1 Del. Admin. Code § 102-6.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 102-6.0 - Additional Agreements

6.1 Upon the Committee's approval of an application for Available Clinical Data or DHIN's agreement to provide de-identified data following the conclusion of any process or procedures required by the Committee or the Board, the requesting party shall sign a legally binding data use agreement.

6.2 The data use agreement will include but not be limited to:

6.2.1 Confirmation of compliance with such confidentiality and data security protocols as may be required by DHIN or the Committee, in all cases to include compliance with HIPAA and relevant Delaware law on the privacy and security of health information;

6.2.2 Confirmation of compliance with the re-disclosure requirements set forth in this regulation and identified in the application;

6.2.3 Commitment to use Available Clinical Data for the sole purpose of executing the project identified in the application and approved by DHIN or the Committee;

6.2.4 Commitment to document data destruction processes at the end of the project; and

6.2.5 Commitment to comply with all statutory and regulatory requirements.

6.3 DHIN may require a successful applicant to enter into such additional agreements as may be determined by DHIN or the Committee, in their discretion, to be necessary or desirable to permit DHIN to comply with its legal obligations in fulfilling the requirements of this regulation.

1 Del. Admin. Code § 102-6.0

25 DE Reg. 624 (12/1/2021) (final)