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Biomedical Device Risk Analysis

Biomedical device risk analysis could be a significant undertaking for an organization. tw-Security's consultants are risk analysis experts and extremely efficient at medical device cybersecurity.

\"\\"Icon\\"\" When we are engaged to assist with biomedical devices risk analysis, we utilize our tools that support our risk analysis methodology based upon the guidance from the National Institute of Standards and Technology (NIST) developing the biomedical device information security risk management documentation foundation. We provide training to manage the findings, corrective action steps, as well as conducting risk profiles to address new inventory.

Classes of Biomedical Devices
(Examples of devices that may store any type of PHI)
  1. Analyzer (Lab Equipment)
  2. Densitometer, Bone
  3. EEG Machine
  4. EKG Machine
  5. Fluoroscopic Unit, Portable
  6. Image Digitization System, Computed Radiography, Reader/Manipul
  7. Infusion Pump, Sigma Spectrum Infusion Pump
  8. Medication Dispensing Cabinet
  9. Module, Data Transfer
  10. Monitor, Anesthesia
  11. Monitor, Bedside, Physiologic Monitor
  12. Monitor, Central Station
  13. Monitor, Stress Exercise
  14. Printer, Dry-Processing
  15. Radiographic System, Digital, Mammographic
  16. Radiographic/Fluoroscopic System, Angiographic
  17. Scanner, CT, Spiral
  18. Scanner, Gamma Camera, Planar Image
  19. Scanner, MRI, Full-Body
  20. Ultrasound, Diagnostic
  21. Ventilators
Reasonably Anticipated Threats:
  1. Hacking or tampering by an external person
  2. Virus, worm, or malicious code
  3. Program error, application bug, and/or operating system errors
  4. Power failure
  5. Theft or loss
  6. Damage due to mishandling 
  7. Unauthorized access to confidential information
  8. Hardware failure


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