ONC Prepub Proposed 2015 HIT Certification Reqs.

The draft of the US ONC proposed 2015 HealthIT ceritfication requirements rule is at the link provided. The final will be published March 30, 2015. This new version requires use of a quality system and states:

“….QMS established by the federal government and SDOs include FDA’s quality system regulation in 21 CFR part 820, ISO 9001, ISO 14971, ISO 13485, and IEC 62304. We encourage health IT developers to choose an established QMS, but developers are not required to do so, and may use either a modified version of an established QMS, or an entirely home grown QMS. In cases where a health IT developer does not use a QMS established by the federal government or an SDO, the health IT developers must illustrate how their QMS maps to one or more QMS established by the federal government or SDO through documentation and explanation that links the components of their QMS to an established QMS and identifies any gaps in their QMS as compared to an established QMS. We clarify that we have no expectation that there will be detailed documentation of historical QMS or their absence. The documentation of the current status of QMS in a health IT development organization would be sufficient.”

The actual proposed regulation is at the bottom of the document. The beginning is the discussion.

2015 ONC HIT Certification Criteria Pre Pub Version

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