Interoperability

August 4, 2020: New Living Textbook Sections Describe Interoperability, Patient Access to Data

Posted on by Karen Staman

Members of the NIH Collaboratory Electronic Health Records Core have authored 2 new sections of the Living Textbook chapter Using Electronic Health Record Data in Pragmatic Clinical Trials:

  • Interoperability
    • This section describes efforts to support interoperability and the sharing of patient data across care teams and organizations, including the creation the United States Core Data for Interoperability (USCDI) standard.
  • Patient Access to Data
    • This section describes provisions of the 21st Century Cures Act intended to support the access, exchange, and use of electronic health information by patients and their caregivers.

Many of the NIH Collaboratory Trials use electronic health record and claims data for pragmatic research, and these data are from a fundamentally different context than data prospectively collected for more traditional, explanatory research. The Living Textbook chapter, Using Electronic Health Record Data in Pragmatic Clinical Trials, describes how data from real-world sources can be used in pragmatic clinical trials to develop and refine research questions, identify the study population and assess baseline prognostic characteristics, implement and monitor the delivery of the intervention, and assess outcomes.

The 2 new sections describe the latest developments and considerations for use of electronic health data in pragmatic clinical trials.

May 26, 2019: Final Rule to Implement Provisions of the 21st Century Cures Act

Posted on by Karen Staman

On May 1, 2020, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) announced a final rule to implement provisions of the 21st Century Cures Act. The final rule is intended to advance interoperability and support the access, exchange, and use of electronic health information by patients and their caregivers.

“Patients should be able to access their electronic medical record at no extra cost. Providers should be able to choose their IT tools that allow them to provide the best care for patients, without excessive costs or technical barriers.” —ONC Cures Act Final Rule Fact Sheet

To enable the use of smartphone applications (apps) for secure access to healthcare data, the rule requires standardized, open application programming interfaces (APIs) to be built using HL7’s FHIR (Fast Health Interoperability Standard). Part of the intention of the rule is to promote competition and support provider and patient independence in choosing which certified apps to acquire and use for healthcare purposes.

The rule establishes the United States Core Data for Interoperability (USCDI) standard, which sets forth data classes and elements that support nationwide interoperability; it also includes a broad range of data elements, such as clinical notes, test results, and medications. The final rule includes a prohibition on “information blocking” to restrict practices that are likely to interfere with access to or exchange of health information.

The rule is effective on June 30, 2020, and compliance is required by November 2, 2020.

February 22, 2019: Proposed Rule to Implement Provisions of the 21st Century Cures Act

Posted on by Karen Staman

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid (CMS) have announced a proposed rule intended to advance interoperability and support the access, exchange, and use of electronic health information. Notably, the rule would require that patients have the ability to electronically access their health information at no cost.

The rule also proposes a United States Core Data for Interoperability (USCDI) standard, which, if adopted, would add data beyond those included in the current common clinical data model to support nationwide interoperability of CMS data. Specifically, clinical notes, data provenance, pediatric vital signs, patient address and phone number (to support data matching) will be added if the measures are adopted.

“Today’s announcement builds on CMS’ efforts to create a more interoperable healthcare system, which improves patient access, seamless data exchange, and enhanced care coordination,” — CMS Administrator Seema Verma, from the NPRM Press Release

There are nine fact sheets on other important aspects of the rule, including sheets on interoperability, the Cures Act, and electronic health information export for patient and provider access.