Patient Data Privacy, Protected Health Information, and Ethics of Real-World Evidence

The use of real-world evidence (RWE) has increased the importance of protecting personal data, as well as analyzing and sharing information within an ethical and secure network for purposes of ensuring compliance with the data-protection legislations, e.g., the General Data Protection Regulation (GDPR) in the European Union (EU), Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the United States (US), and Personal Information Protection and Electronic Documents Act (PIPEDA) in Canada, to name a few. Although data protection laws and ethical & bioethical standards have been developed and implemented in several countries worldwide; explicit, universal, industry-wide ethical and bioethical standards for RWE are still lacking.