Vovk Olga, Ghasempour Ali, Piho Gunnar, Ross Peeter
Department of Software Science, Tallinn University of Technology, Tallinn, Estonia.
IT College, Tallinn University of Technology, Tallinn, Estonia.
Front Med (Lausanne). 2025 Aug 29;12:1639342. doi: 10.3389/fmed.2025.1639342. eCollection 2025.
The secondary use of Electronic Health Records (EHRs) holds significant potential for advancing research, public health, and innovation. However, data sharing is often limited by privacy regulations, requirements, and technical complexity. This study introduces Design Science (DS) research on the evidence-based design of WiseSpace-a tool specifically tailored to address these challenges by enabling the secure, regulation-compliant de-identification of healthcare data, particularly for non-technical users.
The research utilizes DS methodology to develop and evaluate the de-identification solution. This approach includes problem investigation through literature review, existing method and tool evaluation, and expert interviews; treatment design based on the identified challenges; treatment validation; and treatment implementation.
WiseSpace provides tools for personal, identifiable health data detection, de-identification, and re-identification as well as risk assessment. The tool supports common health data standards and its intuitive user interface allows healthcare professionals, individuals, and researchers to perform data management-related tasks without requiring technical expertise.
WiseSpace addresses critical gaps in existing anonymization solutions by providing domain-specific support for healthcare data and ensuring compliance with the General Data Protection Regulation (GDPR) and the European Health Data Space (EHDS). It offers automation and risk mitigation solutions and simplifies workflow, enabling secondary data use. Use cases demonstrate the solution's utility for organizations and individuals.
电子健康记录（EHRs）的二次利用在推进研究、公共卫生和创新方面具有巨大潜力。然而，数据共享往往受到隐私法规、要求和技术复杂性的限制。本研究介绍了设计科学（DS）研究，即关于WiseSpace的循证设计，WiseSpace是一种专门定制的工具，通过实现医疗数据的安全、合规去识别化，特别是为非技术用户，来应对这些挑战。
该研究利用DS方法来开发和评估去识别化解决方案。这种方法包括通过文献综述、现有方法和工具评估以及专家访谈进行问题调查；基于已识别的挑战进行治疗设计；治疗验证；以及治疗实施。
WiseSpace提供了用于个人可识别健康数据检测、去识别化、重新识别以及风险评估的工具。该工具支持常见的健康数据标准，其直观的用户界面使医疗专业人员、个人和研究人员无需技术专长即可执行与数据管理相关的任务。
WiseSpace通过为医疗数据提供特定领域的支持，并确保符合《通用数据保护条例》（GDPR）和欧洲健康数据空间（EHDS），解决了现有匿名化解决方案中的关键差距。它提供了自动化和风险缓解解决方案，并简化了工作流程，从而实现二次数据使用。用例展示了该解决方案对组织和个人的实用性。
