MDS2 (Medical Device)

Disclose and operate audit logging + integrity assurance + cybersecurity risk management features per MDS2 AUDT + IGAU + CYBR sections. Audit Controls (AUDT) including audit event coverage (logon + logoff + access + privileged operations + configuration changes + security tool events) + log retention duration + log integrity protection + SIEM integration + syslog/CEF/IPFIX export. Integrity and Authenticity Assurance (IGAU) including digital signature verification + secure boot + signed firmware updates + tamper detection + chain of custody + integrity monitoring. Cybersecurity Risk Management Practices (CYBR) including manufacturer cybersecurity risk management process + Secure Development Lifecycle (SDLC) attestation + threat modelling + penetration testing + vulnerability management + coordinated disclosure programme + ISO/IEC 27001 + ISO/IEC 27034 alignment + IEC 62443 alignment + NI

• MDS2 AUDT + IGAU + CYBR sections completed
• SIEM integration evidence + syslog/CEF/IPFIX export
• Secure boot + signed firmware + tamper detection evidence
• SDLC attestation + Coordinated Vulnerability Disclosure programme + ISO 29147/30111 alignment
• SBOM disclosure per FDA Section 524B + NTIA + CISA + NEMA SBOM Implementation Guide
• IEC 62443 + NIST CSF / 800-53 alignment evidence

• No SIEM integration despite AUDT disclosure
• Secure boot disclosed but not enabled in deployment
• SBOM not provided despite 2022 form requirements
• Coordinated Vulnerability Disclosure programme not operational

Disclose and operate authentication and authorization features per MDS2 PAUT + NAUT + AUTH sections. Person Authentication (PAUT) including user identification + password complexity + MFA support + biometric authentication + smart-card support + LDAP/Active Directory integration + IDP (Identity Provider) federation + SAML / OAuth / OIDC support. Node Authentication (NAUT) including device-to-device authentication + certificate-based authentication + mutual TLS + IEEE 802.1X port-based authentication + DICOM TLS + HL7 FHIR authentication. Authorization (AUTH) including role-based access control (RBAC) + least privilege enforcement + separation of duties + break-glass emergency access + delegated administration. Auto Logoff (AUTH-01) including configurable session timeout + lock screen + clinical workflow consideration. Emergency Access (EMRG) including break-glass procedures + audit trail

• MDS2 PAUT + NAUT + AUTH + EMRG sections completed
• MFA support disclosure + LDAP/AD/SAML integration evidence
• Break-glass procedure + audit trail evidence
• Session timeout configuration evidence
• Failed login lockout + privilege escalation control evidence

• MFA support not implemented despite disclosure
• Break-glass procedures lack audit trail
• Session timeout disabled for clinical workflow without compensating controls
• Default credentials still in use post-deployment

Disclose and operate device identification + inventory + asset management features per MDS2 MGMT section. Identifies device unique identifiers + UDI Unique Device Identification (FDA UDI rule) + serial numbers + model numbers + software/firmware version inventory. Component inventory including all software libraries + operating systems + third-party software + open-source software + databases + middleware. Network identification including MAC + IP + hostname conventions. Configuration management baseline + change control + drift detection. HDO inventory integration evidence including CMMS Computerised Maintenance Management System + IT asset management + clinical engineering inventory. Lifecycle status disclosure (in development + active + sustaining + end of life). End-of-life and end-of-service-life dates for security updates + commitment timelines.

• MDS2 MGMT section completed for every medical device
• UDI Unique Device Identification per FDA UDI rule
• CMMS integration evidence
• End-of-life and end-of-service-life date register
• Component inventory + SBOM cross-walk

• MGMT section partial or absent
• UDI not captured in HDO asset management system
• End-of-service-life dates not tracked for security update commitments
• Component-level inventory missing limiting vulnerability response

Disclose and operate malware detection + system hardening + cybersecurity upgrade features per MDS2 MLDP + SAHD + CSUP sections. Malware Detection and Protection (MLDP) including anti-malware software support + signature update mechanism + behavioural detection + endpoint detection and response (EDR) compatibility + application allowlisting/denylisting + USB control + removable media policy. System and Application Hardening (SAHD) including hardening baseline + CIS Benchmarks alignment + DISA STIG alignment + unnecessary services disabled + default credentials changed + secure configuration + privileged access restriction + memory protection + ASLR + DEP + secure boot + measured boot + Trusted Platform Module (TPM) support. Cybersecurity Product Upgrades (CSUP) including patch management capability + patch testing + patch deployment frequency + emergency patch deployment + signed patches

• MDS2 MLDP + SAHD + CSUP sections completed
• Anti-malware support evidence + signature update mechanism
• Hardening baseline against CIS Benchmarks + DISA STIG
• Patch management capability + emergency patch deployment + FDA substantive patch coordination
• Application allowlisting / EDR compatibility evidence
• End-of-support transition planning

• Anti-malware disclosed but not deployable due to performance concerns
• Hardening baseline disclosed but not enforced
• Patches available but not applied due to clinical-operation concerns
• End-of-support devices remain in use without compensating controls

Disclose and operate protected health information (PHI) data handling + storage confidentiality + transmission confidentiality and integrity per MDS2 DATA + STCF + TXCF + TXIG sections. Protected Health Information Handling (DATA) including PHI inventory + minimum necessary standard + de-identification capability + anonymisation + pseudonymisation + HIPAA Safe Harbor / Expert Determination support. Health Data Storage Confidentiality (STCF) including encryption at rest + FIPS 140-2/140-3 validated cryptographic modules + AES-256 + key management + hardware security module (HSM) support + database encryption + filesystem encryption. Transmission Confidentiality (TXCF) including encryption in transit + TLS 1.2 minimum (1.3 preferred) + IPSec + DICOM TLS + HL7 over TLS + SFTP/SCP + secure email + VPN support. Transmission Integrity (TXIG) including message authentication codes + digital sig

• MDS2 DATA + STCF + TXCF + TXIG sections completed
• PHI inventory + minimum necessary + de-identification evidence
• FIPS 140-2/140-3 cryptographic module list + AES-256 evidence
• TLS 1.2+ enforcement evidence (TLS 1.3 preferred)
• DICOM TLS + HL7 over TLS + FHIR security + IHE ATNA profile evidence
• Hardware security module (HSM) usage where applicable

• Encryption at rest disclosed but not enabled
• TLS 1.1/1.0 still permitted on legacy interfaces
• DICOM unencrypted + ATNA profile not implemented
• FIPS 140-2 modules expired or end-of-life

Disclose and operate physical security + workstation security + media controls + backup and disaster recovery features per MDS2 PLOK + DTBK sections and related legacy MDS2-17 to MDS2-20. Physical Locks (PLOK) including device chassis locks + USB port locks + cable locks + tamper-evident seals + facility access controls + security cameras + alarm systems. Workstation security including operating-system user account controls + screen locks + clinical-workflow consideration + cleaning and disinfection protocols + ergonomic considerations. Device and Media Controls including portable media restrictions + media sanitisation per NIST 800-88 (clear + purge + destroy) + chain-of-custody for media + secure transport + media accountability. Disposal and re-use procedures including end-of-life sanitisation + decommissioning workflow + asset disposal certificate + environmental compliance + lithium

• MDS2 PLOK + DTBK sections completed
• Physical locks + tamper-evident seals + facility access evidence
• Backup frequency + retention + encryption + integrity verification + restore procedures + RTO/RPO documentation
• Offline backup option for ransomware resilience
• Disposal sanitisation per NIST 800-88 + chain-of-custody + asset disposal certificate

• Physical locks disclosed but not used
• Backup tested only at deployment + restore procedure never validated
• No offline backup leaving devices vulnerable to ransomware encryption
• Disposal sanitisation not performed at decommissioning

Disclose and operate third-party component roadmap + security guidance documentation + vulnerability disclosure programme per MDS2 RDMP + SGUD sections and 2022 SBOM additions. Third Party Components in Product Lifecycle Roadmaps (RDMP) including disclosure of third-party software inventory + open-source software + commercial off-the-shelf (COTS) components + medical-device middleware + database engines + operating systems + libraries + their support and security update commitments + planned upgrades + end-of-life and end-of-support dates + Software Bill of Materials (SBOM) (added 2022 update + aligned with FDA Section 524B + NTIA SBOM minimum elements + CISA SBOM guidance + NEMA SBOM Implementation Guide). Security Guidance Documentation (SGUD) including security configuration guides + Manufacturer-Provided Security Guidance + secure deployment guide + secure operations manual + secure

• MDS2 RDMP + SGUD sections completed
• SBOM per FDA Section 524B + NTIA + CISA + NEMA SBOM Implementation Guide
• Third-party component support and security update commitment register
• Manufacturer-Provided Security Guidance + secure deployment + operations + decommissioning guides
• Coordinated Vulnerability Disclosure programme + security.txt + ISO 29147/30111 alignment
• Joint Security Plan (JSP) participation + HC3 / CISA / H-ISAC coordination

• SBOM not provided despite 2022 form requirements
• Third-party component end-of-support dates not disclosed leaving HDO blind to upcoming security gaps
• Security Guidance Documentation outdated or not provided to HDO
• Vulnerability disclosure programme exists but lacks responsiveness to coordinated reports

Establish the scope of the MDS2 Manufacturer Disclosure Statement for Medical Device Security. Voluntary industry-standard form jointly developed by NEMA Medical Imaging and Technology Alliance (MITA) and HIMSS (Healthcare Information and Management Systems Society) + first issued 2004 + revised 2008 + 2013 (NEMA HN 1-2013) + 2019 (NEMA HN 1-2019 most current widely-used) + 2022 update. Completed by medical-device manufacturers and provided to healthcare delivery organisations (HDOs) during procurement + maintenance + risk assessment to enable HDOs to evaluate cybersecurity posture. Aligned with FDA Premarket and Postmarket Cybersecurity Management of Medical Devices Guidance + FDA Section 524B of FD&C Act (Cybersecurity for Cyber Devices added by Consolidated Appropriations Act 2023 + effective 29 March 2023) + AAMI TIR 57 + AAMI TIR 97 + IEC 80001-1 + IEC 80001-2-2 + IEC 62443 + HIPAA

• MDS2 NEMA HN 1-2019 (or 2022 update) completed form per medical device
• Manufacturer disclosure statement procurement intake process
• FDA Section 524B + Premarket and Postmarket Guidance cross-walk
• Health Sector Coordinating Council Cybersecurity Working Group reference compliance
• Joint Commission LD.04.04.05 + IT.02.01.01 alignment

• MDS2 form not requested during procurement
• Outdated 2013 form accepted instead of 2019/2022
• FDA Section 524B applicability not assessed for new devices post 29 March 2023
• International equivalents (Health Canada + EU MDR + UK MHRA + Australian TGA) not requested for non-US devices