1 Del. Admin. Code § 102-4.0

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

Section 102-4.0 - Structure and Duties of the Committee

4.1 The Committee shall have a chairperson and members appointed by the Board.

4.2 The Committee shall be comprised of five (5) to eleven (11) members and shall be representative of various stakeholder groups, including, where possible, consumers, employers, health plans, hospitals, physicians, ACO Administrators, researchers, and State government.

4.3 The Committee shall finalize a data request application, establish business operating rules for the review and consideration of applications, and determine a schedule for reviewing applications. These business rules shall be subject to periodic updates by the Committee and shall be maintained on the DHIN website.

4.4 The Committee shall consider any comments received from Data Sending Organizations whose Available Clinical Data is being requested. The Committee shall approve an application by majority vote after finding the following:

4.4.1 The intended use is consistent with the Act;

4.4.2 Access to the requested data is necessary to achieve the intended goals, including but not limited to the need for any requested identifiable data;

4.4.3 The request complies with all applicable state and federal laws relating to the privacy and security of PHI; and

4.4.4 The applicant is qualified to serve as a responsible steward of the requested data.

4.5 The Committee reserves the right to ask an applicant to acquire Institutional Review Board review, or its equivalent, prior to approving an application.

4.6 The Committee may ask for any information or assurances from a requesting party that it determines, in its discretion, may be needed in order to evaluate the application.

4.7 After a decision is reached by the Committee, public notice will be posted on the DHIN website that an application for data access was received, by whom it was submitted and for what purposes, and the decision of the Committee to grant or deny the application. The final determination of the Committee shall not be subject to appeal.

1 Del. Admin. Code § 102-4.0

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