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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.