MIRC Clinical Trials Software

MIRC Clinical Trials Software

Medical Imaging Resource CenterMedical Imaging Resource Center

Technical IssuesTechnical Issues

1.1. Image acquisitionImage acquisition

2.2. AnonymizationAnonymization

3.3. Data transportData transport

4.4. Image managementImage management

5.5. Non-image dataNon-image data

6.6. Configuration managementConfiguration management

FCDICOM

FCDICOM

PIDICOM

MIRC Clinical Trial DataflowMIRC Clinical Trial Dataflow

Database

HTTP

InternetHTTP / HTTPS

Typical MIRC DataflowTypical MIRC DataflowPrincipalPrincipal

InvestigatorInvestigator

PACS

MIRCMIRC

Modality

Field CenterField Center

Database

Work-stations

PACS

FieldCenterFieldCenterStorage SCPHTTP ServerAnonymizer

Storage SCUS/W Update

DICOMDICOM

HTTP(S)HTTP(S)

DIC

OM

DIC

OM

Image AcquisitionImage Acquisition

DICOM ImagesDICOM Images

from Modalities orfrom Modalities or

from PACSfrom PACS

Images contain Images contain

clinical PHIclinical PHI

plus trial IDsplus trial IDs

Modality PACS

FieldCenterFieldCenterDICOM Storage DICOM Storage

SCPSCP

DICOMDICOM

• AnonymizationAnonymization– Removal of PHIRemoval of PHI– Replacement of PHI with values that are Replacement of PHI with values that are

the same for all patientsthe same for all patients

• PseudonymizationPseudonymization– Replacement of PHI with values that are Replacement of PHI with values that are

specific to the patient and the trial but specific to the patient and the trial but which are not meaningful anywhere elsewhich are not meaningful anywhere else

Anonymization and Pseudonymization Anonymization and Pseudonymization

The HIPAA 18The HIPAA 181.1. Name Name 2.2. Location; all geographic subdivisions smaller than a state, including Location; all geographic subdivisions smaller than a state, including

street address, city, county, precinct, zip code, and their equivalent street address, city, county, precinct, zip code, and their equivalent geocodes. geocodes.

3.3. Dates (all dates related to the subject of the information, e.g. birth dates, Dates (all dates related to the subject of the information, e.g. birth dates, admission dates, discharge dates, encounter dates, surgery dates, etc.) admission dates, discharge dates, encounter dates, surgery dates, etc.)

4.4. Telephone numbers Telephone numbers 5.5. Fax numbers Fax numbers 6.6. Electronic mail addresses Electronic mail addresses 7.7. Social security numbers Social security numbers 8.8. Medical record numbers Medical record numbers 9.9. Health plan beneficiary numbers Health plan beneficiary numbers 10.10. Account numbers Account numbers 11.11. Certificate / license numbers Certificate / license numbers 12.12. Vehicle identifiers and serial numbers, including license plate numbers Vehicle identifiers and serial numbers, including license plate numbers 13.13. Device identifiers and serial numbers Device identifiers and serial numbers 14.14. Web Universal Resource Locators (URLs) Web Universal Resource Locators (URLs) 15.15. Internet Protocol (IP) address numbers Internet Protocol (IP) address numbers 16.16. Biometric identifiers, including finger and voice prints Biometric identifiers, including finger and voice prints 17.17. Full face photographic images and any comparable images Full face photographic images and any comparable images 18.18. Any other unique identifying number, characteristic, or code Any other unique identifying number, characteristic, or code

PseudonymizationPseudonymization

Element typesElement types– Patient IDPatient ID– Dates (Birth / Study)Dates (Birth / Study)– UIDsUIDs– Accession, non-unique IDsAccession, non-unique IDs

Central vs distributed remappingCentral vs distributed remapping

Hashing vs remappingHashing vs remapping

Mapping / HashingMapping / Hashing

• Central vs local mappingCentral vs local mapping– Central mapping is more controlled, but it Central mapping is more controlled, but it

requires that PHI be kept at the PI’s site.requires that PHI be kept at the PI’s site.– Local mapping is more susceptible to data Local mapping is more susceptible to data

loss, but has a different security profile.loss, but has a different security profile.

• HashingHashing– Very convenient in a multi-center trial and Very convenient in a multi-center trial and

very secure, but inversion can only be very secure, but inversion can only be done through a dictionary attack.done through a dictionary attack.

Anonymizer ScriptingAnonymizer Scripting

• Modality-specificModality-specific• Manufacturer-specificManufacturer-specific• MIRC-defined script languagesMIRC-defined script languages

– DICOMDICOM– XMLXML

• Shared remapping tablesShared remapping tables– Self-consistencySelf-consistency

• Script language documentationScript language documentation– http://mircwiki.rsna.orghttp://mircwiki.rsna.org

Data TransportData Transport

• Principal issue: securityPrincipal issue: security– HTTP – data is in the clearHTTP – data is in the clear– HTTPS – data is encryptedHTTPS – data is encrypted– VPN – data and IPs are encryptedVPN – data and IPs are encrypted

• FirewallsFirewalls

FC PIInternet

HTTP / HTTPS

Negotiating FirewallsNegotiating Firewalls

Connections and portsConnections and ports

Inbound vs outbound connectionsInbound vs outbound connections

Connection streamsConnection streams

WWW example:WWW example:– How the web page gets back to the browserHow the web page gets back to the browser

Browser Web SiteInternet80

Firewalls in Clinical TrialsFirewalls in Clinical Trials

Minimize the need for support at acquisition sitesMinimize the need for support at acquisition sites

Acquisition site:Acquisition site:– Only make outbound connectionsOnly make outbound connections

PI site:PI site:– Allow inbound connections on 8443Allow inbound connections on 8443

FC PIInternet

HTTP / HTTPS

8443

Additional Security: the DMZAdditional Security: the DMZ

Receive data in the DMZReceive data in the DMZ

Poll the DMZ to import to the data managerPoll the DMZ to import to the data manager

DataManager

PI8443

DMZ

InternalNetwork

Image ManagementImage Management

ProcessingProcessing

StorageStorage

Export to participating systemsExport to participating systems–Other PIsOther PIs

–PACS / workstationsPACS / workstations

DatabaseDatabase

Processing PipelineProcessing Pipeline

• Import ServiceImport Service– HTTP / DICOM / HTTP with pollingHTTP / DICOM / HTTP with polling

• PreprocessorPreprocessor– AnonymizerAnonymizer

• Storage ServiceStorage Service• Export ServiceExport Service

– HTTP / HTTPSHTTP / HTTPS– DICOMDICOM– DatabaseDatabase

The RSNA MIRC Software for Clinical Trials

The RSNA MIRC Software for Clinical Trials

• FieldCenterFieldCenter– Acquisition sitesAcquisition sites

• MIRCsiteMIRCsite• ClinicalTrialProcessorClinicalTrialProcessor

– Highly configurableHighly configurable– More flexible and extensibleMore flexible and extensible– Includes all types of stagesIncludes all types of stages– To be released 1Q2008To be released 1Q2008

• See the wiki for documentationSee the wiki for documentation

XMLServerXMLServer

OS FileOS FileSystemSystem

InputInputQueueQueue

StorageStorageServiceService

MIRCMIRCIndexIndex

AdminAdminServiceService

AuthorAuthorServicesServices

FileFileServiceService

Ob

jec

t P

roc

es

so

rO

bje

ct

Pro

ce

ss

or

MIRCMIRCAnonymizerAnonymizer

DICOMDICOMImportImport

QueryQueryServiceService

MIRC Site ServicesMIRC Site ServicesSubmitSubmitServiceService

ZipZipServiceService

TCETCEServiceService

HTTPHTTPExportExport

HTTPHTTPImportImport

DICOMDICOMExportExport

DICOMDICOMImportImport

MIRCMIRCAnonymizerAnonymizer

DatabaseDatabaseExportExport

MIRC Clinical Trial Data TypesMIRC Clinical Trial Data Types

•ImagesImages

– DICOM, multi-mediaDICOM, multi-media

•Text dataText data

– XMLXML

•Trial-specific file collectionsTrial-specific file collections

– Zip (with manifest)Zip (with manifest)

•Undefined file typeUndefined file type

Configuration ManagementConfiguration Management

• IT support at field centers is almost IT support at field centers is almost unavailable.unavailable.

• Initial software installation requires a Initial software installation requires a human being, but it should be simple.human being, but it should be simple.

• Software updates should require a Software updates should require a person to trigger them.person to trigger them.

• Anonymizer scripts should be Anonymizer scripts should be automatically updated.automatically updated.

MIRC Update ServiceMIRC Update Service

MIRCMIRCUpdateUpdateServletServlet

HTTP(S)HTTP(S)

FieldCenterFieldCenterStorage SCPHTTP ServerAnonymizerStorage SCUS/W Update

S/WS/W

Config 1Config 1

Config 2Config 2

Config nConfig n

FieldCenter SitesFieldCenter Sites

The RSNA MIRC SoftwareThe RSNA MIRC Software

Runs on Windows, Mac, Linux, SolarisRuns on Windows, Mac, Linux, SolarisThree components:Three components:

Java / Tomcat / MIRCJava / Tomcat / MIRC

All components are freeAll components are freeMIRC Users Group meetings:MIRC Users Group meetings:

11/2511/25 1:30 - 3:30 1:30 - 3:30 E251E25111/2911/29 12:15 - 2:1512:15 - 2:15 E257E257

Questions/Answers & HelpQuestions/Answers & HelpThe MIRC WikiThe MIRC Wiki

– http://mircwiki.rsna.orghttp://mircwiki.rsna.org

RSNA Forums:RSNA Forums:– http://forums.rsna.orghttp://forums.rsna.org

– User Comments, Questions and AnswersUser Comments, Questions and Answers– RSNA MIRC Software AnnouncementsRSNA MIRC Software Announcements– MIRC Implementers’ CornerMIRC Implementers’ Corner

Subscribe on the Forums siteSubscribe on the Forums site