Wyoming Administrative Code
Agency 048 - Health, Department of
Sub-Agency 0076 - Medical Digital Innovation
Chapter 1 - RULES AND REGULATIONS FOR THE MEDICAL DIGITAL INNOVATION SANDBOX
Section 1-6 - Authorization or Denial of Application

Universal Citation: WY Code of Rules 1-6

Current through September 21, 2024

(a) The Director shall authorize or deny a medical digital innovation sandbox application within ninety (90) days of receiving the application, subject to the following conditions:

(i) If the Department requires a criminal history background check under Section 5(c) of this Chapter, the application is not considered received until the Department receives the required state and national criminal history record information.

(ii) The Department and the applicant may jointly agree to extend the deadline beyond ninety (90) days.

(b) Upon receipt of a medical digital innovation sandbox application, the Department shall evaluate the application according to the following procedures and standards:

(i) The Department shall initially evaluate the application to determine if:
(A) The applicant is eligible pursuant to Section 4 of this Chapter; and

(B) The application is complete pursuant to Section 5 of this Chapter.

(ii) If the Department determines that a complete application has been submitted by an eligible applicant, the Department shall forward the application to the licensing board or authority that administers the statutory or rules requirements for which a waiver is sought, or to each of the respective licensing boards or authorities if a waiver is sought for more than one statutory or rules requirement.
(A) The licensing board or authority shall grant or deny the waiver within forty-five (45) days of receiving the forwarded application from the Department. The licensing board or authority shall promptly notify the Department of its decision in writing.

(B) The licensing board or authority may not grant a waiver unless the waiver is no broader than necessary to accomplish the purposes and standards set forth under the Medical Digital Innovation Sandbox Act, W.S. 40-28-101 to -108.

(C) If the licensing board or authority grants the waiver, the licensing board or authority shall specify in its notice to the Department:
(I) The statutory or rules requirements, or portions thereof, for which a waiver is granted; and

(II) Any minimum record keeping requirements recommended by the licensing board or authority under W.S. W.S. 40-28-105(c).

(D) The waiver is not deemed effective unless:
(I) The Director authorizes the application pursuant to subsection (c) of this Section; and

(II) A consumer protection bond is posted with the Department pursuant to Section 7(a) of this Chapter.

(iii) If the licensing board or authority grants the waiver, the Department shall convene a review committee to evaluate the medical digital innovation sandbox application. In the event that a waiver is sought for more than one statutory or rules requirement, the Department shall convene a review committee only if each of the respective licensing boards and authorities approves their respective waiver.
(A) The review committee must be comprised of at least three Department officials or employees, who possess relevant subject matter expertise and no conflicts of interest.

(B) The review committee shall evaluate the application based on the criteria established under W.S. 40-28-103(f). The review committee may request additional information from the applicant or from outside experts as needed to evaluate the application.

(C) Following its evaluation, the review committee shall recommend the Director to either authorize or deny an application in writing, explaining the basis for the committee's recommendation.

(c) Following the Department's evaluation pursuant to subsection (b) of this Section, the Director shall authorize or deny the medical digital innovation sandbox application, according to the following conditions:

(i) The Director shall deny the application if:
(A) The Department determines the applicant is ineligible;

(B) The Department determines the application is incomplete; or

(C) An appropriate licensing board or authority denies the waiver.

(ii) If the Department determines the applicant is eligible and the licensing board or authority grants the waiver, the Director shall base the decision to authorize or deny the application on the review committee's recommendation. The Director may reach a decision contrary to the review committee's recommendation, subject to his or her discretion and an independent evaluation of the application based on the criteria established under W.S. 40-28-103(f).

(iii) If the Director authorizes an application, the Director may impose conditions on the authorization consistent with the Medical Digital Innovation Sandbox Act, W.S. 40-28-101 to -108

(iv) If the Director denies an application, the applicant is not entitled to request a contested case proceeding pursuant to the Wyoming Administrative Procedure Act, W.S. 16-3-101 to -115.

(v) The Director shall issue his or her decision in writing.
(A) If the Director authorizes the application, the written decision must specify:
(I) The statutory or rule requirements, or portions thereof, for which the waiver is granted;

(II) The length of the initial sandbox period; and

(III) The conditions imposed on the authorization, if any.

(B) If the Director denies the application, the written decision must specify the reason for denial.

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