Scribd
Upload
15 views8 pages

2003 06 17 XML

The document discusses several regulatory initiatives by the FDA to use HL7 XML standards to improve communication and efficiency. It summarizes progress on proposed standards for annotated ECG waveform data, stability data, electronic MedWatch reports, and structured product labeling. Future plans are outlined for establishing these as ANSI standards and developing prototype systems and review tools to implement the standards.

Uploaded by

David Uribe Katz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
15 views8 pages

2003 06 17 XML

The document discusses several regulatory initiatives by the FDA to use HL7 XML standards to improve communication and efficiency. It summarizes progress on proposed standards for annotated ECG waveform data, stability data, electronic MedWatch reports, and structured product labeling. Future plans are outlined for establishing these as ANSI standards and developing prototype systems and review tools to implement the standards.

Uploaded by

David Uribe Katz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 8

Regulatory Initiatives in HL7 Using XML and Structured Documents

Drug Information Association


San Antonio, Texas
Tuesday, June 17, 2003

HL7 XML Standards and FDA

Randy Levin, M.D.


Director, Office of Information Management
Center for Drug Evaluation and Research,
Food and Drug Administration

1
HL7 XML Standards
• Proposed
– Annotated ECG waveform data
– Stability data
– Electronic MedWatch
– Structured Product Labeling
• Future
– Structured protocol
– Clinical study data
2
Annotated ECG Waveform Data
• Purpose
– Improve evaluation of products for cardiac toxicity
• Progress
– HL7 Informative Document approved
– FR notice for comments on proposed HL7 standard
• Future
– Establish as an ANSI standard
• Example implementation
– Viewer
– Development of repository and review tools
3
Stability Data
• Purpose
– Improve communication of results from stability studies and improve
efficiency of the review
• Progress
– Initial HL7 message developed
• Future
– Present concept to international organizations
– Feedback from industry task force
– Establish as an ANSI standard
• Example implementation
– Prototype
– Development of review tools

4
Electronic MedWatch
• Purpose
– Improve reporting of product adverse event from health care
providers
• Progress
– Initial HL7 message developed with CDC
• Future
– Inclusion of report for animal drug products events
– Establish as an ANSI standard
• Example implementation
– Safety network portal
5
Structured Product Labeling
• Purpose
– Improve communication of medication information and
review of labeling changes
• Progress
– Proposed HL7 structured document standard
• Future
– Establish as ANSI standard
• Implementation
– Development of a prototype labeling repository and review
tool
6
Structured Protocol
• Purpose
– Improve communication of protocol information and review
and tracking of protocols
• Progress
– Work ongoing to develop HL7 structured document standard
• Future
– Ballot HL7 structured document standard
• Implementation
– Protocol design in CDISC Submission Data Model

7
Clinical Trial Data
• Purpose
– Improve efficiency of the conduct of clinical trials and review of data
• Progress
– HL7 Informative Document approved for model
– Pilot for testing model
– XML data transport being considered
• Future
– Possible XML file format for study data submissions
• Example implementation
– Development of processing tools, repository and review tools

You might also like