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Towards a Stakeholder-Oriented Blockchain-Based Architecture for Electronic Health Records: Design Science Research Study.

ABSTRACT: BACKGROUND:Data security issues still constitute the main reason for the sluggish dissemination of electronic health records (EHRs). Given that blockchain technology offers the possibility to verify transactions through a decentralized network, it may serve as a solution to secure health-related data. Therefore, we have identified stakeholder-specific requirements and propose a blockchain-based architecture for EHRs, while referring to the already existing scientific discussions on the potential of blockchain for use in EHRs. OBJECTIVE:This study aimed to introduce blockchain technology for EHRs, based on identifying stakeholders and systematically eliciting their requirements, and to discuss the key benefits (KBs) and key challenges (KCs) of blockchain technology in the context of EHRs. METHODS:The blockchain-based architecture was developed in the framework of the design science research paradigm. The requirements were identified using a structured literature review and interviews with nine health care experts. Subsequently, the proposed architecture was evaluated using 4 workshops with 15 participants. RESULTS:We identified three major EHR stakeholder groups and 34 respective requirements. On this basis, we developed a five-layer architecture. The subsequent evaluation of the artifact was followed by the discussion of 12 KBs and 12 KCs of a blockchain-based architecture for EHRs. To address the KCs, we derived five recommendations for action for science and practice. CONCLUSIONS:Our findings indicate that blockchain technology offers considerable potential to advance EHRs. Improvements to currently available EHR solutions are expected, for instance, in the areas of data security, traceability, and automation by smart contracts. Future research could examine the patient's acceptance of blockchain-based EHRs and cost-benefit analyses.

SUBMITTER: Beinke JH

PROVIDER: S-EPMC6914222 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Towards a Stakeholder-Oriented Blockchain-Based Architecture for Electronic Health Records: Design Science Research Study.

Beinke Jan Heinrich JH Fitte Christian C Teuteberg Frank F

Journal of medical Internet research 20191007 10

<h4>Background</h4>Data security issues still constitute the main reason for the sluggish dissemination of electronic health records (EHRs). Given that blockchain technology offers the possibility to verify transactions through a decentralized network, it may serve as a solution to secure health-related data. Therefore, we have identified stakeholder-specific requirements and propose a blockchain-based architecture for EHRs, while referring to the already existing scientific discussions on the p ...[more]

PMID: 31593548

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Project description:BackgroundBlockchain technology has the potential to enable more secure, transparent, and equitable data management. In the health care domain, it has been applied most frequently to electronic health records. In addition to securely managing data, blockchain has significant advantages in distributing data access, control, and ownership to end users. Due to this attribute, among others, the use of blockchain to power personal health records (PHRs) is especially appealing.ObjectiveThis review aims to examine the current landscape, design choices, limitations, and future directions of blockchain-based PHRs.MethodsAdopting the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, a cross-disciplinary systematic review was performed in July 2020 on all eligible articles, including gray literature, from the following 8 databases: ACM, IEEE Xplore, MEDLINE, ScienceDirect, Scopus, SpringerLink, Web of Science, and Google Scholar. Three reviewers independently performed a full-text review and data abstraction using a standardized data collection form.ResultsA total of 58 articles met the inclusion criteria. In the review, we found that the blockchain PHR space has matured over the past 5 years, from purely conceptual ideas initially to an increasing trend of publications describing prototypes and even implementations. Although the eventual application of blockchain in PHRs is intended for the health care industry, the majority of the articles were found in engineering or computer science publications. Among the blockchain PHRs described, permissioned blockchains and off-chain storage were the most common design choices. Although 18 articles described a tethered blockchain PHR, all of them were at the conceptual stage.ConclusionsThis review revealed that although research interest in blockchain PHRs is increasing and that the space is maturing, this technology is still largely in the conceptual stage. Being the first systematic review on blockchain PHRs, this review should serve as a basis for future reviews to track the development of the space.

Project description:BackgroundHealthcare providers are often targeted as research participants, especially for implementation science studies evaluating provider- or system-level issues. Frequently, provider eligibility is based on both provider and patient factors. Manual chart review and self-report are common provider screening strategies but require substantial time, effort, and resources. The automated use of electronic health record (EHR) data may streamline provider identification for implementation science research. Here, we describe an approach to provider screening for a Veterans Health Administration (VHA)-funded study focused on implementing risk-aligned surveillance for bladder cancer patients.MethodsOur goal was to identify providers at 6 pre-specified facilities who performed ≥10 surveillance cystoscopy procedures among bladder cancer patients in the 12 months prior to recruitment start on January 16, 2020, and who were currently practicing at 1 of 6 pre-specified facilities. Using VHA EHR data (using CPT, ICD10 procedure, and ICD10 diagnosis codes), we identified cystoscopy procedures performed after an initial bladder cancer diagnosis (i.e., surveillance procedures). Procedures were linked to VHA staff data to determine the provider of record, the number of cystoscopies they performed, and their current location of practice. To validate this approach, we performed a chart review of 105 procedures performed by a random sample of identified providers. The proportion of correctly identified procedures was calculated (Positive Predictive Value (PPV)), along with binomial 95% confidence intervals (CI).FindingsWe identified 1,917,856 cystoscopies performed on 703,324 patients from October 1, 1999-January 16, 2020, across the nationwide VHA. Of those procedures, 40% were done on patients who had a prior record of bladder cancer and were completed by 15,065 distinct providers. Of those, 61 performed ≥ 10 procedures and were currently practicing at 1 of the 6 facilities of interest in the 1 year prior to study recruitment. The random chart review of 7 providers found 101 of 105 procedures (PPV: 96%; 95% CI: 91% to 99%) were surveillance procedures and were performed by the selected provider on the recorded date.ImplicationsThese results show that EHR data can be used for accurate identification of healthcare providers as research participants when inclusion criteria consist of both patient- (temporal relationship between diagnosis and procedure) and provider-level (frequency of procedure and location of current practice) factors. As administrative codes and provider identifiers are collected in most, if not all, EHRs for billing purposes this approach can be translated from provider recruitment in VHA to other healthcare systems. Implementation studies should consider this method of screening providers.

Project description:BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.

Dataset Information

Towards a Stakeholder-Oriented Blockchain-Based Architecture for Electronic Health Records: Design Science Research Study.

Publications

Towards a Stakeholder-Oriented Blockchain-Based Architecture for Electronic Health Records: Design Science Research Study.

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