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Terms of Service – SimpleReport

12/4/2020

As a Testing Facility (Facility) or its user (Facility User) accessing or using SimpleReport (Application) provided by the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Health and Human Services (HHS), in a CDC cloud environment (“CDC Platform”), you acknowledge and agree that you are solely responsible for and shall abide by these Terms of Service, as well as any relevant sections of CDC’s Privacy Policies (collectively, Terms).

Scope

SimpleReport is a free tool that makes it easy for Coronavirus Disease 2019 (COVID-19) testing sites to record results for rapid point-of-care tests and quickly report required data to public health departments. This Application is being provided by HHS and CDC to enable a Facility to record its testing workflow, for record keeping needs and to route relevant and necessary testing data to state, local, tribal, and territorial public health authorities (STLT Public Health Agencies) in furtherance of public health response activities related to COVID-19. It also allows Facility to designate certain users of the data, as set out in these Terms. The Application through which you interact with relevant public health data is subject to these Terms. Use of the Application constitutes acceptance of these Terms.

Data Rights and Usage

Accounts/Registration

  • General Facility Users

If you are using the Application on behalf of a Facility, you represent and warrant that you have authority to bind that Facility to the Terms and by accepting the Terms, you are doing so on behalf of that Facility (and all references to “you” in the Terms refer to you and that Facility). In order to access the Application, as part of the registration process for the Application, and for your continued use of the Application, you may be required to provide certain information (such as identification or contact details). Any such information you give to CDC or HHS must be accurate and up-to-date, and you must inform us promptly of any updates so that we can keep you informed of any changes to the Application or these Terms which may impact your usage of the Application. Upon Facility registration and the creation of Facility User accounts within the Application, credentials (such as passwords, keys, tokens, and Facility and Facility User identifications (IDs)) will be issued to you by HHS or CDC. These credentials are intended to be used only by you and to identify any software or APIs which you are using. You agree to keep your credentials confidential and make reasonable efforts to prevent and discourage other persons from using your credentials.

  • Administrator User

Upon a Facility’s registration (and on an ongoing basis, as needed), the Facility must designate at least one user from the Facility as the Administrator. This Administrator will have more detailed identity verification. Once the Administrator has their identity verified, the Administrator can add other Facility Users to the Application. The Administrator agrees to verify identity on Facility Users who are added and to inactivate Facility Users who should no longer have access. The Administrator also agree to set permissions appropriately to determine the minimum access necessary for Facility Users to complete their required job duties.

Privacy

You may use the Application to search, display, analyze, retrieve, view and otherwise ‘get’ information from data you are sending via the Application and the Platform. Please note that the data which you are sending via the Application may be subject to the Privacy Act of 1974, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and other laws, and requires special safeguarding. By accessing and using the Application, you agree to strictly abide by all applicable federal and state laws regarding the collection, use, protection and disclosure of information obtained or sent through the Application. If you would like more information about the application of the Privacy Act at CDC, click here.

For purposes of use of this Application, if you are a HIPAA covered entity or acting on behalf of one as a business associate or if the data is maintained in a HIPAA-covered designated record set, you further acknowledge that you will abide by applicable HIPAA regulations (45 CFR Parts 160 and 164) for purposes of appropriate storage, transmission, use and disclosure of any protected health information.

Use of Data

This Application is being provided in order to allow for the recording of Facility testing workflow and record keeping needs and for the routing of relevant data to STLT Public Health Agencies in furtherance of public health response activities related to the COVID-19 pandemic. HHS and CDC acknowledge that though CDC is providing the Platform, CDC does not intend to access the data nor does it intend to review or analyze this data. As such, CDC does not intend to take custody or control of data sent via the Application. The Facility User acknowledges and agrees that CDC and Administrative Users may manage the data sent via the Application for purposes of operating the CDC Platform and transmitting to and facilitating use by STLT Public Health Agencies of such data. Except as may be required by applicable federal law, CDC may not release the data sent via the Application for other purposes than described below. Should data release be requested of CDC, CDC shall notify the requestor that CDC does not have access to this data and refer to requestor to the Facility.

Sharing of Data

Data recorded and stored in the Application is for use by the Facility as needed for workflow, record keeping, and reporting purposes. All COVID-19 test results will be automatically reported to the appropriate STLT Public Health Agency based on both the testing facility ZIP code and the Patient’s ZIP code, including all relevant fields as defined in the HHS COVID-19 Laboratory Reporting Requirements. By entering results that are being reported to STLT Public Health Agency, the Facility attests that it is authorized to report the data via the Application. Though CDC will not actively access and obtain data from the Application, Facility, directly or in coordination with the relevant STLT Public Health Agency, may decide to use the Application to send deidentified data to CDC; such data sent to CDC will be maintained consistent with applicable federal laws.

Other Responsibilities

  • You will be fully accountable for all data you submit and will cooperate with CDC or its agents in the event that CDC has a security concern with respect to any inquiry, submission, or receipt of data to or from CDC.
  • You will promptly inform CDC in the event you identify misuse of and individually identifiable health information or protected health information you submit and/or access from the CDC Platform.
  • You will promptly inform CDC in the event that you can no longer comply with any of the provisions set out in these Terms.
  • You will immediately cease Application use when you no longer meet any of the terms of these Terms.
  • You must adhere to the basic desktop security measures to ensure the security of any individually identifiable information or protected health information to which you have access in the Application.
  • As may be required by applicable law you agree to obtain consent from and notify individuals whose data will be input into the Application that their personal information will be collected and used for public health purposes.
  • When major changes are made to the Application and/or Platform (e.g., disclosure and/or data uses have changed since the notice at the time of original collection), you will be notified by email, and are responsible for notifying and obtaining consent from individuals whose individually identifiable or protected health information is in the Application
  • In the unlikely event of a breach, you will be required to notify individuals whose individually identifiable or protected health information is in the Application and have been impacted by the breach. Assistance may be offered by CDC to aid in this process.
  • You are required to ensure that anyone using the Application has been trained on handling sensitive and personal information.

Service Management

Right to Limit

Your use of the Application may be subject to certain limitations on access or use as set forth within these Terms or otherwise provided by CDC. These limitations are designed to manage the load on the system, promote equitable access, and ensure appropriate privacy protections and these limitations may be adjusted without notice, as deemed necessary by CDC. If CDC reasonably believes that you have attempted to exceed or circumvent these limits, your ability to use the Application may be temporarily or permanently blocked. CDC may monitor your use of the Application to improve the service or to ensure compliance with these Terms and reserves the right to deny any User access to the Application at its reasonable discretion.

Service Termination

If you wish to terminate your access to and use of the Application, you may do so by deactivating your account or by refraining from further use of the Application.

CDC reserves the right (though not the obligation) to: (1) refuse to provide the Application to you, if it is CDC’s opinion that use violates any federal law or CDC policy; or (2) terminate or deny you access to and use of all or part of the Application at any time for any reason which in CDC’s sole discretion it deems necessary, including to prevent violation of federal law or CDC policy. You may petition CDC to regain access to the Application through the support email address provided by CDC for the Application. If CDC determines in its sole discretion that the circumstances which led to the refusal to provide the Application or terminate access to the Application no longer exist, then CDC may restore your access. All provisions of these Terms, which by their nature should survive termination, shall survive termination including, without limitation, warranty disclaimers, and limitations of liability.

Intellectual Property – License Grant and Restrictions.

The Application provided to User are for User’s use. User may not modify, copy, distribute, transmit, display, perform, reproduce, publish, license, create derivative works from, transfer, or sell any information, software, products, or services obtained from CDC. Material provided by CDC are either owned by or the licensed property of the United States Department of Health and Human Services (“HHS”) and the Centers for Disease Control and Prevention (CDC). HHS/CDC grants to you a limited, non-exclusive, non-transferable license to access the Application in the United States for the uses set forth in these Terms.

Disclaimer of Warranties

The Application Platform is provided “as is” and on an “as-available” basis. While CDC will do its best to ensure the service is available and functional at all times, CDC hereby disclaims all warranties of any kind, express or implied, including without limitation the warranties of merchantability, fitness for a particular purpose, and non-infringement. CDC makes no warranty that data will be error free or that access thereto will be continuous or uninterrupted.

Limitations on Liability

In no event will HHS or CDC be liable with respect to any subject matter of these Terms or your use of the Application under any contract, negligence, strict liability or other legal or equitable theory for: (1) any personal injury, or any special, incidental, indirect or consequential damages; (2) the cost of procurement of substitute products or services; or (3) for loss of profits, interruption of use or loss or corruption of data or any other commercial damages or losses.

HHS and CDC are not responsible for confidentiality or any information shared by the Facility or other user of the Application.

Disputes, Choice of Law, Venue, and Conflicts

Any disputes arising out of these Terms and access to or use of the Application shall be governed by applicable United States Federal law. You further agree and consent to the jurisdiction of the Federal Courts located within the District of Columbia and the courts of appeal therefrom and waive any claim of lack of jurisdiction or forum non conveniens.

Indemnification

You agree to indemnify and hold harmless HHS, including CDC, its contractors, employees, agents, and the like, from and against any and all claims and expenses, including attorney’s fees, arising out of your use of the Application, including but not limited to violation of these Terms.

No Waiver of Rights

CDC’s failure to exercise or enforce any right or provision of these Terms shall not constitute waiver of such right or provision.

Data Analytics and Monitoring Metrics

While using the Application, certain general data analytics on the usage patterns and performance of the Application may be gathered and stored automatically to assist with design and development of the Application. This general usage data is not linked to an individual’s identity but IP address and device information may be included. Transactions are audited and stored for site monitoring, performance, and troubleshooting and may be tied to the individual performing an activity. Any such data will be maintained consistent with applicable federal laws.