This text of Wyoming § 7-19-201 ((e) An application made under this section shall be
accompanied by a fee of five hundred dollars ($500.00). The fee
shall be deposited into the medical digital innovation account
as provided in W.S. 40-28-104) is published on Counsel Stack Legal Research, covering Wyoming primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
(f)The department shall authorize or deny a medical
digital innovation sandbox application in writing within ninety
(90)days of receiving the application. The department and the
person who has made an application may jointly agree to extend
the time beyond ninety (90) days. The department may impose
conditions on any authorization, consistent with this act. In
deciding to authorize or deny an application under this
subsection, the department shall consider each of the following:
(i)The nature of the innovative medical digital
assessment product or service proposed to be made available to
consumers in the sandbox, including all relevant technical
details;
(ii)The potential risk to consumers and methods
which will be used to protect consumers and resolve complaints
during the sandbox per
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(f) The department shall authorize or deny a medical
digital innovation sandbox application in writing within ninety
(90) days of receiving the application. The department and the
person who has made an application may jointly agree to extend
the time beyond ninety (90) days. The department may impose
conditions on any authorization, consistent with this act. In
deciding to authorize or deny an application under this
subsection, the department shall consider each of the following:
(i) The nature of the innovative medical digital
assessment product or service proposed to be made available to
consumers in the sandbox, including all relevant technical
details;
(ii) The potential risk to consumers and methods
which will be used to protect consumers and resolve complaints
during the sandbox period;
(iii) A prototyping, use case or scaling plan
proposed by the person, including a statement of arranged
capital;
(iv) Whether the person has the necessary personnel,
adequate medical digital and technical expertise and a
sufficient plan to test, monitor and assess the innovative
medical digital assessment product or service;
(v) Whether any person substantially involved in the
development, operation or management of the innovative medical
digital assessment product or service has:
(A) Been convicted of or is currently under
investigation for federal or state crimes;
(B) Had any professional license revoked or
suspended.
(g) If an application is authorized under subsection (f)
of this section, the department shall specify the statutory or
rule requirements, or portions thereof, for which a waiver is
granted and the length of the initial sandbox period. The
department shall also post notice of the approval of a sandbox
application under this subsection, a summary of the innovative
medical digital assessment product or service and the contact
information of the person making the product or service
available through the sandbox on the internet website of the
department.
(h) A person authorized under subsection (f) of this
section to enter into the medical digital innovation sandbox
shall post a consumer protection bond with the department as
security for potential losses suffered by consumers who use an
innovative medical digital assessment product or service offered
by the person. The bond amount shall be determined by the
department in an amount not less than ten thousand dollars
($10,000.00) and shall be commensurate with the risk profile of
the innovative medical digital assessment product or service.
The department may require that a bond under this subsection be
increased or decreased at any time based on risk profile. Unless
a bond is enforced under W.S. 40-28-108(b)(ii), the department
shall cancel or allow the bond to expire two (2) years after the
date of the conclusion of the sandbox period.
(j) Authorization under subsection (f) of this section
shall not be construed to create a property right.