The Digital Immunization System of the Future: Imagining a Patient-centric, Interoperable Immunization Information System

"[A]s the world prepares for a potential pandemic vaccine for SARS-CoV-2, effective immunization systems will be essential."

The maturity of cloud systems and mobile technologies has created new possibilities for immunisation information systems (IISs), which are centralised repositories of personally identifiable vaccination information. IISs serve a variety of functions, such as identifying certain populations by behavioural and other characteristics who are at risk for under-immunisation and combatting vaccine hesitancy. This paper outlines a vision for the next generation of digital IISs based on the researchers' experience in Canada. Ultimately, these systems aim to improve immunisation practice "by automating and streamlining the role of public health and by providing the public with tools that empower and engage them in the immunization process."

The paper begins by exploring the challenges that IISs of the future will need to address, including the ability to capture quality data, the need to enhance interoperability, and logistical and policy issues. For example, determining accurate vaccination coverage among undocumented migrants and refugees can be difficult in cases where these populations are hesitant to register with health authorities, or there is a lack of coordination in recording multiple doses that are often administered by multiple providers.

Central features of the IIS of the future the researchers envision are:

• The ability to connect the public, healthcare providers, and public health through simultaneous access to immunisation records - A set of interoperable systems (see figure above) would enable each stakeholder (healthcare providers, public health officials, and individuals) would be using a system specifically designed to meet their particular needs. For instance: "With a personal immunization record, patients will be free to store the record where they choose, in the format they choose, and to provide this record to applications of their choice that may provide additional services beyond what can be provided by public health authorities." The researchers stress that the storage of personal health information in an IIS entails the requirement to develop processes and procedures to manage consent directives across the various systems. For example, if a parent does not consent for their teenager to receive a human papillomavirus (HPV) vaccine, but the adolescent (who would be acting as a mature minor) provides consent, both the consent for service and the HPV dose should be blocked from being communicated back to the parent from the IIS.
• Needs analysis, hot-spotting, and vaccine messaging to combat vaccine hesitancy - For example, data linkages identifying unimmunised children would permit public health officials to detect early trends in immunisation sentiment or coverage (or lack thereof) in a specific region or population; upon identifying a pocket of need, health officials could design an intervention tailored to build vaccine confidence by addressing the specific causes underlying suboptimal vaccine coverage.
• Digital consent for immunisation - A system that allows individuals to access comprehensive information about a vaccine prior to a health clinic appointment and provides a platform to give consent digitally could promote more effective care between healthcare providers and patients. For those not comfortable providing consent ahead of time, the IIS could prompt individuals to catalogue their concerns and prepare for a conversation with their provider.
• Adverse event following immunisation (AEFI) reporting - The researchers point out that poor vaccine surveillance systems can create distrust and spread misinformation. They suggest that soliciting public data on AEFIs is particularly useful for detecting unusual or unexpected patterns that might indicate a possible safety problem with a vaccine. Mobile reporting of an AEFI using SMS (text messaging) and web-based reporting has been examined settings such as Cambodia, demonstrating high response rates and providing real-time reporting. A personal immunisation record solution could also provide a channel for public health officials to send notifications to individuals who received a vaccine from a lot determined to be defective; educational information could then be rapidly shared with affected individuals. However, there are some concerns and caveats; for example, such a reporting system could be vulnerable to "exploitation by individuals or groups harbouring anti-vaccination sentiment if mild reactions are flagged and amplified on social media as serious safety concerns. Therefore, further studies are required to evaluate the impact of an app that facilitates mobile AEFI reporting on vaccine hesitancy."
• Digital verifiable immunisation receipts - Providing patients with the ability to prove they have received an immunisation could be integrated into a country's border control procedures.

To enable these solutions, there are some obstacles to be overcome, the researchers stress. To name one: "Public health will need to look to technology to get the data they want without interfering with the providers' interaction with the patient." Also, in the context of a possible vaccine for COVID-19, a large number of doses will need to be administered over a short time, which would challenge IISs with managing safety and effectiveness data in a way that maintains public confidence in the programme. They explain: "The participation of the public in these systems via digital technology will enhance their effectiveness..." Furthermore: "Analogous solutions that leverage technology more readily available in lower-resource settings should be urgently explored as the safe and effective roll-out of a pandemic vaccine, as well as the ongoing monitoring of existing immunization campaigns, is critical."

Despite these challenges, the researchers conclude that future IISs hold the potential to "reduce many of the known barriers that influence immunization rates. In light of the global COVID-19 pandemic, adaptive digital public health information systems will be required to guide the rollout and post-market surveillance of the SARS-CoV-2 vaccine."