support countries integrate WHO global data and health recommendations into digital systems accurately and consistently.
Project Description: 
*i. Background or problem statement* The goal of this project is to dramatically accelerate the adoption and success of the DDCC:VS specification in the real world. Practical challenges, such as precise definitions for encryption, digital signatures, and data mappings from semi-structured data (such as survey results) to structured FHIR resources will be addressed and resolved. PATH Digital Square’s investment will be applied to SantéIMS, a DPGA global good, to implement and align it with the World Health Organization (WHO) published Digital documentation of COVID-19 certificates: vaccination status (DDCC:VS): technical specifications and implementation guidance. The key output is establishing SantéIMS as showcase reference implementation of the WHO’s technical guidance in an advanced, fully integrated, person centered immunization management system. SantéMPI's Existing Functionality and Features SantéIMS, a DGPA nominated “global good” (, is a proven, purpose-built, person-centered, holistic immunization management system and EIR platform that supports management and end-to-end delivery of any type and scale of vaccination program including pandemic response such as COVID-19 vaccination in LMICs and beyond. Its unique, fully integrated “once and done” design and functionality automates end-to-end vaccination workflows, decision support, and stock management, while at the same time seamlessly automating immunization data feedback loops, aggregate reporting and analytics from local clinic, to regional, and national levels and beyond. This complete, dedicated vaccination workflow solution has demonstrated significant improvement in efficiency of administering vaccine clinics, simplifies training requirements for clinic staff operating a vaccine clinic, speeds up interaction with patients and provides a near real-time national dashboard view of vaccination activity from local clinic to regional and national levels. A purpose-built immunization system also allows implementation of advanced clinical workflows and clinical decision support rules. SantéIMS comes pre-configured with the complete WHO vaccine schedule as default, however the schedule and clinical guideline rules are completely customizable to local country or regional needs. SantéIMS supports new clinical workflows such as COVID-19 protocols and can easily be configured support emerging immunization workflows such as HIV and malaria. SantéIMS’s first version (OpenIZ) was funded by PATH in 2016 as part of the Better Immunization Data (BID) initiative and is currently nationally deployed in Tanzania as the Tanzania Immunization Registry (TImR). *ii. Objectives and activities* The key objective is implementing support for the new WHO DDCC:VS standard in the SantéIMS platform. This investment has the potential to benefit the nearly 10 million citizens of Tanzania that have already been registered in TImR to make use of the advanced WHO DDCC:VS functionality such as vaccine passports, as well as all citizens impacted by currently planned or future deployments of SantéIMS. The associated high-level work packages will include: • Functional Requirements documentation for the various aspects of the DDCC:VS artefacts • Design documents for implementing the various aspects of the DDCC:VS artefacts • Prototype “sandbox” environment for testing and/or conformance testing online environment • Source code and documentation for DDCC:VS implementation(s) *iii.Deliverables & schedule* Functional Requirements Document for DDCC:VS Continuity of Care Scenario Month 1 Functional Requirements Document for DDCC:VS Proof of Vaccination Scenario Month 1 Core Data Set Specifications Design Document Month 1 National Trust Architecture Design Document for DDCC:VS Month 1 Continuity of Care module Design Document for SantéIMS Month 2 Proof of Vaccination Design Document for SantéIMS Month 2 National Trust Architecture prototype environment Month 2 Continuity of Care module for SantéIMS (source code + documentation) Month 3-9 Proof of Vaccination module for SantéIMS (source code + documentation) Month 3-9 National Trust Architecture & DDCC:VS conformance testing environment Month 6-12 Testing and refinement of all modules Month 6-12 Public release of source code and documentation Month 12 One of our goals in this initiative is to foster collaboration within the DDCC:VS implementation community in identifying and resolving gaps in the new DDCC:VS artefacts with respect to implementation considerations. With any new standard publication, there will be ambiguities and knowledge gaps that will exist until several implementations have been completed. With respect to the WHO Digital Documentation of COVID-19 Certificates: Vaccination Status (DDCC:VS) recommendations, SSI is offering to establish and facilitate a DDCC:VS implementation working group to identify, discuss, resolve, test, and document technical recommendations regarding the implementation of the standard. This will reduce ambiguity and ensure compatibility of implementations, ultimately reducing effort, accelerating timelines, and lowering the risk for parties wishing to implement the specification or make use of the various tools produced during this effort. For example, practical issues such as precise definitions for encryption, digital signatures, and data mappings from semi-structured data (such as survey results) to structured FHIR resources will be addressed and resolved. This will ensure that implementations from various parties will be technologically compatible and interoperable. The resulting findings and recommendations from this work will be posted for all implementers to leverage. SSI will also bring the results of this activity to appropriate standards bodies such as IHE and/or HL7 Conntectathons as deemed appropriate to gather attention to this work, to engage with additional potential stakeholders and to disseminate the results of the DDCC:VS work more broadly. The overall goal of this exercise is to dramatically accelerate the adoption and success of the DDCC:VS specification in the real world. *iv. Risk mitigation* We do not foresee any significant technical risks as the SantéIMS platform is based on a proven, functionally rich immunization solution which has been in development since 2015 and operating at national scale since 2107. The following summarizes potential risks and mitigation strategy: 1. COVID-19 Pandemic continuation or resurgence > We will continue to leverage our extensive experience and tools for working successfully, remotely with international team members, collaborating partners and stakeholders 2. Budget Risks – cost overrun or insufficient budget > Agile approach with 2-week sprints, monthly budget review, sliding priority system, rolling wave planning if possible 3. Personnel Risks – loss of personnel > Peer-programming and peer-code reviews, cross training build process, hiring staff or leveraging partner resources if needed 4. Knowledge Risks – knowledge transfer > Consortium knowledgebase setup to capture project knowledge, improved documentation 5. Productivity Risks – performance degradation > Structure deliverables to balance workloads, responsibility matrix, ensuring that work-in-progress limits are followed 6. Timeline Risks – timelines too tight or deadline slippage > Agile structured, regular sprint meetings, SCRUM certified project manager 7. Technical Risks – lengthy test correction, misunderstanding of tooling > Implement and follow formal bug and defect framework from project start, involve end-users in user interface testing
Application Status: 
Not Approved


- The full proposal should clarify if you are planning on using the funds on the Immunization DAK
- Clarify plans for the alignment to Instant OpenHIE, how much work is done already if any, and how much is remaining to be fully compliant.
- In the full proposal you also need to show how local capacity development will be incorporated into the work. (at least to one of the countries where the tool is deployed)

Thank you for a great application. Please expand on:

  1. How will the application be expected to incorporate key data standards and align to workflows.
  2. How will certificates be generated for paper records incase clients do not have no access to mobile phones.

 1.   How will the application be expected to incorporate key data standards and align to workflows.

SanteIMS and its predecessor OpenIZ are designed and built based on the specifications released as part of the PATH Better Immunization Data (BID) initiative immunization management system design. These specifications incorporate all key best practice immunization workflows and make use of global immunization data standards published by WHO, HL7 and many others.

2.    How will certificates be generated for paper records in case clients do not have no access to mobile phones.

SanteIMS is already capable of printing immunization certificates and secure QR codes on paper. This initiative will add the ability to print the WHO DDCC:VS conformant certificates.