Nov 14, 2023 | Elimu Informatics
Many organizations that host data platforms and/or disease registries for clinical research are exploring new ways to take advantage of interoperable data that flows more freely from Electronic Health Records (EHRs) as a consequence of the 21st Century Cures Act. They are exploring how to remodel the research data dictionaries to capture data efficiently as a byproduct of clinical workflow in EHRs. While Natural Language Processing and Artificial Intelligence will streamline capture of data that is already in EHRs, these automated tools will not account for the data gaps relevant to registry requirements nor the workflows needed to validate the harvested information.
Unfortunately, in today’s world, many health systems participating in clinical research still invest significant manual labor in pain-staking chart abstraction. To capture data that is extractable from EHRs, they build and maintain one-off data collection and extraction tools and must continuously ensure that the data mappings to standard terminology codes are continuously updated. When registry data dictionaries must change, the process is slow and gated because all of the research sites must update their own systems to align with the updates.
Elimu’s Sapphire® Platform and Professional Services provide all of the necessary components to make this vision of agile research and Real World Data capture a reality. Our professional services team can assist with dictionary remodeling and mapping to standard terminologies so that high quality data can be obtained from EHRs by organizations hosting registry and research databases. Our Sapphire® Platform contains the EHR-integratable App workflows, Clinical Decision Support services, Integration Services and FHIR Server to provide the necessary tools for high-quality, encoded Real World Data acquisition and validation.
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Data Access and Integration:
SMART-on-FHIR apps facilitate seamless access to patient United States Core Data for Interoperability (USCDI) data stored within EHRs, enabling registries and researchers to retrieve relevant clinical information for their studies. This streamlines the data collection process and reduces the need for manual or duplicate data entry, potentially improving data accuracy and reducing administrative burdens.
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Patient Recruitment and Enrollment:
To support patient recruitment for clinical trials and research studies, SMART-on-FHIR apps can be embedded with algorithms and patient-facing and/or clinician-facing workflows. These algorithms can apply criteria to EHR data to identify eligible patients and notify clinicians at the point-of-care. Patient-facing apps can also be designed to enable notification of patients of potential trial eligibility. This can lead to more efficient and targeted recruitment efforts, helping researchers find suitable participants more quickly.
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Real-Time Data Capture:
SMART-on-FHIR apps can be embedded with templates and forms that enable data collection from clinical staff and patients alike. It is often a burden on IT resources to build, encode with standard terminologies, and maintain such forms in each EHR instance. Relevant patient-level and encounter-level USCDI data is easily harvested from the EHR to ensure complete longitudinal data capture.
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Patient Consent and Privacy:
For patients to control access to their health data for research purposes, SMART-on-FHIR apps can be used to integrate consent management tools. This supports compliance with privacy regulations and ethical considerations.
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Customized Workflows:
SMART-on-FHIR apps can be tailored to specific research needs, allowing researchers to create custom data capture forms, surveys, and assessments. This flexibility can improve the quality and relevance of data collected for registries and research.
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Data Quality and Standardization:
As data is entered or retrieved from the EHR, SMART-on-FHIR apps can be embedded with algorithms to enforce data standardization and quality checks. This ensures that the data collected for registries and research studies are consistent and adhere to predefined standards. It is often the case that the data collected for clinical management purposes by clinicians is incomplete with regard to the specific requirements of the registry. In addition, data validations workflows can be designed to surface available EHR data to the clinicians and researchers so that they can ensure data is complete and accurate for submission to registries. When there are gaps in the data, workflows can be defined to enable users to close those gaps.
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Clinical Decision Support:
SMART-on-FHIR apps can incorporate clinical decision support tools that provide relevant information, novel data visualizations and recommendations to care-team members and patients-alike based on EHR and registry data. Insights from research analytics can be delivered to the point-of-care increasing the speed of translation of evidence into clinical practice.
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Interoperability:
The use of FHIR standards and SMART-on-FHIR apps promotes interoperability between different EHR systems. This makes it easier to merge data for specific patients as well as aggregate data from multiple sources and share it across registries and research initiatives.
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Data Analysis and Reporting:
SMART-on-FHIR apps can enable researchers to extract and analyze data from EHRs more efficiently. This potentially accelerates the research process and enabling more timely reporting of findings. These apps can also aid in integrating patient-specific reporting and analytics insights into EHR clinical workflows.
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Reduced IT Staff Burden:
SMART-on-FHIR Apps free up IT staff from the burden of maintenance of complex, native EHR tools to support registry participation by the healthcare systems they support. Now that EHRs have standard FHIR APIs for app integration, the IT staff must simply maintain that integration point rather than manage the overhead of workflow configuration, content build, mapping and extraction algorithms typically required for research participation.
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Agile Data Dictionary and Workflow Updates for Data Acquisition:
SMART-on-FHIR Apps make it possible to rapidly update the data dictionary and data collection tools so that participating sites in research activities are unburdened from each site being required to make changes in their native EHR systems. Required changes can be made efficiently in a single App utilized and shared by many participating research sites even though each site is utilizing and accessing its own HIPAA-compliant real estate on a FHIR-server.
In summary, SMART-on-FHIR apps can enhance the efficiency, accuracy, and quality of data collection, integration, and analysis for registries and clinical research. They provide a technological framework that supports seamless integration between EHR systems and third-party applications, ultimately benefiting care teams, clinical researchers, and patients alike.