Section 97380 - Additional Definitions for this ArticleIn addition to the definitions in section 97300, the following definitions apply to this article:
(a) "Aggregated data" means that the data does not have any record-level information about individuals, and only has collective data that relates to a group or category of services or individuals.(b) "Authorized representative" means, if the data applicant is not an individual, the individual who will have overall responsibility and authority over the requested program data on behalf of the data applicant.(c) "Confidential Data" means program data that has PII or record-level information about patients or individual consumers. This includes aggregated data that is identifiable.(d) "Custom Limited Datasets" are datasets other than standardized limited datasets, with confidential data that do not include any of the direct personal identifiers listed in Section 164.514(e) of Title 45 of the Code of Federal Regulations.(e) "Data Applicant(s)" or "Applicant(s)" means any individual, group of individuals, or organization that submits an application for program data under this Article. For applications under sections 97394 and 97398, data applicant may be used interchangeably with Principal Investigator (PI) and Co-Principal Investigator (Co-PI).(f) "Data Product" means information derived, in whole or in part, from program data, including, but not limited to, visualizations, summary data tables, report findings, listings, or publications.(g) "Data Release Committee" means the committee established pursuant to Health and Safety Code section 127673.84.(h) "Data User" means a data applicant that has been approved for program data under this Article.(i) "Direct Transmission" means the Department sending copies of program data outside the enclave directly to an individual or organization.(j) "Enclave" is the program's secure online data access environment, required by Health and Safety Code Section 127673.82(d), through which individuals will be able to remotely observe, use, or control program data.(k) "Personally Identifiable Information" or "PII" is any information that can be reasonably used to distinguish or trace an individual's identity, either alone or when combined with other information.(l) "Program Data" means all information created, obtained, or maintained by the program. This includes confidential data.(m) "Program Goals" means the purposes stated for the program in Health and Safety Code sections 127671 and 127673.5(a).(n) "Public data products" mean data products created by data users that are intended for disclosure publicly or to individuals not approved for program data under an approved data application.(o) "Record-level" means information about a single individual.(p) "Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge as stated in Section 164.501 of Title 45 of the Code of Federal Regulations.(q) "Research Identifiable Data" means confidential data with the direct personal identifiers listed in Section 164.514(e) of Title 45 of the Code of Federal Regulations.(r) "Researcher" means an individual, who routinely conducts health care or health care related research, and meets all of the following criteria:(1) Has possession of a bachelor's degree or higher-level degree in a field that conducts research. These fields include, but are not limited to, physical sciences, life sciences, social sciences, and medical sciences;(2) Is research-affiliated with a research entity including, but not limited to, public and private universities and medical schools, as well as other organizations that conduct health and social science research, or public departments and agencies; and(3) Has research experience at an accredited university or college, research entity, or public agency.(s) "Standardized limited datasets" are datasets developed by the Department with confidential data that do not include any of the direct personal identifiers listed in Section 164.514(e) of Title 45 of the Code of Federal Regulations and have the minimum necessary personal information for types of purposes specified by the Department.(t) "State agency" means a state agency of the State of California.(u) "Supplemental applications" are applications related to a previously approved project.(v) "Type of Access" means one of the following options for an individual to access program data in the enclave pursuant to an approved data application under this Article: (1) "Contributor Access" which means the individual is able to view documents and reports generated by others, but does not have the ability to query data;(2) "Analyst Access" which means the individual has access to program data in a virtual Windows desktop, can use query tools, has access to shared project folders, and can create custom reports and data products; or(3) "Research Access" which means the same as "analyst access" except "research access" has access to greater amounts of digital storage.Cal. Code Regs. Tit. 22, § 97380
Note: Authority cited: Section 127673, Health and Safety Code. Reference: Sections 127671, 127673.5, 127673.8, 127673.81, 127673.82, 127673.83 and 127673.84, Health and Safety Code.
1. New article 8 (sections 97380-97416) and section filed 11-25-2024; operative 11/25/2024 pursuant to Government Code section 11343.4(b)(3) (Register 2024, No. 48).