The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the HITECH Act (2009) and the HIPAA Omnibus Rule (2013), establishes federal requirements for the privacy and security of Protected Health Information (PHI) in the United States. The HIPAA Security Rule (45 CFR Part 164 Subpart C) requires Covered Entities and Business Associates to implement administrative, physical, and technical safeguards for electronic PHI (ePHI). HHS Office for Civil Rights (OCR) enforces HIPAA.

Why it matters

Connected medical devices increasingly touch PHI - telemetry, patient identifiers, device-derived diagnostic data. The right design pattern is to minimize PHI on the device, encrypt in transit and at rest, segment from non-PHI workloads, and codify the BAA terms in product architecture decisions. Failure to recognize Business Associate status is a leading cause of OCR enforcement against MedTech companies.

Common pitfalls

•Assuming MedTech manufacturers aren't subject to HIPAA - Business Associate status is common.
•Storing PHI in customer-support tooling or analytics platforms without BAAs and equivalent controls.
•Treating de-identified data as 'not PHI' without meeting the Safe Harbor or Expert Determination standards.

Sources

HHS HIPAA Security Rule · HHS OCR
45 CFR Part 164 Subpart C · eCFR
HIPAA Security Rule NPRM (2024) · Federal Register

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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.