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MIRC Clinical Trials Software

MIRC Clinical Trials Software. Medical Imaging Resource Center. Technical Issues. Image acquisition Anonymization Data transport Image management Non-image data Configuration management. MIRC Clinical Trial Dataflow. Internet HTTP / HTTPS. FC. DICOM. Database. HTTP. PI. FC. DICOM.

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MIRC Clinical Trials Software

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  1. MIRC Clinical Trials Software Medical Imaging Resource Center

  2. Technical Issues • Image acquisition • Anonymization • Data transport • Image management • Non-image data • Configuration management

  3. MIRC Clinical Trial Dataflow Internet HTTP / HTTPS FC DICOM Database HTTP PI FC DICOM DICOM

  4. Typical MIRC Dataflow Principal Investigator Field Center Modality PACS Work-stations DICOM PACS DICOM FieldCenter Storage SCP HTTP Server Anonymizer Storage SCU S/W Update HTTP(S) MIRC Database

  5. Image Acquisition DICOM Images from Modalities or from PACS Images contain clinical PHI plus trial IDs Modality PACS DICOM FieldCenter DICOM Storage SCP

  6. Anonymization and Pseudonymization • Anonymization • Removal of PHI • Replacement of PHI with values that are the same for all patients • Pseudonymization • Replacement of PHI with values that are specific to the patient and the trial but which are not meaningful anywhere else

  7. The HIPAA 18 • Name • Location; all geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes. • Dates (all dates related to the subject of the information, e.g. birth dates, admission dates, discharge dates, encounter dates, surgery dates, etc.) • Telephone numbers • Fax numbers • Electronic mail addresses • Social security numbers • Medical record numbers • Health plan beneficiary numbers • Account numbers • Certificate / license numbers • Vehicle identifiers and serial numbers, including license plate numbers • Device identifiers and serial numbers • Web Universal Resource Locators (URLs) • Internet Protocol (IP) address numbers • Biometric identifiers, including finger and voice prints • Full face photographic images and any comparable images • Any other unique identifying number, characteristic, or code

  8. Pseudonymization Element types • Patient ID • Dates (Birth / Study) • UIDs • Accession, non-unique IDs Central vs distributed remapping Hashing vs remapping

  9. Mapping / Hashing • Central vs local mapping • Central mapping is more controlled, but it requires that PHI be kept at the PI’s site. • Local mapping is more susceptible to data loss, but has a different security profile. • Hashing • Very convenient in a multi-center trial and very secure, but inversion can only be done through a dictionary attack.

  10. Anonymizer Scripting • Modality-specific • Manufacturer-specific • MIRC-defined script languages • DICOM • XML • Shared remapping tables • Self-consistency • Script language documentation • http://mircwiki.rsna.org

  11. Internet HTTP / HTTPS Data Transport • Principal issue: security • HTTP – data is in the clear • HTTPS – data is encrypted • VPN – data and IPs are encrypted • Firewalls FC PI

  12. Internet Negotiating Firewalls Connections and ports Inbound vs outbound connections Connection streams WWW example: • How the web page gets back to the browser 80 Browser Web Site

  13. Internet HTTP / HTTPS Firewalls in Clinical Trials Minimize the need for support at acquisition sites Acquisition site: • Only make outbound connections PI site: • Allow inbound connections on 8443 FC PI 8443

  14. Additional Security: the DMZ Receive data in the DMZ Poll the DMZ to import to the data manager Data Manager PI 8443 Internal Network DMZ

  15. Image Management Processing Storage Export to participating systems • Other PIs • PACS / workstations Database

  16. Processing Pipeline • Import Service • HTTP / DICOM / HTTP with polling • Preprocessor • Anonymizer • Storage Service • Export Service • HTTP / HTTPS • DICOM • Database

  17. The RSNA MIRC Software for Clinical Trials • FieldCenter • Acquisition sites • MIRCsite • ClinicalTrialProcessor • Highly configurable • More flexible and extensible • Includes all types of stages • To be released 1Q2008 • See the wiki for documentation

  18. MIRC Site Services Submit Service Zip Service TCE Service HTTP Export XMLServer Input Queue Admin Service HTTP Import Object Processor DICOM Export OS File System Storage Service MIRC Index DICOM Import Query Service MIRC Anonymizer DICOM Import File Service Author Services Database Export MIRC Anonymizer

  19. MIRC Clinical Trial Data Types • Images • DICOM, multi-media • Text data • XML • Trial-specific file collections • Zip (with manifest) • Undefined file type

  20. Configuration Management • IT support at field centers is almost unavailable. • Initial software installation requires a human being, but it should be simple. • Software updates should require a person to trigger them. • Anonymizer scripts should be automatically updated.

  21. MIRC Update Service FieldCenter Storage SCP HTTP Server Anonymizer Storage SCU S/W Update MIRC Update Servlet HTTP(S) S/W Config 1 FieldCenter Sites Config 2 Config n

  22. The RSNA MIRC Software Runs on Windows, Mac, Linux, Solaris Three components: Java / Tomcat / MIRC All components are free MIRC Users Group meetings: 11/25 1:30 - 3:30 E251 11/29 12:15 - 2:15 E257

  23. Questions/Answers & Help The MIRC Wiki • http://mircwiki.rsna.org RSNA Forums: • http://forums.rsna.org • User Comments, Questions and Answers • RSNA MIRC Software Announcements • MIRC Implementers’ Corner Subscribe on the Forums site

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