RESOURCES

Cybersecurity Regulations

United States

FDA 2014 Premarket Guidance
FDA 2016 Postmarket Guidance
FDA 2022 Premarket Guidance (Draft)

International

IMDRF Medical Device Cybersecurity Guidance
Europe: MDCG 2019-16
Canada
Australia TGA

Additional United States Regulator Publications

Additional International Regulator Publications

Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
Best Practices for Communicating Cybersecurity Vulnerabilities to Patients
Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities
FDA Fact Sheet: The FDA’s Role in Medical Device Cybersecurity
Framework for Improving Critical Infrastructure Cybersecurity ver 1.1, NIST, Apr 2018
NIST SP 1800-1: Securing Electronic Health Records on Mobile Devices
NIST SP-1800-8: Securing Wireless Infusion Pumps
NIST SP 1800-24: Securing Picture Archiving and Communication System
NIST SP 1800-30: Securing Telehealth Remote Patient Monitoring Ecosystem

IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices
IMDRF Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Books and publications

Medical Device Cybersecurity

Medical Device Cybersecurity for Engineers and Manufacturers
Cybersecurity for Connected Medical Devices
Medical Device Cybersecurity - A Guide fro HTM Professionals
MDIC and MITRE: "Playbook for Threat Modeling Medical Devices"
MITRE : "Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook"
Rubric for Applying CVSS to Medical Devices, Version 0.12.04, September 3, 2019 (Revised Oct 27, 2020)
MDIC report: "Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure"
H-ISAC Whitepaper: Medical Device Cybersecurity Lifecycle Management, Oct 2020

Cybersecurity

The Cyber Security Body Of Knowledge (CyBOK)
Department of Homeland Security NICCS: A Glossary of Common Cybersecurity Terminology
NIST Computer Security Resource Center: Glossary
European Union Agency For Network and Information Security (ENISA): Overview of cybersecurity and related terminology

Training and Education

Medical Devices and Healthcare

Cybersecurity

University of Minnesota - Center for Medical Device Cybersecurity
Embedded Cybersecurity Training and Certification (Velentium Inc.)
Biohacking Village

SANS Institute
SANS Cyber Security Skills Roadmap
NIST National Initiative for Cybersecurity Education (NICE)
National Cyber Forensics and Training Alliance (NCFTA)
CISA Cybersecurity Workforce Training Guide
European Union Agency for Cybersecurity (ENISA)

Organizations and Events

Medical Devices

Healthcare

Archimedes
H-ISAC
HSCC
HC3
AAMI Cybersecurity Resources

HIMSS
AAMI
AEHIS / CHIME

Standards and frameworks

Medical Devices

Healthcare

ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971: Medical devices — Application of risk management to medical devices
IEC 62304: Medical device software — Software life cycle processes
IEC 81001-5-1: Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
ISO/IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (NOTE: Revised 2021)
ISO/IEC 80001-2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
ISO/IEC 80001-2-8: Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
AAMI TIR 57: Principles for medical device security - Risk management
AAMI TIR 97: Principles for medical device security - Postmarket risk management for device manufacturers
Healthcare and Public Health Sector Coordinating Council (HSCC): Medical Device and Heath IT Joint Security Plan (JSP)
Manufacturer Disclosure Statement for Medical Device Security (MDS2), NEMA, 2019
ANSI/CAN/UL Standard 2900-1: Standard for Software Cybersecurity for Network-Connectable Products, Part1: General Requirements
ANSI/UL 2900-2-1: Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems

NIST SP 800-161 Cybersecurity Supply Chain Risk Management Practices for Systems and Organizations

RESOURCES

Cybersecurity Regulations

United States

International

Books and publications

Medical Device Cybersecurity

Cybersecurity

Training and Education

Medical Devices and Healthcare

Cybersecurity

Organizations and Events

Medical Devices

Healthcare

Standards and frameworks

Medical Devices

Healthcare

Contact

Press

Pricing

FAQ

Blog

Report

Videos