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

Tamanu for COVID-19 digital certificates

Two Sentence Overview: 
This project will adapt the functionality of Tamanu, our patient-level electronic medical record, to generate COVID-19 vaccination certificates in alignment with the World Health Organization’s (WHO) guidelines for implementation, including the generation of secure Visible Digital Seals. This work will be achieved as part of our eHealth reform project in Samoa (where we are delivering an eHealth reform project), but the work will be entirely scalable, with 4 other countries already using Tamanu.
Executive Summary: 
Tamanu is a fit-for-purpose patient-level electronic medical record (EMR) designed to address the distinct healthcare challenges of the Pacific. It is offline-first, open-source, and an existing Global Good. Tamanu is currently used in Samoa to record vaccination status for individual patients and produce vaccination certificates; in Fiji, it is used to record COVID-19 lab test requests and results. We already have an API (HL7 FHIR standard) which is used to send patient information to external systems. This investment would go towards developing vaccination certificates (including secure Visible Digital Seals) in line with the World Health Organization’s Digital documentation of COVID-19 certificates: vaccination status (DDCC:VS): technical specifications and implementation guidance. The system will be in line with HL7 FHIR, a free and open data exchange standard, to ensure that data for the DDCC:VS is captured in a consistent and interoperable way. We will be able to code the data using either the ICAO or EUDCC standards. Our goal is to ensure that patients in the Pacific can travel and participate in the global economy, and the inclusion of vaccination certificates in Tamanu will help us to reach this goal. We are uniquely placed to deliver this work – we have a medium-sized, vertically integrated staff of 40, including software development teams and a highly experienced delivery team of public health experts with deep experience in the Pacific. We have been working in Samoa since 2019 and have close and positive relationships with the Ministry of Health and our donors. We will deliver the work via in-country project managers and remote data stewards, ensuring that the software integrations work in context and that staff being trained are appropriate and receptive. In other potential countries, the situation is similar, with potential uses of this work in 4 other immediate countries.
Consortium Team: 
Prime organization Beyond Essential Systems is an Australian company that creates and implements innovative software solutions for low-resource settings in the Asia-Pacific. They have managed large projects on behalf of partners including the Australian Government Department of Foreign Affairs and Trade (DFAT), New Zealand Ministry of Foreign Affairs and Trade (MFAT), Bill and Melinda Gates Foundation, World Food Program, Save The Children International, UNFPA, UNICEF and WHO. BES is an accredited B-Corp, with a full-time staff of 40, including specialists in public health, procurement, clinical services, project accounting, geospatial epidemiology and a full-time software development team of 22. Our team works across offices in Melbourne and Auckland, with project offices in Samoa, Tonga and Fiji.
Project Description: 
Background The COVID-19 pandemic has had a profound impact on the Indo-Pacific. Managing the social, economic and health impacts of COVID-19 remain a central challenge for the region. At the onset of the pandemic, BES acted quickly to adapt our solutions to support the COVID-19 response which has included significant investment in Tamanu. We have adapted existing Tamanu functionality to develop three COVID-19-specific modules; the COVID-19 Vaccine Module, the COVID-19 Testing Module and the COVID-19 Active Case Management Module. The COVID-19 Vaccine Module is currently being used to support the Samoan COVID-19 vaccination campaign and has been used to record vaccines for >80% of the population as of November 2021. The COVID-19 Testing Module is being used in Fiji to record and enter results for COVID-19 tests. Over 40,000 tests have been recorded in the system as of November 2021. More specifically, the COVID-19 Vaccine Module includes the below functionality: • Patient registration, including all demographic, contact and relevant clinical details • COVID-19 vaccine module enabling the recording of vaccination administration against individual records across both desktop and mobile, with all necessary fields (according to the WHO data model) • Decision support for second dosing • Adverse event following immunisation reporting • Individualised vaccination certificates • COVID-19 reporting suite, with integration to external systems as required, reporting to the household level and including metrics such as patient lists by village according to vaccination status and overdue for second dose As stated above, through the COVID-19 Vaccine Module, Tamanu can generate individualised vaccination certificates. Currently the vaccine certificate can be printed from Tamanu and includes patient details such as name, unique identifier, date of birth and gender; details on vaccination event such as vaccine brand name, dose, batch number, administering centre and person administering the vaccine. The certificate can also be configured to include a watermark. We have made significant progress in the developed of the vaccination certificate though further work is required to ensure alignment with the World Health Organization’s Digital documentation of COVID-19 certificates: vaccination status (DDCC:VS). We will also include a Visible Digital Seal (QR Code) compliant with the ICAO standard (and as an alternative, compliant with the EUDCC standard). We have already held initial discussions with IATA to ensure the VDSs in our Vaccine Certificates will be compliant with their Travel Pass app and we will use a portion of this funding to engage more broadly with other global stakeholders. In addition to the below objectives, consideration will be made to ensure that access to COVID-19 certificate and proof of vaccine status is equitable for all. Objectives To adapt Tamanu to align with WHO’s technical guidance on the digital documentation of COVID-19 certificates the following objectives will be met: - Configure vaccination certificates to include Visible Digital Seal (VDS). The VDS is an individual QR code included on the certificate which is generated using the COVID-19 vaccination information. - Develop online portal for vaccination status checking. - Adapt the Tamanu API to conform with HL-7 FHIR to enable the integration of Tamanu’s COVID-10 certificate with required systems. Deliverables The following work will be delivered: - Demonstration of COVID-19 certificate in alignment with DDCC:VS. - Demonstration of online portal for vaccination status checking. - Published API (conforming with HL-7 FHIR) - Training materials made freely available online (including manuals, training videos and webinar) Schedule February 2022: Configuration of vaccination certificate to include VDS, development of secure online portal for vaccination status checking March-April 2022: Adapt Tamanu API (already HL7 FHIR compliant) to include vaccination details in addition to test details, development of training material Risk mitigation The following have been identified as key risks relevant to the implementation of eHealth initiatives in the Pacific and of EMRs specifically. Long-term Sustainability Software solutions change rapidly, and new technologies are constantly emerging to support better healthcare outcomes. As a result, there is an inherent risk that the proposed modules around vaccine certificates become obsolete, superseded by new global tools or no longer recognised. In the context of the COVID-19 pandemic however, there is a need to accept slightly higher risks and to move more quickly than a usual consensus-gathering process might take. We have designed our tools in line with the current leading global standards and practices and need to move forward – more developed economies in the region (including Australia) have selected the same standards and proceeded with implementation and we have already met with the Australian Passport Office, Australian Department of Foreign Affairs and IATA to try and learn lessons. The work is already being used by Samoa with other planned implementations in early 2022 so we should be able to demonstrate quick scalability. Security/Data Breaches Data breaches are a major risk to any digital health project and are taken very seriously. All data in Tamanu will be encrypted at rest and in transit. Access to data within Tamanu is password-controlled. The ability to view and download data is restricted to specific user groups. We will design our vaccine certificates with all standard security features and the VDS will be encoded with a public encryption key, whilst the private key will be shared only with trusted providers. COVID-19 Certificate Fraud Certificate fraud is a high risk to all COVID-19 vaccination campaigns. The Tamanu vaccine certificate will include a VDS which will help to combat fraud and misuse. The VDS represents the ‘gold standard’ of proof of vaccination and conforms to the global standard set by the ICAO and the model is endorsed by the WHO.
Application Status: 
Approved - partially funded


Many thanks - one final note, we feel we could have prepared something more comprehensive and that there are certainly gaps in our technical documentation but the last few weeks have been very challenging in Australia with COVID cases spiking extremely quickly. Our team are responding to outbreaks in Fiji and Palau and additionally, the last two weeks especially have seen many staff out sick or required to quarantine - this is not an excuse or a request for an extension, just a small explainer. We would welcome the opportunity to clarify any issues further however if they are unclear.

Thank you for a great application. Please elaborate on:

  1. How will the applications be expected to align and strengthen the shelf-readiness.
  2. How will certificates be generated for paper records incase clients do not have no access to mobile phones.

Thank you for the follow-up questions. Please see responses below:

1. The COVID-19 Digital Certificates will form part of the Tamanu vaccination module that has already been developed and is actively being used for Samoa and Nauru’s COVID-19 vaccination campaigns.  Through the development of the COVID-19 Digital Certificate in alignment with the WHO guidelines this will ensure that Tamanu can readily configure and implement COVID-19 vaccination certificates in alignment with country requirements and data standards.  

We were recently able to deploy our vaccination module in Tuvalu in less than a week in preparation for them to commence using Tamanu for their COVID-19 vaccination campaign. The COVID-19 Vaccination Certificate will ideally be included in such deployments once configured, improving Tamanu's shelf-readiness.

2. The certificates will be printable directly from Tamanu Desktop which health workers will have access to print.

Email functionality will also be added to the system so certificates can be sent to an individual's email which they will be able to print themselves if they have access to a printer.