(a) If eligible
under Section
4 of this Chapter, a person may apply to the
Department to make an innovative medical digital assessment product or service
available to consumers in the medical digital innovation sandbox in the form
and manner publicly-posted online at the Department's website:
https://health.wyo.gov.
(b) At a minimum, the application must
include:
(i) A statement of:
(A) The specific statutory or rule
requirements for which a waiver is sought; and
(B) The reasons why these requirements
prohibit the innovative medical digital assessment product or service from
being made available to consumers;
(ii) A description of the innovative medical
digital assessment product or service proposed to be made available to
consumers in the sandbox, including all relevant technical details;
(iii) A description of the potential risks to
consumers and the methods that will be used to protect consumers and resolve
complaints during the sandbox period;
(iv) A proposed prototyping, use case, or
scaling plan, including a statement of arranged capital;
(v) A summary of the experiences and
qualifications of the personnel who will test, monitor, and assess the
innovative medical digital assessment product or service;
(vi) A description of the business entity's
medical digital and technical expertise, including a summary of any products or
services currently available to consumers from the business entity;
(vii) A description of the business entity's
plan to test, monitor, and assess the innovative medical digital assessment
product or service;
(viii) A
statement whether any person substantially involved in the development,
operation, or management of the innovative medical digital assessment product
or services has:
(A) Been convicted of or is
currently under investigation for federal or state crimes; or
(B) Had any professional license revoked or
suspended;
(ix) Proof
that the business entity is a domestic corporation or other organized domestic
entity;
(x) Proof that the business
entity has a physical presence, other than that of a registered office or
agent, in Wyoming;
(xi) If the
applicant is an employee of the business entity, a letter documenting the
entity's consent signed by an authority authorized to act on the entity's
behalf, including, as relevant, the owner, managing partner, board of
directors, president, chief executive officer, or managing member;
and
(xii) The five hundred dollar
($500) application fee.
(c) The Department may require the applicant
and any other individuals who are substantially involved in the development,
operation, or management of the innovative medical digital assessment product
or service to submit to a criminal history background check pursuant to
W.S.
7-19-201.
