G.S. § 114B-6(a)-(f)
Plain Language
The Department of Justice has broad inspection authority over licensed health-information chatbots, including both physical and digital inspections. Digital inspections may cover source code, algorithms, ML models, data practices, cybersecurity, user privacy protections, chatbot behavior testing, and integration with other platforms. The Director may require access to all development, testing, validation, production, distribution, and performance records. Trade secrets and confidential commercial information obtained during inspections are protected from public disclosure. Following inspections, the Director issues a detailed findings report with required corrective actions. Manufacturers and importers must establish and maintain records and submit reports as required by regulation. Licensees must maintain documentation in a form that can be produced to the Department upon request.
Statutory Text
(a) The Department shall enforce the provisions of, and the rules adopted under, this Chapter. (b) The Attorney General shall designate a Director, officers, and employees assigned to the oversight and enforcement of this Chapter. Upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, those officers and employees are authorized to enter, at reasonable times, any factory, warehouse, or establishment in which chatbots licensed under this Chapter are manufactured, processed, or held, and to inspect, in a reasonable manner and within reasonable limits and in a reasonable time. In addition to physical inspections, the Department may conduct digital inspections of licensed chatbots under this Chapter, to include the following: (1) Examination of source code, algorithms, and machine learning models. (2) Review of data processing and storage practices. (3) Evaluation of cybersecurity measures and protocols. (4) Assessment of user data privacy protections. (5) Testing of chatbot responses and behaviors in various scenarios. (6) Audit of data collection, use, and retention practices. (7) Inspection of software development and update processes. (8) Review of remote access and monitoring capabilities. (9) Evaluation of integration with other digital health technologies or platforms. (c) As part of any inspection, whether physical or digital, the Director may require access to all records relating to the development, testing, validation, production, distribution, and performance of a chatbot licensed under this Chapter. (d) Any information obtained during an inspection which falls within the definition of a trade secret or confidential commercial information, as defined in 21 C.F.R. § 20.61, shall be treated as confidential and shall not be disclosed under Chapter 132 of the General Statutes, except as may be necessary in proceedings under this Chapter or other applicable law. (e) Following any inspection, the Director shall provide a detailed report of findings to the manufacturer or importer, including any identified deficiencies and required corrective actions. (f) Every person who is a manufacturer or importer of a licensed chatbot under this Chapter shall establish and maintain such records, and make such reports to the Director, as the Director may by regulation reasonably require to assure the safety and effectiveness of such devices.