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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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