Brönneke Jan Benedikt, Hagen Julia, Kircher Philipp, Matthies Henrik
health innovation hub (hih) des Bundesministeriums für Gesundheit, Torstr. 223, 10115, Berlin, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2021 Oct;64(10):1285-1291. doi: 10.1007/s00103-021-03416-8. Epub 2021 Sep 17.
Due to the rapidly advancing digitalization, healthcare will also change significantly in the next few years. For example, in Germany, new legal framework conditions have already set the course for the electronic patient record (ePA), the e‑prescription, and the integration of digital health applications (DiGA). The new fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) for evaluating the reimbursability of DiGA is an important step that will be followed by others in the coming years.This article uses a future scenario for the year 2030 to describe the legal, technical, and practical changes that could occur by then. In 2030, healthcare could be organized in individual and integrated treatment pathways that offer comprehensive support to the insured. Interoperable digital components could, for example, make structured data available for research purposes. Doubts concerning data protection could become a thing of the past if data protection law is reformed and harmonized and new consent procedures for patients are developed. New professional fields could become established and market access for innovative digital medical products could be further improved.Another important aspect that can help to exploit the potential of digital healthcare is the creation of a European data space based on a technical infrastructure that upholds high ethical and social standards. Active measures on the part of legislators can create the necessary conditions for innovations to be incorporated into the system for the benefit of patients and for the German healthcare system to be able to cope with the ongoing changes in medical technology.
由于数字化的迅速发展,未来几年医疗保健也将发生重大变化。例如,在德国,新的法律框架条件已经为电子病历(ePA)、电子处方以及数字健康应用程序(DiGA)的整合奠定了基础。联邦药品和医疗器械研究所(BfArM)评估DiGA报销资格的新快速程序是重要的一步,未来几年还会有其他举措。本文采用2030年的未来情景来描述届时可能发生的法律、技术和实际变化。到2030年,医疗保健可以按照为投保人提供全面支持的个体化和整合化治疗路径来组织。例如,可互操作的数字组件可以提供结构化数据用于研究目的。如果改革和统一数据保护法并制定新的患者同意程序,对数据保护的疑虑可能会成为过去式。可能会出现新的专业领域,创新数字医疗产品的市场准入可能会进一步改善。有助于挖掘数字医疗保健潜力的另一个重要方面是基于秉持高道德和社会标准的技术基础设施创建欧洲数据空间。立法者采取的积极措施可以为将创新纳入系统以造福患者创造必要条件,并使德国医疗保健系统能够应对医疗技术的持续变化。