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Cybersecurity and International Standards for Medical Devices

With standards, regulations, statutes, etc., many feel this is a speedbump for their product. In the interest of the field, industry patient safety, and security these are a great idea. Without these in place, medical device cybersecurity could become like the Weld West with every entity doing their own thing, not following any guidance.


The FDA has recognized three new standards focused on medical device software security. These cover the total product lifecycle of medical device cybersecurity, data logging, software use, and reasonable software testing.


The first noted standard was ANSI/AAMI 2700-2-1. This standard is focused on medical device software’s safe usage in the integrated clinical environment (ICE). The specific usage is for data loggers to appropriately collect data in these systems. This includes the recording, data, storage, and playback for the data. The data usage would be for safety, quality assurance, and forensic analysis.


The second standard was ANSI/AAMI SW96:2023, which provides guidance on methods to manage security risks. Medical devices present a unique security risk. The standard addresses several security areas to identify threats and vulnerabilities and the controls to put in place to mitigate these.


Lastly ISO IEC IEEE 29119-1 provides guidance on germane topics in the field including software. These standards provide additional guidance and a framework to further the safety and security for the products. By adding these into our security tools, the attack surface is decreasing, and potential attacks are mitigated


About the Author

Charles Parker, II has been working in the info sec field for over a decade, performing pen tests, vulnerability assessments, consulting with small- to medium-sized businesses to mitigate and remediate their issues, and preparing IT and info sec policies and procedures. Mr. Parker’s background includes work in the banking, medical, automotive, and staffing industries.

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