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Vertical

Regulated Product Lifecycle

(provide timeline and break into sections that BR&R are interested in)

Research is part of this


Horizontal

Domain

Use Case

Primary Stakeholder

Probability of Adoption

Related Workgroup

Relevant Projects

FHIR Opportunity





Stakeholders Potential alignment with Workgroups
DomainUse caseProblem StatementHealthcare Providers/OrganizationsPatientsEHR VendorsEDC/CTMS VendorsPharmaceutical IndustryResearch/CRORegistriesRegulatory/FDAFedeal, State, and Local Public HealthEst. Probability of AdoptionBR&RPublic HealthOthers?...Relevant projectsFHIR opportunity
Clinical Research(eSource) Direct transfer of data from Electronic Health Records (EHR) to clinical research Electronic Data Capture (EDC) systems.  Significant amounts of data collected by researches into EDC systems are manually transcribed from EHRs.  This is calculated to be a significant time drain, both costly and error-prone.   Less burden on healthcare-based clinical trials staff for EDC entry. If feasible, bi-directional EHR-to-EDC systems could allow live updates of patient records during clinical trials observations, giving all healthcare providers up-to-date information on patients and keeping EHR and study database consistent For patients participating in clinical trials, bi-directional EHR-to-EDC communication ensures comprehensive patient history at the clinical trials location – whether from standard healthcare visits or from clinical trials visits. Also makes data collected thru personal patient devices and uploaded to EHR available for research.Added capability to interface with digital clinical research systems (selling point) Can improve accuracy and completeness of health recordsAdded capability to interface with health data systems systems (selling point)Reductions in time and costs. Improvements in accuracy and interoperabilityReductions in time and costs. Improvements in accuracy and interoperabilityReductions in time and costs. Improvements in accuracy and interoperability. Increased volume of data collected; Instead of having to develop their own data transfer applications, centers can leverage a data transfer mechanism provided by their EHR.Improved accuracy of submissions More consistency between data submissions High – much research and pilot testing ongoing, some already working on FHIR-based solutions.  Industry is highly interested in making this usable.X develop implementable solutions that facilitate automated data transfer between EHRs and EDCs (either uni-directional or bi-directional). Potential
Clinical ResearchIRB/Common Rule Merideth - U Arkansas
Clinical ResearchInternal EHR-to-CTMS interface and eIRB systems (this connects with eSource and eIRB common rule…)
Clinical ResearchSubmission of study data (such as HCT trials from trial sites) to a central repository Reductions in time and costs. Improvements in accuracy and interoperability Increased volume of data collected; Instead of having to develop their own data transfer applications , centers can leverage a data transfer mechanism provided by their EHR
Clinical Research / RegistriesSubmission of study data to research repositories, such as oncology data for the SEER Registry Reductions in time and costs. Improvements in accuracy and interoperability Increased volume of data collected; Instead of having to develop their own data transfer applications , centers can leverage a data transfer mechanism provided by their EHR
Clinical ResearchClinical trial participant registration, and submission of the registration data to ClinicalTrials.gov and other international registries
Clinical ResearchSubmit subject lab data to CRO and/or sponsor
Clinical ResearchStudy setup, management, and site network management
Clinical ResearchSharing protocol and CRF metadata and subject data among trial stakeholders
Clinical researchCRO perspective use cases? (management of Study / Study site, etc)
PharmacovigilanceAdverse Events: EHR (and/or Insurance Claims) data to identify safety issues in post-market drug use; Identifying potential safety issues for marketed drugs relies on the reporting of adverse events (symptoms potentially due to a particular drug) to FDA.  Enough reports for a drug may lead to active investigations into suspected side-effects of a drug.  Adverse event reporting is a largely manual and passive process for FDA, where symptoms suspected of linkage to a drug are reported by patients and healthcare providers to Industry, FDA, or both.  This process is slow: dependent first on someone suspecting a symptom correlating to a drug and then on taking the effort to report this suspicion. These issues create a major delay in the signal to launch an investigation, leading to delays in FDA decision-making for the protection of the health of the public.Supplements and eases the AE reporting tasks of physicians Identification of adverse events not clearly apparent to an individual physician Faster actions by FDA (labelling changes, recalls, etc.) to protect the health of every person, resulting in fewer adverse events and potentially saving lives. May allow closer monitoring of patient response to new drugsEHR becomes a critical component in pharmaceutical surveillancec / Adverse Event reporting Potential implementation to integrate with EHRs for Adverse Event reportingReduced time to identify critical adverse events for a drug and support for industry AE reporting requirements Reduced time to identify critical adverse events for a drug, resulting in more rapid triggers for investigation and corrective actions, ultimately ensuring more safety for the general public.Reduced time to identify critical adverse events for a drug, resulting in more rapid triggers for investigation and corrective actions, ultimately ensuring more safety for the general public.Moderate.  Much interest Real World Data in support of pharmacovigilance. Many approaches are being used with a a range of “common data models” or other methodologies.  FHIR-based solutions could provide a unifying implementation approach that could cut across silos.  XX Develop implementable solutions to incorporate EHR and/or Insurance Claims data as part of active adverse event surveillance. 
PQ/CMC One section of the pharmaceutical application submission is drug quality - this is essentially the chemistry and manufacturing details of the drug. This information is revised as needed over the course of drug manufacturing. At FDA, majority of this data is currently submitted as (part of eCTD) unstructured text either as PDF documents or other narrative text. Lack of structured and computable data makes the review process time consuming and error-prone due to interpretations. FDA is working to structure and standardize Pharmaceutical Quality/Chemical Manufacturing and Controls data. FHIR is currently being evaluated as an exchange standard for submission of this data by the drug sponsors to the FDA.Develop implementable solutions to submit PQ/CMC data to FDA (and potentially other regulatory bodies) in structured and computable format. Potential integration with "track and trace" and other supply chain efforts. Accuracy, consistency, and standardization of PQ/CMC data increases reliability of drug safety for patients. Potential utility for track&trace and other supply chain efforts can identify patients at risk from production batches that may cause harm. (Scott G: this may be a stretch - please correct if not right)Structured, computable and standardized PQ/CMC data increases reliability of drug safety for patients. Potential utility for track&trace and other supply chain efforts can identify patients at risk from production batches that may cause harm. (Scott G: this may be a stretch - please correct if not right)n/a(do CTMS systems collect or manage any Quality/Manufacturing information? If so, this would support implantations structured output)Provides consistent structured data and exchange formats for internal data management & storage -Ensures industry and FDA are using the “same data” Provides consistent exchange formats for internal data management & storage -Ensures industry and FDA are using the “same data” Receives consistent high-quality data that can be consumed by computer systems without data entry and interpretations - Enables much-needed technology improvements to support quality assessments - Improves crisis responsePotential utility for track&trace and other supply chain efforts can identify patients at risk from production batches that may cause harm. (Scott G: this may be a stretch - please correct if not right)Moderate. Draft FHIR approaches are being assessed by FDAX X
Quality Specification X X FDA PQ/CMC; IDMP
Substance Data (includes ingredients, impurities, excipient) X FDA PQ/CMC; FDA G-SRS; IDMP
Manufacturing Process
Product X SPL; IDMP
Batch Analysis/Stability X FDA PQ/CMC; FDA eStability;
Drug Development Facilities (manufacturers, suppliers, testers) ISO SPOR?
RegistriesDisease registries, focus on a specific disease, e.g. immunodeficienciesContain a rich resource of information but are typically each designed according to its need and little standardization between each other or other potential healthcare data sources. Lack of standardization makes utilizing these data sources in large scale not feasible. Some efforts to create common data models exist (PCORnet supports many PPRNs, OMOP is being explored for Registry support) but these efforts lack fundimental application of data standardsPotential for implementation of decision support or references patients with select diseases or receiving select drugs Reduces data collection burden Would make it easier to comply with government-mandated registry reporting requirementsPotential for implementation of decision support or references patients with select diseasesAdded capability to interface with registries and PPRN systems (selling point)Added capability to interface with registries and PPRN systems (selling point)Standardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications Standardized pan-registry data sources would provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would provide much needed standardization for disease surveillance? Develop profiles and extensions to support implementation of Registry/PPRN standards across organizations
RegistriesTreatment registries (e.g. NMDP: focus on treatment associated with multiple disease; CIBMTR) Contain a rich resource of information but are typically each designed according to its need and little standardization between each other or other potential healthcare data sources. Lack of standardization makes utilizing these data sources in large scale not feasible. Some efforts to create common data models exist (PCORnet supports many PPRNs, OMOP is being explored for Registry support) but these efforts lack fundimental application of data standardsPotential for implementation of decision support or references patients with select diseases or receiving select drugs Reduces data collection burden Would make it easier to comply with government-mandated registry reporting requirementsPotential for implementation of decision support … Standardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications Standardized pan-registry data sources would provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would provide much needed standardization for disease surveillance? Develop profiles and extensions to support implementation of Registry/PPRN standards across organizations
RegistriesDrug registriesContain a rich resource of information but are typically each designed according to its need and little standardization between each other or other potential healthcare data sources. Lack of standardization makes utilizing these data sources in large scale not feasible. Some efforts to create common data models exist (PCORnet supports many PPRNs, OMOP is being explored for Registry support) but these efforts lack fundimental application of data standardsPotential for implementation of decision support or references patients with select diseases or receiving select drugs Reduces data collection burden Would make it easier to comply with government-mandated registry reporting requirementsPotential for implementation of decision support or references patients with receiving select drugs Standardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications Standardized pan-registry data sources would provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would provide much needed standardization for disease surveillance? Develop profiles and extensions to support implementation of Registry/PPRN standards across organizations
RegistriesDevice registriesContain a rich resource of information but are typically each designed according to its need and little standardization between each other or other potential healthcare data sources. Lack of standardization makes utilizing these data sources in large scale not feasible. Some efforts to create common data models exist (PCORnet supports many PPRNs, OMOP is being explored for Registry support) but these efforts lack fundimental application of data standardsPotential for implementation of decision support or references patients with select diseases or receiving select drugs Reduces data collection burden Would make it easier to comply with government-mandated registry reporting requirementsPotential for implementation of decision support … Standardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications Standardized pan-registry data sources would provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would provide much needed standardization for disease surveillance? Develop profiles and extensions to support implementation of Registry/PPRN standards across organizations
RegistriesPatient Powered Research Network (PPRN)Contain a rich resource of information but are typically each designed according to its need and little standardization between each other or other potential healthcare data sources. Lack of standardization makes utilizing these data sources in large scale not feasible. Some efforts to create common data models exist (PCORnet supports many PPRNs, OMOP is being explored for Registry support) but these efforts lack fundimental application of data standardsPotential for implementation of decision support or references patients with select diseases or receiving select drugs Reduces data collection burden Would make it easier to comply with government-mandated registry reporting requirements Added capability to interface with registries and PPRN systems (selling point)Added capability to interface with registries and PPRN systems (selling point)Standardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications and provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would be a data boon to real-world evidence research for new indications Standardized pan-registry data sources would provide much needed standardization for drug safety surveillanceStandardized pan-registry data sources would provide much needed standardization for disease surveillance? Develop profiles and extensions to support implementation of Registry/PPRN standards across organizations
RegistriesHarmonization between systems, standards, vocabularies, etc - reduction in makeshift solutionsThere proliferation of multiple standards for the same content and (ie, ICD vs SNOMED) or common data models (PCORnet, OMOP, Sentinel) and other solutions in order to rectify the fragmented nature of healthcare data in the US. While these interim solutions do make analysis possible, there are inherently makeshift solutions relying on continuous mapping of data - with the risk of data loss and establishing more siloes of information Registries frequently report to different organizations which use different standards. Having an easy mechanisms for converting between standards would faciitate reporting
Patient-owned data Personal Health RecordsThe proliferation of patient-owned information can be a rich source of patient-controlled data to inform both crinical reseach as well as post-market surveillance. Develop profiles and extensions to support the emerging patient-owned data sources FHIR is being increasingly used to represent and exchange such data
Patient-owned dataWearables
Patient-owned dataMobile Apps
Implantable devicesPatient health data, device data
Health researchInteroperability for small, independent healthcare/research orgs.Small industry and research groups require implementable solutions that are inexpensive and cost-effective. Standardization of data will not be successful if significant business sectors are effectively locked-out of standardizaed solutions purely due to complexity or cost of such solutions Availabiilty of low cost, open source FHIR Apps make technology more accessible for smaller providers who also have to meet US Govt requirements for FHIR APIs
?International considerations (languages, certification variability, etc)(international variation in: requirements, data sharing, security, etc. Differing standards - either by requirement or simple preference (ie, de facto), ISO requirements)
?Rapid Analysis of FHIR Resource dataTypical clinical trial processes are not suitable for real world data that may be available in near real-time. FHIR resource data model can be analyzed directly; R on FHIR and emerging clinical decision support tools can improve ability toanalyzeFHIR data directly



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