Recent changes to the Common Rule, which govern Institutional Review Boards (IRB), require implementing new policies to strengthen research protocols involving human subjects. A major challenge in implementing such policies is an inability to automatically and consistently meet these ethical rules while securing sensitive information collected during the study. In this paper, we propose a novel framework, based on blockchain technology, to enforce IRB regulations on data collection. We demonstrate how to design smart contracts and a ledger to meet the requirements of an IRB protocol, including subject recruitment, informed consent management, secondary data sharing, monitoring risks, and generating automated assessments for continuous review. Furthermore, we show how we can employ the immutable transaction log in the blockchain to embed security in research activities by detecting malicious activities and robustly tracking subject involvement. We evaluate our approach by assessing its ability to enforce IRB guidelines in different types of human subjects studies, including a genomic study, a drug trial, and a wearable sensor monitoring study.
This article describes how blockchain technologies can be used in the context of Public Health Surveillance through decentralized sharing of genomic data. A brief analysis of why blockchain technologies are needed in public health is presented together with a distinction between public and private blockchains. Finally, a proposal for a network of blockchains, using the Cosmos framework, together with decentralized storage systems like IPFS and BigchainDB, is included to address the issues of interoperability in the health sector.
Blockchain technology has the potential to transform healthcare delivery by facilitating data sharing between providers and electronic health record (EHR) systems. However, significant roadblocks stand in the way of widespread implementation of this technology across the healthcare industry. Our blockchain-based data-sharing solution addresses two of the most critical challenges associated with using blockchain for health data sharing: protecting sensitive health information and deploying and installing blockchain software across diverse hospital environments. Since transparency is a fundamental feature of blockchain, we enabled user- and group-based secret sharing by adding purpose-built software that leverages a collection of well-established cryptographic algorithms. To streamline deployment, we built a containerized solution that guarantees portability, simplifies installation, and reduces overhead maintenance costs associated with administration. To ensure ease of implementation in a hospital system, we designed our blockchain solution using a distributed microservices architecture that allows us to encapsulate core functions of our system into isolated services that can be scaled independently based on the requirements of a particular hospital system deployment. As part of this architecture, we built core components for securely handling cryptographic secrets, interacting with blockchain nodes, facilitating large file sharing, enabling secondary-index based lookups, and integrating external business logic that governs how users interact with Smart Contracts. The innovative design of our blockchain solution, which addresses critical data security, deployment, and installation challenges, provides the healthcare community with a unique approach that has the power to connect providers while protecting sensitive data.
Clinical research and health information data sharing are but ripples in a growing wave of reimagined applications of distributed ledger technologies beyond the digital marketplace for which they were originally created. This paper explores the use of distributed ledger technologies to facilitate single institutional ethics review of multi-site, collaborative studies in the data-intensive sciences such as genetics and genomics. Immutable record-keeping, automatable protocol amendments and direct connectivity between stakeholders in the research enterprise (e.g., researchers, research ethics committees, institutions, funders and regulators) comprise several of the conceptual and technological advantages of distributed ledger technologies to research ethics review. This novel-use proposal dovetails recent policy reforms to research ethics review across North America that mandate a single ethics review for any study that takes place across more than one research site. Such reforms in the United States, Canada and Australia replace prior institution-by-institution approval mechanisms that contributed to significant research delays and duplicative procedures for collaborative research worldwide. While this paper centers on the Common Rule revision in the United States, the single ethics review mandate is a noteworthy example of regulation evolving in parallel with advances in the data-intensive sciences it governs. The informational exchange capacities of distributed ledger technologies align well with the procedural goals of streamlining the ethics review system under the new Common Rule ahead of its official implementation on January 19, 2020. The ethical, legal and social implications of applying such technologies to ethics review will be explored in this concept paper. Namely, the paper proposes how administrative data from research ethics committees (REC) could be protected and shared responsibly, as well as inter-institutional cooperation negotiated within a centralized network of research ethics committees using the blockchain.
Associating the health-related records and transactions of patients with their numerous “identities” as they interact with different healthcare providers, payers, pharmacy benefit managers and other entities is an expensive and complex problem. With many years of experience addressing this issue in different healthcare systems and Health Information Exchanges (HIEs), it is apparent that there is now a compelling and relatively straightforward technical solution for this problem. Presented here is a broadly feasible and technically compelling argument for a blockchain based approach to addressing these issues. At the same time, challenges ahead and potential strategies to address them are discussed
There are several areas of healthcare and well-being that could be enhanced using blockchain technologies. These include device tracking, clinical trials, pharmaceutical tracing, and health insurance. Within device tracking, hospitals can trace their asset within a blockchain infrastructure, including through the complete lifecycle of a device. The information gathered can then be used to improve patient safety and provide after-market analysis to improve efficiency savings. This paper outlines recent work within the areas of pharmaceutical traceability, data sharing, clinical trials, and device tracking.
This article provides a globally relevant, interdisciplinary perspective intended to aid disparate group of actors, participants, and users that represent the diverse stakeholders of an increasingly complex and technologically reliant healthcare system. Domain expertise reinforced by literature published via industry, technical, and academic venues was used to inform these perspectives.
Effective supply chain management is a challenge in every sector, but in healthcare there is added complexity and risk as a compromised supply chain in healthcare can directly impact patient safety and health outcomes. One potential solution for improving security, integrity, data provenance, and functionality of the health supply chain is blockchain technology.
Blockchain is at the peak of the hype curve right now, and venture capitalists are eager to fund any company with cyber-currency, blockchain, or Bitcoin in the name. As the Editor-in-Chief of Blockchain in Healthcare Today, my goal is to publish high-quality opinion pieces and research papers about use cases that really require blockchain. Just using blockchain in healthcare because it’s cool does not make sense.
Blockchain is the digital ledger technology that is sweeping through a number of industries on a wave of hype. Could the tech’s inherent transparency, security and reliability have applications in the pharmaceutical space? The answer seems to be an emphatic yes, but how could this underpinning technology improve the pharmaceutical supply chain?