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    • Market Access
      • Market Access US & International
      • Market Access Europe
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      • IVD Admission Strategy
      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
    • Technical Documentation
      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
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      • Seminar Overview
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  • Medical Device University
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
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      • Current Vacancies
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April 19, 2016


Health Breach Notification Rule

By Prof. Dr. Christian JohnerApril 19, 2016Leave a comment

The Health Breach Notification Rule defines when health records providers have to report which security issues to whom, within what time frame and in what form. This article provides a brief overview of the requirements of the US Federal Trace Commission (FTC).

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