Sec. 3. Definitions

405 words·~2 min read·/bill/117/s/24/is/section-3

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In this Act: Except as provided in subparagraph (C), the term consumer devices, services, applications, and software means devices, services, applications, and software— that are primarily designed for or marketed to consumers; and a substantial purpose or use of which is to collect or use personal health data. The term consumer devices, services, applications, and software shall include, but is not limited to— direct-to-consumer genetic testing services; cloud-based or mobile technologies that are designed to collect individuals’ personal health data directly or indirectly with individuals’ consent, which could enable sharing of such information, such as wearable fitness trackers; and internet-based social media sites which are primarily designed for, or marketed to, consumers to collect or use personal health data, including sites that share health conditions and experiences.

The term consumer devices, services, applications, and software shall not include— products on which personal health data is derived solely from other information that is not personal health data, such as Global Positioning System data; or 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)).

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. The term National Coordinator means the National Coordinator for Health Information Technology at the Department of Health and Human Services.

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. 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.

The term Secretary means the Secretary of Health and Human Services.

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42 USC 1320d–2

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Sec. 3

Definitions

Cite42 USC 1320d–2

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