Project Scope |
| widescale Some common historical points of view have included: - That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.
- That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.
- Types of data captured in healthcare have been more operational rather than clinical.
- Enabling the Necessary interfaces is an expensive and process-heavy undertaking.
- There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.
Many of these issues are on the path to being resolved; | both the HITECH ACT and Meaningful Use Programs have accelerated adoption of EHR systems across the US and is now continuing to incentivise sites to store more clinically relevant data in their EHR Systems. As an example the ONC Common Clinical Dataset is mandating the availability of many of the core domains of interest to the clinical trials industry. However, the solution to the lack of availability of a common exchange format has not been completely resolved; the HL7 Continuity of Care Document (CCD) is a mature standard, but is not used consistently across implementations or geographies.Potential Solution
Review the HL7 FHIR standard as a basis for future data integrations between Research Systems and Healthcare systems. It will include looking at the existing FHIR based Research standards (including DAF and SDC
Project LeadGeoff Low | Email |
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| Deliverables | Timelines |
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government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator. |
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| colour | Blue |
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| title | Current Status |
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Q1 2024
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Planning for the GB/FSH information session Generation of proposed value use cases for POC Outreach to other HL7/Vulcan projects
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Objectives & Deliverables | Timelines |
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| Begin work on two new Use Cases | Q2 2023 |
| Continue to identify opportunities for presenting and recruiting | Q2 2023 |
| Published Deliverables | Date |
Review FHIR Specification for applicability as a Research Standard | Identify 3-6 use cases which illustrate how FHIR Resources can enable effective data sharing between Healthcare and Research Systems | Prepare White PaperPublished | Other Initiatives
CDISC EHR to CDASH (E2C) Group
The CDISC E2C group is the mechanics or the 'how'; it is predicated on the fact that there is a need for a migration of data from the EHR system to the research system; it has broadened from it's original scope to incorporate the view of the EHR system being the CCD (per RDF) to include FHIR. I think this is an important evolution, there is much more enthusiasm around FHIR than I've seen around any technological healthcare standard - ever!
The PHUSE group is the why - it's taking a look at the standard (and the initiatives) around FHIR and applying them to a few scenarios within the research domain. The expected output will be a white paper with the conclusions of the group about how FHIR will (or will not, perhaps) change clinical research in the future. There will be subsequent projects that will dig into any of the use cases identified to show Pharma and other stakeholders the utility - these will utilise the rules and mappings put together in the E2C project.
Follow on from the PhUSE Semantic Technologies keyCRF Project
Recommended Solutions
HL7 have been publishing a new draft standard; Fast Healthcare Interoperability Resources (FHIR). This is an entirely different paradigm, built around Resources and using REST as a architectural style. This
Recommended Solutions - The FHIR resource-based view of healthcare data is much more aligned to the research 'view' of data;
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- research considers study using CRFs,
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- artificially aligned with clinical data element domains
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- . In the future, these two views of the same data will be more closely aligned from capture through to submission. There is a need for external activities to assist in this alignment (such as mapping to or extending of submission formats, alternative data management processes, focus on the lifecycle of a datapoint, etc). These tasks should be solved in a pre-competitive manner and shared with all stakeholders.
- Increasing government engagement in personal healthcare data has focussed on the need for seamless exchange (including access, consent, format, understandability, etc). Most guidance has recognised that the technology is a key foundation and have chosen FHIR as their preferred format. This is an initiative that the research industry can leverage to more closely engage with the participants in clinical research.
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Stakeholders/Initiatives Specific Actions - Identify gaps and opportunities between the Healthcare and Research realms with a view to providing a shared vocabulary and platform to enable better collaboration.
- Prepare
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- White Papers for Biopharmaceutical Companies providing sample use cases for where the adoption of FHIR will improve the experience of Sponsors, Technology
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Rahul Thandavan | Roche- firms and most importantly sites and site users.
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| Project Members | Company |
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| Aditya Gadiko | MMS Holdings |
| Amy Palmer | CDISC |
| Andrea Falco | OXONepi |
| Andy Iverson | Medtronic |
| Bess LeRoy | CDISC |
| Bill Friggle | 4EStandards |
| Chrstine K Denney | Lilly |
| Dan Krugger | IBM |
| Dave Iberson-Hurst | Assero |
| Greg Jones | Oracle |
| Ingeborg Holt | IBM |
| Jeff Abolafia | Industry |
| Jozef Aerts | XML4Pharma |
| Manuel Anido | Allergan |
| Marc Roosen | JNJ |
| Mark McGilchrist | University of Dundee |
| Mike Hamidi | CDISC |
| Nurcan Coskun | Industry |
| Paul Knowles | Dativa |
| Ramachandran Prasad | Industry |
| Rebecca Baker | CDISC |
| Sam Hume | CDISC |
| Sebastiaan Knijnenburg | Industry |
| Shannon Labout | CDISC |
| Siddharth Arthi | Zifornd |
| Terek Peterson | YPrime |
- Work with stakeholders to socialise and formalise (e.g. through HL7 FHIR Profiles/Implementation Guides) the technology/approach.
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