Health IT U.S. Regulation Update

How Health IT will be regulated was being discussed by the U.S. government in February. A Health IT Patient Safety Action & Surveillance Plan was circulated by the Office of the National Coordinator for HIT (ONC) in December and is at the link provided. https://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf

A report on An Oversight Framework for Assuring Patient Safety in Health was released by the Bipartisan Policy Center in February and can be viewed at: Health IT Legislation.

The ONC solicited members for a work group for developing the report on a framework for regulating HIT required by the Food and Drug Administration Safety Innovation Act (FDASIA) legislation that was adopted last summer.

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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