Corporate Compliance

Ensuring clinical trials privacy

Healthcare Auditing Weekly, May 17, 2005

To ensure that clinical trials in your organization fully comply with HIPAA, it helps to develop a HIPAA monitoring workplan. Don't forget these four steps when putting the plan together:

  • Review your internal audit workplan to assess compliance and potential overlap
  • Outline all privacy rule requirements
  • Conduct a facilitated workshop with administration and key members of clinical staff and investigators to assess potential vulnerabilities
  • Get the plan approved by senior management and the board

The above tip is an excerpt from the book "Hospital Auditing and Monitoring: Sample Programs for Key Risk Areas," copyright 2005 by HCPro, Inc. This book is a step-by-step, practical manual that offers sample audit programs for the most troublesome areas that a hospital must audit. The binder and CD-ROM are filled with actual audit programs used by auditors and compliance officers in the field. Click here for more information or to order your copy today.

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