CareFusion Pyxis Homeland Security Alert

On March 29, 2016, the US Department of Homeland Security issued an Advisory regarding the Carefusion Pyxis SupplyStation System Vulnerabilities that would only require an attacker with low skills.  Specific mitigations listed in the Advisory include:

  • Isolate affected products from the Internet and untrusted systems; however, if additional connectivity is required, use a VPN solution.
  • When remote access is required, use secure methods, such as Virtual Private Networks (VPNs), recognizing that VPNs may have vulnerabilities and should be updated to the most current version available. Also recognize that VPN is only as secure as the connected devices.
  • Monitor and log all network traffic attempting to reach the affected products for suspicious activity.
  • Close all unused ports on affected products.
  • Locate medical devices and remote devices behind firewalls, and isolate them from the business network.
  • Work with local team to ensure all Microsoft patching and ESET virus definitions are up to date. A Security Module for automated WSUS patching and virus definition management is provided to all accounts. SupplyStations Version 8 and Version 9 have been upgraded to ESET.
  • If pcAnywhere is used and has not been upgraded to Version 12.5 Service Pack 4, contact CareFusion’s Customer Support to schedule an upgrade or to have it removed.
  • Use the extended password feature configured for strong passwords, enable the password history tracking feature, and set user passwords to expire according to site policy.

You can see the Advisory at this link:  US Homeland Security Advisory (ICSMA-16-089-01)

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Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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Instructor: Dr Peter Rech, 2nd instructor (optional)

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