معاهدات تبادل داده

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تبادل داده‌های دیجیتالی بخش مهمی از فعالیت‌ کشورهای مختلف و امور بین‌المللی را تشکیل می‌دهند. انجام تبادلات داده‌ نیازمند استانداردهایی است که در قالب سطوح و زبان‌های تبادل داده مطرح می‌شوند. بعد از تعریف استانداردهای شکلی و زبانی، لازم است چارجوبی حقوقی و قانونی برای تبادلات داده تعریف شود تا طی یک تبادل، اهداف طرفین مدنظر قرارگیرد. بدین منظور، معاهدات تبادل داده بین‌ نهادها و سازمان‌های مختلف در سطوح متفاوت منعقد می‌گردد تا ضمن رعایت مسائل قانونی هر کشور، طی زمان مشخص و با هزینه‌ای معقول، نیازهای طرفین برآورده گردد.

TRANSCRIPT

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  • 44

    ( Data exchange agreements)

    6

    6-4. 4 :

    DATA SHARING AGREEMENT

    between

    and

    I. ENTITIES RECEIVING AND PROVIDING DATA

    ENTITY RECEIVING DATA: OFFICE:

    CONTACT PERSON:

    TITLE:

    ADDRESS:

    PHONE NUMBER:

    EMAIL:

    FAX NUMBER:

    ENTITY PROVIDING DATA:

    CONTACT PERSON: TITLE:

    ADDRESS:

    PHONE NUMBER:

    EMAIL:

    FAX NUMBER:

    (NARA)

    II. PURPOSE, AUTHORITY AND TERM OF AGREEMENT

    A. PURPOSE To facilitate the health of Indian tribes and Individual American Indians and

    Alaska Natives X and Y are entering into an agreement which will allow the

    exchange of data and clarification of data access and utilization. Y will provide

    data collected to X for the purposes of .

    B. LEGAL AUTHORITY

  • 42

    ( Data exchange agreements)

    1. X is an Indian Organization/Tribal Epidemiology Center as defined by federal law whose mission is

    2. Y is a State Health Department whose mission is for public benefit.

    C. PERIOD OF PERFORMANCE

    This Agreement shall be effective when signed by both parties and shall

    continue until terminated pursuant to the termination clause contained

    herein.

    III DESCRIPTION OF DATA/DATA WORKPLAN

    The following data will be provided under this agreement:

    All data generated by this project shall be approved for dissemination by the

    Institutional Review Board and .

    IV. ACCESS TO DATA

    A. METHOD OF ACCESS AND TRANSFER Data will be obtained in the following manner:

    B. PERSONS HAVING ACCESS TO DATA All persons who will have access to data must complete a data privacy training

    through < specify >.

    Prior to the transfer of any data, staff members and researchers who will have

    access to the data shall sign the Use and Disclosure of Client Information, (signed

    copies shall be provided to X).

    C. FREQUENCY OF DATA EXCHANGE Data will be exchanged as needed to meet reporting requirements as well as on

    an ongoing basis between X and Y staff for the entire length of the project.

    V. SECURITY OF DATA

    X will not attempt to identify individuals records by any method. Datasets

    containing protected health information (PHI) shall be encrypted. All reasonable

    precautions shall be taken to secure the data from individuals who do not specifically

    have authorized access. Data shall be kept on a password-protected file server

    located in a secure environment. Project data will be kept in a separate directory on

    the server which is also password-protected and will be accessible only by X

    evaluators or staff members specifically authorized access as provided in this

    Agreement.

    VI. CONFIDENTIALITY

  • 49

    ( Data exchange agreements)

    A. REGULATIONS COVERING CONFIDENTIALITY OF DATA The use and disclosure of information obtained under this contract shall be

    subject to 42 CFR Subpart 476. X and Y shall maintain the confidentiality of any

    information which may, in any manner, identify individual subjects.

    As this project is specific to AI/AN, all data collected will have the potential to

    identify AI/AN < tribes, elders, adults, youth, children, etc>. Confidentiality of all

    data therefore must be ensured.

    B. NON-DISCLOSURE OF DATA X and Y shall not disclose, in whole or in part, the data described in this

    agreement to any individual or agency not specifically authorized by this

    agreement.

    Data shall be provided on a timely basis. X and Y will document uses and users of

    the data and will report this information routinely back to the X Principal

    Investigator.

    C. X and Y will not disclose directly to, or use for the benefit of, any third party confidential information, knowledge or data acquired by virtue of its relationship with the other party named in this Agreement, without the prior written approval of the other party. It is understood and agreed by the parties that the obligations of this paragraph shall survive the expiration of termination of this Agreement.

    VII. PAYMENT

    < Specify here or reference a separate contract >

    VIII. PROPERTY RIGHTS

    Original materials prepared by X, including, without limitation: reports, proposals,

    analysis, writings, sound recordings, pictorial reproductions or materials of any type

    whatsoever, are and shall remain the of

    . X/Y will assert no right, claim or

    interest of any nature whatsoever with respect thereto, including specifically but,

    without limitation, any claim to statutory copyright or patent.

    Data Use and Ownership

    X may request data use approval from Y for development of papers or reports. Such

    papers or reports must have the specific written approval of the IRB

    and before such products are submitted for

    presentation or publication.

  • 41

    ( Data exchange agreements)

    Y shall be cited as the source of the data in all tables, reports, presentations, and

    scientific papers, and X shall be cited as the source of interpretations, calculations,

    and/or manipulations of the data.

    At least forty five (45) days prior to submission or presentation at a

    meeting/conference, X will furnish a copy of a proposed publication or presentation

    to the IRB and for review and comment. will have thirty (30) days after receipt of the proposed materials to

    request that X remove confidential or sensitive information from the materials or

    rewrite the materials to protect confidential information from disclosure. X may use,

    reuse and analyze, for teaching and research purposes, the data and findings as

    reviewed by and approved by .

    IX. SEVERABILITY

    If any provision of this Agreement or any provision of any document incorporated by

    reference shall be held invalid, such invalidity shall not affect the other provisions of

    this Agreement which can be given effect without the invalid provision, if such

    remainder conforms to the requirement of applicable law and the fundamental

    purpose of this agreement, and to this end the provisions of this Agreement are

    declared to be severable.

    X. TERMINATION

    Either party may terminate this Agreement upon 30 days prior written notification to

    the other party. If this Agreement is so terminated, the parties shall be liable only

    for performance rendered or costs incurred in accordance with the terms of this

    Agreement prior to the effective date of termination.

    XI. RIGHT OF INSPECTION

    X shall provide Y the right of access to its facilities at all reasonable times, in order to

    monitor and evaluate performance, compliance, and/or quality assurance under this

    contract.

    XII. ALL WRITINGS CONTAINED HEREIN

    This Agreement contains all the terms and conditions agreed upon by the parties.

    No other understandings, oral or otherwise, regarding the subject matter of this

    Agreement shall be deemed to exist or to bind any of the parties hereto.

    Organization X

    ________________________

    Name/Title Date

    ________________________

  • 45

    ( Data exchange agreements)

    Name/Title Date

    Organization Y

    ________________________

    Name/Title Date

    ________________________

    Name/Title Date

    USE AND DISCLOSURE OF CLIENT INFORMATION

    Staff with access to confidential client information are responsible for understanding rules for

    use and disclosure of the information. Outlined below are key elements for staff to

    remember:

    A. CONFIDENTIALITY OF CLIENT DATA

    1. Individually identifiable client data is confidential and is protected by various

    state and federal laws.

    2. Confidential client information includes all personal information (e.g., name,

    birth date, social security number, diagnosis, treatment, etc.) which may, in

    any manner, identify the individual.

    B. USE OF CLIENT DATA

    1. Client data may be used only for purposes directly described in the data

    sharing agreement between X, Y, and Z

    2. Any personal use of client information is strictly prohibited.

    3. Access to data must be limited to those staff whose duties specifically require

    access to such data in the performance of their assigned duties.

    C. DISCLOSURE OF INFORMATION

    1. Identified client information may not be disclosed to other individuals or

    agencies.

    2. Questions related to disclosure are to be directed to X.

    3. Any disclosure of information contrary to 1 above is unauthorized and is

    subject to penalties identified in law.

  • 46

    ( Data exchange agreements)

    Name (print):

    Signature: Date:

    Approved By: Executive Director, Organization X Signature: Date:

    6-2. 2 : 27SSA

    1. Legal authority All disclosures from SSA must be in accordance with the Privacy Act,

    5 U.S.C. 552a, section 1106 of the Social Security Act, and SSAs disclosure

    regulations. Additional legal authority may also control how and when SSA may

    disclose certain data maintained by the agency. We review all requests for

    information to determine whether SSA has applicable legal authority for the disclosure

    requested.

    2. Disclosure Policy- If there is a business need, SSA may verify SSNs, benefit amount,

    or fact of eligibility based on what the law will allow us to disclose. The Privacy Act,

    other federal law, and SSA disclosure regulations control disclosures. A data exchange

    agreement is required for all data exchange activity.

    3. Systems feasibility - Is there a viable systems option available to make an exchange or

    would this exchange require systems development? Development of a new process

    increases cost.

    4. Systems security - FISMA guidance requires SSA to enforce security requirements on

    outside entities with access to federal information and/or federal systems - regardless

    of the method of access. SSA meets this requirement by ensuring that outside entities

    comply with SSA's Information System Security Guidelines for federal, state, and local

    agencies receiving electronic information from SSA.

    5. Cost- SSA will look at the return on investment for any data exchange. Reimbursement

    is usually required.

    6-9. 9 )( :28SSA

    27 From: http://www.ssa.gov/dataexchange/overview.html#sb=1 28 From: http://www.ssa.gov/dataexchange/overview.html#sb=1

  • 47

    ( Data exchange agreements)

    Federal Agencies

    Congressional Budget Office Corporation for National and Community Service

    Department of Commerce Department of Defense

    Department of Education Department of Health and Human Services

    Department of Homeland Security Department of Housing and Urban Development

    Department of the Interior Department of Justice

    Department of Labor Department of State

    Department of the Treasury Department of Veterans Affairs

    Federal Reserve Board Federal Trade Commission

    General Accounting Office National Technical Information Service

    Office of Personnel Management Pension Benefit Guaranty Corporation

    Railroad Retirement Board Selective Service System

    U.S. Department of Agriculture U.S. Postal Service