Under HIPAA, health information is de-identified when it cannot reasonably be used to identify an individual. HHS recognizes two methods: the Safe Harbor method (removal of 18 specified identifiers and no actual knowledge that the residual data could re-identify) and the Expert Determination method (a qualified expert applies statistical/scientific methods and documents that re-identification risk is very small). De-identified data is not PHI and not subject to HIPAA.

Why it matters

MedTech teams that want to use clinical data for AI/ML training, analytics, or research typically need de-identified data. Choosing Safe Harbor is procedurally simpler but data-utility-poor; Expert Determination preserves more analytic value but requires documented expert work and ongoing risk monitoring.

Common pitfalls

•Calling pseudonymized data 'de-identified' - pseudonymization preserves a re-identification key.
•Combining de-identified datasets that, together, re-identify (the mosaic effect).
•Skipping the Expert Determination documentation - without it, the data isn't legally de-identified.

Sources

HHS Guidance: De-Identification of PHI · HHS OCR
NIST SP 800-188 De-Identifying Government Datasets · NIST
HSCC - Health Sector Coordinating Council · HSCC

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.