View and First level Validation of
HL7 XML Annotated ECGs
AMPS
Viewer Light
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Background
AMPS developed the XMLFDA Full
Functional Viewer, a product that was
designed by AMPS to help the FDA officials
for the viewing and validation of the XML
HL7 aECG files until October 2005, before
the release of the FDA Warehouse
software.
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For his contribution Dr. Fabio
Badilini, Chief Scientist at
AMPS, received an Award by
the FDA for: “development of
a format for regulatory
submission of annotated
electrocardiographic
waveform data to meet FDA’s
needs in assessing the
proarrhythmic potential of
drugs”.
Achievements
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AMPS and Mortara Instruments agreed in August 2006 to
cooperate in aligning the HL7 XML validation checks in a future
version of the AMPS XMLFDA Viewer with those implemented
by Mortara in the E-Scribe ECG Warehouse.
The AMPS FDA ECG Suite, the successor of the Full Functional
Viewer, includes the development based on this agreement.
Completely re-designed the FDA ECG Suite provides, under the
same easy-to-use common interface, 3 main features:
O Display of HL7 XML ECG traces
O Validation of HL7 XML ECG traces
O Scoring of HL7 ECG traces
The AMPS FDAEcg Suite
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The AMPS Viewer Light, based on the AMPS FDAEcg Suite,
is the new HL7 XML viewer that replaces the previous
XMLFDA Viewer Light. The AMPS Viewer Light provides a
way to display and validate XML ECG files in the format
supported by the FDA (HL7 XML).
The AMPS Viewer Light has a limited set of functionalities,
when compared to the FDAEcg Suite. Noteworthy
limitations are single file viewing/validation, and no ECG
quality scoring tools.
The AMPS Viewer Light
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The AMPS Viewer Light : Display
Display of HL7
XML ECG Traces
The AMPS Viewer
Light allows to
display annotated
ECGs saved in the
FDA XML format.
The AMPS Viewer
Light can operate
only on a single ECG
at a time.
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The AMPS Viewer Light allows a fully customizable view
of the ECG tracings, including number of leads to be
displayed, different visualization modes, time/amplitude
scale zoom, annotations display, representative beat
display in superimposed fashion…
The AMPS Viewer Light : Display
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The AMPS Viewer
Light has a
validation algorithm
which verifies the
structure of the XML
files. While the
FDAEcg Suite has
validation at three
separate levels, the
AMPS Viewer Light
only offers the first
validation level.
The AMPS Viewer Light: Validation
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Three levels validation
Level 1: syntax checks for well-formed
XML document and HL7 schema
validation
Avaliable with both AMPS Viewer Light and
AMPS FDAEcg Suite
Level 2 : Implementation Guide
Avaliable only with the AMPS FDAEcg Suite
Level 3 : FDA Warehouse
Avaliable only with the AMPS FDAEcg Suite
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Three levels validation
Level one: Well-form XML and against HL7
Schema
A "Well Formed" XML document is a document that
conforms to the XML syntax rules
A valid XML document is a "Well Formed" XML document
which also conforms to the rules of a Document Type
Definition (DTD or Schema). The purpose of a DTD is to
define the building blocks of an XML document, and its
structure through a list of legal elements. This level
checks if all used elements conform to the HL7 Schema
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Two additional level of Validation are only
available with the full Validator, included with the
FDAEcg Suite, and that allows full compatibility
with the submission to the FDA.
Level 2 : Implementation Guide
Level 3 : FDA Warehouse
Viewer Light vs FDAEcg Suite
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The AMPS Viewer Light provides two
different output options:
1: a Brief validation report and legend
2: a Detailed validation report
The versatility of multiple output options
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The Brief validation report and legend
Brief Validation Report
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Detailed Validation Report
The Detailed validation report
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For questions, additional information, or a price proposition
please contact:
E-mail: Marketing@amps-llc.com
Web: www.amps-llc.com
418 Central Park West suite 21 - 10025 - New York - New York
Via Paolo VI, 34 - 25018 - Montichiari (BS) - Italy
127 rue de la Glaciere - 75013 - Paris - France
AMPS LLC
