Klinik für Orthopädie und Orthopädische Chirurgie, Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg.
Gelenkzentrum Bergisch Land, Fabricius Klinik Remscheid.
Z Orthop Unfall. 2021 Jun;159(3):259-265. doi: 10.1055/a-1141-4274. Epub 2020 May 4.
The recently ratified Digital Healthcare Act - DVG - has paved the way, among other issues, for the prescription of health apps. The German DVG creates an entitlement to health apps for the very first time. However, this entitlement is initially limited to low-risk medical devices that have been included in the publicly accessible Register for Digital Health Applications by the German Federal Institute for Drugs and Medical Devices. Listing in the register is granted, if the manufacturer has submitted a health app and verified that it meets basic requirements for medical devices and data security as well as positive health care effects. It is questionable, whether the DVG will lead to sustainable improvements in future patient care. In order to pursue this question and align the DGOUC's digitization strategy closely with its basis, an online survey was conducted among the respective members on the DVG's content and its associated opportunities and risks. A total of 461 German-speaking, predominantly male, experienced and elderly physicians in leading positions took part in the survey. In this study, it was shown that the majority of the participating German orthopaedic and trauma surgeons is not familiar with the DVG's contents. Despite a fundamentally positive attitude towards digitization, scepticism about the use of "apps on prescription" and potential risks still prevails at present. The closing of ranks between medicine, IT and the legislature via interdisciplinary expert groups and the involvement of medical societies might be obligatory.
最近批准的《数字医疗法案》（DVG）为开处健康类应用程序铺平了道路。德国的 DVG 首次为健康类应用程序创造了权利。然而，这种权利最初仅限于已被德国联邦药物和医疗器械研究所列入公共可访问的数字健康应用程序注册的低风险医疗器械。如果制造商提交了健康应用程序，并验证其符合医疗器械和数据安全的基本要求以及对医疗保健的积极影响，则可以获得在注册中的列出。DVG 是否会导致未来患者护理的可持续改善，这一点值得怀疑。为了探讨这个问题，并使 DGOUC 的数字化战略与其基础紧密结合，我们对各自成员就 DVG 的内容及其相关的机会和风险进行了在线调查。共有 461 名讲德语、主要为男性、经验丰富且年龄较大的处于领导地位的医生参与了这项调查。在这项研究中，结果表明，大多数参与的德国骨科和创伤外科医生不熟悉 DVG 的内容。尽管对数字化持基本积极的态度，但目前对“处方应用程序”的使用和潜在风险仍持怀疑态度。通过跨学科专家组和医学协会进行医学、信息技术和立法机构之间的联合，可能是必要的。
