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nist
A draft of a new revision of the NIST Framework for Improving Critical Infrastructure Cybersecurity has been circulated for comment.  This draft (NIST_cybersecurity_framework-v1-1) revision refines, clarifies, and enhances Version 1.0 issued in February 2014.  This is a draft for comment. See copy of draft Framework for Improving Critical Infrastructure Cybersecurity Version 1.1
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The National Institute of Science of Technology issued Version 1 of its framework for improving cybersecurity for critical infrastructure including health care. The full press release is at the link provided.
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The U.S. National Institute of Standards and Technology issued a document entitled “Framework for Improving Critical Infrastructure Cybersecurity” dated February 12, 2014.   This document is now being used by FDA as a reference in its cybersecurity program.  You can download version 1.0 here: Framework for Improving Critical Infrastructure Cybersecurity Version 1.0 See our later post...
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A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT: AAMI TIR38 – AAMI Medical device safety assurance case guidance IEC Health SW Standards Framework ISO 27799 Health informatics “Information management in health using ISO/IEC 27002” IEC TR 80001-2-8, Application of risk management...
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NIST received comments on the Preliminary Cybersecurity Framework for improving critical infrastructure cybersecurity and is updating the framework. They have announced that the final version (Version 1.0) will be released on February 13. When it is released, the Final Framework will be posted at NIST.
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http://www.nist.gov/itl/upload/preliminary-cybersecurity-framework.pdf
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NIST was directed to prepare a cybersecurity framework for critical infrastructure in Presidential Executive Order 13636. Healthcare was identified as one of the areas with critical infrastructure. This draft for comment is only an outline of the framework. NIST_draft_outline_cybersecurity_framework
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http://hissa.nist.gov/effProject/handbook/c++/
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“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures. IEEE-NIH_CBMS_Safety_Model-13
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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