; or (ii) products primarily designed for, or marketed to, covered entities and business associates (as defined for purposes of regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note)). (2) Direct-to-consumer genetic testing services The term direct-to-consumer genetic testing service means a service, which may include a test that analyzes various aspects of an individual's genetic material, that enables a consumer to have access to their genetic information, or to information derived therefrom, without the need to have a health care provider or health insurance issuer participate in the process of gaining access. (3) National coordinator The term National Coordinator means the National Coordinator for Health Information Technology at the Department of Health and Human Services. (4) Operator The term operator means any person who operates any type of consumer devices, services, applications, and software or who provides consumer devices, services, applications, and software for the use of consumers and collects or maintains personal health data from or about the users of such consumer devices, services, applications, and software. (5) Personal health data The term personal health data means any information, including genetic information, whether oral or recorded in any form or medium, that relates to the past, present, or future physical or mental health or condition of an individual and that identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual. (6) Secretary The term Secretary means the Secretary of Health and Human Services. 4. Promulgation of regulations for operators of consumer devices, services, applications, and software (a) In general Not later than 6 months after the date on which the report is submitted under section 5(d), the Secretary, in consultation with the Chairman of the Federal Trade Commission, the National