Healthcare Investigator Undertaking

HEALTHCARE INVESTIGATOR UNDERTAKING

Healthcare Facility Name:     Investigator Name:

Effective Date:

RECITALS

This Undertaking sets forth the obligations of the Investigator and the Facility in connection with Investigator's access to, use of, and handling of protected health information, medical records and other confidential healthcare information in the custody or control of the Healthcare Facility. The Investigator agrees to comply with all applicable law, institutional policies, and the terms set forth below.

FACILITY CONTACT

INVESTIGATOR INFORMATION

SCOPE OF ACCESS AND PURPOSE

Purpose for access (describe the authorized activity, research or audit purpose):

Types of information to be accessed (check all that apply):

AUTHORIZED ACCESS PERIOD

Access commencement date:

Access termination date:

INVESTIGATOR OBLIGATIONS

The Investigator covenants and agrees to the following as conditions to access and use of Facility-held information:

1. Confidentiality and Use: Use protected health information solely for the Purpose for Access identified above and not for any unrelated purpose. No re-disclosure, sale, or transfer of identifiable information is permitted without express written authorization from the Facility and, where required, the subject.
2. Compliance with Law: Comply with all applicable privacy, data protection and health information laws and Facility policies, including applicable provisions governing protected health information.
3. Minimum Necessary: Limit access, copying and retention to the minimum necessary to accomplish the Purpose for Access.
4. Security Safeguards: Implement and maintain administrative, technical and physical safeguards appropriate to the sensitivity of the information accessed.
5. Reporting: Promptly report any unauthorized access, use, loss or disclosure to the Facility Contact Person named above and cooperate in any investigation or remediation.

BREACH NOTIFICATION AND COOPERATION

The Investigator shall notify the Facility Contact Person without unreasonable delay upon discovery of any actual or suspected breach of confidentiality or security. Notification shall include a description of the nature of the breach, affected records, steps taken to mitigate harm, and planned corrective actions. The Investigator will cooperate fully with Facility investigations and any required notifications to affected individuals or authorities.

TRAINING AND AUTHORIZATION

The Investigator affirms completion of required training and orientation for the handling of protected health information and institutional policies governing data privacy.

Training completion date:

RETURN OR DESTRUCTION OF INFORMATION

Upon expiration or termination of this Undertaking or upon request by the Facility, the Investigator shall return or securely destroy all copies of Facility-held information in Investigator's possession in a manner consistent with law and Facility policy, and shall certify in writing the completion of such return or destruction.

INDEMNIFICATION, REMEDIES AND REPRESENTATIONS

The Investigator shall indemnify, defend and hold harmless the Facility from and against any claims, liabilities, damages, losses or expenses (including reasonable attorneys' fees) arising from Investigator's breach of this Undertaking or unauthorized access, use or disclosure. Remedies for breach include immediate suspension of access, termination of this Undertaking and pursuit of legal or equitable relief.

ACKNOWLEDGMENT AND CERTIFICATION

By signing below, the Investigator and the Authorized Representative of the Facility certify that they have read, understand and will comply with the terms of this Undertaking; that access will be limited to authorized personnel and purposes described herein; and that unauthorized access or disclosure may result in disciplinary, civil and criminal penalties under applicable law.

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