Groeben C, Karschuck P, Kormann F, Baunacke M, Wiemer L, Krause H, Fuchs K, Wiedemann A, Schnitzbauer A A, Schmitz A, Ebert D, Struck J P, Borgmann H
Klinik für Urologie, Philipps-Universität Marburg, Baldingerstr., 35033, Marburg, Deutschland.
Urologische Universitätsklinik Heidelberg, Medizinische Fakultät, Universität Heidelberg, Heidelberg, Deutschland, Im Neuenheimer Feld 420 , 69120.
Chirurgie (Heidelb). 2025 Jul 7. doi: 10.1007/s00104-025-02329-5.
Healthcare apps or healthcare applications (DiHA) offer great potential for the modernization of healthcare treatment but place high demands on the digital health landscape. In order to achieve a real additional value for the treatment of patients, clear criteria must be fulfilled. This article is based on a consensus conference of the Digital Health Summit (29-30 August 2024) at the Technical University Brandenburg.
A modified multistage Delphi survey procedure was carried out with interdisciplinary experts from clinical, scientific and industrial sectors to achieve a consensus on the requirements for surgical healthcare apps.
The Delphi procedure led to 30 statements on requirements for surgical apps in Germany. They can provide evidence-based benefits for patient information and reduction of symptoms but must be more stringently tested in clinical studies on benefits and safety. In addition, apps can support training, simplify documentation and organize processes more efficiently. Uniform quality criteria are necessary in the European context. Patient data should be anonymized to assist research, whereby the sovereignty of the data lies by the patients. Regulatory hurdles should be dismantled and DiHAs should be classified according to the evidence and the risk-benefit profile.
In our statements we recommend to actively promote the development and use of healthcare apps to improve the treatment of patients in surgery. This requires targeted support for licensing, research and use, particularly by academic groups, as well as studies on the efficacy of healthcare apps.
医疗保健应用程序(DiHA)为医疗保健治疗的现代化提供了巨大潜力,但对数字健康领域提出了很高的要求。为了实现对患者治疗的真正附加价值,必须满足明确的标准。本文基于勃兰登堡技术大学数字健康峰会(2024年8月29 - 30日)的共识会议。
对来自临床、科学和工业领域的跨学科专家进行了改良的多阶段德尔菲调查程序,以就手术医疗保健应用程序的要求达成共识。
德尔菲程序得出了30条关于德国手术应用程序要求的陈述。它们可以为患者信息和症状减轻提供循证益处,但必须在益处和安全性的临床研究中进行更严格的测试。此外,应用程序可以支持培训、简化文档并更高效地组织流程。在欧洲背景下,统一的质量标准是必要的。患者数据应匿名以协助研究,数据主权归患者所有。应消除监管障碍,DiHA应根据证据和风险效益概况进行分类。
在我们的陈述中,我们建议积极推动医疗保健应用程序的开发和使用,以改善手术患者的治疗。这需要针对性地支持许可、研究和使用,特别是由学术团体提供支持,以及对医疗保健应用程序疗效的研究。