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ONC & CMS Proposed Rules – Part 3: Data Requirements

Matt Humphrey
Dave Levin

By DAVE LEVIN, MD and MATT HUMPHREY

The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions. In part three of this series, we look at how the new USCDI draft helps foster innovation.  

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The U.S. Core Data for Interoperability (USCDI) draft is a step forward toward expanding the 21st Century Cures Act. The Cures Act was helpful in moving the needle for interoperability and defining data blocking. The latest draft of the USCDI is meant to further specify what data should be shared freely.

In this article, we’ll look at the data added to the Common Clinical Data Set (CCDS) used for ONC certification. We’ll walk through the proposed plan to add more data over time. And we’ll explore why this is a step in the right direction toward increased data sharing.

New Shared Data

The bulk of the datasets in the USCDI comes from the Common Clinical Data Set (CCDS), which was last updated in 2015. The new USCDI draft adds two types of data:

  • Clinical notes: both structured and unstructured. EHRs store these notes differently, but both are important and helpful in data analysis.
  • Provenance:  an audit trail of the data, showing where it came from. It is metadata, or information about the data, that shows who created it and when.

The Fast Healthcare Interoperability Resources (FHIR) have created standards around APIs used to access health care data. APIs developed under the FHIR standard aligns with the USCDI to meet the proposed certification rules. The USCDI draft recommends using a FHIR compliant API to access the data.

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