References

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Thomas P. Dover
Butler County Community College

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Information Security (IS)

Framework for Improving Critical Infrastructure Cybersecurity. (2018). US Department of Commerce, National Institute of Standards and Technology.
Health Insurance Portability and Accountability Act of 1996. Pub. L. 104-191. Stat. 1936. HIPAA. Retrieved: https://www.govinfo.gov/content/pkg/...104publ191.pdf
Health Information Technology for Economic and Clinical Health Act. Pub. L. 111-5. Stat. 13001. (2019). HITECH. Retrieved: https://www.hhs.gov/sites/default/fi.../hitechact.pdf
Minimum Security Requirements for Federal Information and Information Systems. Federal Information Processing Standards Publication (FIPS) 200. (2006). US Department of Commerce, National Institute of Standards and Technology.
NIST Special Publication 800-53r5: Security and Privacy Controls for Information Systems and Organizations. (2017). US Department of Commerce, National Institute of Standards and Technology.
Ross, R., Pillitteri, V., Dempsey, K., Riddle, M. and Guissanie, G. (2019). NIST Special Publication 800-171r2: Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations. US Department of Commerce, National Institute of Standards and Technology.
Ross, R., Pillitteri, V., Guissanie, G., Wagner, R., Graubart, R. and Bodeau, D., (2020). NIST Special Publication 172: Enhanced Security Requirements for Protecting Controlled Unclassified Information. A Supplement to NIST Special Publication 800-171. US Department of Commerce, National Institute of Standards and Technology.
Ross, R., Pillitteri, V., Guissanie, G., Wagner, R., Graubart, R. and Bodeau, D., (2020). NIST Special Publication 172A: Assessing Enhanced Security Requirements for Controlled Unclassified Information. US Department of Commerce, National Institute of Standards and Technology.
Federal Information Processing Standards Publication (FIPS) 199. Standards for Security Categorization of Federal Information and Information Systems. (2004). US Department of Commerce, National Institute of Standards and Technology.

Operational Security (OS)

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff (First Draft). (2014). Department of Health and Human Services. Food and Drug Administration, 3
Cybersecurity Safe Harbor provision. Amendment to Health Information Technology for Economic and Clinical Health Act (HITECH), (2021). 42 USC 17931 §13412. Public Law 116-321.
FDA Should Expand Its Consideration of Information Security for Certain Types of Devices. (2012). General Accounting Office. GAO-12-816 Highlights, Medical Devices.
Framework for Improving Critical Infrastructure Cybersecurity. (2018). US Department of Commerce. National Institute of Standards and Technology.
Health Information Technology for Economic and Clinical Health Act. Pub. L. 111-5. Stat. 13001. (2009). HITECH. Retrieved from: https://www.hhs.gov/sites/default/fi.../hitechact.pdf
Health Insurance Portability and Accountability Act of 1996. (1996). Pub. L. 104-191. Stat. 1936. HIPAA. Retrieved from: https://www.govinfo.gov/content/pkg/...104publ191.pdf
Internet of Things Cybersecurity Improvement Act of 2020. H.R. 1668. (2020). Public Law 116-207. United States Congress.
Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure. Medical Device Innovation Consortium. (2018). Retrieved from: https://mdic.org/event/mdicx-cyberse...ty-disclosure/
Medical Device Cybersecurity: What You need to Know. (2020). Retrieved from: https://www.fda.gov/consumers/consum...-you-need-know
Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. (2018). U.S. Food and Drug Administration. FDA-2018-N-1315.
NIST Special Publication (SP) 800-213: IoT Device Cybersecurity for the Federal Government: Establishing IoT Device Cybersecurity Requirements. (2021). US Department of Commerce. National Institute of Standards and Technology, 11.
NIST Special Publication (SP) 800-213A: IoT Device Cybersecurity for the Federal Government: IoT Device Cybersecurity Requirement Catalog. (2021). US Department of Commerce. National Institute of Standards and Technology.
NISTIR 8228: Considerations for Managing Internet of Things (IoT) Cybersecurity and Privacy Risks. (2019). US Department of Commerce. National Institute of Standards and Technology.
NISTIR 8259: Foundational Cybersecurity Activities for IoT Device Manufacturers. (2020). US Department of Commerce. National Institute of Standards and Technology.
NISTIR 8259A: IoT Device Cybersecurity Capability Core Baseline. (2020). US Department of Commerce. National Institute of Standards and Technology.
NISTIR 8259B: IoT Non-technical and Supporting Capability Core Baseline. (2020). National Institute of Standards and Technology.
NISTIR 8259C: Creating a Profile of the IoT Core Baseline and Non-Technical Baseline. (2020). National Institute of Standards and Technology.
NISTIR 8259D: Profile using the IoT Core Baseline and Non-Technical Baseline for the Federal Government. (2020). National Institute of Standards and Technology.
Postmarket Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. (2016). Department of Health and Human Services. Food and Drug Administration, 4.
NIST Special Publication 800-53r5. Security and Privacy Controls for Information Systems and Organizations. (2017). US Department of Commerce. National Institute of Standards and Technology.
Fact Sheet: The FDA’s Role in Medical Device Cybersecurity, Dispelling Myths and Understanding Facts. (2019). Department of Health and Human Services. Food and Drug Administration. Retrieved from: https://www.fda.gov/files/medical%20...fact-sheet.pdf