Standards, Guidance & Notices
Showing 1–10 of 41
MHLW
Notice
Notice
MHLW-PFSB-MDED-0825-No.1
Guideline on the Introduction and Operation of SBOM for Medical Devices (1st Edition)
Guideline compiled under the FY2025 Medical Device Cybersecurity Promotion Project and circulated to industry by MHLW notice for reference. It covers all software contained in a medical device and sets out a stepwise adoption path according to organizational maturity: Stage 1 establishes the capability to create, update and change-manage SBOMs based on the NTIA minimum elements; Stage 2 integrates SBOMs into existing QMS and post-market safety processes, including vulnerability, license and EOL/EOS management, for lifecycle risk management. SPDX 2.2 or later and CycloneDX 1.6 or later are recommended for new adoption; where SWID is already in use, parallel use or conversion may be considered. As the disclosure baseline set by the guideline, manufacturers should be able to provide SBOMs to healthcare facilities, mainly at installation and upon significant software changes, and present them on request at least throughout the product support period. Intended readers span software development, quality assurance, regulatory affairs, PSIRT/information security and field service, as a shared cross-functional reference. Article 12(3) of the Essential Principles and FD&C Act Section 524B are cited as regulatory background.
Published: 2026-08-25
MDSAP
MDSAP AU P0002.011
MDSAP Audit Approach (MDSAP AU P0002.011)
Revision 11 of the MDSAP Audit Approach (document number MDSAP AU P0002.011, revision date 3 August 2026), the audit procedure of the Medical Device Single Audit Program in which the regulatory authorities of the United States, Australia, Brazil, Canada and Japan participate. Main changes from version 010: (1) Cybersecurity. Measurement, Analysis and Improvement Task 12 adds provisions on post-market feedback, including systematic collection of vulnerability reports, security incident data and threat intelligence, used as input to risk management, improvement and design change control. Design and Development Tasks 7 and 12 add US FDA cybersecurity requirements, and Task 7 adds RDC ANVISA 848/2024 Article 1 to the Brazilian requirements. For the FDA, auditors verify that cyber devices cleared or approved after 29 March 2023 meet section 524B(b) of the FD&C Act: a plan to monitor and address post-market vulnerabilities including coordinated vulnerability disclosure, processes and post-market patches to keep the device cybersecure, and a maintained software bill of materials. (2) The predetermined change control plan (PCCP) text in Device Marketing Authorization and Facility Registration Task 3 no longer refers specifically to AI-enabled devices. (3) Other changes include refocusing Management Task 7 on management oversight of risk management across the product life cycle, and additions on UDI for Australia (TGA) and the FDA.
Published: 2026-08-03
NIST
SP
SP
SP 800-213 Rev. 1
IoT Product Cybersecurity Guidelines for the Federal Government: Establishing IoT Product Cybersecurity Requirements
Organizations increasingly use Internet of Things (IoT) products for the mission benefits they can offer, but care must be taken in the acquisition and implementation of this equipment. Understanding that an IoT product is a system element facilitates an understanding of how the IoT product must be considered in the risk management process. The acquisition and integration of an IoT product into an information system may alter the system’s risk assessment based on new risks introduced by the product. An updated risk assessment may require additional or new controls to be selected and implemented in the system. The guidelines in this publication focus on establishing product cybersecurity requirements to support security controls. This publication provides general considerations of how IoT products may impact an information system’s risk assessment and subsequent allocation of controls that may be necessary. Readers are encouraged to reference SP 800-30, Revision 1, Guide for
Published: 2026-06-24
NIST
IR
IR
IR 8259 Rev. 1
Foundational Cybersecurity Activities for IoT Product Manufacturers
Internet of Things (IoT) products often lack product cybersecurity capabilities their customers—organizations and individuals—can use to help mitigate their cybersecurity risks. Manufacturers can help their customers by improving the securability of their IoT products by providing necessary cybersecurity functionality and by providing customers with the cybersecurity-related information they need. This publication describes recommended activities related to cybersecurity that manufacturers should consider performing before their IoT products are sold to customers. These foundational cybersecurity activities can help manufacturers lessen the cybersecurity-related efforts needed by customers, which in turn can reduce the prevalence and severity of compromises.
Published: 2026-04-20
MHLW
Notice
Notice
Admin-Notice-2026-03-19_VPNSecurity
Notice on Strengthening Cybersecurity Measures for Network Devices such as VPN Equipment Connected to Medical Devices (Caution Alert) (Administrative Notice, March 19, 2026)
Caution alert (administrative notice, 19 March 2026) issued by the Japanese Ministry of Health, Labour and Welfare (MHLW) in response to a rise in ransomware attacks that exploit VPN equipment and other network devices connected to medical devices. It calls on marketing authorization holders to (1) confirm, under maintenance contracts with healthcare facilities, who is responsible for managing attached network equipment such as VPN devices, (2) check that firmware is up to date and identify any devices that are no longer supported, and (3) strengthen security by informing facilities about unsupported devices and applying stronger authentication and access control.
Published: 2026-03-25
FDA
CDRH
CDRH
FDA-2026-D-Cybersecurity-QMS
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Under Section 524B of the FD&C Act, added by the 2023 Consolidated Appropriations Act, this guidance requires SBOM submission, a vulnerability disclosure process, and coordinated vulnerability disclosure (CVD) planning as part of premarket review. The title change from "Quality System" to "Quality Management System" reflects FDA's move from the legacy QSR to the ISO 13485-based QMSR. IEC 81001-5-1 and AAMI TIR57 appear as two of several optional frameworks manufacturers may draw on for secure product development — alongside JSP2 and ISA/IEC 62443-4-1 — rather than as standards the guidance formally aligns with.
Published: 2026-02-03
AAMI
TIR
TIR
AAMI CR515:2025
AAMI CR515:2025 - Cybersecurity Considerations Specific to Machine Learning-enabled Medical Devices
AAMI CR515:2025 establishes cybersecurity considerations specific to machine learning-enabled medical devices. Recognized by the FDA as a consensus standard (Recognition Number: 13-153) on December 22, 2025, the document serves as a normative reference in the Software/Informatics domain. The standard specifies security risk management requirements essential for the development and operational deployment of medical devices incorporating artificial intelligence and machine learning technologies. Manufacturers should implement the specified cybersecurity controls and risk management procedures to address vulnerabilities introduced by machine learning algorithms, including model drift, adversarial attacks, and data integrity threats. The document provides manufacturers with practical guidance for integrating cybersecurity considerations throughout the device lifecycle, from initial algorithm development through post-market surveillance and model updates.
Published: 2025-12-22
IEC
IEC TS 81001-2-2:2025
Health software and health IT systems safety, effectiveness and security — Part 2-2: Coordination — Guidance for the implementation, disclosure and communication of security needs, risks and controls
Withdraws and replaces IEC TR 80001-2-2. Provides guidance for communication of security needs, risks and controls for health software connected to IT networks.
Published: 2025-10-01
NIST
IR
IR
IR 8259 Rev. 1 (2pd)
Foundational Cybersecurity Activities for IoT Product Manufacturers
Internet of Things (IoT) products often lack product cybersecurity capabilities their customers—organizations and individuals—can use to help mitigate their cybersecurity risks. Manufacturers can help their customers by improving the securability of their IoT products by providing necessary cybersecurity functionality and by providing customers with the cybersecurity-related information they need. This publication describes recommended activities related to cybersecurity that manufacturers should consider performing before their IoT products are sold to customers. These foundational cybersecurity activities can help manufacturers lessen the cybersecurity-related efforts needed by customers, which in turn can reduce the prevalence and severity of compromises.
Published: 2025-09-30
JFMDA
Notice
Notice
jfmda_20250929_33bce5c8
Alert Regarding the Expiration of Windows Secure Boot Certificates
For medical devices running Windows under an embedded license agreement, from Windows Embedded 8 Standard onward, that use the Secure Boot function, the expiration of the Secure Boot certificates in June 2026 may have serious impacts, such as the devices no longer being able to receive subsequent security updates or becoming unstable all at once. JFMDA asks readers to read the attached alert and take action. Issued by the Medical Device Cybersecurity WG of the JFMDA Liaison and Coordination Meeting.
Published: 2025-09-29