Sunday, December 30, 2012

Public Comment by Feb 4: ONC Health IT Safety Plan

ONC recently released its Health IT Patient Safety Action and Surveillance Plan for public comments, which are due by Feb 4, 2013. Comments can be sent to

The report can be found HERE, as well as a brief Fact Sheet.  The report is related to the IOM's 2011 recommendations from Health IT & Patient Safety: Building Safer Systems for Better Care.


Patient safety objectives

  1. Use health IT to make care safer 
  2. Continuously improve the safety of health IT

Increase the quantity and quality of data and knowledge about health IT safety

  1. Make it easier for clinicians to report patient safety events and risks using EHR technology.
  2. Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks. 
  3. Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.
  4. Incorporate health IT safety in post-market surveillance of certified EHR technology through ONC-Authorized Certification Bodies (ONC-ACBs).
  5. Align CMS health and safety standards with the safety of health IT, and train surveyors. 
  6. Collect data on health IT safety events through the Quality & Safety Review System (QSRS).
  7. Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database.

Target resources and corrective actions to improve health IT safety and patient safety

  1. Use Meaningful Use of EHR technology to improve patient safety.
  2. Incorporate safety into certification criteria for health IT products.
  3. Support research and development of testing, user tools, and best practices related to health IT safety and its safe use.
  4. Incorporate health IT safety into medical education and training for all health care providers.
  5. Investigate and take corrective action, when necessary, to address serious adverse events or unsafe conditions involving EHR technology. 

Promote a culture of safety related to health IT

  1. Develop health IT safety priority areas, measures, and targets.
  2. Publish a report on a strategy and recommendations for an appropriate, risk-based regulatory framework for health IT. 
  3. Establish an ONC Safety Program to coordinate the implementation the Health IT Safety Plan. 
  4. Encourage state governments to incorporate health IT into their patient safety oversight programs.  
  5. Encourage private sector leadership and shared responsibility for health IT patient safety.


  1. Encourage private sector leadership and shared responsibility for health IT patient safety.

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