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去中心化数字健康服务在创新压力与监管负担之间左右为难。

Decentralized Digital Health Services Caught Between the Pressure for Innovation and the Burden of Regulations.

作者信息

Meier Lea, Tippenhauer Kevin, Sariyar Murat

机构信息

Bern University of Applied Sciences, Institute for Medical Informatics I4MI, Switzerland.

出版信息

Stud Health Technol Inform. 2021 May 27;281:1046-1050. doi: 10.3233/SHTI210344.

DOI:10.3233/SHTI210344
PMID:34042838
Abstract

Multiple challenges await third-party digital health services when trying to enter the health market. Prominent examples of such services are clinical decision support systems provided as external software. Uncertainty about their challenges, technical as well as legal, pose serious hurdles for many innovations to be adopted early on. There are many options and trade-offs to provide digital healthcare solutions as a third-party service. This paper discusses them by referring to a pharmacogenetic decision support service. By providing best-practices, scenario descriptions and templates designed for third-party services with respect to legal and technical issues, obstacles and uncertainties can be reduced, which will have an impact on better diagnoses and treatments in the healthcare system.

摘要

第三方数字健康服务在试图进入健康市场时面临多重挑战。此类服务的突出例子是作为外部软件提供的临床决策支持系统。其技术和法律方面挑战的不确定性,给许多早期采用的创新带来了严重障碍。作为第三方服务提供数字医疗解决方案有多种选择和权衡。本文通过参考一项药物遗传学决策支持服务来讨论这些问题。通过提供针对第三方服务在法律和技术问题方面设计的最佳实践、场景描述和模板,可以减少障碍和不确定性,这将对医疗系统中更好的诊断和治疗产生影响。

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