Project Scope |
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; 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. Solution Work with stakeholders to adopt the HL7 Fast Healthcare Interoperability Resources (FHIR) standard as a basis for future data integrations between Research Systems and Healthcare systems. |
Chandi Kodthiwada | chandi.kodthiwada@takeda.comglow@mdsolWendy Dobson (| Kerry Robson, PHUSE Project |
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| colour | Blue |
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| title | Current Status |
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Following the breakout session at CSS, the project has now updated it's scope and is looking to address their deliverables and adapt their timelines accordingly. This project is calling for a Co-Lead and project members |
Deliverables | Timelines |
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Review FHIR Specification for applicability as a Research Standard | Q12021 |
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 |
Identify 3-6 use cases which illustrate how FHIR Resources can enable effective data sharing between Healthcare and Research Systems | Q12021 |
Prepare White Paper | Q22021Published Stakeholders/Initiatives
HL7 Vulcan HL7 Biomedical Research and Regulatory (BR&R) CDISC to FHIR Joint Mapping IG
Recommended Solutions - The FHIR resource-based view of healthcare data is much more aligned to the research 'view' of data; research considers study using CRFs, artificially aligned with clinical data element domains. 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).
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- 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.
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- 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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- firms and most importantly sites and site users.
- Work with stakeholders to socialise and formalise (e.g. through HL7 FHIR Profiles/Implementation Guides) the technology/approach.
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Project Members | Company |
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| Aditya Gadiko | MMS |
| Andy Richardson | Zenetar |
| Barbara Blockley | Industry |
| Denzin Coskun | Industry |
| Greg Jones | Oracle |
| Hugh Glover | Blue Wave Informatics |
| Jeff Abolafia | Pinnacle 21 |
| Jozef Aerts | XML4Pharma |
| Michael Ward | Eli Lilly |
| Mike Hamidi | CSG Inc |
| Paul Brown | Ualberta |
| Ramaiah Muvvala | Inductive Quotient |
| Rebecca Baker | CDISC |
| Rahul Thandavan | Roche |
Scott Bahlavooni | Nektar