MEDICAL INFORMATICS DATA SHARING AGREEMENT
BY AND AMONG THE UNIVERSITY OF KANSAS HOSPITAL AUTHORITY,
THE UNIVERSITY OF KANSAS, ON BEHALF OF ITS SCHOOL OF MEDICINE, AND
KANSAS UNIVERSITY PHYSICIANS, INC.
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CC 2295479v12
MEDICAL INFORMATICS DATA SHARING AGREEMENT
BY AND AMONG THE UNIVERSITY OF KANSAS HOSPITAL AUTHORITY,
THE UNIVERSITY OF KANSAS, ON BEHALF OF ITS SCHOOL OF MEDICINE, AND
KANSAS UNIVERSITY PHYSICIANS, INC.
This Medical Informatics Data Sharing Agreement (the “Agreement”) effective as of the ___ day of August, 2010 (the “Effective Date”) is entered into by and among the University of Kansas Hospital Authority (“KUH”), a body politic and corporate and an independent instrumentality of the State of Kansas, established by the University of Kansas Hospital Authority Act (the “Act”), the University of Kansas (“University”), an agency of the State of Kansas, on behalf of the University of Kansas Medical Center and its Kansas City School of Medicine and Schools of Nursing and Allied Health (together, “KUMC”), and Kansas University Physicians, Inc., a Kansas not-for-profit corporation (“UKP”).
RECITALS
WHEREAS, one of KUMC’s goals is to expand the range of educational and research opportunities for its faculty, residents and students; and
WHEREAS, KUH has the statutory mission to facilitate and support the education, research, and public service activities of KUMC and its health sciences schools, to provide patient care and specialized services not widely available elsewhere in the state and to continue the historic tradition of care by KUH to medically indigent citizens of Kansas; and
WHEREAS, UKP is the Faculty Practice Plan for the physicians employed by the various non-profit clinical foundations associated with KUMC who also serve as faculty for KUMC and medical staff for KUH; and
WHEREAS, KUH, KUMC and UKP acknowledge that they have executed an affiliation agreement regarding teaching and research, under which the parties collaborate and mutually support each other’s missions; and
WHEREAS, the collection and sharing of biomedical data furthers professional education and expands medical knowledge by creating a streamlined collection of key data, information and relationships that impact clinical outcomes, thereby catalyzing the research collaborations among the parties and permitting the study of patient outcomes, including the effectiveness of particular treatments and methodologies; and
WHEREAS, KUH, KUMC and UKP desire to lead the way in biomedical informatics data sharing through the formation of the Healthcare Enterprise Repository for Ontological Narration (“HERON”) and the sharing of biomedical data with appropriate privacy and security protections, in order to facilitate information sharing, strengthen outreach and research capabilities, facilitate translational research and enable the deployment of increasingly sophisticated techniques to optimize care;
NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants herein contained, and on the terms and subject to the conditions herein set forth, KUH, KUMC and UKP hereby covenant and agree as follows:
ARTICLE I.DEFINITIONS AND KEY TERMS
In addition to the defined terms that appear throughout the Agreement, the following terms (whether or not capitalized in this Agreement) shall have the following meanings:
1.01Agreement. The term “Agreement” shall mean the Medical Informatics Data Sharing Agreement, as is set forth in this document.
1.02De-identified Information. The term “De-identified Information” shall mean Information that has been de-identified in accordance with the requirements for de-identification of protected health information under 45 CFR §164.514(b).
1.03HERON. The term “HERON” shall mean the KUMC Healthcare Enterprise Repository for Ontological Narration.
1.04Information. The term “Information” shall mean written or electronic patient information or data of the type identified in Section 2.02 of this Agreement, and includes Information or data provided in any form, including De-identified Information and Limited Data Sets.
1.05Individual. The term “Individual” shall have the same meaning as the term “individual” in 45 CFR § 164.501 and shall include a person who qualifies as a personal representative in accordance with 45 CFR § 164.502(g).
1.06Limited Data Set. The term “Limited Data Set” shall have the same meaning as the term “limited data set” in 45 CFR §164.514(e), and shall include Protected Health Information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual: names, postal address information (other than town or city, state, and zip code), 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.
1.07Participant. The term “Participant” shall mean the parties to this Agreement, including KUMC, KUH and UKP.
1.08Privacy Rule. The term “Privacy Rule” shall mean the Standards for Privacy of Individually Identifiable Information at 45 CFR Part 160 and Part 164, Subparts A and E, as amended from time to time.
1.09Protected Health Information (PHI). The term “Protected Health Information” or “PHI” shall have the same meaning as the term “protected health information” in 45 CFR § 164.501.
1.10Qualified Faculty. The term “Qualified Faculty” shall mean Kansas University Medical Center faculty appointees who are appointed at or above Instructor level.
1.11Security Rule. The term “Security Rule” shall mean the Standards for Security of Individually Identifiable Information at 45 CFR Parts 160, 162 and 164.
ARTICLE II.COVENANTS, TERMS AND CONDITIONS
2.01Creation of HERON. KUMC shall create and establish the Healthcare Enterprise Repository for Ontological Narration (HERON) to receive and store Information from the Participants and to supply Information to Qualified Faculty, pursuant to the terms of this Agreement.
2.02Submission Information. Each of the Participants agrees that, to the extent that the Participant has the capability to submit such information electronically at no additional cost to the Participant, the Participant shall submit to KUMC for inclusion in HERON, at a minimum, the following data, collectively “Information,” from the sources identified below:
(a)Encounter information for each emergency department, outpatient clinic visit or hospital visit, including: patient demographic information, reason for visit, treating health care provider(s), date of visit, place of visit, diagnoses, and procedures; and
(b)Vital signs, pathology reports, radiology reports, discharge summaries, operative notes, inpatient medications, laboratory test results, cardiology studies, orders, allergies, history and physicals, nursing observations and assessments, outpatient prescriptions, and other diagnostic tests.
(c)Although financial information related to payment of patients’ claims whether governmental, commercial or self-pay may be part of the submission of Information, the Parties agree such financial information shall not be available for research projects unless such information is specifically approved by unanimous vote of the Executive Committee.
KUH shall submit the Information stored on its EPIC/O2 system (or its successor system) and UKP shall submit the Information stored on the IDX system (or its successor system). Unless otherwise mutually agreed by the Participants, the Participants will not provide such data stored on other systems or in paper format. The HERON Executive Oversight Committee has the authority to modify the definition of Information as necessary to meet the needs of the Participants. No Participant will be required to provide information or any other data it is holding pursuant to a promise of, or a legal obligation requiring, confidentiality.
Participants may submit Information in addition to the minimum set of data required by this Section 2.02 and are encouraged to submit any and all information that may be relevant to the clinical care of a patient. Notwithstanding the foregoing, Participants shall not be required to submit alcohol and drug abuse patient records that are maintained in connection with the performance of any federally assisted alcohol and drug abuse program which are protected from disclosure by 42 C.F.R. Part 2, psychotherapy notes as defined by 45 C.F.R. § 164.501, or where otherwise prohibited by state or federal law.
2.03Storage of Information. The Information submitted by the Participants shall be initially stored by KUMC in non-HERON format in one or more electronic files dedicated to each Participant and then merged into an integrated repository in HERON format that contains Information submitted by all Participants for use as set forth herein. The integrated repository will be stored on a server dedicated to this purpose. Information transmitted (data in motion) and Information stored (data at rest) shall be secured in accordance with Security Rule and information regarding implementation shall be provided to the Executive Committee. De-identified data from the integrated repository will then be moved to a separate dedicated server for use as set forth herein.
2.04HERON Oversight.
(a)HERON Executive Oversight Committee (“Executive Committee”). The Executive Committee shall be composed of three (3) representatives from each Participant, one of whom shall serve as the voting member and the other two shall serve as advisory members. The Executive Committee shall oversee and coordinate the operations of HERON, develop written business policies for the operation of HERON pursuant to this Agreement, and have full authority to act on behalf of the Participants with regard to HERON operations. Upon execution of this Agreement, the initial members of the Executive Committee shall be as follows:
KUMC: Chief of Staff
Director of Medical Informatics;
Vice Chancellor for Research
KUH: Executive Vice President, Chief Operating Officer & Chief Nursing Officer;
Executive Vice President and Chief Financial Officer;
Senior Vice President Ambulatory Services and Chief Information Officer
UKP: Director, Information Technology
Director, Compliance & Privacy
Chief Operating Officer
Thereafter, the number of members of the Executive Committee shall be determined by the unanimous vote of the voting members of the Executive Committee.
(b)Executive Committee Meetings; Notice and Quorum. The Participants shall notify the KUMC Director of Medical Informatics in writing of any change in their voting and advisory Executive Committee representative(s). The Executive Committee shall meet from time to time, upon at least seven (7) days’ prior notice to the members, upon the unanimous consent of all the voting members of the Executive Committee, to consider and resolve various issues surrounding HERON, including but not limited to: technical issues, confidentiality, the scope of Information stored and accessed by Participants, the use of the Information, and any other issues related to HERON or the Participants’ participation therein, as set forth in this Agreement or as determined necessary by the Executive Committee. Attendance by any member of the Executive Committee at a meeting shall serve as waiver in writing of any notice of the meeting unless the purpose of the attendance is to object to the meeting or action to be taken at the meeting. If a Participant’s voting member cannot be present at a meeting, such voting member shall delegate his or her vote to one of that Participant’s advisory directors. At least one (1) member representing each Participant, shall constitute a quorum, and the unanimous consent of all three voting members (or their respective delegates) of the Executive Committee shall be required to take action.
(c)Data Request Oversight Committee. The Executive Committee shall designate an equal number of representatives from each Participant to serve on the Data Request Oversight Committee (DROC), which will be overseen by the Executive Committee. The DROC shall have the responsibility and authority to review and approve, disapprove or defer requests, to access data from HERON, as set forth in Section 2.05 below. The Executive Committee shall be responsible for developing and implementing guidelines and procedures for the operation of the DROC, as the Executive Committee deems necessary to administer the HERON system and access to HERON information, provided that any action or decision of the DROC shall require the consent of at least one representative from each Participant.
(d)Communications; Force of Committee Decisions. Communications and notices regarding HERON shall be provided to the named representative(s) of the Executive Committee or the DROC as appropriate and the Participants shall be able to fully rely on the actions and representations of a Participant’s voting member of the Executive Committee (or his/her delegate) with respect to HERON and actions taken under this Agreement. Any decisions made by the Executive Committee or the DROC, upon matters over which it has been given authority under this Agreement, as amended from time to time by unanimous written agreement of the Participants, shall control the relationship between the Participants and their respective obligations hereunder, and shall be binding on all Participants, unless a Participant objects in writing within ten (10) days after a Committee decision is made with which the Participant objects. Such an objecting Participant shall be entitled to abstain from complying with such decision without penalty unless the Participant’s concerns regarding the decision are accommodated by the other Participants to this Agreement to the sole and absolute satisfaction of the objecting Participant. Participants shall be permitted to have observers at meetings of the Executive Committee and the DROC as needed to help accomplish the work of HERON.
2.05Access to HERON Information. Access to HERON Information shall be permitted by KUMC as follows:
(a)Access to Perform Queries Preparatory to Research. Qualified Faculty and research collaborators approved by the DROC shall be permitted by KUMC to directly perform queries of HERON to generate patient cohorts or “patient counts” for the purpose of assisting them in determining study feasibility, eligibility criteria, hypothesis generation, or other questions preparatory to research. The results of such queries shall consist of De-identified Information consistent with HERON business policies approved by the Executive Committee. Submission of a research proposal, DROC approval pursuant to section 2.06 below, or IRB approval shall not be required for such access or queries. The Qualified Faculty member and/or approved research collaborator will be required to submit to KUMC an executed HERON System Access Agreement prior to access for this purpose, which agreement shall prohibit the downloading or printing of the HERON Information obtained as a result of the queries and shall require the conduct of the cohort identification in a responsible manner as outlined in the HERON System Access Agreement. A copy of the HERON System Access Agreement is set forth as Exhibit A. The Executive Committee shall have the authority to revise the HERON System Access Agreement as deemed necessary by the Executive Committee. Queries for cohort identification shall be permitted by KUMC using secure query technologies such as the NIH i2b2 framework, shall require the user to submit a valid user name and password to gain access to HERON, and will be logged by KUMC for review by the DROC.
(b)Access for Other Research Purposes. Qualified Faculty and Research Team Members (as defined in the Data Use Agreement) approved by the DROC in accordance with Section 2.06 of this Agreement, shall be permitted by KUMC to directly access HERON once project approval by the DROC has been obtained as set forth in section 2.06 below. Such access shall enable the Qualified Faculty member or collaborating researcher to perform queries, the results of which shall consist of a Limited Data Set(s) consistent with the HERON business policies approved by the Executive Committee. IRB approval shall not be required for such access or queries. The Qualified Faculty member and/or Research Team Member will be required to submit to KUMC an executed HERON Data Use Agreement prior to access for this purpose. The Executive Committee shall have the authority to revise the HERON Data Use Agreement as deemed necessary by the Executive Committee. The queries shall be permitted by KUMC using secure query technologies such as the NIH i2b2 framework, shall require the user to submit a valid user name and password to gain access to HERON, and will be logged by KUMC for review by the DROC. Any request for the use or disclosure of HERON Information for research purposes, other than as described in section 2.05(a) or this 2.05(b), must be proposed to and approved by the DROC, and must be approved by the KUMC Human Subjects Committee in accordance with its usual policies and procedures.
(c)Participant Access for Other Purposes. Each Participant will have access to the Information it contributes to HERON for audit purposes, in accordance with its own internal regulations governing access to its own internal records. Each Participant shall provide the list of the personnel under its control who may access the HERON system for this purpose to the KUMC Director of Medical Informatics, which list will be updated by the Participant on an ongoing basis as needed. Participants may request approval from the DROC to accessHERON Information of other Participants, with the consent of such Participants. In the event the request requires additional configuration of the HERON system to produce the Information in the manner desired by the Participant, KUMC may charge the Participant a reasonable fee for the required configuration and associated access. Without limiting the foregoing, no Participant will use the Information for competitive institutional or individual advantage of any party other than KUMC, KUH, and UKP. No Participant will (and will not allow any of Participant’s agents to), under any circumstance, sell any Information obtained from HERON to any individual or entity.
(d)Participants’ Representation Regarding Legality of Access. Each Participant represents and warrants that it is authorized under applicable laws and regulations to enter into this Agreement and carry out its obligations hereunder.
(e)Access by Individuals. Unless otherwise permitted in this Agreement, no Individual shall have direct access to Information on HERON. Requests if any from Individuals for access or amendment to their PHI in a Designated Record Set as defined under HIPAA shall be referred to the relevant Participant so that the Participant can prepare a timely response to the Individual.
(f)Access Reporting. The KUMC Director of Medical Informatics or other designated KUMC representative shall provide the DROC, the Executive Committee and the Participants a report of all approved HERON queries and associated system use on a monthly basis including, without limitation, expiration or termination of an ongoing research project. The foregoing reports shall be provided at no cost.
2.06DROC Review and Approval.