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Cybersecurity

Ask anyone in healthcare technology management (HTM) what worries them most about the future of medical devices and they’ll likely say the same thing: cybersecurity.

 

Cybersecurity Resources



Cybersecurity risks and their impact on the safety and security of patients, employees, and organizations are a real threat in today’s digital landscape. Learn from experts in the field on protecting your critical systems and sensitive information from attacks. 

This collection contains AAMI standards, technical information reports, books, articles from BI&T, as well as other resources that will help you make the decisions needed to safeguard your data. Take advantage of this collection's discounted price —plus receive multiple resources to help you ensure the security of your system. 

  • ANSI/AAMI/IEC TIR80001-2-2, Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
  • AAMI/IEC TIR80001-2-8, Application of risk management for IT-networks incorporating medical devices—Part 2-8: Application guidance—Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
  • AAMI TIR57, Principles for medical device security—Risk management
  • AAMI TIR97, Principles for medical device security—Postmarket risk management for device manufacturers
  • Medical Device Cybersecurity: A Guide for HTM Professionals
  • The Medical Device Connectivity FAQs
  • Resources from the field

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Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
The purpose of this document is to provide guidance to multiple stakeholders regarding the appropriate use of public cloud computing both as a component of medical devices and in support of quality systems. Cloud technology providers, medical device manufacturers, regulatory professionals and regulators alike should be able to refer to this document to identify known best practices for ensuring that the public cloud computing component of any medical device (or quality system) works both within the spirit and the letter of regulations designed to ensure that medical devices improve patient outcomes and/or help manage healthcare costs, while also being safe and effective..

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Principles for medical device security—Postmarket risk management for device manufacturers
This technical information report (TIR) provides guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. This TIR is intended to be used in conjunction with AAMI TIR57:2016.

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Latest Cybersecurity News

 

  • A computer screen reflects onto glasses. Medical Device Cybersecurity Hygiene for Frontline Professionals
    Matthew Victoria
    Jun 5, 2022
    What errors render a medical device vulnerable to cybersecurity threats? This was the central query of the AAMI eXchange session “Medical Device Cybersecurity Hygiene for Frontline Professionals,” presented by cybersecurity experts Steve Grimes and Axel Wirth. 
  • Photo Portrait of Priyanka Shah ECRI Project Engineer Recognized with Young Professional AAMI Award
    Jun 5, 2022
    Priyanka Shah has been honored with a 2022 AAMI award, recognizing her commitment and insights in the health technology field. Shah, a senior project engineer at ECRI in Pennsylvania, was presented with AAMI’s Young Professional Award in June at the AAMI eXchange conference in San Antonio, Texas.
  • Photo portrait of Samantha Jacques McLaren Health Leader Recognized With 2022 AAMI Award
    Jun 5, 2022
    Samantha Jacques, PhD has been honored with a 2022 AAMI award, recognizing her commitment and insights in the health technology field. Jacques, vice president of Clinical Engineering at McLaren Health Care in Michigan, was presented with the John D. Hughes Iconoclast award in June at the AAMI eXchange conference in San Antonio, Texas.
  • AAMIeXchange2022MainStage_sq Focus on the Future: “HTM, I See You”
    Martha Vockley
    Jun 5, 2022
    “HTM, I see you,” said AAMI President and CEO Pamela Arora in the Opening Keynote at the AAMI eXchange in San Antonio, Texas. Arora shared her personal story and interviewed a star-studded cast of professionals for the event's Saturday main stage event.
  • Christian Dameff headshot UCSD Medical Director of Cybersecurity Recognized With 2022 AAMI Award ​
    Jun 4, 2022
    Christian Dameff, MD, has been honored with a 2022 AAMI award, recognizing his commitment and insights in the health technology field. Please join us in congratulating this Cybersecurity Visionary. 
  • A rusty hook on a red email envelope to represent a phishing attack. Growing Impact of Cybersecurity in HTM Inspires Learning Opportunities at AAMI eXchange
    Cole Demert
    May 25, 2022
    "Cybersecurity is becoming increasingly important both for manufacturers and HDO" says the founder and CEO of ASIMILY. Find out why you should care about sprucing up the cybersecurity preparedness in you department, and what learning opportunities a dedicated track at AAMI eXchange has to offer.
  • Tablet_reading_academic_happy_423948206_sq AAMI Recognizes Authors in Cloud Computing, Cybersecurity, and Smart Pumps
    Gavin Stern
    Apr 27, 2022
    A team exploring the frontier of medical device cloud computing, a cybersecurity duo capturing best practices for frontline personnel, and a nurse/pharmacist research team have all made outstanding contributions to AAMI’s publications in the past year. Congratulations to the 2022 recipients of our AAMI Publications Awards recipients!

Related Events

 

  • FDA’s New Risk-Based Computer Software Assurance Approach for PPQS
    August 9 to 11, 2022
  • Production & Quality System Software (Nov22)
    November 3 to 4, 2022
  • Medical Device Software Validation (Nov22)
    November 8 to 10, 2022
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