References Regarding Cybersecurity for Network-Connected Medical Devices

Medical Device Security: An Industry Under Attack and Unprepared to Defend” https://www.synopsys.com/content/dam/synopsys/sig-assets/reports/medical-device-security-ponemon-synopsys.pdf

“Report On Improving Cybersecurity In The Health Care Industry” https://www.phe.gov/Preparedness/planning/CyberTF/Documents/report2017.pdf

“Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality ” http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/BIT/2016_BIT_JF_CybersecurityManufacturers.pdf

Mayo Clinic “Medical Device Risk Assessment Vendor Packet Instructions” https://www.mayoclinic.org/documents/medical-device-vendor…/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” https://www.iso.org/obp/ui/#iso:std:iec:tr:80001:-2-1:ed-1:v1:en

“Principles for Medical Device Security – Risk Management” http://my.aami.org/store/detail.aspx?id=TIR57-PDF &

http://my.aami.org/aamiresources/previewfiles/TIR57_1607_Preview.pdf

“Baseline Security Recommendations for IoT in the Context of Critical Information Infrastructures” https://www.enisa.europa.eu/publications/baseline-security-recommendations-for-iot

Food & Drug Administration:

Cybersecurity” https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA, 2 Oct 2014, https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm356190.pdf

Postmarket Management of Cybersecurity in Medical Devices, FDA, 28 Dec 2016, https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482022.pdf

“FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices” https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/

Proposed Legislation: 

Partnership Stressed in IoMT Medical Device Cybersecurity Bill” https://healthitsecurity.com/news/partnership-stressed-in-iomt-medical-device-cybersecurity-bill & https://www.congress.gov/bill/115th-congress/house-bill/3985

“The Medical Device Cybersecurity Act of 2017” https://www.congress.gov/bill/115th-congress/senate-bill/1656

Senate bill takes aim at medical device cybersecurity” https://www.fiercehealthcare.com/privacy-security/senate-bill-takes-aim-at-medical-device-cybersecurity

 

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