HIPAA Compliance for Electronic Records

Instructor: David Nettleton
Product ID: 704422
  • Duration: 75 Min
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This HIPAA training program will highlight electronic record security regulations including requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.

Why Should You Attend:

This webinar will detail the regulations for electronic records related to Health Insurance Portability and Accountability Act (HIPAA) patient medical data. What makes this session unique is the understanding of how Part 11 and HIPAA industry standards have evolved together thereby reinforcing each other.

Areas Covered in the Webinar:

  • Evolution of 21 CFR Part 11 to the latest HIPAA regulations for patient medical records.
  • Specifics of the regulations, 45 CFR Parts 160, 162, and 164 the HIPAA electronic record security regulation that became effective in 2005.
  • How to configure your system and processes for compliance.
  • Which data and systems are subject to HIPAA
  • What HIPAA means, not just what it says?
  • Examine the regulatory requirements for the four primary areas of compliance: SOPs, software product features, infrastructure qualification, and validation documentation.
  • Evaluate the regulatory requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.
  • SOPs required for the IT infrastructure.
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Who Will Benefit:

  • Computer system users
  • IT personnel
  • QA/QC personnel
  • Managers
  • Executives

Instructor Profile:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

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