26:2H-7d Certain health care equipment exempt.
18. Notwithstanding the provisions of P.L.1971, c.136 (C.26:2H-1 et seq.) to the contrary, health care equipment which involves new technology that is not identified in N.J.A.C.8:33 et seq., shall not be subject to certificate of need requirements and may be initiated in the State in accordance with the requirements of this section.
a. The new technology shall be directly related to a health care service for which the provider is already licensed and has obtained a certificate of need, when required.
b. The provider shall notify the Commissioner of Health about the intent to initiate the new technology at least 60 days prior to the date the provider will begin use of the technology.
c. The new technology shall have pre-market approval from the federal Food and Drug Administration.
d. The provider shall use the new technology in accordance with guidelines approved by The Joint Commission until such time as the Department of Health has adopted licensing standards for the new technology. The provider shall be required to comply with the department's licensing standards for the new technology upon adoption of the standards.
e. The provider shall agree to submit to the department appropriate patient information and other data concerning use of the new technology to assist the department in establishing licensing standards. The provider shall submit the information and other data on a quarterly basis until such time as licensing standards are adopted for the new technology.
f. The commissioner may suspend a provider's use of the new technology if he determines that the provider is not in compliance with the requirements of this section.
L.1998, c.43, s.18; amended 2012, c.17, s.171.