Healthcare

In March 2020, the world was devastated by a global pandemic that fundamentally restructured the way we live and do business. Now, a year to date later, we are lucky to be at the point where multiple vaccines have been approved and administered to the public. Alas, vaccinating the global population against COVID-19 has proved to be one of the biggest challenges humanity has ever faced, both with unique distribution and logistical challenges. 

To date, as per March 10th, there have currently been ~93.6 million vaccine doses administered in the US and 23.7 million administered in the UK¹.

At the moment, there are multiple different COVID-19 vaccines that have been authorized and recommended, with others in advanced stages of development. While they have all been developed with the same goal in mind, there are substantial differences between the jabs from their composition and reported effectiveness, to their price and ease of conservation, and distribution obligations. For instance, some vaccines are incredibly time and temperature-sensitive, requiring a life of 5-8 days only with temperatures as low as -75C, whereas others can be maintained stable for 30 days at a temperature between 2C and 8C. Needless to say, the logistics and operations of selling, storing, shipping, and administering each of these vaccines is incredibly time-consuming and overwhelmingly manual, only increasing the burden when one administrator must manage large purchase order quantities of two or more different Covid-19 vaccines.

With particular reference to the distribution of the vaccine, a few challenges must be noted. Namely

• Demand Forecasting – What is the total quantity required for shipment 
• Supply Chain Management – How it should be sent to purchases and distributed once arrived to host countries
• Quality Assurance – How and by whom it should be administered, and with what specific procedure to ensure appropriate provision
• Monitor and Mitigation – How people who have received the vaccine should be monitored, particularly where potential collateral effects may rise 

With these vaccines quickly coming to market, it is no surprise that governments and enterprises around the world are exploring solutions, such as vaccine credentials or digital immunization certificates, that can streamline the rollout of vaccines. Many of these solutions leverage combined emerging technologies such as artificial intelligence, machine learning, Internet of Things, and distributed ledger or blockchain technologies

The Powerful Combination of Internet of Things (IoT) and Distributed Ledger Technologies (DLT)

 The combination of IoT and blockchain, in particular, opens the door for new systems that inherently reduce inefficiencies and increase transparency for all involved parties. Take a supply chain for example: the accessibility and geolocation functionality of IoT, paired with the accounting of blockchain and DLTs has created new systems that foster supply chain accountability and integrity unlike any before seen solutions. The coupling of these technologies allow an asset to be tracked from the moment the raw materials are mined and among every step of the supply chain until it is with the end consumer. Without leveraging various device intercommunication capabilities and a strong audit system such as the one perpetuated by DLT, this would be virtually impossible (without large-scale human intervention).

Everis and NTT Data have developed such a tool that combines IoT and Hyperledger Fabric, allowing users to track any type of virtualized asset such as bulk or trade item products, additives, packaging materials, logistic units, and more, from any device. The solution utilizes Hyperledger Fabric to ensure that corresponding transactions are stored and accounted for when reviewing the movement of the assets. This ensures data security, transparency, and an indisputable audit trail, while allowing for automation (via smart contracts), simplification due to a shared truth (ledger), increased security, and certification capabilities.  

Future Applications of Blockchain/DLT in Covid-19 Vaccinations

As both Covid-19 vaccines and DLT+ IoT technology solutions remain in their infancy, only early implementations have been seen – as such, we can expect to see a variety of future applications that have not yet been pushed to production. This may include implementations to alleviate key pains including negotiations, logistics, and fraud prevention.

• Supply Chain Integrity and Validity of Origin: Analysts project that Covid-19 vaccines will be the highest demand counterfeit drug on the black market for 2021³. Track and trace DLT networks with blockchain-based authenticity certificates could allow purchasers to ensure the origin of the vaccination and track the journey throughout an often global fragmented supply chain. We believe that leveraging IoT and a mature enterprise blockchain such as Hyperledger Fabric would create an accountability and tracking flow to benefit all parties, virtually removing the possibility of receiving fraudulent or counterfeit drugs. In this case, Hyperledger Fabric’s architecture and IoT could benefit the proposed solution as outlined below.

	Hyperledger Fabric(4)	IoT
Flexibility	The programmability of Hyperledger Fabric allows for the flexibility required to digitize complex supply chain operations. For example, trust assumptions for chaincodes are separated from trust assumptions for ordering, ensuring that ordering services can be provided by one set of nodes and tolerate some failure or misbehaviour, depending on the lenience in the business case at hand. It also allows for separate channels per company or shipment, and that endorses may be different for each chaincode, allowing for customization while maintaining privacy and security. In this use case, this is particularly relevant as the system design can be built to ensure end-to-end tracking where any (movement) data is logged or payments are made leaving no room for the entry of malicious actors.	IoT allows for multiple types of devices to communicate with one another achieved thanks to different IoT protocols such as Bluetooth, ZigBee, MQTT or CoAP. This ensures that sensors or equipment, from the time of production through to delivery, can communicate with devices of key stakeholders throughout the entire process, from the time of production through to delivery,  adding a layer of reassurance for all parties. There is no room for counterfeit drugs to enter the value chain if tracking is end-to-end.
Confidentiality	There is a possibility to add confidentiality requirements to chaincodes, so that content and state of transactions can only be updated if requirements are met. This ensures that the strictest of confidentiality is ensured across the supply chain.	Confidentiality is often embedded in the design of IoT systems. In this use case, it would be key to ensure that the security and authentication measures only permit participants who have defined roles in the system which require the logging of data. As such, end purchasers can review the roles of all parties involved throughout the entire production and shipping process.
Consensus	The modular architecture allows for pluggable consensus, which provides an added level of customization. The endorsement policies can include checking the certificate details, roles of the requester, or executing chain code. This allows for originating companies to build a consensus mechanism that suits only their operational process and can remove any possibilities for counterfeit drugs to enter the value chain. It also retains a level of programmability and flexibility, which may be required to build a solution across multi-national vaccine supply chains.	With specific solution design and consented user permissions, there is no room for disruption across IoT devices or networks.

Cargo Storage Space: With temperature and time-sensitive lifecycles, the vaccines must be shipped in specific conditions. By tracking cargo ship storage space and corresponding vaccinations through asset tracking DLT networks, logistical burdens can be minimized. 

Smart Contracts for Negotiations: To date, many governments around the world have found themselves susceptible to private battles with vaccination companies. With high global demand and few verified suppliers, private companies hold essentially all bargaining power. As seen in Canada, Italy, and other countries, this allows the companies to delay sending vaccinations even after payments have been made and force better conditions including import tax payment delays, among other critical legal disputes⁵. By leveraging a smart contract in the negotiation process, any room for intermediation is removed as they will be self-executing with previously agreed upon terms. 

Ultimately, it is clear that there is a strong cause to leverage IoT and DLT technologies to ameliorate the current Covid-19 vaccination system, from logistics to temperature monitoring and negotiations. Though there are currently only a few systems in production, we can assume that the efficiencies brought forth perpetuate more use cases in the future. 

1. https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/
2. https://developer.ibm.com/patterns/develop-an-iot-asset-tracking-app-using-blockchain/
3. https://www.afro.who.int/news/fighting-fake-immunization-travel-certificates-frontier-technologies
4. https://hyperledger-fabric.readthedocs.io/en/release-1.3/arch-deep-dive.html
5. https://www.ctvnews.ca/health/coronavirus/negotiating-contracts-for-vaccines-in-development-needed-flexibility-anand-1.5218491

Cover image by torstensimon from Pixabay.

The accelerating digitization of the healthcare sector has led to the creation of large volumes of sensitive data stored online. Swiss eHealth strategy promotes the adoption of the electronic patient record to allow registered patients and authorized healthcare professionals to access medical data anytime and anywhere. To achieve this, a reliable, compliant, and privacy-preserving solution is required to support definition, maintenance, and enforcement of fine-grained authorizations (consents). Convergence of distributed ledger technology and intelligent data management approaches provides a unique opportunity to bring trust, transparency, auditability, and optimization of medical data management and other healthcare processes. 

Recent research works and numerous PoC implementations actively demonstrate the value of blockchain technology for connecting health care stakeholders in order to help maintain a complete history of patient’s health care data, ensure traceability of the data exchange and automate claims and reimbursement processing. Transparent and auditable prescription monitoring may help to avoid incompatibility of the prescribed medications and can provide incentives for writing fewer prescriptions for certain medications such as opioids. In the pharmaceutical supply chain, blockchain can bring traceability to the tracking of pharmaceutical goods, from verification of the producer, to the transportation and storage conditions and control over drugs returned to the pharmaceutical company. Applying blockchain technology in biomedical research may facilitate new ways for patients to contribute with their healthcare data while ensuring privacy and security and  may  speed-up participant recruitment and collection of large and integrated heterogeneous data. When building such heterogeneous datasets, ensuring authenticity of the data and their sources is essential in order to make informed unbiased decisions and get valuable insights from the data. 

What are the important aspects and potential hurdles that deserve attention from practitioners when employing blockchain in the healthcare settings? While domain-specific requirements to the system functionality vary depending on the application, desirable properties of a resilient healthcare infrastructure for management of the sensitive data distributed among multiple sources are: data and process interoperability, privacy, security, and compliance. For instance, in the case of connecting healthcare stakeholders to facilitate management of patients’ history, some of the most important requirements are ensuring patients’ rights to access and share their sensitive data but also to erase their personal data. To achieve these, the system must ensure interoperability (i.e., must have the ability to exchange and interpret the data) and must be privacy-preserving (i.e, the patients must be able to have full control over the sharing/access revocation/erasure of their data). 

Data erasure (i.e., the possibility to erase the data) itself is not an “out-of-the box property” of the blockchain technology. It is challenging to comply with the right of data erasure when using immutable ledger. However, different approaches exist to address this issue including off-chain management of sensitive data, privacy-preserving techniques (such as encryption, zero-knowledge proofs (ZKP), secure multi-party computations (MPC), and data pseudonymization and anonymization. If anonymized data are released, a reliable infrastructure is required to support a trustworthy collaborative environment and to verify that the data were not altered. 

The choice of the appropriate approach depends on the underlying blockchain technology, the number of participants in the network and the sensitivity and volume of the data, among others. Moreover, patient control over his identifiable data and his actions (for instance, providing consent or authorizations) has to be efficiently verifiable and compatible with access to the data in an emergency situation such as when the patient is unconscious.

Hyperledger Fabric is a permissioned blockchain technology framework that has been actively employed in the implementations of blockchain-based systems for healthcare data management. To ensure privacy of data subjects, Fabric mainly relies (i) on multiple channels support, which make it possible to limit the access to the data to certain participants of the consortia, and (ii) on private collections where sensitive data can be exchanged peer-to-peer and stored in the private databases, yet accessible from chaincode on authorized peers and hashed to verify authenticity. Storing only hash on-chain is also used to provide verifiability of vast amounts of anonymized data for data-driven research and applications. In this case, contrary to limiting the access to the data, it is of a high importance to set up a reliable multi-cloud environment and collaborative framework – a step forward towards attaining interoperability. 

Blockchain infrastructure offered by Swisscom provides support for multi-cloud environments. Multiple non-endorsing peers provided by Swisscom are now dedicated to support verifiability of public COVID-19 related data, as a part of the multi-party, multi-source verifiable data sharing platform MiPasa. To address the scale of the problem, the types of data, languages, time-zones and jurisdictions,- many vendors joined forces to strengthen and support this blockchain-based shared infrastructure to unlock the potential of the data and deliver integrated, trusted, and verifiable insights across multiple industries around the globe. 

Four billion prescriptions were dispensed at US pharmacies in 2019, and even conservative estimates suggest that over 100 million prescriptions may be incorrectly dispensed. To address this problem, healthcare leaders are actively working to put new tools into the hands of pharmacists to ensure the right drugs reach the right people.

Part of that effort is the Drug Supply Chain Security Act (DSCSA), an ongoing, decade-long effort to track and trace prescription drugs in the United States. The DSCSA is intended to enhance the FDA’s ability to help protect consumers from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The vision is to have an interoperable system in place by 2023 that will allow for drug tracing, product verification, and prompt detection and response protocols to handle all suspect medications. To get the system in place, the FDA turned to the public in 2019 and asked for new, cutting-edge approaches to improve the prescription pipeline.

LedgerDomain, an enterprise-grade blockchain solutions provider known for its work on developing the next generation of healthcare and pharmaceutical supply chains, was one of the companies that responded to the FDA’s request. LedgerDomain’s proposal of a blockchain-based solution in collaboration with UCLA and the pharmaceutical company Biogen was selected by the FDA as part of its pilot project program. 

LedgerDomain’s pilot centered on the development and live testing of BRUINchain, a blockchain-based system that meets DSCSA standards for pharmaceutical dispensers all within a shared-permission yet private ecosystem. While the pharmaceutical supply chain has numerous stakeholders, BRUINChain, which is built on Hyperledger Fabric, establishes one version of the truth for the pipeline that is immutable and invaluable.

The team tested BRUINchain within UCLA Health’s network of 500 pharmacists and technicians, focused on tracking the drug Spinraza, the first medication approved to treat children and adults with a rare and often fatal genetic disease called spinal muscular atrophy. The results exceeded UCLA Health and LedgerDomain’s expectations. The BRUINchain app’s barcode scanning functionality on iPhones was 100 percent effective, and the Hyperledger Fabric-based system was able to track every dose of Spinraza at UCLA Health, down to which refrigerator each dose was stored in across the campus. Even before the pilot ended, the team was adding new functionality and products as the network of pharmacists grew more reliant on the BRUINchain system. 

Hyperledger teamed up with LedgerDomain on a detailed case study on the BRUINchain pilot, including deployment details and results, projected cost and time saving and next steps based on the solution’s success to date.

Read the full case study here.

Before new medicines can reach the patients that need them, the pharmaceutical and biotech companies that develop them must seek FDA approval. As part of this process, pharmaceutical companies sponsor highly controlled clinical studies in medical centers, called “sites.” The number of active studies has doubled over the last 10 years, and study sites are bursting at the seams. With the rise of personalized medicine and increasingly specialized shipping and storage requirements, this trend can only accelerate.

At LedgerDomain we’ve partnered to tackle this challenge with a broad spectrum of industry leaders, including pharmas, contract manufacturers, research organizations, academic sites, and couriers. At the heart of this effort is the world’s first iOS blockchain app for pharmaceutical supply chain, which we presented last month to the Hyperledger Healthcare Special Interest Group (HC SIG).

Today we’d like to dig beneath the surface of our efforts in this space. We’ll cover some lessons we’ve learned along the way, and how blockchain can speed innovative medicines to the patients who need them. We’ll also give you a sneak peek at a live pilot happening right now, where a blockchain-based solution is being used to deliver lifesaving medicines to real patients.

Why Hyperledger for healthcare?

We chose to join the Linux Foundation and Hyperledger in 2016 after a simple realization – most of our clients and prospects were apprehensive about coin-based models. Hyperledger Fabric represented a different approach to blockchain that aligned with their values at a deeper level. It’s no wonder that the community has come a long way since, emerging as the blockchain platform of choice for global enterprises. 

Coin-based models can serve as a fantastic incentive for participation, but not everyone in every jurisdiction is ready for cryptocurrency. A second factor that sets Hyperledger Fabric apart is its focus on privacy. While everyone is looking for the magic bullet that will enhance track-and-trace capabilities across the drug supply chain, nobody wants to risk leaking patient health records from a public blockchain across the dark web.

The DocuSeal framework

Highly regulated enterprise communities have unique requirements. Much of our work on Hyperledger Fabric has centered on specialized multi-threaded experiences designed for compliance with HIPAA, GDPR, Cal Privacy, and data privacy laws just over the horizon, performing at scale.

With that in mind, we built DocuSeal, a framework designed for blockchain-powered document authentication through an iOS application. With DocuSeal, uploaded documents are sealed in private storage, tied to a unique hash that’s immutably stored on a private blockchain. Documents can be shared with other users or deleted.

DocuSeal makes it possible to verify the authenticity of any document each time it’s accessed. At the same time, the “right to be forgotten” is preserved, as the private storage can be wiped if necessary while the hashes on the blockchain are preserved. To assure real-time performance metrics, we use Selvedge, our enterprise-grade blockchain app server developed in Golang on Hyperledger Fabric. 

We designed the DocuSeal framework so users could be up and running in minutes with simple document storage and sharing – similar to Dropbox – plus serious security and timestamping. But underneath this simple interface, our stakeholders can leverage the power of smart contracts to drive inter-enterprise workflows.

How blockchain can speed innovative medicines to the patients who need them

Testing new medications is an extraordinarily complex process. Right now, over 800 biotechs and pharmas are working with their vendors to supply medicines for over 10,000 clinical studies to tens of thousands of clinical sites. And the number of studies is constantly growing.

While some clinical sites are just a doctor and an assistant, large academic centers aren’t like your neighborhood Walgreens or Boots. They’re massive warehouses with pallets loaded with experimental medications. One of our partners, UCLA, has 700 clinical studies sponsored by 100 different companies. This is a massive undertaking where no single pharma’s proprietary system can predominate, so everyone has fallen back on paper.

With that in mind, in 2017, we joined forces with other industry leaders as part of the Clinical Supply Blockchain Working Group (CSBWG), which includes Pfizer, IQVIA, UPS, Merck, UCLA Health, GSK, Thermo Fisher, and Biogen. Over the course of two years, we built out a pilot on Hyperledger Fabric to address this challenge directly. We named it KitChain

(Want a deeper dive on technical specifications? Check out our white paper!)

Big picture: supply chains and blockchain

KitChain was a major milestone for the supply chain for clinical studies, but meanwhile the stakeholders on the commercial pharmaceutical supply chain were struggling to meet their own challenges. Everyone is looking ahead to 2023, when the Drug Supply Chain Security Act (DSCSA) will come into full effect with sweeping requirements for traceability across the entire pharmaceutical supply chain.

With that in mind, the US Food & Drug Administration (FDA) came out earlier this year in search of enterprising stakeholders to help them tackle the problem of counterfeit and suspect medicines. 

In response to the FDA’s call for pilots to address this challenge, we partnered with UCLA Health to launch the only pilot of its kind. We’re building and testing a last-mile blockchain-driven solution designed to help deliver lifesaving medications to real patients. This solution features an intuitive iOS client running on our Selvedge app server and smart contracts, all powered by Hyperledger Fabric.

This is a “rubber hits the road” moment for supply blockchain: out of the workshop and into the real world. Our living supply chain solution captures all the transactions – from the loading dock to the patient. It will capture the data needed to develop trends and analytics, and be able to surface risk management issues. But most of all, it’s designed to handle the human element – because in the real world, sometimes things happen you don’t expect. A blockchain system that doesn’t allow for human factors will no longer reflect the ground truth. These are all things we’re working on right now, and we look forward to sharing our findings and connecting with you in Phoenix at Hyperledger Global Forum 2020.

The Hyperledger community has grown and matured over the last three years, and we’re honored to be a part of building the future of blockchain. Delivering our full-stack enterprise-grade solution by ourselves would have been impossible, but by joining Hyperledger and the Linux Foundation, we’ve been able to contribute while standing on the shoulders of giants.

About the Author

Ben Taylor is the CEO of LedgerDomain, founded in 2016 to bring Hyperledger blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies.

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