CDISC & HL7 Moving the Clinical Research Agenda …...The Fundamentals of FHIR • A next generation standards framework & platform, built on 30 years of HL7 experience, designed for

CDISC & HL7 Moving the Clinical Research Agenda Forward


Sam Hume, CDISC

Wayne Kubick, HL7

Speaker Introduction

Wayne R. Kubick, BA, MBA

Chief Technology OfficerHealth Level Seven International@WayneKubick

Sr. Executive with more than 25 years of experience in pharmaceutical clinical research processes, standards and technologies.

Former CTO, CDISC

Speaker Introduction

Sam Hume, D.Sc.

Head of Data Exchange TechnologiesClinical Data Interchange Standards Consortium@swhume

[email protected]

I specialize in clinical research and healthcare informatics including data exchange, data integration, software development, and related research projects.

mailto:[email protected]

About Health Leven 7 International• ANSI-accredited healthcare standards development organization with

>2500 members in more than 55 countries

– >300 standards products

– Major product families: v2, v3, CDA, FHIR

– Regulated Research products: SPL, ICSR, IDMP

• HL7 Vision: A world in which everyone can securely access and use the right health data when and where they need it

• HL7 Mission: To provide standards that empower global health data interoperability www.hl7.org

http://www.hl7.org/

The Fundamentals of FHIR

• A next generation standards framework & platform, built on 30 years of HL7 experience, designed for implementation

• Based on REST, a pattern for using web technologies to manage information (the platform used by Facebook, Twitter…) and APIs

• Content based on Resources: essential, portable modular information components easily assembled into working systems

• - Like web pages directed toward computers; fast and scalable

• Flexible outputs: web, messages, documents, servicesREST

Documents

Messages Services

FHIR

Resources

Smallest logically discrete units

of “transaction of interest” to

healthcare

US Core Data for Interoperability (USCDI) & Trusted Exchange Framework

https://www.healthit.gov/sites/default/files/draft-uscdi.pdf

https://www.healthit.gov/sites/default/files/draft-uscdi.pdf

EHRFHIR

API

Feasibility, Investigator & Subject Searches

CDA

Archive

Copy

Pre-populate EDC CRFs

Drilldown analysis of source data by

regulatory reviewers

Bulk transfer of clinical data for analytics

Monitor Protocol Execution

Collect Patient-Originated Data; eConsent

Apply Data Corrections simultaneously to

EHR & EDC

Drive pragmatic trials and precision

medicine

How HL7 FHIR Can Improve Biomedical Research

10

Global Standards Development Organization (SDO)

Founded in 1997 (all volunteers)

>440 organizational members

Standards for clinical & translational research

Mission: To develop and support global, platform-independent data

standards that enable information system interoperability to improve

medical research and related areas of healthcare

Clinical Data Interchange Standards Consortium

Support Common Functions for All Research

Data Collection

Providing Common Structure & Terminology for:

Data Aggregation

(Tabulation)

Data Analysis Data Transfer

CDISC Standards Cover the Full Clinical & Translational Lifecycle

ODM v2 & CDISC SHAREModern, extensible data transport & sharing standard supporting software

innovation, process automation & interoperability among enterprise systems.

End to End

Standards

CDISC SHARE

Aligning CDISC Models with RWD RWE

RWD RWEDecision Support

CDISC is:

• Working to connect EHRs to CDASH using FHIR

• Building connected views of data that align with RWD

• Developing terminology for ePRO

• Continuing to support registries and pragmatic trials

Pre-populating Case Report Form Data

CDISC is:

• Extending CDASH and ODM to represent metadata that maps EHR data to

CDASH CRFs using FHIR resources

• Maintaining the FHIR to CDASH mapping metadata in the CDISC SHARE MDR

• Developing a standard ODMv2 API to pre-populate CRFs across EDC systems

Some Talking Points• Digital health data, which is becoming more accessible, consistent and

reliable under 21st Century Cures through FHIR APIs, can provide significant benefits for Biopharma research

• Research would benefit by learning how to use data in its original form as represented via FHIR resources, minimizing transformations, terminology conversions and mapping

• CDISC standards such as CDASH and SDTM are still significant, and required for the near future for regulatory submissions, but can also likely be adapted as views on FHIR resources in the future.

• The vast power, potential and widespread acceptance of the FHIR platform standard will likely catalyze many new opportunities to improve healthcare treatment and outcomes.


Sam Hume, CDISC

Wayne Kubick, HL7