Privacy & Regulatory Benefits

Generating data that never existed avoids the pitfalls of re-identification and linkage attacks inherent in de-identification. Since synthetic datasets contain no actual patient entries, they fall outside most definitions of “personal data,” simplifying ethics reviews and data-use agreements.

Regulatory advantages:

1. HIPAA Safe Harbor replacement: No need for expert determination when data are fully synthetic
2. GDPR compatibility: Synthetic data can be shared without invoking “processing of personal data” rules
3. Cross-institutional collaboration: Institutions can exchange synthetic cohorts without complex legal contracts

By adopting synthetic data, healthcare teams can accelerate model development, allow open-source benchmarking, and democratize access while upholding the highest standards of patient confidentiality.