These are the references as cited in the post CYBERSECURITY IN MEDICAL DEVICES
1 Health Canada Pre-market Requirements for Medical Device Cybersecurity. 2019. https://www.lne-america.com/cybersecurity-guidance.pdf
2 Australia Therapeutic Goods Administration (TGA) medical device cybersecurity guidance for industry. 2019 https://www.tga.gov.au/sites/default/files/medical-device-cyber-security-guidance-industry.pdf
3 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20170505&from=EN
4 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0746-20170505&from=EN
5 The Directive on security of network and information systems (NIS Directive).
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016L1148&from=EN
6 General Data Protection Regulation (EU) 2016/679 (GDPR).
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02016R0679-20160504&from=EN
7 EU Cybersecurity Act (Regulation (EU) 2019/881)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32019R0881&from=EN
8 https://www.fda.gov/medical-devices/digital-health/cybersecurity
9 https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical- device-good-manufacturing-practices
10 https://www.hhs.gov/hipaa/for-professionals/security/index.html
11 https://www.ftc.gov/tips-advice/business-center/guidance/start-security-guide-business
12 https://www.justice.gov/criminal-ccips/cybersecurity-unit
13 https://www.oag.ca.gov/privacy/databreach/reporting
14 https://www.sec.gov/news/press-release/2018-22
15 https://www.iso27001security.com/html/27032.html
16 https://www.fda.gov/training-and-continuing-education/cdrh-learn/international-medical-device-regulators- forum-imdrf-medical-device-single-audit-program-mdsap-pilot
17 http://www.imdrf.org/documents/documents.asp
18 https://healthsectorcouncil.org/
19 https://healthsectorcouncil.org/hscc-joint-cybersecurity-working-group-executive-committee/
20 https://healthsectorcouncil.org/the-joint-security-plan/
21 https://www.healthit.gov/
22 https://www.healthit.gov/isa/sites/isa/files/ISA.html
23 https://www.healthit.gov/sites/default/files/page/2020-01/2020-2025FederalHealthIT%20StrategicPlan_0.pdf
24 FDA News Release: FDA outlines cybersecurity recommendations for medical device manufacturers. January 15, 2016. https://www.fda.gov/news-events/press-announcements/fda-outlines-cybersecurity-recommendations- medical-device-manufacturers
25 FDA Publication. Postmarket Management of Cybersecurity in Medical Devices. DECEMBER 2016. https://www.fda.gov/media/95862/download
26 https://www.linkedin.com/in/soodytronson/
27 STLG Law Firm. https://www.stlgip.com/
28 Presque. https://www.mypresque.com/
29 Women Securing the Future with TIPPSS for IoT Trust, Identity, Privacy, Protection, Safety, Security for the Internet of Things https://www.springer.com/gp/book/9783030157043