HHS published voluntary HPH Cybersecurity Performance Goals in January 2024 in collaboration with CISA and industry. They adapt CISA cross-sector CPGs and draw on HICP, NIST CSF and the HPH sector implementation guide. Essential goals establish foundational priorities; Enhanced goals support more advanced practices. This is not a formal linear hierarchy from CSF through HICP.

Why it matters

HPH-CPGs are quickly becoming the primary measuring stick for healthcare cybersecurity maturity. HHS has signaled that future rulemaking under the HIPAA Security Rule and conditions of participation for Medicare may incorporate CPG-style requirements. Medical device manufacturers should expect hospital RFPs and procurement reviews to ask explicitly which CPGs your product helps the hospital achieve, particularly around asset inventory, vulnerability management, MFA, and incident response.

Common pitfalls

•Treating Essential CPGs as the ceiling, they are the floor. Enhanced Goals reflect what mature health systems are already doing.
•Mapping device features to CPGs in marketing without evidence, hospitals will ask for technical artifacts (MDS2, SBOM, configuration guides) tied to specific CPGs.
•Assess supplier requirements in actual contracts and applicable business associate agreements. HPH CPGs do not automatically flow down as legal requirements, and not every device supplier is a business associate.

Sources

Cross-Sector Cybersecurity Performance Goals · CISA
MDCG Cybersecurity Guidance · MDCG
HSCC - Health Sector Coordinating Council · HSCC
HHS HPH CPGs · HHS
HHS CPG document · HHS
HHS current Security Rule · 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.