1 Del. Admin. Code § 104-4.0

Current through Reigster Vol. 28, No. 6, December 1, 2024

Section 104-4.0 - Structure and Duties of the Committee

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

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, 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 Reporting Entities whose Claims Data is being requested in all circumstances where Committee review is required by the enabling legislation and these regulations. The Committee shall approve an application by majority vote after finding the following:

4.4.1 The intended use is consistent with the statutory purpose of the HCCD;

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

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

4.4.4 The request complies, to the fullest extent practicable, with guidance found in Statement 6 of the Department of Justice and Federal Trade Commission Enforcement Policy regarding the exchange of price and cost information;

4.4.5 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 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.

4.7 In circumstances in which no Committee review of the application is required by this regulation, DHIN staff shall consider the information identified in subsection 4.4 prior to releasing data, and reserves the same rights as the Committee in subsection 4.5. DHIN's final determination shall not be subject to appeal. DHIN shall post disclosures made without Committee review as required by subsection 3.5.

1 Del. Admin. Code § 104-4.0

25 DE Reg. 625 (12/1/2021) (final)