63% of MDS2 (Medical Device) you already have
API 1164 already covers about 63% of MDS2 (Medical Device), leaving
3 of 8 controls as genuinely new work.
Already covered 4
Likely covered 1
New work 3
What is genuinely new work
Nothing in API 1164 reaches these. This is the list to scope.
MDS2-Device-Identification-Inventory-MGMT-Configuration-Asset-ManagementMDS2 Device Identification + MGMT + Configuration + Asset Management + HDO Inventory
MDS2-Malware-Detection-MLDP-System-Hardening-SAHD-Cybersecurity-Upgrades-CSUP-Patch-ManagementMDS2 Malware Detection + MLDP + System Hardening + SAHD + Cybersecurity Upgrades + CSUP + Patch Management
MDS2-Scope-NEMA-HN-1-2019-HIMSS-AAMI-Manufacturer-Disclosure-FDA-Section-524B-Procurement-VoluntaryMDS2 Scope + NEMA HN 1-2019 + HIMSS + AAMI + FDA Section 524B + Procurement + Voluntary Industry Standard
Show the 5 you already have
MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-MonitoringMDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring
MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPSMDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS
MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUTMDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management
MDS2-Physical-Security-PLOK-Workstation-Disposal-Backup-DTBK-Disaster-RecoveryMDS2 Physical Security + PLOK + Workstation + Disposal + Backup + DTBK + Disaster Recovery
MDS2-Roadmap-Third-Party-RDMP-Security-Guidance-SGUD-SBOM-Vulnerability-Disclosure-ProgrammeMDS2 Roadmap + RDMP + Third Party + Security Guidance + SGUD + SBOM + Vulnerability Disclosure + Coordinated
How this is calculated
Already covered means a mapping runs from a control in API 1164 to that control. Likely
covered means no direct mapping exists but both frameworks map to the same control in a third
standard. New work means neither. We keep those separate rather than adding them into one
friendlier number, because blending them would present a two-hop inference as a verified
fact.
Coverage is not symmetric.
Run it the other way and you will get a
different number; both are correct.
From 332,959 cross-framework control
mappings across 723 frameworks, 531 of them verified against
their source documents. It does not tell you that you are compliant: a mapped control means
the two standards ask for the same thing, not that you have done it.
Try another pair ยท
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