Common use of Covered Entities Clause in Contracts

Covered Entities. For each Study, the Institution and the applicable Principal Investigator each represent, certify and covenant that they may be or have affiliates that are “Covered Entities” under the provisions of the Health Insurance Portability and Accountability Act of 1996 and any regulations and official guidance promulgated thereunder (“HIPAA”). Institution and the Principal Investigator shall handle all Study Documentation (including Subjects’ medical records) in accordance with all applicable HIPAA requirements and all other Applicable Laws and shall ensure that they obtain from each Subject a valid authorization that complies with HIPAA and is, in form and substance, acceptable to SPONSOR, in order for the Institution and the Principal Investigator to provide SPONSOR with the Study Documentation and to satisfy their other obligations under this Agreement with respect to the Study Documentation.

Covered Entities. For each Study, the The Institution and the applicable Principal Investigator each represent, certify and covenant that they may be or have affiliates that are it is a “Covered Entities” under the provisions of the Health Insurance Portability and Accountability Act of 1996 and any regulations and official guidance promulgated thereunder (“HIPAA”). The Institution and the Principal Investigator shall handle all Study Documentation (including Subjects’ medical records) in accordance with all applicable HIPAA requirements and all other Applicable Laws and shall ensure that they obtain from each Subject a valid authorization that complies with HIPAA and is, in form and substance, acceptable to SPONSOR, in order for the Institution and the Principal Investigator to provide SPONSOR with the Study Documentation and to satisfy their other obligations under this Agreement with respect to the Study Documentation.

Covered Entities. For each Study, the Institution and the applicable Principal Investigator each represent, certify and covenant that they may be or have affiliates that are “Covered Entities” under the provisions of the Health Insurance Portability and Accountability Act of 1996 and any regulations and official guidance promulgated thereunder (“HIPAA”). Institution and the Principal Investigator shall handle all Study Documentation (including Subjects’ medical records) in accordance with all applicable HIPAA requirements and all other Applicable Laws and shall ensure that they obtain from each Subject a valid authorization that complies with HIPAA and is, in form and substance, acceptable to SPONSOR, in order for the Institution and the Principal Investigator to provide SPONSOR with the Study Documentation and to satisfy their other obligations under this Agreement with respect to the Study Documentation, unless otherwise approved by SPONSOR.

Covered Entities. For each StudyTrial, the Institution and the applicable Principal Investigator each represent, certify and covenant that they may be or have affiliates that are “Covered Entities” under the provisions of the Health Insurance Portability and Accountability Act of 1996 and any regulations and official guidance promulgated thereunder (“HIPAA”). Institution and the Principal Investigator shall handle all Study Trial Documentation (including Subjects’ medical records) in accordance with all applicable HIPAA requirements and all other Applicable Laws and shall ensure that they obtain from each Subject a valid authorization that complies with HIPAA and is, in form and substance, acceptable to SPONSOR, in order for the Institution and the Principal Investigator to provide SPONSOR with the Study Trial Documentation and to satisfy their other obligations under this Agreement with respect to the Study Trial Documentation, unless otherwise approved by SPONSOR.