Real-World Data

Real-World Data (RWD) refers to data collected from sources outside of clinical trials, including EHRs, wearables, and insurance claims. According to GDPR Article 9, this constitutes special categories of personal data requiring enhanced protection. In a risk management context, RWD must be managed under ISO 27701 standards to ensure data-centric privacy controls. Unlike controlled clinical trial data, RWD is often unstructured and high-volume, necessitating robust de-identification techniques to be legally usable for research. Companies must distinguish between identifiable RWD and truly anonymous data to avoid regulatory violations under both GDPR and Taiwan's Personal Data Protection Act. The risk-adjusted value of RWD lies in its ability to provide insights into diverse patient populations, but only if the data-handling framework is both scalable and compliant.

Implementation follows three stages: Classification, Processing, and Monitoring. First, companies categorize RWD by sensitivity (e.g., genetic data vs.- general demographics) as per ISO 27701. Second, a secure data-processing pipeline is established, utilizing encryption (AES-256) and pseudonymization to de-risk the data-handling process. Third, continuous monitoring via SIEM systems ensures all RTO (Recovery Time Objective) and RPO (Recovery Point Objective)--related data-handling risks are addressed. A European pharmaceutical firm implementing these steps reported a 70% reduction in data-related compliance risks within the first year. The key KPI is the reduction in unauthorized access incidents, which typically drops by over 90% after implementing standardized RTO/RPO-aligned controls for RWD-handling systems.

Taiwan enterprises face three primary challenges: Regulatory ambiguity, technical-talent shortage, and fragmented data silos. The Taiwan Personal Data Protection Act (PDPA)-—specifically Article 27—requires strict handling of sensitive health data, which can be interpreted differently by various regulators. To overcome this, companies should adopt the GDPR standard as their baseline, ensuring global compliance. Secondly, the shortage of privacy engineers can be addressed by partnering with specialized consultants like Winners Consulting. Finally, data silos can be resolved by investing in interoperable standards like HL7 FHIR (Fast Healthcare Interoperability Resources). The recommended roadmap is: Month 1-2: Gap analysis; Month 3-5: Framework design and tool selection; Month 6-9: Implementation and employee training; Month 10-12: Audit and optimization.

Winners Consulting Services Co., Ltd. specializes in Real-World Data compliance for Taiwan enterprises, delivering compliant management systems within 90 days. We provide end-to-end assistance, from DPIA assessments to ISO 27701 certification readiness. Free consultation: https://winners.com.tw/contact