1. (a) the applicant deviates significantly from its approved demonstration project design or protocols without approval from the commissioner;
2. (b) there is a significant change in the information or assurances contained in the application which were relevant factors upon which the application was granted favorable recommendation by the technical advisory groups and approved by the commissioner; or

3. (c) the applicant submits a written request to withdraw from the demonstration and the request is approved by the commissioner. A request to terminate a demonstration project prior to its scheduled completion must include documentation of at least one of the following factors:

   1. (1) that sufficient evidence of the costs associated with and benefits of the technology is available; or
   2. (2) that continuation of the project would result in serious financial hardship to the facility.

In addition to any other basis upon which an operating certificate or an approval of construction may be cancelled, terminated, withdrawn, or annulled pursuant to article 28 of the Public Health Law and this Chapter, an applicant's approval to participate in a medical technology demonstration project may be cancelled or terminated by the commissioner if: