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[对列入德国联邦药品和医疗器械管理局可报销数字健康应用目录的永久性心理社会数字健康应用的批判性评估]

[Critical Evaluation of Permanently Listed Psychosocial Digital Health Applications into the Directory for Reimbursable Digital Health Applications of the BfArM].

作者信息

Wolff Lara Luisa, Rapp Michael, Mocek Anja

机构信息

Department of Rehabilitation Medicine, University of Potsdam.

Social and Preventive Medicine, University of Potsdam.

出版信息

Psychiatr Prax. 2023 Mar;50(2):67-79. doi: 10.1055/a-1875-3635. Epub 2022 Sep 28.

Abstract

Digital health applications (DiGA) delivered as psychosocial therapeutic interventions entail a huge potential through their proven medical benefit or patient-relevant structure and process improvements. Their usage as first-line or concomitant therapy is refunded by the German health insurances. Therefore, the digital health applications have to pass a complex evidence process as requested by the Federal Institute for Drugs and Medical Services. The present article aimed at critically evaluating the available evidence of the permanently registered DiGA using the Critically Appraised Topic method. In conclusion, all studies fulfil at least two thirds of the evaluation criteria, implying that the overall evidence is of sufficient quality.

摘要

作为心理社会治疗干预措施提供的数字健康应用程序(DiGA),因其已证实的医疗益处或与患者相关的结构及流程改进而具有巨大潜力。德国健康保险公司为其作为一线治疗或辅助治疗的使用提供报销。因此,数字健康应用程序必须按照联邦药品和医疗器械研究所的要求通过复杂的证据审核流程。本文旨在使用关键评估主题方法对永久注册的DiGA的现有证据进行批判性评估。总之,所有研究至少满足三分之二的评估标准,这意味着总体证据质量足够。

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