As COVID-19 vaccination increases the US is preparing for a phased reopening. A key factor of that reopening in the United States and some other countries may be a requirement for individuals to prove that they have been vaccinated against COVID-19. “Proof” will likely be embodied in a paper – or perhaps electronic – certificate whose source and contents can be independently verified to ensure validity. Uses of such a certificate include international travel, and perhaps also domestic regional travel (like what is being proposed in the European Union), and perhaps also domestic travel, admission to large venues such as sporting events or other entertainment, and even school or business admission.
The digital community has been especially active in thinking about how digital vaccine certificates might be implemented. Most of the major initiatives are international in focus and many consumer-oriented software and app developers are engaged in these efforts. Open source solutions and open standards are a key components to the emerging solution set.
All of the efforts seem to have identified three roles: the “issuer” who has the vaccination information initially; the “holder” who is usually the citizen who wants to show that information when required; and the “verifier” who wants to view that information and validate its authenticity. There are many, many unknowns about how these roles will play out, especially when both data and people cross international borders where policies and medical practices differ.
Part 1 of this series discussed several potential sources of data for the certificate in the US.
The initiatives identified in Part 2 below and much of the emerging dialogue on this issue are focused on the techniques and technologies for allowing the patient to present these data to support the use cases identified with little emphasis on the source of the data. There are many initiatives underway around the world and they are attacking the problem from different perspectives. Some are national initiatives within specific countries or regions (like the EU). Some are vendor-driven and focus on particular product solutions in a wide-open, competitive marketplace. Some are focused on the use of open source electronic health records as the driver for more fundamental management of clinical data – including COVID vaccination data – with digital vaccine credentials being just one of the by-products of that effort.
There are at least four major initiatives that are focusing on the standards that may be necessary for a vaccine credential with no apparent convergence in their activities (though Good Health Pass in one effort trying to foster collaboration across projects). Inclusion of any particular effort here should not be interpreted as an endorsement of its activities but merely as a way to share information about its activities:
- Vaccine Credential Initiative (VCI): This initiative is backed by a number of major technology players and non-profit organizations, including the Commons Project and its CommonPass. This group is actively working on developing prototype software that implements a set of features based on the SMART Health Cards Framework and drawing on W3C standards. Major artifacts include a draft FHIR Implementation Guide, active development and discussion on Github, and bi-weekly workgroup calls.
- COVID-19 Credential Initiative (CCI): This initiative is affiliated with Linux Foundation Public Health (LFPH). It strives to develop open source solutions for vaccine credentialing and involves over 300 individuals and more than 100 organizations. Several work streams have been initiated including a marketing and communications task force, a use case implementation workgroup, a rules and governance workgroup, a schema task force, and interestingly, a US-focused subgroup. CCI seems to be a little further behind on any actual software development and a little more interested in focusing on the sources of data.
- WHO Smart Vaccination Certificate Working Group (WHO): This is a software neutral group that is going to focus on common specifications for this functionality. WHO is assembling a panel of experts to guide its activities. Interestingly, the WHO is piloting an approach for a digital version of its international certificate of vaccination(“yellow card”) with the country of Estonia based on an architecture described in a white paper by its vendor partner. WHO is also working with W3C on its vaccination credential work and the European Union already has guidance on sharing this data.
- Path-Check Paper Credential: Also worth mentioning is an effort to recognize that not all individuals are able to possess or access a digital certificate, and there is a place for digitally-enabled paper-first verifiable certificates as well. CCI is convening a summit on this topic.
The initiatives identified above and much of the emerging dialogue on this issue are focused on the techniques and technologies for allowing the patient to present these data to support the use cases identified with little emphasis on the source of the data. HLN, a leading public health informatics consulting company, offers critical thinking, products, and strategies to assist public health agencies and their data exchange partners in understanding the landscape and crafting data management solutions. Our award-winning Immunization Calculation Engine (ICE), a fully open source immunization evaluation and forecasting system, is often one important piece of the puzzle since forecasting future doses is an important part of any vaccination campaign.
In the third installment, we think about the path forward in vaccine credentialing for the US.