Section 40-28-106 - Revocation or Suspension of Medical Digital Innovation Sandbox Authorization. Note: This Is Effective as of 1/1/2020.

WY Stat § 40-28-106 (2019) (N/A)

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40-28-106. Revocation or suspension of medical digital innovation sandbox authorization. Note: this is effective as of 1/1/2020.

(a) The department may, by order, revoke or suspend authorization granted to a person under W.S. 40-28-103(f) if:

(i) The person has violated or refused to comply with this act or any lawful rule, order or decision adopted by the department;

(ii) A fact or condition exists that, if it had existed or become known at the time of the medical digital innovation sandbox application, would have warranted denial of the application or the imposition of material conditions;

(iii) A material error, false statement, misrepresentation or material omission was made in the medical digital innovation sandbox application; or

(iv) After consultation with the person, continued testing of the innovative medical digital assessment product or service would:

(A) Be likely to harm consumers; or

(B) No longer serve the purposes of this act because of the medical digital or operational failure of the product or service.

(b) Written notification of a revocation or suspension order made under subsection (a) of this section shall be served using any means authorized by law, and if the notice relates to a suspension, include any conditions or remedial action which shall be completed before the suspension will be lifted by the department.

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Section 40-28-107 - Extension of Sandbox Period. Note: This Is Effective as of 1/1/2020.