Background: Blockchain has the potential to disrupt the current modes of patient data access, accumulation, contribution, exchange, and control. Using interoperability standards, smart contracts, and cryptographic identities, patients can securely exchange data with providers and regulate access. The resulting comprehensive, longitudinal medical records can significantly improve the cost and quality of patient care for individuals and populations alike. Objective: This work presents HealthChain, a novel patient-centered blockchain framework. The intent is to bolster patient engagement, data curation, and regulated dissemination of accumulated information in a secure, interoperable environment. A mixed-block blockchain is proposed to support immutable logging and redactable patient blocks. Patient data are generated and exchanged through Health Level-7 Fast Healthcare Interoperability Resources, allowing seamless transfer with compliant systems. In addition, patients receive cryptographic identities in the form of public and private key pairs. Public keys are stored in the blockchain and are suitable for securing and verifying transactions. Furthermore, the envisaged system uses proxy re-encryption (PRE) to share information through revocable, smart contracts, ensuring the preservation of privacy and confidentiality. Finally, several PRE improvements are offered to enhance performance and security. Methods: The framework was formulated to address key barriers to blockchain adoption in health care, namely, information security, interoperability, data integrity, identity validation, and scalability. It supports 16 configurations through the manipulation of 4 modes. An open-source, proof-of-concept tool was developed to evaluate the performance of the novel patient block components and system configurations. To demonstrate the utility of the proposed framework and evaluate resource consumption, extensive testing was performed on each of the 16 configurations over a variety of scenarios involving a variable number of existing and imported records. Results: The results indicate several clear high-performing, low-bandwidth configurations, although they are not the strongest cryptographically. Of the strongest models, one’s anticipated cumulative record size is shown to influence the selection. Although the most efficient algorithm is ultimately user specific, Advanced Encryption Standard–encrypted data with static keys, incremental server storage, and no additional server-side encryption are the fastest and least bandwidth intensive, whereas proxy re-encrypted data with dynamic keys, incremental server storage, and additional server-side encryption are the best performing of the strongest configurations. Conclusions: Blockchain is a potent and viable technology for patient-centered access to and exchange of health information. By integrating a structured, interoperable design with patient-accumulated and generated data shared through smart contracts into a universally accessible blockchain, HealthChain presents patients and providers with access to consistent and comprehensive medical records. Challenges addressed include data security, interoperability, block storage, and patient-administered data access, with several configurations emerging for further consideration regarding speed and security.

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A Blockchain Framework for Patient-Centered Health Records and Exchange (HealthChain): Evaluation and Proof-of-Concept Study

Background: Blockchain offers a promising new distributed technology to address the challenges of data standardization, system interoperability, security, privacy, and accessibility of medical records.
Objective: The purpose of this review is to assess the research on the use of blockchain technology for patient care and the associated challenges and to provide a research agenda for future research.
Methods: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. We queried the Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, Excerpta Medica dataBASE (EMBASE), and Web of Science databases for peer-reviewed research articles published up to December 2019 that examined the implementation of blockchain technology in health care settings. We identified 800 articles from which we selected 70 empirical research articles for a detailed review.
Results: Blockchain-based patient care applications include medical information systems, personal health records, mobile health and telemedicine, data preservation systems and social networks, health information exchanges and remote monitoring systems, and medical research systems. These blockchain-based health care applications may improve patient engagement and empowerment, improve health care provider access to information, and enhance the use of health care information for medical research.
Conclusions: Blockchain health information technology (HIT) provides benefits such as ensuring data privacy and security of health data, facilitating interoperability of heterogeneous HIT systems, and improving the quality of health care outcomes. However, barriers to using blockchain technology to build HIT include security and privacy vulnerabilities, user resistance, high computing power requirements and implementation costs, inefficient consensus algorithms, and challenges of integrating blockchain with existing HIT. With 51% of the research focused on medical information systems such as electronic health record and electronic medical record, and 53% of the research focused on data security and privacy issues, this review shows that HIT research is primarily focused on the use of blockchain technologies to address the current challenges HIT faces. Although Blockchain presents significant potential for disrupting health care, most ideas are in their infancy.

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The Current State of Research, Challenges, and Future Research Directions of Blockchain Technology in Patient Care: Systematic Review.

Clinical trials (CTs) are essential for the advancement of medical research, paving the way for the development and adoption of new treatments, and contributing to the evolution of healthcare. An essential factor for the success of a CT is the appropriate management of its participants and their personal data. According to the current regulations, collecting and using personal data from participants must comply with rigorous standards. Therefore, healthcare institutes need to obtain freely given, specific, informed, and unambiguous consent before being able to collect the data. Some of the major limitations of the current technological solutions are the lack of control over the granularity of consent grants, as well as the difficulty of handling dynamic changes of consent over time. In this paper, we present SCoDES, an approach for trusted and decentralized management of dynamic consent in clinical trials, based on blockchain technology (BCT). The usage of blockchain provides a set of features that allow maintaining consent information with trust guarantees while avoiding the need for a dedicated or centralized third trusted party. We provide a full implementation of SCoDES, made available as a self-contained infrastructure, with the possibility to interact with external services, and using hyperledger as a blockchain framework.

Dynamic consent management for clinical trials via private blockchain technology

Blockchain technology has disclosed unprecedented opportunities in the healthcare sector by unlocking the true value of interoperability. Specifically, the striking features of blockchain technology, such as data provenance, transparency, decentralized transaction validation, and immutability, can help to compensate for stringent data management issues (e.g., patient recruitment, persistent monitoring, data management, and data analytics and accurate reporting) in clinical trials (CTs). Although several research studies show that blockchain solutions help to improve patient retention, data integrity, privacy and ensure CTs compliance with regulatory policies, a comprehensive survey on this topic is lacking. In this survey, we provide insights into the adoption of blockchain technology in CTs. We categorize and classify the literature by devising a meticulous taxonomy of the decentralized tasks of CT and practices based on indispensable parameters. Furthermore, we provide insights on works in progress toward deploying blockchain solutions in CTs. Finally, we identify and discuss several challenges that hinder the successful implementation of blockchain technologies in CTs.

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Applications of Blockchain Technology in Clinical Trials: Review and Open Challenges

Blockchain technology plays a significant role in the industrial development. Many industries can potentially benefit from the innovations blockchain decentralization technology and privacy protocols offer with regard to securing, data access, auditing and managing transactions within digital platforms. Blockchain is based on distributed and secure decentralized protocols in which there is no single authority, and no single point of control; the data blocks are generated, added, and validated by the nodes of the network themselves. This article provides insights into the current developments within blockchain technology and explores its ability to revolutionize the multiple industrial application areas such as supply chain industry, Internet of Things (IoT), healthcare, governance, finance and manufacturing. It investigates and provides insights into the security issues and threats related to the blockchain implementations by assessing the research through a systematic literature review. This article proposes possible solutions in detail for enhancing the security of the blockchain for industrial applications along with significant directions for future explorations. The study further suggests how in recent years the adoption of blockchain technology by multiple industrial sectors has gained momentum while in the finance sector it is touching new heights day by day.

https://www.mdpi.com/2079-9292/10/8/951/pdf

Security Aspects of Blockchain Technology Intended for Industrial Applications

Background: Blockchain technology is emerging as an innovative tool in data and software security. Objective: This study aims to explore the role of blockchain in supporting clinical trials data management and develop a proof-of-concept implementation of a patient-facing and researcher-facing system. Methods: Blockchain-based Smart Contracts were built using the Ethereum platform. Results: We described BlockTrial, a system that uses a Web-based interface to allow users to run trials-related Smart Contracts on an Ethereum network. Functions allow patients to grant researchers access to their data and allow researchers to submit queries for data that are stored off chain. As a type of distributed ledger, the system generates a durable and transparent log of these and other transactions. BlockTrial could be used to increase the trustworthiness of data collected during clinical research with benefits to researchers, regulators, and drug companies alike. In addition, the system could empower patients to become more active and fully informed partners in research. Conclusions: Blockchain technology presents an opportunity to address some of the common threats to the integrity of data collected in clinical trials and ensure that the analysis of these data comply with prespecified plans. Further technical work is needed to add additional functions. Policies must be developed to determine the optimal models for participation in the system by its various stakeholders.

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Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study.

Automated Detection of Helium Bubbles in Irradiated X-750.

Imaging nanoscale features using transmission electron microscopy is key to predicting and assessing the mechanical behavior of structural materials in nuclear reactors. Analyzing these micrographs is often a tedious and labour intensive manual process. It is a prime candidate for automation. Here, a region-based convolutional neural network is adapted to detect helium bubbles in micrographs of neutron-irradiated Inconel X-750 reactor spacer springs. We demonstrate that this neural network produces analyses of similar accuracy and reproducibility to that produced by humans. Further, we show this method as being four orders of magnitude faster than manual analysis allowing for generation of significant quantities of data. The proposed method can be used with micrographs of different Fresnel contrasts and magnification levels.

Automated Classification of Helium Ingress in Irradiated X-750

Background Clinical trials help to advance medical, endovascular, and surgical therapies to improved outcomes for individuals who sustain a stroke. We conducted a systematic overview of the ClinicalTrials.gov database to describe: 1) the distribution and characteristics of interventions in current stroke clinical trials, 2) the progress of existing trials, and 3) outcomes of completed trials. The ClinicalTrials gov database was searched using the term ‘stroke’, with automated mapping to related search terms. Trials were screened based on prespecified inclusion and exclusion criteria. Included trials were categorized by stroke type (ischemic or hemorrhagic) and intervention modality (medical, surgical, or endovascular). Relevant data were extracted from the included trials, which were also connected to related published studies. Results Of 6,486 retrieved trials, 390 (6.0%) trials with 169,724 patients were classified as interventional. In total, 318 (81.8%) were medical drug trials, 3 (0.8%) were surgical, and 69 (17.7%) were endovascular. The growth in medical trials, most of which focused on thrombolysis, outpaced the growth in endovascular trials. Most studies (206, 52.8%) were either Phase I or II, with a plurality of Phase II studies (167, 42.5%). Of all the studies, 170 (43.6%) were supported by industry. The most common primary outcome measures were modified Rankin Scale (133, 34.4%), safety and adverse events (56, 14.4%), and the incidence of symptomatic intracranial hemorrhage (38, 9.7%). In total, 10.3% (40/390) of studies were terminated, with a smaller proportion (10/390, 2.6%) withdrawn. A total of 122 (31.2%) clinical trials had corresponding published studies, of which 67 (54.9%) were classified as positive and 55 (45.1%) were negative. Conclusions The number of clinical trials focused on stroke treatment has increased, largely driven by the increase in medical trials. The results of most published studies are promising. Disclosures K. Nandoliya: None. N. Shlobin: None. J. Klein: None. B. Jahromi: None. M. Potts: None. 

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E-286 Exploring the landscape of clinical trials for stroke: a systematic overview of the clinicaltrials.gov database

<h3>Introduction</h3> Innovative technologies continue to improve interventional and surgical treatment of intracranial aneurysms, improving the safety and efficacy of interventions. Understanding clinical trial trends related to the treatment of intracranial aneurysms provides insight into future practice developments. <h3>Materials and Methods</h3> Using the general search term ‘aneurysm’ and other relevant filters, all clinical trials related to treatment of intracranial aneurysm registered in Clinicaltrials.gov from the past 20 years (January 1, 2001 to September 30th, 2021) were categorized and reviewed. <h3>Results</h3> We identified 1623 trials relating to cerebral aneurysms, of which 17% focused on cerebral aneurysm treatments. These studies occurred across 30 countries - most frequently in the United States (35%), followed by China (16%), France (12%), and Germany (8%). More than half (57%) were multi-centered. Twenty-four percent involved surgical clipping, 52% coil embolization, 23% flow-diversion, and 23% drug therapy. Recent aneurysmal hemorrhage was a selection criterion in 20%. The number of trials increased over the two included decades from 52 in 2000–2010 to 221 in 2011–2021. The percentage of endovascular device studies increased across decades (44% versus 57%), with a notable increase in studies involving flow diversion (12% versus 25%, p=0.03). Conversely, the percentage of surgical clipping and drug trials both decreased (27% to 23% and 29% to 22%, respectively). A total of 80 linked publications were identified for the included trials, of which 51 were concluded as having a positive result in line with the study hypothesis. <h3>Conclusions</h3> The field of cerebral aneurysm treatment has seen a marked increase in clinical trials over the past two decades. This trend is largely attributable to the study of endovascular devices, especially those involving flow diversion. <h3>Disclosures</h3> <b>J. Klein:</b> None. <b>N. Shlobin:</b> None. <b>K. Nandoliya:</b> None. <b>B. Jahromi:</b> None. <b>M. Potts:</b> None. 

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Jacob Klein

Papers

Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study.

Automated Detection of Helium Bubbles in Irradiated X-750.

Automated Classification of Helium Ingress in Irradiated X-750

E-286 Exploring the landscape of clinical trials for stroke: a systematic overview of the clinicaltrials.gov database

E-002 Intracranial aneurysm clinical trials: trends of developing treatments in the last two decades