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 1-7 - Operation in the Sandbox

Universal Citation: WY Code of Rules 1-7

Current through September 21, 2024

(a) Prior to the commencement of the sandbox period, a person authorized to operate in the sandbox shall:

(i) Post a consumer protection bond with the Department in an amount established by the Department pursuant to W.S. 40-28-103(h); and

(ii) Provide the Department a copy of the written statement to consumers required under W.S. W.S. 40-28-105(b).

(b) A person authorized to operate in the sandbox shall maintain comprehensive records relating to the innovative medical digital assessment product or service pursuant to W.S. 40-28-105(c).

(c) No less than thirty days prior to the expiration of the sandbox period, a person authorized to operate in the sandbox shall:

(i) Provide notice to all consumers pursuant to W.S. 40-28-105(e); and

(ii) Provide the Department a written description of the plan to wind-down operations with existing consumers pursuant to W.S. 40-28-105(e), as well as a copy of the notice provided to consumers.

(d) The Director may revoke or suspend an authorization to operate in the sandbox at any time pursuant to W.S. 40-28-106. If the Director revokes or suspends an authorization, the person formerly authorized to operate in the sandbox is not entitled to request a contested case proceeding pursuant to the Wyoming Administrative Procedure Act, W.S. 16-3-101 to -115.

(e) A person authorized to operate in the sandbox may apply for an extension of the initial sandbox period pursuant to W.S. 40-28-107, in the form and manner publicly-posted online at the Department's website: https://health.wyo.gov. If the Director denies an application for extension, 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. An application for extension shall, at minimum, include the following:

(i) All relevant supporting information demonstrating that either:
(A) Statutory or rule amendments are necessary to conduct business in Wyoming on a permanent basis; or

(B) An application for a license or other authorization required to conduct business in Wyoming on a permanent basis has been filed with the appropriate office and approval is currently pending;

(ii) The length of time for which an extension is requested, not to exceed twelve months; and

(iii) Written approval of the extension from the licensing board or authority, or each of the licensing boards and authorities, if more than one, that approved the initial waiver.

Disclaimer: These regulations may not be the most recent version. Wyoming may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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