(a)Except as otherwise provided by W.S. 40-28-107, a
person authorized under W.S. 40-28-103(f) to enter into the
medical digital innovation sandbox may make an innovative
medical digital assessment product or service available to
consumers during the sandbox period.
(b)Before a consumer purchases or enters into an
agreement to receive an innovative medical digital assessment
product or service through the medical digital innovation
sandbox, the person making the product or service available
shall provide a written statement of the following to the
consumer:
(i)The name and contact information of the person
making the product or service available to consumers;
(ii)That the product or service has been authorized
to be made available to consumers for a temporary period by the
department a
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(a) Except as otherwise provided by W.S. 40-28-107, a
person authorized under W.S. 40-28-103(f) to enter into the
medical digital innovation sandbox may make an innovative
medical digital assessment product or service available to
consumers during the sandbox period.
(b) Before a consumer purchases or enters into an
agreement to receive an innovative medical digital assessment
product or service through the medical digital innovation
sandbox, the person making the product or service available
shall provide a written statement of the following to the
consumer:
(i) The name and contact information of the person
making the product or service available to consumers;
(ii) That the product or service has been authorized
to be made available to consumers for a temporary period by the
department and the appropriate licensing board or authority, as
applicable, under the laws of Wyoming;
(iii) That the state of Wyoming does not endorse the
product or service and is not subject to liability for losses or
damages caused by the product or service;
(iv) That the product or service is undergoing
testing, may not function as intended and may entail medical
assessment risk;
(v) That the person making the product or service
available to consumers is not immune from civil liability for
any losses or damages caused by the product or service;
(vi) The expected end date of the sandbox period;
(vii) The name and contact information of the
department and board or authority, as applicable, and
notification that suspected legal violations, complaints or
other comments related to the product or service may be
submitted to the department;
(viii) Any other statements or disclosures required
by rule of the department which are necessary to further the
purposes of this act.
(c) A person authorized to make an innovative medical
digital assessment product or service available to consumers in
the medical digital innovation sandbox shall maintain
comprehensive records relating to the innovative medical digital
assessment product or service. The person shall keep these
records for not less than five (5) years after the conclusion of
the sandbox period. The department may specify further records
requirements under this subsection by rule.
(d) The department or licensing board or authority, as
applicable, may examine the records maintained under subsection
(c) of this section at any time, with or without notice. All
direct and indirect costs of an examination conducted under this
subsection shall be paid by the person making the innovative
medical digital assessment product or service available in the
medical digital innovation sandbox. Records made available under
this subsection shall be confidential and shall not be subject
to disclosure under the Wyoming Public Records Act but may be
released to appropriate state and federal agencies for the
purposes of investigation.
(e) Unless granted an extension pursuant to W.S. 40-28-
107, not less than thirty (30) days before the conclusion of the
sandbox period, a person who makes an innovative medical digital
assessment product or service available in the medical digital
innovation sandbox shall provide written notification to
consumers regarding the conclusion of the sandbox period and
shall not make the product or service available to any new
consumers after the conclusion of the sandbox period until legal
authority outside of the sandbox exists to make the product or
service available to consumers. The person shall wind down
operations with existing consumers within sixty (60) days after
the conclusion of the sandbox period, except that, after the
sixtieth day, the person may:
(i) Collect and receive money owed to the person,
based on agreements with consumers made before the conclusion of
the sandbox period;
(ii) Take necessary legal action; and
(iii) Take other actions authorized by the department
by rule which are not inconsistent with this subsection.
(f) The department may enter into agreements with state,
federal or foreign regulatory agencies to allow persons who make
an innovative medical digital assessment product or service
available in Wyoming through the medical digital innovation
sandbox to make their products or services available in other
jurisdictions and to allow persons operating in similar medical
digital innovation sandboxes in other jurisdictions to make
innovative medical digital assessment products and services
available in Wyoming under the standards of this act.