Quality Systems Regulations

What Does Quality Systems Regulations Mean?

Quality systems (QS) regulations help govern health information technology (HIT). These regulations mandate (or will mandate) the standards in HIT and electronic health record (EHR) systems development and implementation including:

  • Electronic audit trails
  • Capture replay capabilities
  • Electronic approval processes

Techopedia Explains Quality Systems Regulations

The Certification Commission for Health Information Technology (CCHIT) has been charged with the certification of EHR vendors and eligible providers (EP) who design their own EHR systems. The Office of the National Coordinator for Health Information Technology (ONCHIT) is within the Department for Health and Human Services (HHS) and it has appointed CCHIT to oversee and certify EHR vendors who meet meaningful use (MU) EHR standards.

CCHIT is a private, industry-based organization with many bioethics advocates and professionals concerned about the lack of governing IT standards within EHR systems as they relate to QS regulations or patient safety. CCHIT is continuously stepping up its certification processes such that private EHR vendors meet ethical concerns relating to patient safety, electronic reporting and health outcomes, although critics say the governing standards need to be fine-tuned.

IT professionals are required in health information technology for writing supplemental or additional computer software that can perfect EHR security and protect patient safety. Primary needs include approval processes, electronic audit trails, and ongoing monitoring and data capture replay capabilities within these systems. QS regulations will likely increase the value of and need for IT developers and other personnel to audit private EHR vendors and ensure patient welfare, healthful outcomes and more opportunities for eligible providers (EP) to invest in quality EHR systems.


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Margaret Rouse
Technology Expert

Margaret is an award-winning technical writer and teacher known for her ability to explain complex technical subjects to a non-technical business audience. Over the past twenty years, her IT definitions have been published by Que in an encyclopedia of technology terms and cited in articles by the New York Times, Time Magazine, USA Today, ZDNet, PC Magazine, and Discovery Magazine. She joined Techopedia in 2011. Margaret's idea of a fun day is helping IT and business professionals learn to speak each other’s highly specialized languages.