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MDS2 (Medical Device)

Self-Assess
United States (American National Standard); used internationally
vANSI/NEMA HN 1-2019 (supersedes HN 1-2013)
4 domains
25 controls

ANSI/NEMA HN 1-2019, the Manufacturer Disclosure Statement for Medical Device Security (MDS2): the standard form on which a medical device manufacturer discloses, question by question, what personal data the device holds and moves and which security capabilities it has (logoff, audit, authorisation, patching, de-identification, backup, emergency access, integrity, malware protection, node and person authentication, connectivity, physical locks, third-party roadmap, SBOM, hardening, security guidance, storage and transmission confidentiality and integrity, remote service), so a healthcare delivery organisation can assess and manage the device's security risk. Built from the standard's own sections and the 2019 form's questions.

Verified

MDS2 (Medical Device) is a compliance framework from United States (American National Standard); used internationally with 4 domains and 25 controls that map to 113 other frameworks. The largest domains are Data protection, connectivity and service capabilities (2.3.8, 2.3.9, 2.3.11, 2.3.13, 2.3.14, 2.3.16, 2.3.21 to 2.3.25) – MDS2 (Medical Device) (11 controls), Data handling, access and accountability capabilities (2.3.3 to 2.3.6, 2.3.10, 2.3.15) – MDS2 (Medical Device) (6 controls), Updates, software supply chain and hardening (2.3.7, 2.3.12, 2.3.17 to 2.3.20) – MDS2 (Medical Device) (6 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (4)

Data handling, access and accountability capabilities (2.3.3 to 2.3.6, 2.3.10, 2.3.15) – MDS2 (Medical Device)

6 controls
Controls in the Data handling, access and accountability capabilities (2.3.3 to 2.3.6, 2.3.10, 2.3.15) – MDS2 (Medical Device) domain of MDS2 (Medical Device): 6 controls
CodeTitle
mds2-medical-device::ALOFALOF Automatic logoff: disclose re-authentication after inactivity and whether the timeout is configurable
mds2-medical-device::AUDTAUDT Audit controls: disclose what the device logs, how logs are timed, exported, protected and reviewed
mds2-medical-device::AUTHAUTH Authorization: disclose how the device blocks unauthorised users and manages privileges
mds2-medical-device::EMRGEMRG Emergency access: disclose any break-glass access to PII in a medical emergency
mds2-medical-device::MPIIMPII Management of personally identifiable information: disclose what PII the device holds and every path by which it moves
mds2-medical-device::PAUTPAUT Person authentication: disclose unique accounts, external authentication, lockout, default accounts, password rules, MFA, SSO and credential storage

Data protection, connectivity and service capabilities (2.3.8, 2.3.9, 2.3.11, 2.3.13, 2.3.14, 2.3.16, 2.3.21 to 2.3.25) – MDS2 (Medical Device)

11 controls
Controls in the Data protection, connectivity and service capabilities (2.3.8, 2.3.9, 2.3.11, 2.3.13, 2.3.14, 2.3.16, 2.3.21 to 2.3.25) – MDS2 (Medical Device) domain of MDS2 (Medical Device): 11 controls
CodeTitle
mds2-medical-device::CONNCONN Connectivity capabilities: disclose every wireless, physical and network connection, protocol, API and internet dependency
mds2-medical-device::DIDTDIDT Health data de-identification: disclose the device's built-in de-identification and the standard it follows
mds2-medical-device::DTBKDTBK Data backup and disaster recovery: disclose where data lives long-term and how data, configuration and software are backed up and restored
mds2-medical-device::IGAUIGAU Health data integrity and authenticity: disclose integrity checks and fault protection for stored health data
mds2-medical-device::NAUTNAUT Node authentication: disclose mutual authentication of communicating nodes, network access control and certificate use
mds2-medical-device::OTHROTHR Other security considerations: disclose security risks and controls not covered elsewhere, compensating controls included
mds2-medical-device::PLOKPLOK Physical locks: disclose whether PII-bearing components and removable media are physically secured
mds2-medical-device::RMOTRMOT Remote service: disclose remote service connections, who initiates them, session indication, patient data visibility and other remote functions
mds2-medical-device::STCFSTCF Health data storage confidentiality: disclose encryption of stored data, its coverage and defaults, key management and database location
mds2-medical-device::TXCFTXCF Transmission confidentiality: disclose cabling, encryption in transit, destination limits, authenticated connections and secure protocols
mds2-medical-device::TXIGTXIG Transmission integrity: disclose protection against alteration in transit and externally cabled sub-components

Device description and disclosure (2.3.1 and 2.3.2) – MDS2 (Medical Device)

2 controls
Controls in the Device description and disclosure (2.3.1 and 2.3.2) – MDS2 (Medical Device) domain of MDS2 (Medical Device): 2 controls
CodeTitle
mds2-medical-device::2.3.12.3.1 Complete every question of the form with Yes, No or N/A, and explain through notes
mds2-medical-device::DOCDOC Device description: identify the device, its networked use, vulnerability disclosure, ISAO membership, diagrams and SaMD status

Updates, software supply chain and hardening (2.3.7, 2.3.12, 2.3.17 to 2.3.20) – MDS2 (Medical Device)

6 controls
Controls in the Updates, software supply chain and hardening (2.3.7, 2.3.12, 2.3.17 to 2.3.20) – MDS2 (Medical Device) domain of MDS2 (Medical Device): 6 controls
CodeTitle
mds2-medical-device::CSUPCSUP Cybersecurity product upgrades: disclose who can patch each software component, how, and how updates are assessed and announced
mds2-medical-device::MLDPMLDP Malware detection and protection: disclose anti-malware support, its limits, compensating controls, allow-listing and host intrusion detection
mds2-medical-device::RDMPRDMP Roadmap for third-party components in the device life cycle: disclose secure development, supplier evaluation, support dates and end-of-life planning
mds2-medical-device::SAHDSAHD System and application hardening: disclose hardening standards, certification, integrity checking, access control, disabled accounts, ports, services and boot protection
mds2-medical-device::SBOMSBOM Software bill of materials: disclose whether an SBOM exists, its format and fields, how to list installed components and how it is updated
mds2-medical-device::SGUDSGUD Security guidance: disclose owner and operator security documentation, data sanitisation, account documentation and recommended compensating controls

Your Compliance Coverage

If you comply with MDS2 (Medical Device), you already cover:

OWASP DevSecOps Maturity Model (DSOMM)

15%

5 controls mapped

Compare →

ISO 27799:2025

15%

5 controls mapped

Compare →

FFIEC Cybersecurity Assessment Tool (CAT)

15%

5 controls mapped

Compare →

+ 110 more: ISO 28001:2007 Supply Chain Security Management (15%), CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 (15%)

See all 113 mapped frameworks ↓

Maps to 113 other frameworks

33 total controls
OWASP DevSecOps Maturity Model (DSOMM)
5 source controls mapped|3 target controls covered
15%
ISO 27799:2025
5 source controls mapped|12 target controls covered
15%
FFIEC Cybersecurity Assessment Tool (CAT)
5 source controls mapped|5 target controls covered
15%
ISO 28001:2007 Supply Chain Security Management
5 source controls mapped|3 target controls covered
15%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
5 source controls mapped|8 target controls covered
15%
ISO/IEC 27011:2024
5 source controls mapped|7 target controls covered
15%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
5 source controls mapped|8 target controls covered
15%
FTC GLBA Safeguards Rule (16 CFR Part 314)
5 source controls mapped|2 target controls covered
15%
OWASP ASVS
4 source controls mapped|5 target controls covered
12%
Turkey KVKK
4 source controls mapped|2 target controls covered
12%
Protective Security Policy Framework (PSPF) Release 2026
4 source controls mapped|2 target controls covered
12%
Privacy Act 1988 (Australia)
4 source controls mapped|3 target controls covered
12%
OWASP Top 10:2025
4 source controls mapped|6 target controls covered
12%
OWASP MASVS
4 source controls mapped|4 target controls covered
12%
MITRE D3FEND
4 source controls mapped|2 target controls covered
12%
ISO/IEC 27010:2015
4 source controls mapped|4 target controls covered
12%
BSI IT-Grundschutz
4 source controls mapped|11 target controls covered
12%
Malaysia PDPA 2010
4 source controls mapped|3 target controls covered
12%
ISO/IEC 27043:2015
4 source controls mapped|9 target controls covered
12%
IEC 62351 - Power Systems Communication Security
4 source controls mapped|3 target controls covered
12%
South Korea PIPA
4 source controls mapped|2 target controls covered
12%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|5 target controls covered
12%
IATA Operational Safety Audit (IOSA) Standards Manual
4 source controls mapped|1 target controls covered
12%
API 1164
4 source controls mapped|4 target controls covered
12%
Annex 11 to EU GMP - Computerised Systems
4 source controls mapped|3 target controls covered
12%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
4 source controls mapped|7 target controls covered
12%
ISO/IEC 27019:2024
4 source controls mapped|4 target controls covered
12%
US Consumer Product Safety Act (CPSC) Manufacturer and Importer Duties
4 source controls mapped|3 target controls covered
12%
ISO/SAE 21434
4 source controls mapped|9 target controls covered
12%
IEC 62443
4 source controls mapped|4 target controls covered
12%
Bahrain PDPL
4 source controls mapped|4 target controls covered
12%
South Korea ISMS-P
4 source controls mapped|7 target controls covered
12%
Mauritius DPA
4 source controls mapped|4 target controls covered
12%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|2 target controls covered
12%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
4 source controls mapped|4 target controls covered
12%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
4 source controls mapped|2 target controls covered
12%
ASD Strategies to Mitigate Cyber Security Incidents
4 source controls mapped|6 target controls covered
12%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
3 source controls mapped|1 target controls covered
9%
OWASP API Security Top 10 - 2023
3 source controls mapped|4 target controls covered
9%
ITU-T X.805 - Security Architecture for End-to-End Communications
3 source controls mapped|2 target controls covered
9%
ITIL 4
3 source controls mapped|1 target controls covered
9%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|2 target controls covered
9%
Canada ITSG-33 - IT Security Risk Management
3 source controls mapped|1 target controls covered
9%
APPI
3 source controls mapped|2 target controls covered
9%
ISO/IEC 20000-1:2018
3 source controls mapped|1 target controls covered
9%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
3 source controls mapped|2 target controls covered
9%
FBI CJIS Security Policy
3 source controls mapped|5 target controls covered
9%
Vermont Data Privacy and Online Surveillance Act
3 source controls mapped|2 target controls covered
9%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|2 target controls covered
9%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|4 target controls covered
9%
Russia Federal Law on Personal Data (152-FZ)
3 source controls mapped|2 target controls covered
9%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
9%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|4 target controls covered
9%
Aged Care Quality Standards 2019 (repealed edition)
3 source controls mapped|3 target controls covered
9%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|4 target controls covered
9%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
9%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
3 source controls mapped|4 target controls covered
9%
IEC 60601-1 - Medical Electrical Equipment Safety
3 source controls mapped|1 target controls covered
9%
ISO/IEC 27400:2022
3 source controls mapped|4 target controls covered
9%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|1 target controls covered
9%
ICH Q10 - Pharmaceutical Quality System
3 source controls mapped|3 target controls covered
9%
Vietnam Law on Cybersecurity (No. 116/2025/QH15)
2 source controls mapped|1 target controls covered
6%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
6%
GDPR
2 source controls mapped|3 target controls covered
6%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
6%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|3 target controls covered
6%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
2 source controls mapped|1 target controls covered
6%
Albania Law No. 124/2024 on Personal Data Protection
2 source controls mapped|1 target controls covered
6%
ISO 26000:2010
2 source controls mapped|1 target controls covered
6%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|2 target controls covered
6%
Barbados Data Protection Act 2019
2 source controls mapped|3 target controls covered
6%
AML/CTF Act 2006 (Australia)
2 source controls mapped|2 target controls covered
6%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
6%
ISO/IEC 23837:2023
2 source controls mapped|4 target controls covered
6%
ISO/IEC 29115:2013 - Entity Authentication Assurance Framework
2 source controls mapped|4 target controls covered
6%
FIDO2 / WebAuthn
2 source controls mapped|1 target controls covered
6%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
3%
US Gramm-Leach-Bliley Act (GLBA) - Higher Education Safeguards Rule
1 source controls mapped|2 target controls covered
3%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|2 target controls covered
3%
NIST Privacy Framework
1 source controls mapped|1 target controls covered
3%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|2 target controls covered
3%
SQF Code Edition 9 - Safe Quality Food
1 source controls mapped|2 target controls covered
3%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|2 target controls covered
3%
Aged Care Act 2024 (Australia)
1 source controls mapped|1 target controls covered
3%
ISO 22000:2018
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
3%
EASA Part-IS - Information Security in Aviation
1 source controls mapped|2 target controls covered
3%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
3%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
3%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
3%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
3%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|1 target controls covered
3%
Authorised Economic Operator (AEO) Programmes - Global Standards
1 source controls mapped|1 target controls covered
3%
Kuwait National Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|1 target controls covered
3%
APRA CPS 230 Operational Risk Management
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
3%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
1 source controls mapped|1 target controls covered
3%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|4 target controls covered
3%
Monetary Authority of Singapore Technology Risk Management Guidelines
1 source controls mapped|1 target controls covered
3%
MiFID II / MiFIR
1 source controls mapped|1 target controls covered
3%
FedRAMP Rev 5
1 source controls mapped|3 target controls covered
3%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
3%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|1 target controls covered
3%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
3%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
3%
SWIFT CSCF
1 source controls mapped|1 target controls covered
3%
Armenia Law on Protection of Personal Data (2015)
1 source controls mapped|1 target controls covered
3%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|2 target controls covered
3%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
3%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
3%
Compare MDS2 (Medical Device) with OWASP DevSecOps Maturity Model (DSOMM)

Coverage is not the same as your position

This page shows what MDS2 (Medical Device) overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.

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What is MDS2 (Medical Device) and who does it apply to?

MDS2 (Medical Device) is a compliance framework from United States (American National Standard); used internationally with 4 domains and 25 controls. ANSI/NEMA HN 1-2019, the Manufacturer Disclosure Statement for Medical Device Security (MDS2): the standard form on which a medical device manufacturer discloses, question by question, what personal data the device holds and moves and which security capabilities it has (logoff, audit, authorisation, patching, de-identification, backup, emergency access, integrity, malware protection, node and person authentication, connectivity, physical locks, third-party roadmap, SBOM, hardening, security guidance, storage and transmission confidentiality and integrity, remote service), so a healthcare delivery organisation can assess and manage the device's security risk. Built from the standard's own sections and the 2019 form's questions. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does MDS2 (Medical Device) actually require?

MDS2 (Medical Device) has 25 controls organised across 4 domains. The largest domains are Data protection, connectivity and service capabilities (2.3.8, 2.3.9, 2.3.11, 2.3.13, 2.3.14, 2.3.16, 2.3.21 to 2.3.25) – MDS2 (Medical Device) (11 controls), Data handling, access and accountability capabilities (2.3.3 to 2.3.6, 2.3.10, 2.3.15) – MDS2 (Medical Device) (6 controls), Updates, software supply chain and hardening (2.3.7, 2.3.12, 2.3.17 to 2.3.20) – MDS2 (Medical Device) (6 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of MDS2 (Medical Device) do I already cover?

MDS2 (Medical Device) maps to 113 other compliance frameworks. The top mapping partners are OWASP DevSecOps Maturity Model (DSOMM) (15% coverage), ISO 27799:2025 (15% coverage), FFIEC Cybersecurity Assessment Tool (CAT) (15% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement MDS2 (Medical Device)?

Start your MDS2 (Medical Device) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about MDS2 (Medical Device) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 25 controls and track your progress.

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