Security CoP

MITA Unveils Medical Device Security, Risk Management Standard

  • [Shahid Shah]
  • November 23, 2019
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MITA Unveils Medical Device Security, Risk Management Standard

The Medical Imaging & Technology Alliance (MITA) published a medical device cybersecurity playbook aimed to support radiologists and health delivery organizations with building risk management processes around device-related concerns.

The Manufacturer Disclosure Statement for Medical Device Security (MDS2) is a voluntary standard focused on outlining security control features integrated into medical devices. The guidance was developed in partnership with industry stakeholders and aligns with the Food and Drug Administration’s playbook released in 2018.

The guide is designed to provide standardize information around security, as well as the privacy control features found within medical devices. Officials stressed that the standard is best used as an input into an operational security plan and that all security controls may not be appropriate for all devices.

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last modified November 23, 2019