Health Industry Cybersecurity Practices (HICP) is a publication series produced by the HHS 405(d) Task Group, a public-private collaboration of the Department of Health and Human Services and more than 200 healthcare and cybersecurity organizations. HICP defines voluntary, consensus-based cybersecurity practices scoped to small, medium, and large healthcare organizations. The 2023 edition (HICP 2023) updated the original 10 practice areas and aligned them to the NIST Cybersecurity Framework.

Why it matters

HICP can support healthcare cybersecurity planning and recognized-security-practices evidence. Buyers may request alignment and device-security documentation, but HICP does not create a general manufacturer procurement or MDS2 mandate.

Common pitfalls

•Confusing HICP with the HIPAA Security Rule, HIPAA sets requirements, HICP describes how to meet them.
•Manufacturers ignoring HICP because it's hospital-facing, your products must enable hospital HICP conformance, particularly around asset management, identity, and vulnerability management.
•Citing HICP 2018, the current edition is HICP 2023, with updated technical volumes and a separate Cybersecurity Framework Implementation Guide.

Sources

405(d) Program, HICP 2023 · HHS
HHS 405(d) Program · HHS
HSCC - Health Sector Coordinating Council · HSCC
HHS recognized security practices guidance · HHS
US Code 42 USC 17941 · uscode.house.gov
HHS HPH CPGs · HHS

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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.