U.S. HHS Dep. Health IT Safety and Surveillance Plan

The U.S. Department of Health and Human Services (of which FDA is a part) published “Health Information Technology Patient Safety Action & Surveillance Plan.” The plan defines several types of action:

  • Learn – mainly monitoring of safety of Health IT in the field
  • Improve – Investigate adverse events and take corrective action. Set safety priorities and incorporate safety into certification criteria for Health IT while supporting research and development of testing, best practices, and training.
  • Lead – Encourage private sector leadership for Health IT Safety and developed a risk-based regulatory framework for Health IT including for State governments.

The full plan is at the following link: Safety Master Plan.

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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