MIRC Clinical Trials Software Medical Imaging Resource Center

MIRC Clinical Trials Software Medical Imaging Resource Center

Technical Issues 1. 2. 3. 4. 5. 6. Image acquisition Anonymization Data transport Image management Non-image data Configuration management

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

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

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

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

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 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

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

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.

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

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

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

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 Internet HTTP / HTTPS 8443 PI

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

Image Management Processing Storage Export to participating systems – Other PIs – PACS / workstations Database

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

The RSNA MIRC Software for Clinical Trials • Field. Center – Acquisition sites • MIRCsite • Clinical. Trial. Processor – Highly configurable – More flexible and extensible – Includes all types of stages – To be released 1 Q 2008 • See the wiki for documentation

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

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

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.

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

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 11/29 1: 30 - 3: 30 12: 15 - 2: 15 E 251 E 257

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