Using Electronic Health Record Data in Pragmatic Clinical Trials
Section 10
Patient Access to Data
New developments in regulation and technology—particularly related to patient- or consumer-mediated data exchange—are changing the nature of how researchers might access data (Cimino et al. 2014; Bracha et al. 2019). To implement provisions of the 21st Century Cures Act, 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; one aspect of the rule is intended to 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 adoption of the data standards mentioned in the Interoperability section will help organizations develop patient interfaces to their data, and increase the number of apps that can use those data to support patients in their health decision-making and engagement in their care, including their ability to participate in clinical research and pragmatic trials.
SECTIONS
sections
- Introduction
- Interoperability
- Data as a Surrogate for Clinical Phenomena
- Developing and Refining the Research Questions
- Specific Uses for EHR Data in PCTs
- Estimating and Identifying the Study Population and Assessing Baseline Prognostic Characteristics
- Implementing and Monitoring the Delivery of an Intervention
- Assessing Outcomes
- The Research Question Drives the Data Requirements
- Patient Access to Data
- Additional Resources
current section : Patient Access to Data
- Introduction
- Interoperability
- Data as a Surrogate for Clinical Phenomena
- Developing and Refining the Research Questions
- Specific Uses for EHR Data in PCTs
- Estimating and Identifying the Study Population and Assessing Baseline Prognostic Characteristics
- Implementing and Monitoring the Delivery of an Intervention
- Assessing Outcomes
- The Research Question Drives the Data Requirements
- Patient Access to Data
- Additional Resources