Stark Susanne, Schorr Susanne Gabriele, Pittelkow Merle-Marie, Strech Daniel
Berlin Institute of Health at Charité - Universitätsmedizin Berlin, QUEST Center for Responsible Research, Berlin, Germany.
BMC Health Serv Res. 2025 Mar 18;25(1):402. doi: 10.1186/s12913-025-12500-7.
Reusing health data, for example for research into the quality of care or healthcare planning, has far-reaching potential. Current ethical discussions on developing health data platforms (e.g. the German Medical Informatics Initiative, MII) have primarily addressed patient-related benefits and risks of reusing this data. Less is known about the perspectives of healthcare providers, such as hospitals, that make health data available through these platforms. However, the risks they perceive and a resulting reluctance to share data, along with the lack of strategies for managing these risks, could significantly impede research with health data. In this exploratory qualitative study, we investigated the interests and risks relevant to healthcare providers in the secondary use of health data, and strategies to address these risks (pre-registration: https://osf.io/uxds ).
We conducted online expert interviews (N = 21) between May and August 2023 with German representatives of different stakeholder groups (e.g. healthcare providers, researchers, patient representatives, data protection officers) with expertise in the secondary use of health data and the associated interests and risks for providers. We analysed the data using the deductive-inductive approach to qualitative content analysis.
Interviewees attributed several potentials reusing health data, such as improving healthcare quality and transparency. They also pointed to risks, including their causes and consequences for providers' reputation, economic and existential situation. Risks included a) biased results and interpretation of data analyses due to inadequate data validity and inappropriate analytical approaches, b) questionable reuse purposes, c) liability risks due to a lack of control over shared data and unresolved legal questions, and d) improved transparency that may reveal challenges and misconduct in healthcare. Suggested strategies for risk mitigation related to use and access decisions on secondary use requests. These include a) developing risk-reducing policies, b) ensuring transparent decision-making processes by involving all relevant stakeholders and applying structured risk-benefit assessments, and c) measures to improve the validity of secondary analyses. In addition, the interviewees identified further need for action to be addressed by providers, researchers and policymakers.
These findings point to needs and opportunities for action to manage risks that providers associate with health data reuse. Decision-making processes on secondary use requests should be based on normative principles, and quality, safety and trust in health data reuse should be enhanced. These recommendations should be taken up by responsible stakeholders in initiatives such as the MII, among researchers and policymakers to reduce reluctance and promote research with health data.
重复使用健康数据，例如用于医疗质量研究或医疗规划，具有深远的潜力。当前关于开发健康数据平台（如德国医学信息学倡议，MII）的伦理讨论主要涉及重复使用此类数据给患者带来的益处和风险。对于通过这些平台提供健康数据的医疗服务提供者（如医院）的观点，我们了解得较少。然而，他们所感知到的风险以及由此产生的数据共享顾虑，再加上缺乏管理这些风险的策略，可能会严重阻碍健康数据研究。在这项探索性定性研究中，我们调查了医疗服务提供者在二次使用健康数据方面的相关利益和风险，以及应对这些风险的策略（预注册：https://osf.io/uxds ）。
2023年5月至8月期间，我们对德国不同利益相关者群体（如医疗服务提供者、研究人员、患者代表、数据保护官员）的代表进行了在线专家访谈（N = 21），这些代表在健康数据二次使用及相关利益和风险方面具有专业知识。我们采用演绎 - 归纳法对定性内容进行分析。
受访者认为重复使用健康数据有诸多潜力，如提高医疗质量和透明度。他们也指出了风险，包括对提供者声誉、经济和生存状况的成因及后果。风险包括：a）由于数据有效性不足和分析方法不当导致数据分析结果和解释存在偏差；b）重复使用目的存疑；c）由于对共享数据缺乏控制以及法律问题未解决而产生的责任风险；d）透明度提高可能会揭示医疗保健中的挑战和不当行为。针对二次使用请求的使用和访问决策，建议了减轻风险的策略。这些策略包括：a）制定降低风险的政策；b）通过让所有相关利益者参与并应用结构化的风险效益评估，确保决策过程透明；c）采取措施提高二次分析的有效性。此外，受访者还确定了提供者、研究人员和政策制定者需要进一步采取行动加以解决的问题。
这些发现指出了应对提供者与健康数据重复使用相关风险的行动需求和机会。二次使用请求的决策过程应基于规范性原则，应提高健康数据重复使用中的质量、安全性和信任度。在诸如MII等倡议中，研究人员和政策制定者等责任利益相关者应采纳这些建议，以减少顾虑并促进健康数据研究。
