j stockhausen challenge_domain_us_fhir_dev_2016
TRANSCRIPT
NOVEMBER - 2016 PAGE 1
FHIR IN THE DOMAIN OF ULTRASOUND
J. StockhausenTOMTEC IMAGING SYSTEM GmbH
NOVEMBER - 2016
NOVEMBER - 2016 PAGE 2
CONTENT
¬TOMTEC & Context
FHIR
¬ImagingStudy
¬Observation
¬AuditEvent
NOVEMBER - 2016 PAGE 3
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
NOVEMBER - 2016 PAGE 7
CONTEXT
NOVEMBER - 2016 PAGE 10
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
NOVEMBER - 2016 PAGE 11
FHIR?
Propritary
Protocol
Reporting / EMR
System
Propritary
Protocol
Review Analysis
Communication based
on single frames or bytes
File to Network
PDF, XML, CSV, SR
NOVEMBER - 2016 PAGE 12
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
NOVEMBER - 2016 PAGE 13
CAN FHIR HELP?
¬ Data Model and Communication
¬ Up to date technology
¬ Complete set of tools, implementations and validation.
¬ DICOM is subset
¬ Bar is low
NOVEMBER - 2016 PAGE 14
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
NOVEMBER - 2016 PAGE 16
DICOM DATA MODEL - IMAGINGSTUDY
Study
Patient
Series
Instance
(e.g. Image/Clip)
NOVEMBER - 2016 PAGE 17
DICOM DATA MODEL - IMAGINGSTUDY
¬ Can replace heavy C-FIND
¬ Less handshaking
¬ Probably faster
¬ Simple query semantics
Study
Patient
Series
Instance
(e.g. Image/Clip)
NOVEMBER - 2016 PAGE 18
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.“
NOVEMBER - 2016 PAGE 19
OBSERVATION
NOVEMBER - 2016 PAGE 20
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
NOVEMBER - 2016 PAGE 21
SIMPSON BI-PLANE
NOVEMBER - 2016 PAGE 22
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.]
NOVEMBER - 2016 PAGE 23
EJECTION FRACTION
𝐸𝐹 =𝐸𝐷𝑉 − 𝐸𝑆𝑉
𝐸𝐷𝑉
𝐸𝐷𝑉
𝐸𝑆𝑉
NOVEMBER - 2016 PAGE 24
OSERVATIONS RELATIONS
Observation Value
Value
Value
Value
has a
relates to
has
com
ponents
Quantity and CodeableConcept …
NOVEMBER - 2016 PAGE 25
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
NOVEMBER - 2016 PAGE 26
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
NOVEMBER - 2016 PAGE 27
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
NOVEMBER - 2016 PAGE 28
FURTHER CHALLANGES
¬ Same Observations for different Stages
¬ Mix measurements on cart / on workstation
¬ Same Observations for different locations
(regional values)
NOVEMBER - 2016 PAGE 29
AUDIT EVENT
NOVEMBER - 2016 PAGE 30
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]
NOVEMBER - 2016 PAGE 31
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]
NOVEMBER - 2016 PAGE 32
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
NOVEMBER - 2016 PAGE 33
ARCHITECTURE
Source
AuditEvent
Sender
Server
DB
Analyse
Syslog
Forward
WinLog
Forward
Source
SenderSource
NOVEMBER - 2016 PAGE 34
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
NOVEMBER - 2016 PAGE 35
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 / ….