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电子健康实施:关于法律、伦理、财务和技术方面的范围界定审查

eHealth implementation : a scoping review on legal, ethical, financial, and technological aspects.

作者信息

Bente Britt E, Van Dongen Anne, Verdaasdonk Ruud, van Gemert-Pijnen Lisette

机构信息

Centre for eHealth and Wellbeing Research, Department of Psychology, Health and Technology, Faculty of Behavioural, Management and Social Sciences, University of Twente, Esnchede, Netherlands.

Section of Health, Technology and Implementation, Technical Medical Centre, University of Twente, Enschede, Netherlands.

出版信息

Front Digit Health. 2024 Mar 8;6:1332707. doi: 10.3389/fdgth.2024.1332707. eCollection 2024.

DOI:10.3389/fdgth.2024.1332707
PMID:38524249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10957613/
Abstract

BACKGROUND

The evolution of eHealth development has shifted from standalone tools to comprehensive digital health environments, fostering data exchange among diverse stakeholders and systems. Nevertheless, existing research and implementation frameworks have primarily emphasized technological and organizational aspects of eHealth implementation, overlooking the intricate legal, ethical, and financial considerations. It is essential to discover what legal, ethical, financial, and technological challenges should be considered to ensure successful and sustainable implementation of eHealth.

OBJECTIVE

This review aims to provide insights into barriers and facilitators of legal, ethical, financial, and technological aspects for successful implementation of complex eHealth technologies, which impacts multiple levels and multiple stakeholders.

METHODS

A scoping review was conducted by querying PubMed, Scopus, Web of Science, and ACM Digital Library (2018-2023) for studies describing the implementation process of eHealth technologies that facilitate data exchange. Studies solely reporting clinical outcomes or conducted outside Europe were excluded. Two independent reviewers selected the studies. A conceptual framework was constructed through axial and inductive coding, extracting data from literature on legal, ethical, financial, and technological aspects of eHealth implementation. This framework guided systematic extraction and interpretation.

RESULTS

The search resulted in 7.308 studies that were screened for eligibility, of which 35 (0.48%) were included. Legal barriers revolve around data confidentiality and security, necessitating clear regulatory guidelines. Ethical barriers span consent, responsibility, liability, and validation complexities, necessitating robust frameworks. Financial barriers stem from inadequate funding, requiring (commercial) partnerships and business models. Technological issues include interoperability, integration, and malfunctioning, necessitating strategies for enhancing data reliability, improving accessibility, and aligning eHealth technology with existing systems for smoother integration.

CONCLUSIONS

This research highlights the multifaceted nature of eHealth implementation, encompassing legal, ethical, financial, and technological considerations. Collaborative stakeholder engagement is paramount for effective decision-making and aligns with the transition from standalone eHealth tools to integrated digital health environments. Identifying suitable stakeholders and recognizing their stakes and values enriches implementation strategies with expertise and guidance across all aspects. Future research should explore the timing of these considerations and practical solutions for regulatory compliance, funding, navigation of responsibility and liability, and business models for reimbursement strategies.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/1aa74c9dfc2a/fdgth-06-1332707-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/42d7477fb867/fdgth-06-1332707-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/4e1eb21ffe29/fdgth-06-1332707-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/1aa74c9dfc2a/fdgth-06-1332707-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/42d7477fb867/fdgth-06-1332707-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/4e1eb21ffe29/fdgth-06-1332707-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f7b/10957613/1aa74c9dfc2a/fdgth-06-1332707-g003.jpg
摘要

背景

电子健康(eHealth)的发展已从独立工具转向全面的数字健康环境,促进了不同利益相关者和系统之间的数据交换。然而,现有的研究和实施框架主要强调eHealth实施的技术和组织方面,忽视了复杂的法律、伦理和财务考量。发现确保eHealth成功和可持续实施应考虑哪些法律、伦理、财务和技术挑战至关重要。

目的

本综述旨在深入了解成功实施复杂eHealth技术在法律、伦理、财务和技术方面的障碍与促进因素,这些技术会影响多个层面和多个利益相关者。

方法

通过查询PubMed、Scopus、Web of Science和ACM数字图书馆(2018 - 2023年)进行范围综述,以查找描述促进数据交换的eHealth技术实施过程的研究。仅报告临床结果或在欧洲以外进行的研究被排除。两名独立评审员筛选研究。通过轴向编码和归纳编码构建概念框架,从关于eHealth实施的法律、伦理、财务和技术方面的文献中提取数据。该框架指导系统的提取和解释。

结果

检索结果为7308项研究,对其进行了资格筛选,其中35项(0.48%)被纳入。法律障碍围绕数据保密和安全,需要明确的监管指南。伦理障碍涵盖同意、责任、赔偿责任和验证复杂性,需要强大的框架。财务障碍源于资金不足,需要(商业)伙伴关系和商业模式。技术问题包括互操作性、集成和故障,需要提高数据可靠性、改善可及性以及使eHealth技术与现有系统对齐以实现更顺畅集成的策略。

结论

本研究强调了eHealth实施的多面性,包括法律、伦理、财务和技术考量。利益相关者的协作参与对于有效决策至关重要,并且与从独立的eHealth工具向集成数字健康环境的转变相一致。确定合适的利益相关者并认识到他们的利益和价值观,可为实施策略提供各方面的专业知识和指导。未来的研究应探讨这些考量的时机以及监管合规、资金、责任和赔偿责任的界定以及报销策略商业模式的实际解决方案。

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