2010 i2b2/va Challenge Rules of Conduct

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1 2010i2b2/VAChallengeRulesofConduct The2010i2b2/VAChallengeisasharedtask.Theformatofthesharedtaskandtheprinciples whichbindtheparticipantsofthissharedtaskareasfollows: 1.Inordertosupportthesharedtask,i2b2andVAwillprovidetheparticipantswithdatafrom PartnersHealthcare,UniversityofPittsburghMedicalCenter,andBethIsraelDeaconess MedicalCenter. 2.Thedatawillbedistributedwithdatauseagreementsthatsatisfytheconditionsofeachof theabove namedinstitutions. 3.Allteamsarerequiredtosignthedatauseagreementsofalloftheinstitutionsinorderto gainaccesstothedata.pleaseprint,sign,andfaxyourdatauseagreementsto Alsofollowtheonlineaccountregistrationprocessthroughthei2b2website. 4.i2b2andVAwillfirstreleaseannotatedtrainingdata.Teamscanusethisdatatodevelop theirsystems.thesystemsareexpectedtobefullyautomatic,i.e.,nohumaninterventionin theiroutput. 5.Evaluationistoberunonheld outtestdata.teamsarenotallowedtotrainontestdata.all developmentandtrainingmuststopbeforeteamsdownloadthetestdata.teamsare expectedtogeneratefullyautomaticsystemoutputsonthetestdata.manualinterventions withthetestdatapredictionsarenotacceptable. 6.Gainingaccesstoanyportionofthe2010Challengedatacommitstheteamstoparticipatein theevaluationthatwillberunbyi2b2andthevainjuly2010.teamscannotwithdrawfrom theevaluationaftergainingaccesstothedata. 7.Gainingaccesstoanyportionofthe2010Challengedatacommitstheteamstosubmita paperdescribingtheirdevelopedsystemtoi2b2andtheva. 8.Gainingaccesstoanyportionofthe2010Challengedatacommitstheteamstopresenttheir workinthefollowupworkshoptobeorganizedbyi2b2andtheva(shouldtheirsubmitted paperbeacceptedforpresentation).

2 9.Inreturnforfollowingthroughwiththecommitmentsoutlinedinitems6,7,and8,the teamscanconductresearchandpublishpapersonthereleaseddataoneyearbeforeanyone else.the2010challengedatawillonlybeavailabletotheresearchcommunity at largeone yearaftertheevaluationsothatshared taskparticipantshaveampletimetopublishtheirwork ontheshared taskdata. Ihavereadandunderstoodthe2010i2b2/VAChallengerulesofconduct.(Allteammembers mustsign). Name: Institution: Signature: Date:

3 Partners HealthCare i2b2 National Center for Biomedical Computing DATA USE AND CONFIDENTIALITY AGREEMENT for participation in the Challenges in Natural Language Processing for Clinical Data Shared Task Competition Partners HealthCare System, Inc. on behalf of itself and its affiliates (collectively, "Partners") controls certain patient-level data, in the form of patient discharge summaries, from its clinical information systems, which have been de-identified within the meaning of the HIPAA Privacy Rule (the "Data"). Partners wishes to make the Data, in the form of one or more "Datasets," available to eligible registrants in connection with the i2b2 National Center for Biomedical Computing Challenges in Natural Language Processing for Clinical Data Shared Task Competition (the "Competition"). Partners is making the Data available solely for the purpose of enabling registrants to conduct research (the "Purpose"). This Data Use and Confidentiality Agreement explains the terms and conditions of access to the Data by registrants in the Competition. ANY REGISTRANT WHO WISHES TO ACCESS THE DATA MUST READ THE FOLLOWING TERMS AND AGREE TO THEM BY ENTERING THE INFORMATION REQUESTED BELOW AND BY PRINTING, SIGNING, AND RETURNING THE AGREEMENT TO PARTNERS AS DIRECTED BELOW. Registrant is either (check one): an individual, requesting Data under this Agreement on behalf of himself/herself Name: Professional Title: Institution or Organization Address: Telephone: Fax: OR a corporation, requesting Data under this Agreement on behalf of itself and its agents and employees Principal Place of Business: Contact Name/Title: Telephone: Fax: 1. Registrant understands and agrees that any Data / Datasets that Partners provides to Registrant are proprietary and confidential to Partners. 2. Registrant agrees that Registrant will use the Data / Datasets solely for research and for no other purpose. 3. Registrant agrees that Registrant will not attempt to identify or re-identify any individual patient or group of patients from the Data / Datasets. 4. Registrant agrees that Registrant will not disclose, disseminate, or otherwise share the Data / Datasets to or with any other person or entity except with persons or entities on Registrantʼs Competition team, as

4 expressly listed below, each of which persons/entities Registrant will inform of the obligations with respect to use and confidentiality of the Data under this Agreement: Persons/Entities on Registrantʼs Competition team Signature address Registrant shall be responsible for compliance by these persons/entities with the terms of this Agreement and any breach thereof. 5. Registrant agrees not to use the name or logo of Partners or any of its affiliates or any of their respective trustees, directors, officers, staff members, employees, students or agents for any purpose without Partnersʼ prior written approval excepting in the course of presentation and or publication deriving from the Competition wherein the data source is acknowledged. 6. All Data / Datasets disclosed pursuant to this Agreement, including without limitation all written and tangible forms thereof, shall be and remain the property of Partners. Upon termination of this Agreement as provided in Section 7 below, Registrant shall cease using the Data / Datasets. 7. Partners may terminate Registrantʼs access to Data / Datasets under this Agreement for any reason upon written notice to Registrant. 8. Registrantʼs obligations under this Agreement shall survive the expiration or termination of the Agreement. 9. This Agreement may be modified or amended only in a writing signed by duly authorized representatives of both Registrant and Partners. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts. Any claim or action brought under this Agreement shall be brought in the federal or state courts of Massachusetts. Return completed Agreement by fax to: Susanne E. Churchill, Ph.D. Executive Director, i2b2 National Center for Biomedical Computing Fax: BY ENTERING THE INFORMATION REQUESTED IN THIS AGREEMENT AND BY PRINTING, SIGNING, AND RETURNING THE AGREEMENT TO PARTNERS AS DIRECTED ABOVE, REGISTRANT AFFIRMS THAT REGISTRANT HAS READ THE TERMS AND CONDITIONS OF ACCESS TO DATA FOR THE COMPETITION AND AGREES TO THEM. REGISTRANT Signature of Registrant or Registrantʼs Duly Authorized Representative Title: Date:

5 MIMIC II DATA USE AGREEMENT As a condition of being granted access to restricted data from PhysioNet, I agree to the following terms and conditions: 1. I will not attempt to identify any individual referenced in restricted data from PhysioNet. 2. I will exercise all reasonable and prudent care to avoid disclosure of the identity of any individual referenced in restricted data from PhysioNet in any publication or other communication. 3. I will not share access to restricted data from PhysioNet with anyone else. 4. I will exercise all reasonable and prudent care to maintain the physical and electronic security of restricted data from PhysioNet. 5. If I find information within restricted data from PhysioNet that I believe might permit identification of any individual, I will report the location of this information promptly by to citing the location of the specific information in question so that it can be investigated and removed if necessary. 6. I have requested access to restricted data from PhysioNet for the sole purpose of lawful use in scientific research, and I will use my privilege of access, if it is granted, for this purpose and no other. 7. I have completed a training program in protecting human research participants and I am submitting proof of having done so. 8. This agreement may be terminated by either party at any time, but my obligations with respect to restricted data from PhysioNet shall continue after termination. My name: Telephone number, including country/area code (required): Institution: Title or position: Street address: City: State/Province: ZIP/postal code: Country: Name of human studies training course completed: Date completed: General research area for which the data will be used: Date of this agreement:

6 UPMC/University of Pittsburgh Medical Center DATA USE AGREEMENT FOR LIMITED DATA SETS This Data Use Agreement for Limited Data Sets (the Agreement ) is made this day of, 20 by and between UPMC/University of Pittsburgh Medical Center ( UPMC ), the University of Pittsburgh Department of Biomedical Informatics ( DBMI ), and ( Recipient ) (title:, Institution ). WHEREAS, 45 CFR 164, Subpart E (titled Standards for Privacy of Individually Identifiable Health Information and herein referred to as the HIPAA Privacy Rule ) allows UPMC to make available for the purposes of research, to Recipient, provided that Recipient agrees to be bound by the terms of this Agreement; and WHEREAS, Recipient desires for UPMC to make available the de-identified data set as described below and agrees to be bound by the terms and conditions of this Agreement; and WHEREAS, UPMC agrees to make available such data set, provided that Recipient agrees to abide by the terms and conditions of this Agreement as well as applicable UPMC policies and IRB requirements. NOW, THEREFORE, in consideration of the mutual covenants and promises hereinafter set forth, the parties hereto agree as follows: A. DEFINITIONS For the purposes of this Agreement, terms used herein shall have the same definition as set forth in the HIPAA Privacy Rule. B. DATA TO BE PROVIDED BY UPMC The de-identified data set provided pursuant to this Agreement contains data acquired from the University of Pittsburgh NLP Repository (the Repository ), which contains de-identified reports taken from the UPMC MARS system. Such data shall be limited to data that is the Minimum Necessary to reasonably accomplish the Authorized Purposes identified in Section (C)(1) of this Agreement. For the purpose of this Agreement and consistent with the HIPAA Privacy Rule, Minimum Necessary is defined as that protected health information that is reasonably necessary to achieve the purpose of the disclosure and is disclosed to only Those persons or classes of persons, as appropriate, in its workforce who need access to protected health information to carry out their duties. Consistent with the HIPAA Privacy Rule, the following identifiers of the individual or of relatives, employers, or household members of the individual: (A) Names; (B) All geographic subdivisions smaller than a State, including street address, 1

7 UPMC/University of Pittsburgh Medical Center DATA USE AGREEMENT FOR LIMITED DATA SETS city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. (C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and (R) Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section. C. PERMITTED USES AND DISCLOSURES 1. Recipient agrees to limit the use and disclosure of the data set to the following purposes ( Authorized Purposes ): [INVESTIGATOR - SPECIFY THE GENERAL PURPOSE(S) OF THE PROPOSED RESEARCH.] 2. The Recipient shall allow only the following individuals access to the data set for the Authorized Purposes and consistent with the assurances and obligations set forth in this Agreement: [INVESTIGATOR - ADD LIST OF AUTHORIZED INDIVIDUALS WHO WILL HAVE ACCESS TO THE LIMITED DATA SET AND ARE LISTED ON YOUR APPROVED IRB PROTOCOL]. 3. Recipient acknowledges that such individuals have a need to access the limited data set to carry out their duties. 2

8 D. ASSURANCES UPMC/University of Pittsburgh Medical Center DATA USE AGREEMENT FOR LIMITED DATA SETS 1. Recipient shall not use or further disclose the data set other than as permitted by this Agreement or as otherwise required by law. 2. Recipient shall use appropriate safeguards to prevent use or disclosure of the data set other than as permitted by this Agreement. 3. Recipient shall report to DBMI any use or disclosure of the data set not provided for by this Agreement of which Recipient becomes aware. 4. Recipient shall ensure that any specified agents listed in C.2. above to whom it provides the data set agrees to the same restrictions and conditions. 5. Recipient shall not re-identify the information or contact the individuals for whose records are contained within the data set. 6. Recipient shall not give any of the data from the data set to a third party. 7. Recipient shall use the data expressly for the purpose of research involving natural language processing. 8. Recipient shall store the data on a password-protected computer within the network domain of the recipient and shall only provide password access to specified agents (see C.2 above). 9. Recipient shall deposit any annotations performed on reports from the Repository, following Repository Guidelines for Annotations. Recipient will keep the annotation information updated over time, adding any new annotations made in the future. 10. Recipient will reference the accession numbers assigned to the annotated datasets deposited back into the Repository by Recipient in manuscripts describing any research performed with data from the Repository. 11. If Recipient changes the IRB protocol using data from this data set, Recipient will send UPMC the updated version of the approved IRB protocol. If Recipient adds new investigators to the IRB protocol, Recipient will also send UPMC a revised version of this document, with an updated list of specified agents (C.2.). 12. Recipient agrees to UPMC s rights to audit recipient if UPMC believes Recipient may be violating this Agreement. 3

9 UPMC/University of Pittsburgh Medical Center DATA USE AGREEMENT FOR LIMITED DATA SETS E. BREACH AND TERMINATION 1. In the event that this Agreement is breached by Recipient, UPMC at its sole discretion, may a) terminate this Agreement upon written notice to Recipient or b) request that Recipient, to the satisfaction of UPMC, take appropriate steps to cure such breach. If Recipient fails to cure such breach to the satisfaction of UPMC or in the time prescribed by UPMC, UPMC may terminate this Agreement upon written notice to Recipient. 2. Should this Agreement be terminated for any reason, including, but not limited to Recipient s decision to cease use of the data set data, Recipient agrees to destroy or return all of the data set data provided pursuant to this Agreement (including copies or derivative versions thereof). F. MISCELLANEOUS 1. Notices Any notice permitted or required as provided for herein shall be in writing and to the contact and address as noted below or as may be provided by either party to the other in writing from time to time. Notice to UPMC shall be to: UPMC Ethics and Compliance Office University of Pittsburgh Medical Center U.S. Steel Tower Floor 58 Pittsburgh, PA Notice to DBMI shall be to: University of Pittsburgh Department of Biomedical Informatics Attn: NLP Repository 200 Meyran Avenue M-183 Vale Pittsburgh, PA Notice to Recipient shall be to: Name: Address: 2. Governing Law This Agreement shall be governed by, and construed in accordance with, the laws of the Commonwealth of Pennsylvania. 4

10 UPMC/University of Pittsburgh Medical Center DATA USE AGREEMENT FOR LIMITED DATA SETS UPMC/University of Pittsburgh Medical Center Name (print): Title: Signature: Date: Recipient Name (print): Title: Signature: Date: Department of Biomedical Informatics Name (print): Title: Signature: Date: 5

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