2022 Wyoming Statutes
Title 40 - Trade and Commerce
Chapter 28 - Medical Digital Innovation Sandbox Act
Section 40-28-105 - Operation of Medical Digital Innovation Sandbox.

40-28-105. Operation of medical digital innovation sandbox.

(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.