Key takeaways
- A sourcing note: FDA's recognized-consensus-standard entry is fetched directly from accessdata.fda.gov.
- Each category gets a short disclosure — typically whether the control is implemented, not applicable, or absent, with space for notes — rather than a long narrative.
- FDA recognizes ANSI/NEMA HN 1-2019 as a consensus standard — recognition number 13-123, recognized 19 December 2022 — meaning a manufacturer can point to conformance with it as part of a security risk assessment.
- MDS2 is self-reported.
MDS2 (Manufacturer Disclosure Statement for Medical Device Security) is the standardized, 23-category form medical device manufacturers complete so hospitals and health systems can assess a device's security controls before procurement — a HIMSS/NEMA standard now in its ANSI/NEMA HN 1-2019 edition, recognized by FDA as a consensus standard but, by FDA's own account, not a substitute for the cybersecurity evidence Section 524B of the FD&C Act otherwise requires. Used well, it replaces dozens of vendor-specific security questionnaires with one comparable format; used as a checkbox, it is only as reliable as whoever in the manufacturer's organization filled it in.
A sourcing note: FDA's recognized-consensus-standard entry is fetched directly from accessdata.fda.gov. ANSI/NEMA HN 1-2019 itself is a paid standard (available for purchase from ANSI, NEMA, Intertek and other standards resellers, with a no-cost copy also distributed via AAMI); this guide's fetch tooling could extract the form's 23 category headings from a publicly available copy of the standard's table of contents, but the full text of each category's questions was not independently re-verified against the paid edition — confirm exact question wording against your own licensed copy of HN 1-2019 before using this guide as authoritative on any single category.
What MDS2 is, and why it exists
Before MDS2, a hospital buying an infusion pump, imaging system or patient monitor had no standard way to ask a manufacturer about its security controls — every health system wrote its own questionnaire, and every manufacturer answered a different one. HIMSS and NEMA published the first MDS2 in 2004 to fix that with a single, comparable form; updates followed as HN 1-2008 and HN 1-2013, and the current edition, ANSI/NEMA HN 1-2019, was revised under NEMA's Medical Imaging and Technology Alliance (MITA). It supersedes the 2013 version and runs 36 pages: the form itself, plus instructions for completing it. The intended workflow is straightforward — the manufacturer discloses, once, in a format every hospital's biomedical or IT security team already knows how to read, rather than negotiating a bespoke questionnaire per sale.
The 23 categories, at a glance
| Code | Category |
|---|---|
| MPII | Management of Personally Identifiable Information |
| ALOF | Automatic Logoff |
| AUDT | Audit Controls |
| AUTH | Authorization |
| CSUP | Cybersecurity Product Upgrades |
| DIDT | Health Data De-Identification |
| DTBK | Data Backup and Disaster Recovery |
| EMRG | Emergency Access |
| IGAU | Health Data Integrity and Authenticity |
| MLDP | Malware Detection/Protection |
| NAUT | Node Authentication |
| CONN | Connectivity Capabilities |
| PAUT | Person Authentication |
| PLOK | Physical Locks |
| RDMP | Roadmap for Third-Party Applications |
| SBOM | Software Bill of Materials |
| SAHD | System and Application Hardening |
| SGUD | Security Guides |
| STCF | Data Storage Confidentiality |
| TXCF | Transmission Confidentiality |
| TXIG | Transmission Integrity |
| RMOT | Remote Service |
| OTHR | Other Security Considerations |
Each category gets a short disclosure — typically whether the control is implemented, not applicable, or absent, with space for notes — rather than a long narrative. Two categories are worth flagging for device makers already building other parts of a security program: SBOM is a direct line item on the form, so a manufacturer already producing a firmware SBOM or hardware BOM is answering this category with existing evidence rather than starting from scratch, and NAUT/PAUT (node and person authentication) are frequently where procurement teams and clinical engineers focus follow-up questions, since weak device-to-device authentication on a hospital network has direct patient-safety implications.
What MDS2 does not prove
FDA recognizes ANSI/NEMA HN 1-2019 as a consensus standard — recognition number 13-123, recognized 19 December 2022 — meaning a manufacturer can point to conformance with it as part of a security risk assessment. But FDA's own recognition record is explicit that this is not sufficient on its own: conformance to the standard "may not satisfy all cybersecurity requirements" under Section 524B of the FD&C Act, and FDA directs manufacturers to its separate cybersecurity, software and postmarket management guidance for what a submission actually needs. In practice that means MDS2 sits alongside, not in place of, the evidence FDA's premarket cybersecurity guidance expects — a threat model, a vulnerability-management plan, and testing evidence — and alongside an ongoing security risk management file maintained under AAMI SW96, which MDS2 was never designed to replace.
Why a completed form is not the same as a verified one
MDS2 is self-reported. Healthcare procurement commentary on using the form in practice describes a specific, recurring failure mode: a form routed through a sales channel can come back incomplete or inaccurate, because the person completing it may not be the engineer who actually knows the product's security posture, and nothing in the standard itself requires independent verification of the answers or sign-off above the sales team. It is also a snapshot — completed at launch or at a point in a product's life, not automatically refreshed when a vulnerability is disclosed or a security control changes. That gap is exactly what an ongoing PSIRT and coordinated vulnerability disclosure process exists to cover: MDS2 tells a hospital what the device was built with, a PSIRT tells them what has changed since.
A workable starting point
Assign MDS2 completion to engineering and security, not salesThe 23 answers should reflect what the product actually does, drawn from the same evidence base as your SBOM and security risk management file. Treat SBOM and NAUT/PAUT answers as load-bearingThese are the categories hospital procurement and clinical engineering teams scrutinize most; back them with real artifacts, not a blanket "yes." Republish when the product's security posture changes materiallyHN 1-2019 sets no mandatory review interval, so build your own trigger — a new firmware release, a disclosed vulnerability, or a support-lifecycle change — into your release process. For hospitals and integrators: corroborate, don't just collectUse MDS2 to compare devices on a like-for-like basis, then check high-stakes answers against the vendor's published advisories and support commitments before relying on them. Keep MDS2, your SBOM and your FDA submission evidence consistentA mismatch between what the MDS2 form discloses and what a premarket submission or published SBOM shows is the kind of inconsistency a hospital's security review — or an FDA reviewer — is positioned to notice.
MDS2 solves a real coordination problem: one form instead of dozens of bespoke questionnaires. It does not solve the harder problem of making sure the answers are accurate and current, which is a function of who inside the manufacturer owns it and how it connects to the rest of the product's security evidence — SBOM, risk management file and PSIRT — not a property of the form itself.
This guide is general information, not legal or regulatory advice. Confirm exact MDS2 category wording against your own licensed copy of ANSI/NEMA HN 1-2019, and confirm premarket submission requirements directly with FDA's Division of Medical Device Cybersecurity.
Sources
- FDA: Recognized Consensus Standard — ANSI NEMA HN 1-2019, Manufacturer Disclosure Statement for Medical Device Security (recognition number 13-123, recognized 19 December 2022)
- AAMI array: "Standards Spotlight: Revised MDS2 Expands Documentation of Security Control Features"
- Journal of Healthcare Contracting: "Cybersecurity: Make MDS2 part of the procurement process"
- NEMA: Manufacturer Disclosure Statement for Medical Device Security (MDS2) standard listing
Frequently asked questions
What is MDS2 and who publishes it?
MDS2 (Manufacturer Disclosure Statement for Medical Device Security) is a standardized form medical device manufacturers complete so that healthcare delivery organizations (HDOs) can assess a device's security controls before procurement, without each hospital writing its own vendor security questionnaire. It began in 2004 as a joint effort of the Healthcare Information and Management Systems Society (HIMSS) and the National Electrical Manufacturers Association (NEMA), with updates published as HIMSS/NEMA Standard HN 1-2008 and HN 1-2013. The current edition, ANSI/NEMA HN 1-2019, was revised under the leadership of NEMA's Medical Imaging and Technology Alliance (MITA) and supersedes the 2013 version; it is a 36-page document consisting of the MDS2 form itself plus instructions for completing it.
What does the MDS2 form actually ask about?
The ANSI/NEMA HN 1-2019 form is organized into 23 named security categories, each with its own short code: Management of Personally Identifiable Information (MPII), Automatic Logoff (ALOF), Audit Controls (AUDT), Authorization (AUTH), Cybersecurity Product Upgrades (CSUP), Health Data De-Identification (DIDT), Data Backup and Disaster Recovery (DTBK), Emergency Access (EMRG), Health Data Integrity and Authenticity (IGAU), Malware Detection/Protection (MLDP), Node Authentication (NAUT), Connectivity Capabilities (CONN), Person Authentication (PAUT), Physical Locks (PLOK), Roadmap for Third-Party Applications (RDMP), Software Bill of Materials (SBOM), System and Application Hardening (SAHD), Security Guides (SGUD), Data Storage Confidentiality (STCF), Transmission Confidentiality (TXCF), Transmission Integrity (TXIG), Remote Service (RMOT) and Other Security Considerations (OTHR). For each, the manufacturer answers whether the control is present, with space for notes — a manufacturer disclosing it ships a [firmware SBOM](/guides/firmware-sbom/) under the SBOM category, for example, is answering one of these 23 questions directly, not a separate requirement.
Does a completed MDS2 mean a device is secure, or satisfy FDA requirements?
No, on both counts. FDA recognizes ANSI/NEMA HN 1-2019 as a consensus standard (recognition number 13-123, recognized 19 December 2022) that can support a manufacturer's security risk assessment, but FDA's own recognition entry states explicitly that conformance to this standard alone may not satisfy all cybersecurity requirements under Section 524B of the FD&C Act, and that manufacturers should also consult FDA's cybersecurity, software and postmarket management guidance documents. MDS2 itself makes a narrower claim: it is a disclosure of which controls a device has, in the manufacturer's own words, not an independent security assessment, a penetration test result, a [security risk management file under AAMI SW96](/guides/aami-sw96-medical-device-security-risk-management/), or a substitute for the evidence [FDA's premarket cybersecurity guidance](/guides/fda-premarket-cybersecurity-medical-devices/) expects in a 510(k) or PMA submission.
What are MDS2's known limitations in practice?
The form is self-reported, and healthcare procurement commentary on using it describes the predictable consequence: forms submitted through a sales channel can come back incomplete or with inaccurate information, because the person filling it out may not be the engineer who knows the product's actual security posture, and there is no independent verification built into the standard itself. It is also a point-in-time snapshot — a form completed at launch does not reflect a vulnerability disclosed two years later, which is why [a published PSIRT and vulnerability disclosure process](/guides/first-psirt-services-framework/) matters alongside it, not instead of it. Procurement guidance commonly recommends getting MDS2 responses attested at a level above the sales team, and treating a completed form as the start of a security conversation with a hospital's biomedical or IT security group, not the end of one.
How should a manufacturer or hospital actually use MDS2 well?
For a manufacturer: assign MDS2 completion to the same team that owns your security risk management file and SBOM, not to sales, so the 23 answers match what engineering actually knows about the product, and update the form when the product's security posture changes materially — the standard itself does not set a mandatory review interval. For a hospital or integrator: use MDS2 as a structured starting point for comparing devices on a like-for-like basis, but corroborate high-stakes answers — especially NAUT, AUTH, TXCF and SBOM — against the vendor's published security advisories, support-lifecycle commitments and, where available, independent testing, rather than treating a 'yes' on the form as verified fact.
In this cluster
