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Project Scope

Increasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with widescale adoption, for a variety of reasons.

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 LeadsEmail

Geoff Low

glow@mdsol.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.eu

CURRENT STATUS Q42020

Had breakout sessions at CSS and now looking at how to evolve the team

Deliverables

Timelines

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 Paper


Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API

Published

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 resource-based view of healthcare data is much more aligned to the research 'view' of data; we consider studies using CRFs, typically aligned with clinical data element domains - which some might describe as clinical data resources. The alignment between the terminologies is a known problem and groups such as the CDISC EHR to CDASH (E2C) are looking to come up with a shared semantic layer between the data standards (as well as work previously done with the CDISC BRIDG model)

  • The publication of the Federal Notice in 2015 and the updated Draft Guidance in 2016 have shown the FDA's commitment to increased adoption of eSource in Clinical Research. In particular, the Draft Guidance showed a renewed focus on bi-directional integration of data between Research and Healthcare systems; something that would not easily be achieved given current technology and processes. FHIR offers the possibility of making this a reality

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 a white paper for Biopharmaceutical Companies providing sample use cases for where the adoption of FHIR will improve the experience of Sponsors, Technology Firms and most importantly sites and site users

Project Members

Company

Aditya GadikoMMS Holdings
Amy PalmerCDISC
Andrea FalcoOXONepi
Andy IversonMedtronic
Bess LeRoyCDISC
Bill Friggle4EStandards
Chrstine K DenneyLilly
Dan KruggerIBM
Dave Iberson-HurstAssero
Greg JonesOracle
Ingeborg HoltIBM
Jeff AbolafiaIndustry
Jozef AertsXML4Pharma
Manuel AnidoAllergan
Marc RoosenJNJ
Mark McGilchristUniversity of Dundee
Mike HamidiCDISC
Nurcan CoskunIndustry
Paul KnowlesDativa
Ramachandran PrasadIndustry
Rebecca BakerCDISC
Sam HumeCDISC
Sebastiaan KnijnenburgIndustry
Shannon LaboutCDISC
Siddharth Arthi Zifornd
Terek PetersonYPrime
Rahul ThandavanRoche
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