ONC & CMS Proposed Rules – Part 3: Data Requirements

Matt Humphrey
Dave Levin


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.  


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.

Exhibit 1: USCDI API Endpoints

Another Step in the Right Direction

The USCDI has expanded upon the CCDS, which is a much-needed next step forward for data sharing. It also outlines an expansion process to include more data over time. In the expansion process, data is classified as USCDI based on agreement among stakeholders. The process moves the data from emerging, to candidate, to USCDI status. With the outlined expansion process, it’s clear that the current USCDI data set is not complete and there is a recognized need to share more data.

By specifying the data that must be shared to qualify for ONC certification, the USCDI gives us a better idea of how information blocking may be defined going forward. But it does not say that by not sharing this data, or by not getting ONC certified, that information blocking is taking place. The specific definitions of information blocking, exceptions and potential penalties are spelled out in other sections of the law and proposed regulations.

So far, the USCDI focuses on clinical data and does not include any data pertaining to revenue cycle or to payers though other portions of the law and proposed rules do address new insurance-related data requirements. There is a widely held desire to calculate clinical quality measures, which isn’t possible without making claims data available. This data provides an insight beyond the clinical, an insight we’ll be missing until this data is included. With the expansion plan in place for more data to be made available, there is hope that non-clinical data will soon be shared as well.

What This Means for the Future

The latest draft of the USCDI and the framework for expansion proves that they see the need to share more data. This acknowledgment shows a continuing evolution of these standards.

As the USCDI evolves and more data is shared, methods of access to the data defined will be updated as well. As more data is made available, APIs will be modified to expose that data. APIs created to meet the rules and standardized datasets of the FHIR standard and USCDI will help us reach the next level of interoperability. This increased access to information will improve health care efficiency and the quality of care for patients.

Dave Levin, MD is co-founder and Chief Medical Officer for Sansoro Health where he focuses on bringing true interoperability to health care. Dave is a nationally recognized speaker, author and the former CMIO for the Cleveland Clinic.

Matt Humphrey is a Solutions Architect at Sansoro Health with over 15 years of experience successfully managing the delivery of health care IT solutions.