CyberSecurity

CYBERSECURITY RISKS IN MEDICAL DEVICES ARE REAL

By: Eric M. Luyer, Market Research Analyst 

The Healthcare Industry Has a New Set of Threats on Its Hands

PPP_IGLOB_CLP_Global_Computer_Network_Red_Color_Pencil_HEXConnected medical devices-like other computer systems-can be vulnerable to security breaches and have a potential major impact on safety and effectiveness of the device.  Specifically, in a healthcare environment, this vulnerability increases asmedical devices and medical equipment are becoming more connected through the internet to other medical devices, patients and/or to hospital networks (also referred to as the Internet of Medical Things).

To address the cybersecurity threat, in December 2016 FDA issued Guidance on Postmarket Management of Cybersecurity in Medical Devices.

The agency highly recommends that both hospitals and medical device manufacturers implement a proactive, comprehensive risk management program that includes:

  • Implementing the National Institute of Standards and Technology (NIST) Framework on Critical Infrastructure Cybersecurity
  • Establishing and communicating processes for vulnerability intake and handling
  • Adopting a coordinated disclosure policy and practice
  • Deploying mitigations that address cybersecurity risk early and prior to exploitation
  • Engaging in collaborative information sharing for cyber vulnerabilities and threats

The time to implement a proactive, comprehensive risk management program to eliminate cybersecurity threats is now.

To read the article in its entirety as published in MedTech Intelligence, please follow this link.
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