Md. Code Regs. 10.25.05.10

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.25.05.10 - Executive Director Review and Decision on Requests for Data

A. Before making a decision on an application requesting data, the Executive Director shall:

(1) Review and consider the DRAC's written report and recommendation;

(2) Review all public comment received;

(3) Determine whether the approval criteria set forth in Regulation .09C of this chapter have been met; and

(4) Determine whether any of the disapproval criteria set forth in Regulation .09C of this chapter exists for disapproval of an application under Regulation .09D of this chapter.

B. If the Executive Director determines that there is insufficient information upon which to base a decision on an application, the Executive Director may refer an application back to the DRAC with a request that the DRAC, through Commission staff, obtain and provide more specific or additional information, conduct a more detailed review and evaluation of the review criteria, and, if appropriate, submit a revised written report and recommendation.

C. After considering the DRAC's written report and recommendation on an application, the Executive Director shall issue a written decision:

(1) Approving an application;

(2) Approving an application subject to conditions, which shall be included as conditions in the data use agreement required under Regulation .13 of this chapter; or

(3) Disapproving an application.

D. If the Executive Director decides not to adopt the DRAC's recommendation, specifically to approve an application that the DRAC has recommended be disapproved, or to disapprove an application that the DRAC has recommended be approved, then the Executive Director shall prepare a proposed recommended decision and refer to the full Commission for consideration and issuance of a final decision affirming, reversing, or modifying the Executive Director's recommended decision.

E. The Executive Director may exercise the discretion not to make a decision on an application and refer the DRAC's written report and recommendation, and all public comment received on an application, to a review panel of 3 Commission members, which shall include a consumer member of the Commission. A review panel may render a final written decision on the application, or elect not to make a decision and refer the application to the full Commission for a decision.

F. The Executive Director may not make a decision on an application that proposes to develop and sell a product that contains requested de-identified data and shall refer the application, the DRAC's written report and recommendation, and all public comment received on the application to the full Commission for a decision.

G. The Executive Director, a review panel, or the full Commission, as applicable, shall issue a written decision notifying an applicant that an application has been approved, approved with conditions, or disapproved. The written decision shall state the conditions imposed, if any, and, if an application is disapproved, state the reasons for disapproval.

Md. Code Regs. 10.25.05.10

Regulation .10 adopted effective 48:25 Md. R.1071-1098, eff. 12/13/2021