J stockhausen challenge_domain_us_fhir_dev_2016

NOVEMBER - 2016 PAGE 1

FHIR IN THE DOMAIN OF ULTRASOUND

J. StockhausenTOMTEC IMAGING SYSTEM GmbH

NOVEMBER - 2016


CONTENT

¬TOMTEC & Context

FHIR

¬ImagingStudy

¬Observation

¬AuditEvent


25 Years on the market

¬ Founded 1990 in Munich, Germany

¬ Invented 3D Echoe in 1990

¬ 100% privately held

Worldwide operations

¬ ~ 100 employees

¬ TOMTEC GmbH/ Corp USA

Leader in Cardiology Imaging

¬ Multi-Modality

¬ 2D/3D/4D Ultrasound

¬ Advanced Quantification (US,XA)

¬ Image Management Technology

¬ EAE/ASE standardization working group for Strain


CONTEXT


FHIR?

Enterprise PACS

LTA

departemental

PACS

HIS

Propritary

Protocol

Reporting / EMR

System

Propritary

Protocol

Review AnalysisOrganize

Communication based

on single frames or bytes

File to Network

PDF, XML, CSV, SR


FHIR?

Propritary

Protocol

Reporting / EMR

System

Propritary

Protocol

Review Analysis

Communication based

on single frames or bytes

File to Network

PDF, XML, CSV, SR


WHY PROPRITARY PROTOCOL?

Type Content

Image Data DICOM Tags

Byte stream

Patient/Study Data Current & Releated Patient/Study

Results Measurements

SC, SR

TXT, XML

Lifecycle Start / Idle / Run

Switch Study

GUI Reparenting / Resize

Enabel / Disable features


CAN FHIR HELP?

¬ Data Model and Communication

¬ Up to date technology

¬ Complete set of tools, implementations and validation.

¬ DICOM is subset

¬ Bar is low


FHIR CAN HELP!

Type Content FHIR

Image Data DICOM Tags ImagingStudy

Byte stream (WADO-RS)

Patient/Study Data Current & Releated Patient/Study ImagingStudy / Patient

Results Measurements Observation

SC, SR

TXT, XML

Lifecycle Start / Idle / Run (AuditEvent)

Switch Study

GUI Reparenting / Resize

Enabel / Disable features


DICOM DATA MODEL - IMAGINGSTUDY

Study

Patient

Series

Instance

(e.g. Image/Clip)


DICOM DATA MODEL - IMAGINGSTUDY

¬ Can replace heavy C-FIND

¬ Less handshaking

¬ Probably faster

¬ Simple query semantics

Study

Patient

Series

Instance

(e.g. Image/Clip)


DICOM DATA MODEL – HEAVY METAL vs. US

Study

Patient

Series

Instance

(e.g. Image/Clip)

„This is my stack of images.

Let‘s compose it to a 3D Object“

„I don‘t care about series.

I can do Multiframe and 3D in one file!

And I like Colors in RGB and YBR.“


OBSERVATION


MEASUREMENTS

Echo is different

¬ Heart is moving.

¬ Scalar or global values are not sufficient.

¬ Great demand for named measurements for complex anatomy

¬ Vendor specific storage is common.

LOINC + SNOMED + Vendor specific


SIMPSON BI-PLANE


MEASUREMERNTS IN CARDIOLOGY

¬ 2 Clips (Planes, 4CH, 2CH)

¬ 2 Frames per Clips (ED, ES)

¬ 7 Global Named Values

¬ 4 Named Values per Plane

¬ 4 Additional Values per Plane

¬ Index in relation to BSA / HR

[ASE Guidlines; J Am Soc Echocardiogr 2015;28:1-39.]


EJECTION FRACTION

𝐸𝐹 =𝐸𝐷𝑉 − 𝐸𝑆𝑉

𝐸𝐷𝑉

𝐸𝐷𝑉

𝐸𝑆𝑉


OSERVATIONS RELATIONS

Observation Value

Value

Value

Value

has a

relates to

has

com

ponents

Quantity and CodeableConcept …


OBSERVATIONS RELATIONS - MULTIPLICITIES

Observation Value

Value

Value

Value

has a

relates to

has

com

ponent

Avg. 97.85ml

98.50ml

97.20ml

{EDV_1; EDV_2} => EDV_average


OBSERVATIONS RELATIONS – 2ND ORDER

Observation Value

Value

Value

Value

has a

relates to

has

com

ponents

Avg. 64.4%

65.0%

63.8% ?

{EF(EDV_1,ESV_1); EF(EDV_2,ESV_2)} => EF_Average


OBSERVATIONS RELATIONS - INDEX

Observation Value

Value

Value

Value

has a

releates to

has

com

ponents

3.84 l/min

63.01ml

60/min

?

Observation Value

Observation Value

{HR; SV} => CO


FURTHER CHALLANGES

¬ Same Observations for different Stages

¬ Mix measurements on cart / on workstation

¬ Same Observations for different locations

(regional values)


AUDIT EVENT


FDA

¬ PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

(e) Use of secure, computer-generated, time-stamped audit trails to independently

record the date and time of operator entries and actions that create, modify, or delete

electronic records. Record changes shall not obscure previously recorded information.

Such audit trail documentation shall be retained for a period at least as long as that

required for the subject electronic records and shall be available for agency review and

copying.

[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1]


DICOM - AUDIT TRAIL MESSAGE

¬ Format is XML

¬ Messages are stored in syslog ( ≠ Windows Logs)

…

The XML audit trail message shall be inserted into the MSG portion of the SYSLOG-MSG

element of the syslog message as defined in RFC 5424 "The Syslog Protocol". The XML

audit message may contain Unicode characters that are encoded using the UTF-8

encoding rules.

…

[http://dicom.nema.org/medical/dicom/current/output/chtml/part15/sect_A.6.html]


FHIR – AS ALTERNATIVE

¬ DICOM is subset

¬ Reuse data internally

¬ HAPI plays nicely

Code Display

110100 Application Activity Audit event: Application Activity has taken place

110101 Audit Log Used Audit event: Audit Log has been used

110102 Begin Transferring DICOM Instances Audit event: Storage of DICOM Instances has begun

110103 DICOM Instances Accessed Audit event: DICOM Instances have been created, read, updated, or deleted

110104 DICOM Instances Transferred Audit event: Storage of DICOM Instances has been completed

110105 DICOM Study Deleted Audit event: Entire Study has been deleted

110106 Export Audit event: Data has been exported out of the system

110107 Import Audit event: Data has been imported into the system

110108 Network Entry Audit event: System has joined or left network

110109 Order Record Audit event: Order has been created, read, updated or deleted

110110 Patient Record Audit event: Patient Record has been created, read, updated, or deleted

110111 Procedure Record Audit event: Procedure Record has been created, read, updated, or deleted

110112 Query Audit event: Query has been made

110113 Security Alert Audit event: Security Alert has been raised

110114 User Authentication Audit event: User Authentication has been attempted


ARCHITECTURE

Source

AuditEvent

Sender

Server

DB

Analyse

Syslog

Forward

WinLog

Forward

Source

SenderSource


SUMMARY

¬ FHIR plays nice with DICOM, thus easy to integrate in existing systems

¬ FHIR provides:

DataMode

State of the art REST API

Usable reference implementations (e.g. HAPI)

¬ BTW: The world is not only CT / MR


If you got Answers Contact me or HR at www.tomtec.de

Looking for a SW Engineer

¬ medical visualization, measurement and measured value management software

¬ passionated for programming, C++ (Qt) or JAVA

… / agile / full CI / international environment / flat hierarchies / benefits / massages / free coffee / ….

J stockhausen challenge_domain_us_fhir_dev_2016

Healthcare

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