Threat and Vulnerability Identification

Maps to

IEC 81001-5-1: §7.2

IEC 62443-4-1: §TM-1

Requirement text

Identify and document vulnerabilities, threats, and adverse impacts on confidentiality, integrity, and availability. All products shall have a threat model including: a) correct flow of categorized information, b) trust boundaries, c) processes, d) data stores, e) interacting external entities, f) internal and external communication protocols, g) externally accessible physical ports including debug ports, h) circuit board connections (JTAG, debug headers), i) potential attack vectors including hardware, j) potential threats, k) security-related issues, l) external dependencies (drivers, third-party apps). The threat model shall be reviewed by the development team and reviewed periodically (at least annually) for released products. Issues shall be addressed per 9.4 and 9.5.

What changed

IEC 81001-5-1:2021 is the first standalone cybersecurity standard purpose-built for health software and medical device software. Published in December 2021, it was adapted from IEC 62443-4-1 (industrial control systems security) to address the unique safety and regulatory context of medical devices — adding 64 health-specific requirements that account for patient safety, clinical workflows, and the manufacturer-HDO relationship.

The standard mirrors IEC 62304's lifecycle structure but adds security-specific activities at every phase — planning, development, testing, release, and maintenance. It requires security risk management to be integrated with ISO 14971 safety risk management, not treated as a separate IT concern. FDA formally recognized it as Consensus Standard #13-112 in December 2022 and references it as providing a framework for the Secure Product Development Framework (SPDF) required by Section 524B.

EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028. Despite this delay, Notified Bodies and Competent Authorities universally recognize it as "state of the art" for health software cybersecurity under MDR GSPR Annex I, Section 17.2. Missing or inadequate cybersecurity documentation is already a top cause of Notified Body major non-conformities for SaMD. A December 2025 Interpretation Sheet (ISH1:2025) clarified software item classification into maintained, supported, and required software categories, affecting risk transfer and post-market obligations.

Atomic constraints

•Vulnerabilities, threats, and adverse CIA impacts SHALL be identified and documented.
•A threat model SHALL exist for all products.
•The threat model SHALL document information flows with categorization.
•The threat model SHALL document trust boundaries.
•The threat model SHALL document processes.
•The threat model SHALL document data stores.
•The threat model SHALL document interacting external entities.
•The threat model SHALL document internal and external communication protocols.
•The threat model SHALL document externally accessible physical ports including debug ports.
•The threat model SHALL document circuit board connections (JTAG, debug headers).
•The threat model SHALL document potential attack vectors including hardware-based vectors.
•The threat model SHALL document potential threats.
•The threat model SHALL document security-related issues.
•The threat model SHALL document external software dependencies.
•The threat model SHALL be reviewed by the development team.
•For released products, the threat model SHALL be reviewed periodically, at least annually.
•Issues identified in the threat model SHALL be addressed per clauses 9.4 and 9.5.

Common gaps

Threat identification limited to a single methodology

major

Organizations use only one threat identification method (typically STRIDE or informal brainstorming) without cross-referencing with attack libraries (MITRE ATT&CK), vulnerability databases, or medical device-specific threat catalogs. MITRE's Medical Device Playbook recommends combining multiple techniques.

Evidence signals

•
FILE_EXISTS
Threat.*Model|STRIDE|Data.*Flow.*Diagram|DFD|Attack.*Surface|Security.*Architecture
•
CONTENT_MATCH
Does this document contain a threat model identifying trust boundaries, data flows, external entities, attack vectors (including physical ports and hardware interfaces), and potential threats to confidentiality, integrity, and availability?

Audit defense

The Threat Model for [your product] (Doc ID: [your document ID]) documents all 12 IEC 81001-5-1 §7.2 elements, including hardware attack surfaces (debug ports, JTAG) and external dependencies. Annual review records demonstrate the threat model is maintained as a living document, with findings addressed through the Problem Resolution procedure.

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