OUR MEMBERSHIP PLAN:
RESOURCES
Cybersecurity Regulations
United States
International
Additional United States Regulator Publications
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Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
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Best Practices for Communicating Cybersecurity Vulnerabilities to Patients
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FDA Fact Sheet: The FDA’s Role in Medical Device Cybersecurity
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Framework for Improving Critical Infrastructure Cybersecurity ver 1.1, NIST, Apr 2018
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NIST SP 1800-1: Securing Electronic Health Records on Mobile Devices
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NIST SP 1800-24: Securing Picture Archiving and Communication System
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NIST SP 1800-30: Securing Telehealth Remote Patient Monitoring Ecosystem
Additional International Regulator Publications
Books and publications
Medical Device Cybersecurity
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Medical Device Cybersecurity for Engineers and Manufacturers
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Medical Device Cybersecurity - A Guide fro HTM Professionals
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MDIC and MITRE: "Playbook for Threat Modeling Medical Devices"
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MITRE : "Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook"
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MDIC report: "Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure"
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H-ISAC Whitepaper: Medical Device Cybersecurity Lifecycle Management, Oct 2020
Cybersecurity
Training and Education
Medical Devices and Healthcare
Cybersecurity
Organizations and Events
Medical Devices
Healthcare
Standards and frameworks
Medical Devices
Healthcare
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ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
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ISO 14971: Medical devices — Application of risk management to medical devices
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IEC 62304: Medical device software — Software life cycle processes
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AAMI TIR 57: Principles for medical device security - Risk management
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Manufacturer Disclosure Statement for Medical Device Security (MDS2), NEMA, 2019