Virginia Administrative Code › Title 12 - HEALTH › Agency 35 - DEPARTMENT OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES › Chapter 180 - REGULATIONS TO ENSURE THE PROTECTION OF SUBJECTS IN HUMAN RESEARCH › Section 12VAC35-180-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter shall
				  have the following meanings unless the context clearly indicates
				  otherwise:
"Affiliated with the institution" means employed by the
				  institution or a member of a household containing an employee of the
				  institution.
"Board" means the State Board of Behavioral Health and
				  Developmental Services.
"Commissioner" means the Commissioner of the Department of
				  Behavioral Health and Developmental Services.
"Community services board" or "CSB" means the public body
				  established pursuant to §
									37.2-501
				  of the Code of Virginia that provides mental health, developmental, and
				  substance abuse services to individuals within each city or county that
				  established it. For the purpose of these regulations, community services board
				  also includes a behavioral health authority established pursuant to §
									37.2-602
				  of the Code of Virginia.
"Department" means the Department of Behavioral Health and
				  Developmental Services.
"Health information" means "health information" pursuant to
				  45
				  CFR 160.103 or any information, whether oral
				  or recorded in any form or medium, that:
1. Is created or received by a health care
				provider, health plan, public health authority, employer, life insurer, school
				or university, or health care clearinghouse; and
2. Relates to the past, present, or future
				physical or mental health or condition of an individual; the provision of
				health care to an individual; or the past, present, or future payment for the
				provision of health care to an individual.
"Human research" means any systematic investigation,
				  including research development, testing, and evaluation, utilizing human
				  subjects, that is designed to develop or contribute to generalized knowledge.
				  Human research shall not include research exempt from federal research
				  regulation pursuant to
				  45 CFR
				  46.101(b).
"Individual" means a human subject pursuant to
				  45 CFR
				  46.102(e)(1) about whom an
				  investigator (whether professional or student) conducting research obtains (i)
				  data through interaction with the individual; or (ii) identifiable private
				  information pursuant to
				  45 CFR
				  46.102(e)(5).
"Individually identifiable health information" means
				  information that is a subset of health information, including demographic
				  information collected from an individual, and:
1. Is created or received by a health care
				provider, health plan, employer, or health care clearinghouse; and
2. Relates to the past, present, or future
				physical or mental health or condition of an individual; the provision of
				health care to an individual; or the past, present, or future payment for the
				provision of health care to an individual; and
a. That identifies the individual;
				or
b. With respect to which there
				is a reasonable basis to believe the information can be used to identify the
				individual.