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 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
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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Medical Device Software Validation (Mar24)
March 19 to 21, 2024
Understanding ANSI/AAMI SW96:2023 – Security Risk Management Guidance (Apr 2024)
April 9 to 11, 2024
Production & Quality System Software (April24)
April 24 to 25, 2024
Medical Device Software Validation (May24)
May 20 to 22, 2024