40-28-103. Medical digital innovation sandbox application; standards for approval; consumer protection bond.
(a) A person shall apply to the department to make an innovative medical digital assessment product or service available to consumers in the medical digital innovation sandbox, based on the licensing board or authority that administers the statute or rule, or portion thereof, for which a waiver is sought. If an application is filed with a licensing board or authority that does not administer the statute or rule for which a waiver is sought, the receiving board or authority shall forward the application to the correct board or authority. The person shall specify in an application the statutory or rule requirements for which a waiver is sought and the reasons why these requirements prohibit the innovative medical digital assessment product or service from being made available to consumers. The application shall also contain the elements required for authorization which are set forth in subsection (f) of this section. The department shall, by rule, prescribe a method of application.
(b) A business entity making an application under this section shall be a domestic corporation or other organized domestic entity with a physical presence, other than that of a registered office or agent, in Wyoming.
(c) Before an employee applies on behalf of an institution, firm or other entity intending to make an innovative medical digital assessment product or service available through the medical digital innovation sandbox, the employee shall obtain the consent of the institution, firm or entity before filing an application under this section.
(d) The individual filing an application under this section and the individuals who are substantially involved in the development, operation or management of the innovative medical digital assessment product or service shall, if requested by the department as a condition of the application, submit to a criminal history background check pursuant to W.S. 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.
(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.