Sareban Mahdi, Treff Gunnar, Smeddinck Jan David, Hussein Rada, Niebauer Josef
University Institute of Sports Medicine, Prevention and Rehabilitation, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.
Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria.
Digit Health. 2025 Jan 6;11:20552076241299062. doi: 10.1177/20552076241299062. eCollection 2025 Jan-Dec.
Digital therapeutics (DTx) are software-based interventions that aim to prevent or treat especially non-communicable diseases. Currently, no framework for reimbursement of DTx exists in Austria. The aim of this study was to gather a comprehensive perspective on regulatory considerations of Austrian stakeholders with regard to reimbursement of DTx and to outline strategies for establishing a national reimbursement framework.
Based on a stakeholder analysis, seven semi-structured interviews with Austrian experts from the digital health-related fields medicine, public health, health technology assessment, health industry and social security providers were conducted. Interviews were analyzed according to seven predefined themes.
Overall, participants agreed that reimbursement of DTx by the public insurance in Austria is desirable. Prerequisites are (i) a high user and prescriber acceptance of DTx, which must be integrated into a transparent and interoperable Austrian e-Health infrastructure, (ii) a sufficient, risk-based level of evidence for clinical effectiveness, (iii) national authorities that transparently provide evidence-base, indications, contra-indications and potential risks, (iv) adopting European regulations about data security, secondary use of data and use of artificial intelligence and (v) a health-economical evaluation of DTx.
A comprehensive national strategy for reimbursing DTx will need to consider technical, scientific and socio-economical requirements, patient safety and liability, secure health data handling and use of artificial intelligence in order to establish a sound framework with equitable access also for socioeconomically disadvantaged persons in order to address the growing burden of non-communicable diseases.
数字疗法（DTx）是基于软件的干预措施，旨在预防或治疗特别是非传染性疾病。目前，奥地利不存在数字疗法报销框架。本研究的目的是全面了解奥地利利益相关者在数字疗法报销方面的监管考虑因素，并概述建立国家报销框架的策略。
基于利益相关者分析，对来自数字健康相关领域（医学、公共卫生、卫生技术评估、健康产业和社会保障提供者）的七位奥地利专家进行了半结构化访谈。访谈根据七个预先定义的主题进行分析。
总体而言，参与者一致认为奥地利公共保险对数字疗法进行报销是可取的。前提条件包括：（i）用户和开处方者对数字疗法的高度接受，数字疗法必须整合到透明且可互操作的奥地利电子健康基础设施中；（ii）有足够的、基于风险的临床有效性证据水平；（iii）国家当局透明地提供证据基础、适应症、禁忌症和潜在风险；（iv）采用欧洲关于数据安全、数据二次使用和人工智能使用的法规；（v）对数字疗法进行健康经济评估。
一项全面的数字疗法报销国家战略需要考虑技术、科学和社会经济要求、患者安全和责任、安全的健康数据处理以及人工智能的使用，以便建立一个健全的框架，使社会经济弱势群体也能公平获得，从而应对日益增长的非传染性疾病负担。
