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Applicability of Blockchain-Based Implementation for Risk Management in Healthcare Projects. 基于区块链的医疗项目风险管理实施的适用性。
Pub Date : 2022-03-14 eCollection Date: 2022-01-01 DOI: 10.30953/bhty.v5.191
In Bae Chung, Carlos Caldas

Hospitals provide diverse tasks essential for the delivery of patient care and are comprised of many functional units. This makes healthcare projects in construction highly complex among other types of building projects due to the specific regulations, multiple functions it must provide, complicated mechanical and electrical systems, and so on. This complexity embodies potential risk events during its construction, which not only influences the completion of the project but can impact the patients' safety and health conditions even after the project is finished. To prevent such outcomes, risk management is a crucial process that can identify, evaluate, and properly mitigate risks along the project lifecycle. A key aspect of risk management is that it requires the interaction and contribution from multiple stakeholders of the project. Various frameworks and tools that enable collaborative management of risks among multiple stakeholders have been developed in the past. However, the developed frameworks are not suitable in the sense that it does not protect the confidentiality of individual inputs from the stakeholders. Moreover, these frameworks are centralized systems, which can bring issues related to the security and transparency of the information that is being stored. Blockchain technology is an emergent distributed ledger technology (DLT) that can provide solutions to the listed problems found in centralized systems. It is a novel system that records information on a decentralized, distributed ledger, where transactions are constantly duplicated and updated. This study explores the applicability of blockchain technology for healthcare risk management. The key functional elements of blockchain that can resolve the challenges faced by prior risk management frameworks have been identified and discussed. Based on the discussions, a conceptual information management model for managing healthcare project risks on a blockchain has been conceived. The development of the initial prototype has been explained. The research study illustrates the process, benefits, and limitations of adopting the blockchain technology for collaborative risk management in healthcare projects.

医院承担着为病人提供护理所必需的各种任务,由许多功能单元组成。这就使得医疗项目的施工在其他类型的建筑项目中变得非常复杂,因为它有特定的法规、必须提供的多种功能、复杂的机械和电气系统等等。这种复杂性蕴含着施工过程中潜在的风险事件,不仅影响项目的完工,甚至在项目完工后也会影响患者的安全和健康状况。为了防止出现这样的结果,风险管理是一个至关重要的过程,它可以识别、评估和适当降低项目生命周期中的风险。风险管理的一个关键方面是,它需要项目的多个利益相关者进行互动并做出贡献。过去已经开发了各种框架和工具,使多个利益相关者能够协同管理风险。然而,已开发的框架并不合适,因为它无法保护利益相关者个人投入的机密性。此外,这些框架都是集中式系统,会带来与所存储信息的安全性和透明度有关的问题。区块链技术是一种新兴的分布式账本技术(DLT),可以为集中式系统中存在的问题提供解决方案。它是一种新颖的系统,将信息记录在分散的分布式账本上,交易在账本上不断复制和更新。本研究探讨了区块链技术在医疗风险管理中的适用性。研究确定并讨论了区块链的关键功能要素,这些要素可以解决以往风险管理框架所面临的挑战。在讨论的基础上,构思了一个在区块链上管理医疗项目风险的概念信息管理模型。对初始原型的开发进行了说明。本研究阐述了在医疗保健项目中采用区块链技术进行协作风险管理的过程、益处和局限性。
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引用次数: 0
Clinical, Organizational and Regulatory, and Ethical and Social (CORES) Issues and Recommendations on Blockchain Deployment for Healthcare: Evidence from Experts. 关于医疗保健区块链部署的临床、组织和监管以及伦理和社会(CORES)问题和建议:专家提供的证据。
Pub Date : 2022-03-14 eCollection Date: 2022-01-01 DOI: 10.30953/bhty.v5.199
John Robert Bautista, Muhammad Usman, Daniel Toshio Harrell, Eric T Meyer, Anjum Khurshid

Objective: While existing research by our team has demonstrated the feasibility of building a decentralized identity management application ("MediLinker") for health information, there are implementation issues related to testing such blockchain-based health applications in real-world clinical settings. In this study, we identified clinical, organizational and regulatory, and ethical and social (CORES) issues, including recommendations, associated with deploying MediLinker, and blockchain in general, for clinical testing.

Methods: CORES issues and recommendations were identified through a focus group with 11 academic, industry, and government experts on March 26, 2021. They were grouped according to their expertise: clinical care (n = 4), organizational and regulatory concerns (n = 4), and ethical and social issues (n = 3). The focus group was conducted via Zoom in which experts were briefed about the study aims, formed into breakout groups to identify key issues based on their group's expertise, and reconvened to share identified issues with other groups and to discuss potential recommendations to address such issues. The focus group was video recorded and transcribed. The resulting transcriptions and meeting notes were imported to MAXQDA 2018 for thematic analysis.

Results: Clinical experts identified issues that concern the clinical system, clinical administrators, clinicians, and patients. Organizational and regulatory experts emphasized issues on accountability, compliance, and legal safeguards. Ethics and social-context experts raised issues on trust, transparency, digital divide, and health-related digital autonomy. Accordingly, experts proposed six recommendations that could address most of the identified issues: (1) design interfaces based on patient preferences, (2) ensure testing with diverse populations, (3) ensure compliance with existing policies, (4) present potential positive outcomes to top management, (5) maintain clinical workflow, and (6) increase the public's awareness of blockchain.

Conclusions: This study identified a myriad of CORES issues associated with deploying MediLinker in clinical settings. Moreover, the study also uncovered several recommendations that could address such issues. The findings raise awareness on CORES issues that should be considered when designing, developing, and deploying blockchain for healthcare. Further, the findings provide additional insights into the development of MediLinker from a prototype to a minimum viable product for clinical testing. Future studies can use CORES as a socio-technical model to identify issues and recommendations associated with deploying health information technologies in clinical settings.

目标:虽然我们团队的现有研究已经证明了为健康信息构建去中心化身份管理应用程序("MediLinker")的可行性,但在现实世界的临床环境中测试此类基于区块链的健康应用程序还存在实施问题。在本研究中,我们确定了与部署 MediLinker 和一般区块链进行临床测试相关的临床、组织和监管以及伦理和社会(CORES)问题,包括建议:2021 年 3 月 26 日,11 位学术界、业界和政府专家通过焦点小组确定了 CORES 问题和建议。他们根据各自的专长进行了分组:临床护理(4 人)、组织和监管问题(4 人)以及伦理和社会问题(3 人)。焦点小组通过 Zoom 进行,专家们在小组中听取了关于研究目的的简要介绍,分成若干小组,根据各自小组的专长确定关键问题,然后再次召开会议,与其他小组分享确定的问题,并讨论解决这些问题的潜在建议。对焦点小组进行了录像和誊写。由此产生的转录和会议记录被导入 MAXQDA 2018 进行专题分析:临床专家指出了临床系统、临床管理者、临床医生和患者关心的问题。组织和监管专家强调了问责、合规和法律保障方面的问题。伦理和社会环境专家提出了信任、透明度、数字鸿沟以及与健康相关的数字自主权等问题。因此,专家们提出了六项建议,这些建议可以解决大多数已发现的问题:(1)根据患者的偏好设计界面;(2)确保在不同人群中进行测试;(3)确保遵守现有政策;(4)向高层管理人员展示潜在的积极成果;(5)保持临床工作流程;以及(6)提高公众对区块链的认识:本研究发现了与在临床环境中部署 MediLinker 相关的大量 CORES 问题。此外,本研究还发现了几项可解决这些问题的建议。研究结果提高了人们对 CORES 问题的认识,在设计、开发和部署医疗保健区块链时应考虑这些问题。此外,研究结果还为 MediLinker 从原型发展为用于临床测试的最小可行产品提供了更多见解。未来的研究可以使用 CORES 作为社会技术模型,以确定与在临床环境中部署医疗信息技术相关的问题和建议。
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引用次数: 0
Improving Transitions of Care: Designing a Blockchain Application for Patient Identity Management. 改善护理过渡:为患者身份管理设计区块链应用程序。
Pub Date : 2022-03-14 eCollection Date: 2022-01-01 DOI: 10.30953/bhty.v5.200
Mustafa Abdul-Moheeth, Muhammad Usman, Daniel Toshio Harrell, Anjum Khurshid
<p><strong>Background: </strong>The current healthcare ecosystem in the United States is plagued by inefficiencies in transitions of patient care between healthcare providers due in large part to a lack of interoperability among the many electronic medical record (EMR) systems that exist today. Both providers and patients experience significant frustration due to the negative effects of increased costs, unnecessary administrative burden, and duplication of services that occur because of data fragmentation in the system. Blockchain technology provides a potential solution to mitigate or eliminate these gaps by allowing for exchange of healthcare information that is distributed, auditable, immutable, and respectful of patient autonomy. Our multidisciplinary team identified key tasks required for a transition of care to design and develop a blockchain application, MediLinker, which served as a patient-centric identity management system to address issues of data fragmentation ultimately aiding in the delivery of high-value care services.</p><p><strong>Methods: </strong>The MediLinker application was evaluated for its ability to accomplish various key tasks needed for a successful transition of patient care in an outpatient setting. Our team created 20 unique patient use cases covering a diversity of medical needs and social circumstances that were played out by participants who were asked to perform various tasks as they received case across a simulated healthcare ecosystem composed of four clinics, a research institution, and other ancillary public services. Tasks included, but were not limited to, clinic enrollment, verification of identity, medication reconciliation, sharing insurance and billing information, and updating demographic information. With this iteration of MediLinker, we specifically focused on the functionality of digital guardianship and patient revocation of healthcare information. In addition, throughout the simulation, we surveyed participant perceptions regarding the use of MediLinker and blockchain technology to better ascertain comfortability and usability of the application.</p><p><strong>Results: </strong>Quantitative evaluation of simulation results revealed that MediLinker was able to successfully accomplish all seven clinical scenarios tested across the 20 patient use cases. MediLinker successfully achieved its goal of patient-centered interoperability as participants transitioned their simulated healthcare data, including COVID-19 vaccination status and current medications, across the four clinic sites and research institution. In addition to completing all key tasks designated, all eligible participants were able to enroll with and subsequently revoke data access with our simulated research site. MediLinker had a low data-entry error rate, with most errors occurring due to work-flow vulnerabilities. Our qualitative analysis of user perceptions indicated that comfortability and trust with blockchain technology, such as M
背景:美国目前的医疗保健生态系统受到医疗保健提供者之间病人护理过渡效率低下的困扰,这在很大程度上是由于目前存在的许多电子病历(EMR)系统之间缺乏互操作性。由于系统中的数据支离破碎,造成成本增加、不必要的行政负担和重复服务等负面影响,医疗服务提供者和患者都感到非常沮丧。区块链技术允许进行分布式、可审计、不可更改且尊重患者自主权的医疗保健信息交换,从而为减轻或消除这些差距提供了潜在的解决方案。我们的多学科团队确定了医疗过渡所需的关键任务,设计并开发了区块链应用 MediLinker,作为以患者为中心的身份管理系统,解决数据分散的问题,最终帮助提供高价值的医疗服务:我们对 MediLinker 应用程序进行了评估,以确定其是否能够完成门诊病人护理成功过渡所需的各种关键任务。我们的团队创建了 20 个独特的患者使用案例,涵盖了各种医疗需求和社会环境,参与者在接受由四家诊所、一家研究机构和其他辅助性公共服务机构组成的模拟医疗保健生态系统的病例时,需要执行各种任务。任务包括但不限于诊所注册、身份验证、药物对账、共享保险和账单信息以及更新人口信息。在 MediLinker 的这次迭代中,我们特别关注了数字监护和病人撤销医疗信息的功能。此外,在整个模拟过程中,我们还调查了参与者对使用 MediLinker 和区块链技术的看法,以更好地确定应用程序的舒适性和可用性:模拟结果的定量评估显示,MediLinker能够成功完成20个患者使用案例中的所有7个临床场景测试。MediLinker成功实现了以患者为中心的互操作性目标,参与者在四个诊所和研究机构之间转换了他们的模拟医疗保健数据,包括COVID-19疫苗接种情况和当前用药情况。除了完成所有指定的关键任务外,所有符合条件的参与者都能在我们的模拟研究机构注册并随后取消数据访问权限。MediLinker 的数据录入错误率很低,大多数错误都是由于工作流程漏洞造成的。我们对用户看法的定性分析表明,随着教育程度的提高和对区块链技术(如MediLinker)接触的增加,用户对该技术的舒适度和信任度也在提高:在当前的医疗保健生态系统中,无处不在的数据碎片化问题给医疗服务提供者和患者都带来了巨大压力。区块链在健康身份管理方面的应用,如 MediLinker,为解决目前存在的低效率问题提供了可行的解决方案。MediLinker 在我们模拟的医疗保健系统中提供的互操作性有可能通过及时、安全和以专利为中心的方式共享医疗保健信息的关键方面来改善护理的过渡,从而提供一致和个性化的高价值护理。区块链技术在广泛应用方面似乎面临着与其他新型干预措施类似的挑战,即认可度、信任度和可用性。要想在现实世界中充分发挥这种技术的潜力并改变现代医疗保健的实践,还需要进一步的开发和推广。
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引用次数: 0
FROM SHARING TO SELLING: CHALLENGES AND OPPORTUNITIES OF ESTABLISHING A DIGITAL HEALTH DATA MARKETPLACE USING BLOCKCHAIN TECHNOLOGIES. 从共享到销售:使用区块链技术建立数字健康数据市场的挑战和机遇。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.184
Mohamed A Maher, Imtiaz A Khan

During the COVID-19 pandemic, we witnessed how sharing of biological and biomedical data facilitated researchers, medical practitioners, and policymakers to tackle the pandemic on a global scale. Despite the growing use of electronic health records (EHRs) by medical practitioners and wearable digital gadgets by individuals, 80% of health and medical data remain unused, adding little value to the work of researchers and medical practitioners. Legislative constraints related to health data sharing, centralized siloed design of traditional data management systems, and most importantly, lack of incentivization models are thought to be the underpinning bottlenecks for sharing health data. With the advent of the General Data Protection Regulation (GDPR) of the European Union (EU) and the development of technologies like blockchain and distributed ledger technologies (DLTs), it is now possible to create a new paradigm of data sharing by changing the incentivization model from current authoritative or altruistic form to a shared economic model where financial incentivization will be the main driver for data sharing. This can be achieved by setting up a digital health data marketplace (DHDM). Here, we review papers that proposed technical models or implemented frameworks that use blockchain-like technologies for health data. We seek to understand and compare different technical challenges associated with implementing and optimizing the DHDM operation outlined in these articles. We also examine legal limitations in the context of the EU and other countries such as the USA to accommodate any compliance requirement for such a marketplace. Last but not least, we review papers that investigated the short-, medium-, and long-term socioeconomic impact of such a marketplace on a wide range of stakeholders.

在2019冠状病毒病大流行期间,我们见证了生物和生物医学数据的共享如何促进研究人员、医疗从业者和政策制定者在全球范围内应对这一流行病。尽管医疗从业者越来越多地使用电子健康记录(EHRs),个人也越来越多地使用可穿戴数字设备,但80%的健康和医疗数据仍未被使用,这对研究人员和医疗从业者的工作几乎没有任何价值。与卫生数据共享相关的立法限制、传统数据管理系统的集中式孤立设计,以及最重要的是缺乏激励模型,被认为是卫生数据共享的主要瓶颈。随着欧盟(EU)通用数据保护条例(GDPR)的出台以及区块链和分布式账本技术(dlt)等技术的发展,现在有可能通过将激励模式从当前的权威或利他形式转变为共享经济模式来创建新的数据共享范式,其中财务激励将成为数据共享的主要驱动力。这可以通过建立数字健康数据市场(DHDM)来实现。在这里,我们回顾了提出技术模型或实施框架的论文,这些框架使用类似区块链的技术来获取健康数据。我们试图理解和比较与实现和优化这些文章中概述的DHDM操作相关的不同技术挑战。我们还研究了欧盟和其他国家(如美国)背景下的法律限制,以适应此类市场的任何合规要求。最后但并非最不重要的是,我们回顾了研究这种市场对广泛利益相关者的短期、中期和长期社会经济影响的论文。
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引用次数: 5
BLOCKCHAIN IN HEALTHCARE TODAY: 2022 PREDICTIONS. 今天医疗保健领域的区块链:2022年预测。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.194
Daniel Conway, Mohan Venkataraman, Daniel Laverick, Gabriela Pelin, Anton Hasselgren

Each year, Blockchain and Healthcare Today reaches out to journal board members, annual ConV2X Symposium speakers, and ecosystem subject matter experts to share their near-term views and perspectives for blockchain technology advances in healthcare. This article presents insights into where authors anticipate market opportunities and where gaps exist that should be addressed for regional and global collaboration, governance, and efficiency for the year 2022.

每年,《区块链与医疗保健今日》都会联系期刊董事会成员、年度ConV2X研讨会发言人和生态系统主题专家,分享他们对区块链技术在医疗保健领域进步的近期看法和观点。本文介绍了作者对市场机会的预测,以及为2022年的区域和全球合作、治理和效率应解决的差距。
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引用次数: 0
Decentralized Identity Management for E-Health Applications: State-of-the-Art and Guidance for Future Work. 电子健康应用的分散身份管理:最新技术和未来工作指导。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.195
Abylay Satybaldy, Anton Hasselgren, Mariusz Nowostawski

Background: The increasing use of various online services requires an efficient digital identity management (DIM) approach. Unfortunately, the original Internet protocols were not designed with built-in identity management, which creates challenges related to privacy, security, and usability. There is an increasing societal concern regarding the management of these sensitive data, access to it, and where it is stored. Blockchain technology can potentially offer a secure solution to address these issues in a decentralized manner without centralized authority. This is important for e-health services where the patient and the healthcare provider often are required to prove their identity. Blockchain technology can be utilized for creating digital identities and making its management easier, thus giving a higher degree of control to the user than what current solutions offer. It can be used to create a digital identity on the blockchain, making it easier for individuals and entities to manage, giving them greater control over who has their personal information and how they handle it. In addition, it might be utilized to create a higher degree of trust and security for e-health applications.

Objective: The aim of this research work was to review the state-of-the-art regarding blockchain-based decentralized identity management for healthcare applications. Based on this summary, we provide a viewpoint on how blockchain-based decentralized identity frameworks might be utilized for virtualized healthcare applications.

Methods: This research study applied a scoping, semi-systematic review approach to summarize the state-of-the-art. Included identity management systems were evaluated based on seven criteria: autonomy, authority, availability, approval, confidentiality, tenacity, and Interoperability.

Results: Seven blockchain-based identity management systems were included and evaluated in this work: these include solutions built with Ethereum, Hyperledger Indy, Hyperledger Fabric, Hedera, and Sovrin blockchains.

Conclusions: DIM is crucial for virtual health care. Decentralized identity management for healthcare purposes is currently being explored in both academia and the private sector. More work is needed with the aim of improving the efficiency of current DIM solutions and to fully understand what technical frameworks are best suited for e-health applications.

背景:各种在线服务的使用日益增加,需要一种有效的数字身份管理(DIM)方法。不幸的是,最初的Internet协议没有设计内置身份管理,这带来了与隐私、安全性和可用性相关的挑战。对于这些敏感数据的管理、访问和存储位置,社会越来越关注。区块链技术可以提供一种安全的解决方案,以分散的方式解决这些问题,而不需要集中的权力。这对于经常要求患者和医疗保健提供者证明其身份的电子医疗服务非常重要。区块链技术可用于创建数字身份并使其管理更容易,从而为用户提供比当前解决方案更高程度的控制。它可用于在区块链上创建数字身份,使个人和实体更容易管理,使他们能够更好地控制谁拥有他们的个人信息以及他们如何处理这些信息。此外,它还可用于为电子保健应用程序创建更高程度的信任和安全性。目的:本研究工作的目的是回顾医疗保健应用中基于区块链的去中心化身份管理的最新进展。基于这一总结,我们就如何将基于区块链的去中心化身份框架用于虚拟化医疗保健应用程序提供了一个观点。方法:本研究采用范围界定、半系统回顾的方法来总结研究现状。所包含的身份管理系统基于七个标准进行评估:自主性、权威性、可用性、批准性、机密性、持久性和互操作性。结果:在这项工作中包括并评估了七个基于区块链的身份管理系统:这些系统包括使用以太坊、Hyperledger Indy、Hyperledger Fabric、Hedera和Sovrin区块链构建的解决方案。结论:DIM对虚拟医疗至关重要。学术界和私营部门目前正在探索用于医疗保健目的的分散身份管理。需要做更多的工作,以提高当前DIM解决方案的效率,并充分了解哪些技术框架最适合电子保健应用。
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引用次数: 1
Securing the Chain of Custody and Integrity of Data in a Global North-South Partnership to Monitor the Quality of Essential Medicines. 在监测基本药物质量的全球南北伙伴关系中确保监管链和数据完整性。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.230
Kathleen Hayes, Natalie Meyers, Christopher Sweet, Ayenew Ashenef, Tim Johann, Marya Lieberman, David Kochalko

Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high-quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1,000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies the blockchain to organize and manage key data generated during the DPAL workflow, including a sample's progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with these data will create a permanent and verifiable chain of custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing the blockchain technology for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices.

在低收入和中等收入国家(LMICs),伪劣药品约占药品供应链的10%,这些国家缺乏监管和实验室资源,限制了进行有效上市后监督的能力,并允许伪劣产品渗透到供应链中。2014年建立了分布式药物分析实验室(DPAL),以扩大对来自低收入国家的药物剂型的检测;DPAL是一个由美国和国外的学术机构组成的联盟,为来自中低收入国家合作伙伴的药物剂型提供高质量、经过验证的化学分析。分析结果报告给相关监管机构,并用于为国内利益相关者做出的采购决策提供信息。随着DPAL项目扩展到每年测试超过1000种药物剂型,数据管理和样品跟踪方面的挑战已经浮出水面。在这里,我们描述了DPAL和ARTiFACTs之间的一个试点项目,该项目应用区块链来组织和管理DPAL工作流程中生成的关键数据,包括样本在工作流程中的进度、其物理位置、元数据的来源和实验室声誉。用这些数据记录时间和日期戳将为样品创建一个永久的、可验证的监管链。这种安全的分布式账本将链接到一个易于使用的仪表板,允许利益相关者实时查看每个样本的结果和实验细节,并验证DPAL分析数据的完整性。将这种基于区块链的系统作为试点引入,将使我们能够通过真实用户分析真实样本来测试该技术。在所有DPAL站点实施区块链之前,将记录用户的反馈并对系统进行必要的调整。实施区块链技术管理DPAL数据的预期好处包括对路由工作的有效管理,提高吞吐量,为样本及其数据创建符合DPAL分布式特性的监管链,以及使用分析结果来检测产品内部和跨品牌的质量模式,并开发增强的采样技术和最佳实践。
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引用次数: 1
Health Datasets as Assets: Blockchain-Based Valuation and Transaction Methods. 健康数据集作为资产:基于区块链的估值和交易方法。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.185
Wendy M Charles, Brooke M Delgado

There is increasing recognition about health-oriented datasets that could be regarded as intangible assets: distinct assets with future economic benefits but without physical properties. While health-oriented datasets - particularly health records - are ascribed monetary value on the black market, there are few established methods for assessing the value for legitimate research and business purposes. The emergence of blockchain has created new commercial opportunities for transferring assets without intermediaries. Therefore, blockchain is proposed as a medium by which research datasets could be transacted to provide future value. For authorized individuals to verify their transactions, blockchain methodologies offer security, auditability, and transparency. The authors share data valuation methodologies consistent with accounting principles and include discussions of black market valuation of health data. Furthermore, this article describes blockchain-based methods of managing real-time payment/micropayment strategies.

人们越来越认识到,面向健康的数据集可以被视为无形资产:具有未来经济效益但没有物理属性的独特资产。虽然面向健康的数据集——特别是健康记录——在黑市上被赋予了货币价值,但很少有确定的方法来评估用于合法研究和商业目的的价值。区块链的出现为无需中介机构的资产转移创造了新的商业机会。因此,区块链被提议作为一种媒介,通过它可以交易研究数据集,以提供未来的价值。对于授权个人验证其交易,区块链方法提供了安全性、可审计性和透明度。作者分享了符合会计原则的数据估值方法,并讨论了黑市对卫生数据的估值。此外,本文还描述了基于区块链的管理实时支付/微支付策略的方法。
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引用次数: 5
Ensuring Trust in Pharmaceutical Supply Chains by Data Protection by Design Approach to Blockchains. 通过区块链设计方法的数据保护确保对药品供应链的信任。
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.232
Halid Kayhan

Pharmaceutical supply chains are complex structures that include various participants. Furthermore, blockchains are viewed as a promising solution to increase effectiveness and overcome some of the main challenges in these supply chains-especially lack of trust. The European Union (EU) set strict rules in the domain of pharmaceutical supply chains in order to protect patient safety and public health. In addition, blockchains bring legal requirements. Among these requirements, personal data protection is of utmost importance. This is because, as has been argued for years, blockchains and the EU data protection regime are in conflict by their natures. However, it is also claimed that when rightly designed and combined with other technological solutions, blockchains potentially offer great opportunities to enhance data protection. Nevertheless, potential for blockchains in the pharmaceutical supply chain is not yet been realized as most use cases are in the proof of concept or pilot stage. This article examines the debates surrounding blockchains and data protection. The goal is to draw constructive conclusions on whether blockchain solutions can be designed in data protection-enhancing ways and whether this might help realize the potential for blockchain in pharmaceutical supply chains-particularly by creating trust. For this purpose, the example of an ongoing EU-funded innovative research project called PharmaLedger as a case study to concretize its theoretical examinations is examined. This project is chosen because it gathers a wide variety of stakeholders representing different interests and aims to create a digital trust ecosystem in health care by providing a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating the delivery of innovation that benefits the entire ecosystem from manufacturers to patients.

药品供应链是复杂的结构,包括各种参与者。此外,区块链被视为一种有希望的解决方案,可以提高效率并克服这些供应链中的一些主要挑战,特别是缺乏信任。欧洲联盟(欧盟)在药品供应链领域制定了严格的规则,以保护患者安全和公众健康。此外,区块链带来了法律要求。在这些要求中,保护个人资料是最重要的。这是因为,正如多年来一直争论的那样,区块链和欧盟数据保护制度就其性质而言存在冲突。然而,也有人声称,当正确设计并与其他技术解决方案相结合时,区块链可能为加强数据保护提供巨大的机会。然而,区块链在制药供应链中的潜力尚未实现,因为大多数用例都处于概念验证或试点阶段。本文探讨了围绕区块链和数据保护的争论。其目标是就区块链解决方案是否可以以增强数据保护的方式设计,以及这是否有助于实现区块链在制药供应链中的潜力,特别是通过建立信任,得出建设性的结论。为此,本文以正在进行的欧盟资助的创新研究项目PharmaLedger为例,对其理论检验进行了具体化研究。之所以选择这个项目,是因为它聚集了代表不同利益的各种利益相关者,旨在通过提供一个广泛信任的平台,支持区块链医疗解决方案的设计和采用,同时加速创新的交付,使从制造商到患者的整个生态系统受益,从而在医疗保健领域创建一个数字信任生态系统。
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引用次数: 1
Technical Design and Development of A Self-Sovereign Identity Management Platform for Patient-Centric Health Care Using Blockchain Technology. 基于区块链技术的以患者为中心的医疗保健自主身份管理平台的技术设计与开发
Pub Date : 2022-01-01 DOI: 10.30953/bhty.v5.196
Daniel Toshio Harrell, Muhammad Usman, Ladd Hanson, Mustafa Abdul-Moheeth, Ishav Desai, Jahnavi Shriram, Eliel de Oliveira, John Robert Bautista, Eric T Meyer, Anjum Khurshid

Objective: Clinical data in the United States are highly fragmented, stored in numerous different databases, and are defined by service providers or clinical specialties rather than by individuals or their families. As a result, linking or aggregating a complete record for a patient is a major technological, legal, and operational challenge. One of the factors that has made clinical data integration so difficult to achieve is the lack of a universal ID for everyone. This leads to other related problems of having to prove identity at each interaction with the health system and repeatedly providing basic information on demographics, insurance, payment, and medical conditions. Traditional solutions that require complex governance, expensive technology, and risks to privacy and security of the data have failed adequately to solve this interoperability problem. We describe the technical design decisions of a patient-centric decentralized health identity management system using the blockchain technology, called MediLinker, to address some of these challenges.

Design: Our multidisciplinary research group developed and implemented an identity wallet, which uses the blockchain technology to manage verifiable credentials issued by healthcare clinics, banks, and insurance companies. To manage patient's self-sovereign identity, we leveraged the Hyperledger Indy blockchain framework to store patient's decentralized identifiers (DIDs) and the schemas or format for each credential type. In contrast, the credentials containing patient data are stored 'off-ledger' in each person's wallet and accessible via a computer or smartphone. We used Hyperledger Aries as a middleware layer (API: Application Programming Interface) to connect Hyperledger Indy with the front-end, which was developed using a JavaScript framework, ReactJS (Web Application) and React Native (iOS Application).

Results: MediLinker allows users to store their personal data on digital wallets, which they control. It uses a decentralized trusted identity using Hyperledger Indy and Hyperledger Aries. Patients use MediLinker to register and share their information securely and in a trusted system with healthcare and other service providers. Each MediLinker wallet can have six credential types: health ID with patient demographics, insurance, medication list including COVID-19 vaccination status, credit card, medical power of attorney (MPOA) for guardians of pediatric or geriatric patients, and research consent. The system allows for in-person and remote granting and revoking of such permissions for care, research, or other purposes without repeatedly requiring physical identity documents or enrollment information.

Conclusion: We successfully developed and tested a blockchain-based technical architecture, described in this article, as an identity management system that may be operationalized and scaled for future impl

目的:美国的临床数据高度碎片化,存储在许多不同的数据库中,并且由服务提供者或临床专业定义,而不是由个人或其家庭定义。因此,连接或汇总患者的完整记录是一项重大的技术、法律和操作挑战。使临床数据整合如此难以实现的因素之一是缺乏每个人的通用ID。这导致了其他相关问题,即在每次与卫生系统互动时必须证明身份,并反复提供有关人口统计、保险、支付和医疗条件的基本信息。传统的解决方案需要复杂的治理、昂贵的技术以及对数据隐私和安全的风险,这些解决方案都无法解决这种互操作性问题。我们描述了以患者为中心的分散健康身份管理系统的技术设计决策,该系统使用名为MediLinker的区块链技术来解决其中的一些挑战。设计:我们的多学科研究小组开发并实现了一个身份钱包,它使用区块链技术来管理医疗诊所、银行和保险公司颁发的可验证凭证。为了管理患者的自我主权身份,我们利用Hyperledger Indy区块链框架来存储患者的分散标识符(did)以及每种凭据类型的模式或格式。相比之下,包含患者数据的凭证存储在每个人的钱包中,可以通过电脑或智能手机访问。我们使用Hyperledger Aries作为中间件层(API: Application Programming Interface)将Hyperledger Indy与前端连接起来,该前端使用JavaScript框架,ReactJS (Web Application)和React Native (iOS Application)进行开发。结果:MediLinker允许用户将他们的个人数据存储在他们控制的数字钱包中。它使用超级账本Indy和超级账本Aries的去中心化可信身份。患者使用MediLinker在可信任的系统中与医疗保健和其他服务提供商安全地注册和共享他们的信息。每个MediLinker钱包可以有六种凭证类型:包含患者人口统计信息的健康ID、保险、包括COVID-19疫苗接种状态在内的药物清单、信用卡、儿科或老年患者监护人的医疗授权书(MPOA)以及研究同意书。该系统允许为了护理、研究或其他目的而亲自和远程授予和撤销此类许可,而无需反复要求物理身份证件或注册信息。结论:我们成功开发并测试了本文中描述的基于区块链的技术架构,作为一种身份管理系统,可以在未来实施时进行操作和扩展,以改善患者体验并控制其个人信息。
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引用次数: 6
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Blockchain in healthcare today
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