Accelerating Digital Health Trends and Transformation through Scientific Communications

The editorial is taken from commentary presented at the ConVerge2Xcelerate (#ConV2X) 2021 Symposium entitled "Blueprint for a New Digital Health Era." Tory Cenaj is the Owner and Publisher of Partners in Digital Health (PDH). The views expressed are solely her own and do not reflect those of the editorial board, reviewers, ambassadors, licensees or staff members affiliated with PDH.

Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot

Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost. Design: In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology. Results: A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; €722 to €10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected. Conclusion: Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation.

A Proposal for Decentralized, Global, Verifiable Health Care Credential Standards Grounded in Pharmaceutical Authorized Trading Partners

The twin forces of privacy law and data breaches have fundamentally challenged how we collect, store, and share sensitive information. Within this landscape, healthcare information is sacrosanct – and intimately tied to identity and data ownership. Building on prior work with UCLA Health, Genentech (a member of the Roche Group), Sanofi, Amgen, Biogen, and others, we offer this opinion piece to promote the development of a standard for decentralized Verifiable Credentials (VCs). This will empower Authorized Trading Partners (ATPs) in the pharmaceutical supply chain to trade and exchange information in compliance with the US federal law. Starting with credentialing and interoperability for the ATP community, our ultimate goal was to chart a path to a global standard for all health care VCs – providing individuals and health-care professionals control over their own data. By sharing our results and releasing essential components of the work to the public domain, we hope to align and connect with other foundational efforts, thus evolving standards within a truly open framework with broad stakeholder involvement.

Commercially Successful Blockchain Healthcare Projects: A Scoping Review

Background: The healthcare industry is the new frontier for blockchain technology. Given its properties of immutability and decentralization, blockchain represents an opportunity for unprecedented level of privacy and security for all stakeholders by ensuring data integrity while giving patients control over their own health data. On a backdrop of rising interest in blockchain in general and blockchain healthcare applications in particular, there has been a proliferation of blockchain healthcare projects over the past few years. The aim of this review is to identify and understand real-world blockchain healthcare projects that have attained commercial success in the highly competitive blockchain market. Methods and findings: A scoping review was performed in January 2021 on all projects in the CoinMarketCap database. Following a pre-defined inclusion and exclusion criteria, eligible projects were selected. A single reviewer then reviewed each project’s official website and whitepaper (where available) and performed data abstraction; 10 blockchain healthcare projects fulfilled the selection criteria. The review found that these projects made up 0.24% of the total number of actively tracked projects on CoinMarketCap. In terms of market capitalization, the total market capitalization for the projects was US$65,078,849, comprising less than 0.01% of the total market capitalization of all projects. Among the projects, the most frequent type was for personal health tracking. Conclusions: This review revealed that blockchain health projects currently comprise a small fraction of the overall number of commercially successful blockchain projects. However, because this sub-industry is still in its early stages, there are reasons to be optimistic that many more blockchain health projects will emerge and attain commercial success in future. Findings from this review done from an entrepreneurial perspective should help with the identification of future projects most likely to succeed.

Evaluation of Decentralized Verifiable Credentials to Authenticate Authorized Trading Partners and Verify Drug Provenance

Summary: In 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law to address the growing threat of counterfeit drugs and to ensure prescription drugs remain safe and effective for patients. As part of this law, US pharmaceutical supply chain stakeholders are required to confirm the authorized status of trading partners for transactions and information disclosures, even when there is no prior business relationship. While larger Authorized Trading Partners (ATPs) have connectivity solutions in place, newer and smaller ATPs have not traditionally participated, including tens of thousands of dispensers. To unlock the full potential of the interoperable system mandated by the DSCSA, the authors tested eXtended ATP (XATP), a blockchain-backed framework for ATP authentication and enhanced verification in a real-world pharmacy with genuine drug packages. The objective of this research study was to prove that electronic authentication and enhanced verification can be achieved between ATPs using a mobile-based solution. Moreover, we tested accurate reading of drug and associated electronic med guides, flagging of expired and recalled drugs, and correct generation of documentation to support saleable returns. Methods: This study involved two dispensers and three participating manufacturers. Dispensers were onboarded to a mobile application and used supporting documentation to authenticate their identities, and then scanned 2D drug barcodes to submit drug verification requests to manufacturers (including 11 additional, randomly selected manufacturers). Genuine and synthetic drug package barcodes were used to test workflows against genuine and synthetic manufacturer serialization data records. Manufacturers authenticated the identity of requesting dispensers with verifiable credentials and responded to verification requests. Results: Enhanced drug verification was achieved, with 100% of requests successfully delivered to participating manufacturers and 88% of requests being delivered to other manufacturers (based on the pharmacist selection of random packages from the pharmacy). Drug verification matching against synthetic serialization data records resulted in 86% accuracy, with the 14% error rate attributed to human factors. All barcodes were successfully scanned and provided package-accurate data, and 97% of randomly selected packages successfully generated drug package inserts. All synthetic recalls and expired drugs were successfully flagged. Four of the manufacturers contacted were among the top 15 pharmaceutical manufacturers globally; all four responded. Conclusions: The XATP framework provides a secure, reliable, and seamless remote method to conduct enhanced verification as required by law. Interoperability between manufacturers and dispensers with no prior business relationship can be achieved on ‘day zero’ using mobile devices that enable digital authentication and rapid barcode scanning. As users retain control of their own private keys, the framework also mitigates the single-point-of-attack risks associated with centrally managed systems.

The Case for Establishing a Blockchain Research and Development Program at an Academic Medical Center

Objective: To develop a research and development program to study factors that will support research, education and innovation using blockchain technology for health in an effective and sustainable manner. We proposed to conduct qualitative research to generate insights for developing a market strategy to build a research lab for the promotion of blockchain technologies in health in academic environments. The team aimed to identify the key barriers and opportunities for developing a sustainable research lab that generates research, education, and application of blockchain in healthcare at an academic medical institution and test those strategies in a real-world scenario. Methods: The research team identified potential customers and stakeholders through interviews and snowball sampling. The team conducted semi-structured interviews with 4 faculty researchers, 10 industry leaders, and 6 students from a variety of disciplines and organizations. The findings of these research activities informed our understanding of the needs of stratified customers and helped identify key assets and activities the lab will have to offer to meet those needs. Results: The research insights from data analysis were used to build the business model for establishing a blockchain in health impact lab. This systematic study of areas where blockchain technology can impact health will guide the future development of research agenda for the researchers on campus. Conclusion: Based on our learnings, we hope to design a Blockchain in Health Impact Lab to serve as a platform for students and faculty to come together with industry partners and explore current challenges of blockchain in healthcare. The academic medical center’s partnership with other healthcare providers will help create real-world opportunities to demonstrate and implement new technologies.

Leveraging the Hyperledger Fabric for Enhancing the Efficacy of Clinical Decision Support Systems

Adopting and implementing the Clinical Decision Support System (CDSS) technology is a critical element in an effort to improve national quality initiatives and evidence-based practice at the point of care. CDSS is envisioned to be a potential solution to many current challenges in the healthcare sphere, which includes information overload, practice improvement, eliminating treatment errors, and reducing medical consultation costs. However, the CDSS did not manage to achieve these goals to the desired levels and provide context-appropriate alerts, although integrated with the electronic health records (EHRs) (1). Clinical decision support alerts can save lives, but frequent ones can cause increased cognitive burden to clinicians, worsen alert fatigue, and increase the duplication of tests. This ultimately increases health care costs without refining patient outcomes. Studies show that 49–96% of clinical alerts are ignored, raising questions about the effectiveness of CDSS (1). Blockchain, a decentralized, distributed digital ledger that contains a plethora of continuously updated, time-stamped, and highly encrypted virtual record, can be a key to addressing these challenges (2). The blockchain technology if integrated with the CDSS can serve as a potential solution to eliminating current drawbacks with CDSS (3). This article addresses the most significant and chronic problems facing the successful implementation of CDSS and how leveraging the Hyperledger Fabric can alleviate the clinical alert fatigue and reduce physician’s burnout using patient-specific information. The proposed architecture framework for this study is designed to equip the CDSS with overall patient information at the point of care. This then empowers the physicians with the blockchain-integrated CDSS, which holds the potential to reduce clinician’s cognitive burden, medical errors, and costs and ultimately enhance patient outcomes. The research study broadly discusses how the blockchain technology can be a potential solution, reasons for selecting the Hyperledger Fabric, and elaborates on how the Hyperledger Fabric can be leveraged to enhance the efficacy of CDSS.

Blockchain predictions for health care in 2021

With coronavirus (COVID) spreading across the world and the health care system being pushed toward more digitization and technology, last year was a unique year of human tragedy. There is a silver lining to this tragedy, that is, providers, payers, and pharma companies have shifted quickly toward better technologies, including artificial intelligence (AI) blockchain, and so on.

Critical Care Equipment Management Reimagined in an Emergency

Summary: The COVID19 pandemic created a surge in demand for critical care equipment against a backdrop of fast-moving geographic virus hotspots. A team from IBM Europe was put together to prove that a devolved healthcare system can be rapidly bridged by a mix of advanced and legacy technologies to provide a federated view of critical care equipment deployment and use during an emergency. This was achieved with the deployment of predictive analytics and blockchain, integrated with conventional hospital management system. The corollary investigation determined the manner in which this system can be harnessed in a postemergency recovery to provide a national supply chain efficiency backbone. Method: During a period of 2 weeks, a team of IBM consultants set up a technology sandbox environment to represent a network of an equipment manufacturer, a central national emergency monitoring center, and several hospitals managed by their respective trust organization. Within this environment, a hospital asset management system, Maximo, was configured to manage and track critical care equipment within a hospital; a blockchain traceability platform, IBM’s Blockchain Transparency System, was configured to ingest multiple hospital data reports; and a predictive analytic dashboard, Watson Analytics, would retrieve data from the blockchain platform to supplement other data sources to provide national views and support decision-making for the supply and movement of equipment. Three key principles in the design of this environment are speed, reuse, and minimal intrusion. Results: The hypothesis was to test whether the chosen technologies can overcome the challenges of misaligned demand and supply of critical care equipment during a national emergency. The execution of the tests led to successful simulation of three scenarios: (1) the tracking of the location and usage history of any single equipment that has been placed into the network; (2) the movement of equipment between independent hospitals is recorded and reported; (3) a real-time interrogation of the current location and status of all registered equipment. Conclusions: The successful completion of this proof of concept has demonstrated that emerging technology can be used to overcome poor macro level coordination and planning, which are the drawbacks of a devolved healthcare system. The corollary was that this proof also demonstrated that blockchain technology can be used to prolong the useful life of conventional technology.

2020 Reflections: How a Pandemic Will Catalyze Innovation

This article reflects on key use cases that have received recent attention in the COVID-19 response as a result of the HIMSS Blockchain Task Force exploration of opportunities for futher blockchain adoption.