Standards, Guidance & Notices
Showing 1–10 of 30
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)
MHLW caution alert regarding cybersecurity measures for VPN devices and network equipment connected to medical devices, emphasizing the need for strengthened security protocols to protect medical device networks from cyber threats.
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
Replaces the September 2023 final guidance. Title updated from "Quality System" to "Quality Management System" reflecting the QMSR final rule (21 CFR Part 820, effective February 2, 2026), which incorporates ISO 13485:2016 by reference. Core requirements for SPDF, premarket cybersecurity documentation, SBOM submission, and CVD policy remain. Adds terminology (Threat surface, Quality of Service) in Appendix 5.
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: Guidance for the disclosure, communication and implementation of security needs, risks and controls
Consolidates and upgrades IEC TR 80001-2-2:2012 and IEC TR 80001-2-8:2016 from TR to TS. Strengthens alignment with MDS2 (Manufacturer Disclosure Statement for Medical Device Security). Specifies guidance for disclosure, communication and implementation of security needs, risks and controls. SBOM handling is treated separately from MDS2.
Published: 2025-10-01
IEC
IEC/TS 81001-2-2:2025
Health software and health IT systems safety, effectiveness and security — Part 2-2: 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: 2025-01-01
NIST
CSWP
CSWP
CSWP 33
Product Development Cybersecurity Handbook: Concepts and Considerations for IoT Product Manufacturers
As interest in Internet of Things (IoT) technologies has grown, so have concerns and attention to cybersecurity of the newly network-connected products and services offered in many sectors, including energy services, water/waste-water services, automobiles, consumer electronics, and government. This Product Development Cybersecurity Handbook will describe concepts important to developing and deploying secure IoT products for any sector or use case, including discussion of IoT Product architecture, deployment, roles and cybersecurity perspectives. This publication extends and elaborates on NIST’s prior work related to development of IoT products. In addition to discussing the concepts, this publication also demonstrates their application and discusses how satisfaction of cybersecurity in IoT products can be approached.
Published: 2024-04-03
NIST
CSWP
CSWP
CSWP 29
The NIST Cybersecurity Framework (CSF) 2.0
The NIST Cybersecurity Framework (CSF) 2.0 provides guidance to industry, government agencies, and other organizations to manage cybersecurity risks. It offers a taxonomy of high-level cybersecurity outcomes that can be used by any organization — regardless of its size, sector, or maturity — to better understand, assess, prioritize, and communicate its cybersecurity efforts. The CSF does not prescribe how outcomes should be achieved. Rather, it links to online resources that provide additional guidance on practices and controls that could be used to achieve those outcomes. This document describes CSF 2.0, its components, and some of the many ways that it can be used.
Published: 2024-02-26
MHLW
Notice
Notice
Admin-Notice-2024-01-31
Q&A on Cybersecurity of Medical Devices (2024 Version)
Expanded Q&A set on application and conformance assessment of Essential Principles Article 12(3). Provides guidance on system architecture diagram formats, post-transition application handling, third-party testing utilization, SBOM documentation scope, and legacy product compliance strategies based on practical implementation experience.
Published: 2024-01-31
MHLW
Notice
Notice
MHLW-PSEHB-PSD-0115-No.2
Fundamental Approach to Adverse Event Reporting Related to Medical Device Cybersecurity
Notice clarifying handling of cybersecurity events in adverse event/serious adverse event reporting systems. Addresses reporting applicability for patient harm from cyber attacks or vulnerability exploitation, decision-making flowcharts, and manufacturer response procedures. Serves as foundational regulatory documentation for post-market cybersecurity management.
Published: 2024-01-15