References Regarding Cybersecurity for Network-Connected Medical Devices

Updated 27 Aug 2019:

Health Care Industry Cybersecurity Task Force June 2017 Report on Improving Cybersecurity in the Health Care Industry 

Healthcare and Public Health Sector Coordinating Council, Medical Device and Health IT Joint Security Plan, January 2019 

The FDA’s Role in Medical Device Cybersecurity, Dispelling Myths and Understanding Facts

MITRE, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook 

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

“Postmarket Management of Cybersecurity in Medical Devices”

“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” ( cm089543.htm) 

“Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” ( cm077812.htm)

Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication (2013) 

Cybersecurity for Networked Medical Devices is a Shared Responsibility: FDA Safety Reminder (updated Oct. 2014)

Medical Device Software Patching, IHE PCD in Cooperation with MDISS (Oct. 2015),  

Medical Equipment Management, Medical Device Cyber Security Best Practice Guide, IHE PCD (Oct. 2015),  

Medical Equipment Management, Cyber Security, IHE PCD (May 2011), 27.pdf  

Building Code for Medical Device Software Security, IEEE Computer Society, May 2015,  

Medical Device Isolation Architecture Guide, V2.0, US Department of Veterans Affairs (Aug. 2009), himss/files/production/public/HIMSSorg/Content/files/MedicalDeviceIsolationArchitectureGuidev2.pdf  

VA Enterprise Design Patterns Privacy and Security – Medical Device Security, Jan 2017  

“Medical Devices Security Technical Implementation Guide, V1, R1” Defense Information Systems Agency (DISA), July 2010,  

Medical Devices Security Technical Implementation Guide, V1 R1, Defense Information Systems Agency (DISA) (July 2010),  

Manufacturer Disclosure Statement for Medical Device Security, NEMA (Oct. 2013);  

ANSI UL  2900-2-1 First Edition 2017  Standard For Safety, Software Cybersecurity For Network-Connectable Products, Part 2-1: Particular Requirements For Network Connectable Components Of Healthcare And Wellness Systems 

ANSI UL  2900-1 First Edition 2017  Standard For Safety, Standard For Software Cybersecurity Network-Connectable Products, Part 1: General Requirements 

Patching Off-the-Shelf Software Used in Medical Information Systems, NEMA/COCIR/JIRA Security and Privacy Committee, Oct. 2004, content/uploads/2011/02/Patching_OffTheShelfSoftware_Used_in_MedIS_October_2004.pdf  

Office of Inspector General: FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical Devices:  

I Am The Calvary “Hippocratic Oath for Connected Medical Devices” 

MedCrypt: What Medical Device Vendors can learn from past Cybersecurity Vulnerability Disclosures  

Medcrypt: A Medical Device Cybersecurity Toolbox 

Medcrypt: A Tool in Medical Device Cybersecurity 

Medcrypt: Impact of Monitoring on Medical Device Vulnerabilities 

“Anatomy of an Attack – Medical Device Hijack (MEDJACK)”, TrapX, 2015  

“MEDJACK 2: Old malware used in new medical device hijacking attacks to breach hospitals”; Network World; Jun 27, 2016; medical-device-hijacking-attacks-to-breach-hospitals.html  

“Securing Hospitals – A Research Study and Blueprint”, Independent Security Evaluators (ISE), Feb. 2016, 

 ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes

OWASP Secure Medical Device Deployment Standard, Version 1.0 9/12/17  

OWASP OWASP Secure Medical Device Deployment Standard: Purchasing Assessment Criteria Version 1.0 9/12/17 

AAMI TIR57: Principles for medical device security—Risk management 

AAMI Medical Device Cybersecurity: A Guide for HTM Professionals 

Framework for Improving Critical Infrastructure Cybersecurity, Version 1.1, National Institute of Standards and Technology 

NIST SPECIAL PUBLICATION 1800-8, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations   

MAUDE – Manufacturer and User Facility Device Experience 

FDA: Recognized Consensus Standards [search terms: risk; device; cybersecurity]

Selection of Cybersecurity-Related Standards in Development for Medical Devices 

  • ISO/IEC 81001-1 Health software and health IT systems safety, effectiveness, and security – Part 1: Foundational principles, concepts and terms 
  • IEC 80001-5-1 Safety, effectiveness, and security in the implementation and use of connected medical devices or connected health software – Part 5: Security – Part 5-1: Activities in the product lifecycle 
  • IEC 60601-4-5 Guidance and interpretation – Safety related technical security specifications for medical devices 
  • IEC 62304 Medical device software – Software life cycle processes 
  • AAMI TIR97/Ed. 1, Principles for medical device security – Post-market security management for device manufacturers 
  • AAMI SW96/Ed. 1, Medical Devices – Application of security risk management to medical devices 

OLDER Links circa 2018:

Medical Device Security: An Industry Under Attack and Unprepared to Defend”

“Report On Improving Cybersecurity In The Health Care Industry”

“Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality ”

Mayo Clinic “Medical Device Risk Assessment Vendor Packet Instructions”…/doc-20389647

“IEC 80001-2-1:2012 – Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples”

“Principles for Medical Device Security – Risk Management” &

“Baseline Security Recommendations for IoT in the Context of Critical Information Infrastructures”

Food & Drug Administration:


“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA, 2 Oct 2014,

Postmarket Management of Cybersecurity in Medical Devices, FDA, 28 Dec 2016,

“FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices”

Proposed Legislation: 

Partnership Stressed in IoMT Medical Device Cybersecurity Bill” &

“The Medical Device Cybersecurity Act of 2017”

Senate bill takes aim at medical device cybersecurity”