COVID-19 pandemic brought to the fore the importance of authoritative data and authenticated data sources in medical field. From the early days of reporting on cases and hospitalizations around the world, individual test results reported by test providers in and outside the regular labs, to vaccine supply chains and vaccination records as shots-in-arms ramp up the health authorities, researchers, pharma industry, and regulators depend on accurate, real-time, trusted data from a vast number of diverse government and commercial organizations. And in some cases distrust of government authorities makes it vital that the data is stored in a tamper-evident manner so that its integrity can be audited and proven.
Perhaps then it’s not surprising that blockchain solutions have been used to enable these capabilities. Oracle customers have been using enterprise blockchain to address similar requirements in financial services, supply chain, and other sectors for a few years. Embracing the needs of the healthcare community and supporting customer and partner deployments as part of COVID-19 fight has been a significant focus for Oracle blockchain team during the pandemic – bringing our tools to the fight and helping partners and customers make a difference. Below are some of the examples of blockchain solutions deployed over the last 12 month.
Scientists around the world depend on data sources from a variety of national and international health authorities. But can they always trust the authenticity and integrity of the data they download and reference in their results? One of the early projects launched in the spring of 2020 to tackle these concerns was MiPasa.com – focusing on verified provenance and tracking of on-line datasets related to the spread of COVID-19 – datasets coming from the World Health Organization (WHO), national health authorities, hospital systems, etc. Ensuring that the datasets originated from the organizations they claimed to be from and to protect the data from tampering by anchoring the files on a blockchain (storing the dataset hash, digital signature of the originator, and related metadata for retrieval and verification) was the focus of the MiPasa.com data aggregation and analytics platform created by HACERA. It used a heterogeneous blockchain network created by Oracle’s partner HACERA integrating donated Hyperledger Fabric blockchain nodes from Oracle, IBM, and Microsoft clouds using the experience and standards from the Fabric Interop Working Group. Diversifying blockchain nodes across three enterprise clouds and multiple geographic regions was a key to ensuring decentralization and resilience. Building on verified data, MiPasa combined a variety of analytic tools with the blockchain infrastructure needed to make informed decisions based on data, insights and collaboration, at scale.
In 2021 MiPasa is expending both the underlying infrastructure and its decentralized app that is using Unbounded Network to support live vaccination dashboards and verifications through secure integrations of growing worldwide vaccination data. This allows multiple parties to share data and a range of mobile applications to integrate at scale to consume verified data in order to check the authenticity and validation period of test results and vaccination records. This makes it easier to meet the required travel rules and restrictions, help companies manage the safety of their staff through an ecosystem of data that is anchored by MiPasa’s blockchain network including Oracle Blockchain Platform nodes alongside IBM and MS Azure nodes leveraging the Unbounded Network.
By the summer of 2020 we’ve started seeing ramped up COVID-19 testing, but getting the accurate and complete data from various testing labs on a timely basis needed for health surveillance and pandemic mitigation efforts was a challenge. Test data reporting by various labs, agencies, and test manufacturers, who enable results collection, sometimes relied on ad-hoc processes and fragile tools – subject to omissions caused by human and network errors, risks to data integrity and potential for inaccuracies and fraud, inconsistent treatment of PII, etc. As FDA started approving at-home test kits and testing moved beyond the controlled environment of medical labs to work places, colleges and universities, airports, sports venues, etc., and eventually to at-home testing, these challenges grow – creating an urgent need to increase the trust in the completeness, integrity, and accuracy of the reported data, and the pandemic mitigation efforts that rely on it. Oracle has participated in US Department of Health and Human Services (HHS) At-Anywhere Diagnostics Design-a-Thon and won 1st place for its COVID-19 Immutable Test Results Submission and Visualization solution leveraging Oracle Blockchain Platform and Oracle Analytics.
Before the Design-a-Thon, Oracle worked with HHS to address the requirements for single source of truth across multiple agencies, data integrity, immutability/tamper-evidence, and privacy/confidentiality of the test results. We’ve deployed a permissioned enterprise-grade blockchain network using Oracle Blockchain Platform with APIs exposed via OCI API Gateway for submitting test results from one of the earliest available rapid tests – Abbott Labs BinaxNOW. These tests started shipping in the fall of 2020 to many non-lab locations (e.g., workplaces, nursing homes, etc.) where Abbott’s NAVICA mobile app was used to record the results and report them to Abbott. To meet the HHS goal of getting these test results on a near real-time basis and storing them on a secure immutable ledger, Oracle Blockchain Platform nodes for Abbott Labs, HHS, and other agencies are deployed in the Oracle Government Cloud, which has FedRAMP authorization. The BinaxNOW feed from Abbott Labs (originating in MS Azure cloud) into the HHS blockchain network has been live since early 2021 and has recently been incorporated into the HHS Protect Public Data Hub.
In parallel we have worked on extending the network with additional nodes to support on-boarding of additional test devices and manufacturers participating in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) program, which is aiming to speed innovation in the technologies for COVID-19 testing. While dozens of companies are working on bringing testing devices to market, Oracle and our partner Data Robot have been working with HHS to enable the use of the blockchain network as a secure, immutable ledger for standards-based direct reporting of COVID-19 test results from multiple diagnostic data systems, called Wireless Automated Transmission for Electronic Reporting Systems (WATERS). This system provides OAuth2-secured APIs for ingesting individual results via a REST call with JSON payload or a file submission in csv, hl7 (and soon FHIR formats). Once the call is authorized by the API Gateway, the data is pre-processed using Oracle Functions and Oracle Streams to un-batch files and validate the HHS-standardized fields, and the individual test records are then submitted to an Oracle blockchain node for persistence on the HHS blockchain network. The HHS-dedicated node also synchronizes the data through OBP rich history functionality into a database for access via Oracle Analytics as well as HHS Protect. As NIH RADx participants bring new testing devices into the market and FDA approved at-home tests accelerate their roll out, this infrastructure is ready to securely receive and store the results in the tamper-proof ledger distributed across HHS and other government organizations. Recently this system has received a conditional Authority-To-Operate (c-ATO) from HHS and has started live processing the results reported from Ellume COVID-19 Home Test users, with a number of other companies in pre-production testing. This capability will supplement the data from major lab facilities with “at-anywhere” testing data and help HHS and other agencies better estimate COVID-19 positivity rates, quickly identify hotspot outbreaks, evaluate regional risks, and use predictive analytics for just-in-time resource allocation and optimization of equipment, staffing, opening/closing facilities, distribution of vaccines and therapeutics, and more.
With the emergence of quick and easy-to-administer tests, which will gain momentum for use at home and in non-traditional testing venues, public health agencies at federal and state level will benefit from a secure, immutable, resilient, and authenticated (at a site or device level) data collection and reporting infrastructure based on managed Blockchain-as-a-Service (BaaS) capabilities that can be rapidly scaled in a cloud. Already we see efforts in some states to collect data from NIH RADx-spurred devices used in schools, congregate residence facilities, nursing homes, etc. Looking out a couple years, this new real-time data collection capability can be very useful beyond COVID-19 in public health monitoring in US and other countries. The key principles of standardized data reporting with security, non-repudiation, and tamper-evident distributed ledger combined with self-sovereign control over sharing PHI/PII information to ensure individual privacy enables public health agencies to leverage the aggregate data to detect and quickly react to emerging disease threats.
Capturing testing results and vaccination progress for government pandemic surveillance is just part of the need. Individuals need to be able to show their own negative testing results or that they’ve been vaccinated for air travel (at least internationally), have access to work sites, and potentially other gatherings (e.g., sports games, concerts, etc.) after lock-downs ease. However, as with other faked vaccination records seen around the world (e.g., fake yellow fever travel cards in Zimbabwe), the paper cards being issued today can be easily forged and even digital records linked to QR codes are not entirely safe, while so-called digital immunity passports, which are verifiable, can be controversial.
However, in US everyone has the right under HIPAA to access digital copies of their health information, including test results and vaccination records, and authorize an app to store this information on a blockchain with self-sovereign access control, making it cryptographically verifiable while protecting the individual’s right to decide who and when can access the data. Self-sovereign control by individuals is key to the acceptance of any digital immunity certifications, while cryptographic verification is a required baseline to avoid fraud – both of these requirements can be provided by a blockchain framework to ensure privacy and integrity of the data. There are multiple solutions emerging in the market, including two from Oracle partners Vottun and IDRamp. Vottun’s proof-of-health-credentials solution enables healthcare facilities to post test results that are immutable, secure, and that can be cryptographically verified on Oracle Blockchain Platform. IDRamp’s decentralized identity solution based on W3C Verifiable Credentials standard provides Hyperledger Aries compatible wallet, which leverages Hyperledger Indy deployed in Oracle Cloud to maintain credentials and Oracle Blockchain Platform to maintain a tamper-proof identity proofing records and access grants audit trail.
Of course, not everyone is going to be vaccinated even when supply of vaccines is no longer a barrier. People with allergies or other medical conditions may not be able to use current vaccines, while others are concerned about limited testing and potential long term effects, or impact of the new variants. Negative test results might be a useful alternative or supplement to vaccination records, and health credentials could combine both as long as they are relying on data from authoritative and verifiable sources.
Oracle is also participating in the recently announced Vaccination Credential Initiative (VCI) – a voluntary coalition of public organizations and private companies. The primary aim of VCI is to enable individuals to access a trustworthy and verifiable copy of their vaccination records in digital or paper form leveraging SMART Health Cards Framework based on W3C Verifiable Credentials specification to create an open and interoperable technical foundation that can support national and global needs. VCI efforts are just beginning and we will share updates in this blog as they evolve.
With the recent focus in the news on the details of vaccines manufacturing and distribution, more people are becoming aware of the pharmaceutical industry dependencies on complex supply chains for chemical ingredients, glass vials, etc. as well reliance on contract manufacturing partners, and extensive distribution chains involving 3rd parties before the drugs reach hospitals, clinics, and pharmacies. However, according to WHO research, an estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, and with the high rates of imported drugs in the high-income countries the problem reaches everywhere. For example, in Sweden a survey showed that 78.5% of the physicians had heard the term ‘illegal and falsified medicines’ and 36.5% had met patients they suspected had taken it. COVID-19 vaccines are certainly not immune from these issues (see a recent Wired article on Dark Web Teeming with Vaccine Listings.) In addition with vaccines being very temperature sensitive tracking the environmental conditions during transport and storage is critical, and there’s a heightened risk of some vaccine shipments degraded in transit or thawed but left over at the end of the day nevertheless appearing on the dark web.
Based on the need to manage and update the provenance and environmental data from a wide range of sources, blockchain-based track & trace solutions, such as Oracle Intelligent Track and Trace are being explored globally as a better way to handle the decentralized tracking needs. They can ensure that every step and each hand-off between organizations is properly tracked in a tamper-proof ledger, including identity verification of the personnel involved in distribution of shipments, and combine this data with IOT sensors reporting on the geo-location, temperature, and other environmental conditions for full traceability. Linking all of this information in an easily accessible cloud-based distributed blockchain ledger based on open standards enables verification of authenticity and quality at point of vaccination, both by the healthcare staff, and, optionally, by the patient using an app to scan a bar code or QR code on a vial in order to view the lot lineage and its related trusted records attested to by all the relevant participants. For more info, here's a live product tour through a pharma industry vaccine tracking use case.
While these examples are gaining visibility in COVID-19 fight, once the use of blockchain has been pioneered in these different use cases in 2020 and extended in 2021, its benefits will become evident in transforming disease testing and public health surveillance, electronic records sharing, and drugs traceability in healthcare overall, and we will most likely see the COVID-19 specific solutions evolve to broader use in 2021 and the next few years.