SoftwareCPR Standards Summary May 2014

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 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
  • NIST Special Publication 800-160 Systems Security Engineering. This guidance infuses systems security engineering techniques, methods, and practices into the systems and software engineering processes defined in ISO/IEC 15288. This NIST document is publicly available at the link provided. NIST SP800-160 Draft

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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