SPONSOR Not Covered By HIPAA. SPONSOR represents, warrants and covenants, and the Institution and the Principal Investigator acknowledge such representation, warranty and covenant, that, except as otherwise required by Applicable Law, no component of SPONSOR or any of its affiliates that will be performing any of SPONSOR’s obligations under this Agreement: (a) is a “Covered Entity,” (b) will become a “Business Associate” of a Covered Entity by performing its obligations under this Agreement or (c) is otherwise governed by HIPAA. Nevertheless, SPONSOR agrees to fully cooperate and to not interfere with the efforts of Institution to maintain compliance with HIPAA and other applicable laws and regulations concerning the use, disclosure, and maintenance of patient medical records and other health information. SPONSOR agrees to abide by the terms of the informed consent form and HIPAA authorization signed by Subjects, and to comply with all federal and state health information confidentiality laws and regulations applicable to it. If SPONSOR gains access to any Subject medical records or protected health information that is not covered by an informed consent form or HIPAA authorization, SPONSOR shall hold such information in the strictest confidence, shall not remove records containing such information from the Institution and, if inadvertently removed, shall immediately return any records containing such information to the Institution.
SPONSOR Not Covered By HIPAA. SPONSOR represents, warrants and covenants, and the Institution and the Principal Investigator acknowledge such representation, warranty and covenant, that, except as otherwise required by Applicable Law, no component of SPONSOR or any of its affiliates that will be performing any of SPONSOR’s obligations under this Agreement: (a) is a “Covered Entity,” (b) will become a “Business Associate” of a Covered Entity by performing its obligations under this Agreement or (c) is otherwise governed by HIPAA. Nevertheless, SPONSOR agrees to fully cooperate and to not interfere with the efforts of Institution to maintain compliance with HIPAA and other applicable laws and regulations concerning the use, disclosure, and maintenance of patient medical records and other health information. SPONSOR agrees to abide by the terms of the informed consent form and HIPAA authorization signed by Subjects, and to comply with all federal and state health information confidentiality laws and regulations applicable to it. If SPONSOR gains access to any Subject medical records or protected health information that is not covered by an informed consent form or HIPAA authorization, SPONSOR shall hold such information in the strictest confidence, shall not remove records containing such information from the Institution and, if inadvertently removed, shall immediately return, without retaining a copy, any records containing such information to the Institution. SPONSOR will not contact any Subject unless permitted by the signed ICF. SPONSOR will not use or share individually identifiable health information for any mailing list or for any marketing purpose. SPONSOR will use all reasonable efforts to protect the privacy and security of individually identifiable health information and will require its business partners to do so also. SPONSOR will collect, use, store, and disclose any specimens/tissue it receives only in accordance with the Protocol and signed ICF, and in any event will not collect, use, store, or disclose any individually identifiable health information attached to or contained within the specimens/tissue in any manner that would violate this Section. No other provision of this Agreement shall be construed to override the provisions of this section.
SPONSOR Not Covered By HIPAA. SPONSOR represents, warrants and covenants, and the Institution and the Principal Investigator acknowledge and agree, that no component of SPONSOR or any of its affiliates that will be performing any of SPONSOR’s obligations under this Agreement: (a) is a “Covered Entity,” (b) will become a “Business Associate” of a Covered Entity by performing its obligations under this Agreement or (c) is otherwise governed by HIPAA.
