Tracing HHS Blockchain Adoption

 In Healthcare Pulse

Blockchain is the technology that has traditionally been associated with enabling digital currencies like Bitcoin, but companies have been pushing to introduce blockchain to the healthcare industry through new offerings, start-ups, and pilot initiatives.

Government agencies have also begun exploring this technology in various capacities over the past several years, but opinions on uptake have been divided. So, what really is the state of HHS blockchain adoption, and what does future usage look like?

What IS Blockchain?

Blockchain is a technology protocol that enables the recording of transaction data in a secure and publicly available way. While there are many technical details, a broader explanation of blockchain’s fundamental concepts and characteristics illustrates its relevant applications outside of digital currencies.

Blockchain is often used as a distributed ledger – a decentralized public database recording all transactions within a system.

To ensure that all parties have identical, legitimate ledgers, the blockchain protocol leverages the pooled computational resources of the entire network to determine whether new transactions added to the ledger are valid and should be included by all users.

This approach results in a system with two key characteristics:

  • Immutability: It is effectively impossible for any party to modify past and present records, as all participants’ copies of the ledger must be in agreement per the protocol.
  • Transparency: Transactions are collectively verified, and the resulting ledger is accessible by all relevant participants.

Designing a robust blockchain system is complex and requires the development of new software infrastructures.

Certain processes benefit more from this technology, and relevant problems should include some combination of the following considerations:

  • Traceability: Organizations must be able to audit a consistent data record of interactions, transactions, and user accesses.
  • Reliability: Data must be verifiable, accurate, and resistant to tampering and adjustment.
  • Accessibility: Many users within or between organizations must contribute or access data in a secure and consistent format.

HHS blockchain adoption has the potential to be transformative, as the department deals with high contractual volumes, requires secure and transparent datasets, and oversees a huge diversity of programs, if agencies can find meaningful use cases to warrant the needed technical investments.

HHS Blockchain Adoption To Date

HHS and its agencies, in particular the FDA, have been early federal pioneers in blockchain programs and pilots. Specifically, three use cases have seen early traction:

  • procurement/grants management,
  • supply chain tracking, and
  • health data sharing.

HHS Accelerate: Procurement

HHS Accelerate is a blockchain-powered contracting infrastructure that enables department-wide procurement data sharing, contract streamlining, and analytics for decision-making.

This is one of the most well-known HHS blockchain applications, as former CIO Jose Arrieta was a vocal champion of this program from its initial 2018 pilot to becoming the federal government’s first blockchain program to receive an authority-to-operate in 2020.

Given the system’s initial successes in 2020, this new department-wide procurement approach may trickle down to the OpDiv level, resulting in increased technology familiarity as OpDivs transition onto the blockchain-based system.

This process has potentially already begun, as the NIH awarded contracts in 2020 for strategic blockchain transition and infrastructure support for Accelerate. HHS Accelerate marks an important milestone for blockchain visibility and utilization at HHS.

FDA RAPID: Data Sharing

Beginning in late 2015, CDER’s Data Mining and Informatics Evaluation and Research team, in collaboration with industry, developed the Real-Time Application for Portable Interactive Devices (RAPID) system, a blockchain-based solution for mobile solutions enabling real-time health data exchange. This emerged as a relatively mature platform by 2019 and has been utilized in support of the FDA’s Opiate Surveillance Data Strategy.

FDA and its industry partner also conducted a 2018 pilot with the FDA’s Office of Translational Sciences and four hospitals aimed at improving access to interoperable health data to improve patient outcomes.

Together, they developed a blockchain solution with an “off-chain” data sharing system to protect PHI. While this pilot was planned to expand to 20+ hospitals, no public updates were announced, and momentum appears to have stagnated.

FDA DSCSA Pilot: Supply Chains

The FDA is in the process of developing its next-generation interoperable, traceable electronic supply chain system for 2023 as part of the Drug Supply Chain Security Act (DSCSA). Towards this goal, the FDA established a 2019 pilot to explore various technologies, and 6 of the 20 selected projects were based on blockchain.

The key requirements for the electronic supply chain system include traceability, verification, and distribution, making it a natural fit for the blockchain technology. Pilots concluded by mid-2020, and most notably, the blockchain solutions all successfully met the stated key objectives.

The FDA recently held a lessons-learned public meeting in Dec. 2020, writing that “many potential technologies or solution approaches, including blockchain-based systems, do demonstrate significant promise but still need more time to be fully understood and tested.”

As the FDA continues evaluating the pilot results, blockchain capabilities will likely become a notable requirement for the future DSCSA program of record.

HHS Blockchain Adoption Models

The history of adoption at HHS highlights three types of potential customers for blockchain technologies, each of which requires its own strategic consideration given the varying views of HHS blockchain use cases.

  • High-Alignment: These customers, such as the FDA, are currently and actively engaging with blockchain technology due to strong mission alignment. Utilization is maturing, with nascent opportunities emerging and pilots reaching maturity. These should serve as the most immediate near-term targets, with focus on shaping opportunities.
  • Slowed Interest: These customers, such as the CDC, have previously expressed interest in blockchain, but momentum appears to have slowed despite potential mission alignment. Adoption may rekindle depending on internal influences (e.g., top-down departmental initiatives or peer agency successes) or external influences (e.g., industry investment in partnerships). These customers should be continually assessed or actively shaped.
  • Generating Use Cases: These agencies, such as CMS and the VA, have evaluated blockchain but found no immediate use cases. Some have even gone so far as to resist consideration. While there may be a fundamental misalignment between the agency’s mission/activities and the technological use cases for blockchain, it may also be that customers require input to identify tailored and mission-specific capability alignments. This will require active resource allocation, BD, and assessment, making these customers long-term targets.

Evaluating your current/potential customer positioning and understanding their current blockchain perspective should be a key component of assessing your HHS blockchain strategy.

Blockchain: An Increasingly Important, but not Fundamental, Building Block

Recently, blockchain has received notable support from HHS leadership at various levels. Former HHS CIO Jose Arrieta and former HHS Division of Acquisition CTO Oki Mek were strong proponents of blockchain and spearheaded HHS Accelerate; former acting FDA CIO Amy Abernethy implemented the ongoing 2019 Technology Modernization Action Plan and previously cited blockchain as a technology of interest.

Individual HHS blockchain programs and pilots continue to drive interest in blockchain. However, the abrupt departure of Arrieta in 2020, unexpected departure of Abernethy in 2021, recent appointment of Mek as HHS Chief Artificial Intelligence Officer, and evolving Biden administration priorities for HHS create uncertainty for continuity of leadership interest.

Unlike AI or advanced analytics, blockchain has specialized applications and requires buy-in from many stakeholders, whether along a supply chain or across hospitals providing protected health information for research.

Blockchain is a rapidly maturing, but ultimately enabling, technology, and traditional approaches may already efficiently satisfy needs in many areas.

While it is important to build out blockchain capabilities as adoption accelerates and HHS blockchain use cases evolve, it is also necessary to examine the relevance of this technology to one’s client- and problem-set.

Continual assessment of HHS’ blockchain strategies and the problems they seek to solve, and how you may be able to address them with blockchain or other emerging technologies, will be key as the HHS leadership landscape settles and technology plans emerge.

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