048.0076.1.7
Ch. 1, § 7. Operation in the Sandbox
Cite as Medical Digital Innovation Rules, Ch. 1, § 7
(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. 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.