Bill Text: CA AB2058 | 2023-2024 | Regular Session | Amended

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Bill Title: Automated decision systems.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Engrossed) 2024-05-22 - Referred to Com. on HEALTH. [AB2058 Detail]

Download: California-2023-AB2058-Amended.html

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Amended  IN  Assembly  March 18, 2024

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill

No. 2058

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Introduced by Assembly Member Weber

February 01, 2024

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An act relating to public health. to add Section 111612 to the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL'S DIGEST

AB 2058, as amended, Weber. Automated decision systems.

Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. Existing law authorizes the department to establish performance standards for devices designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device.

This bill would require a medical device to have a legible disclosure on the product, the packaging, or within informational material included with the packaging for the device to include known limitations on the effectiveness of the device because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to age, color, disability, ethnicity, gender, or race. By expanding the scope of a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law requires the Department of Technology to conduct, in coordination with other interagency bodies as it deems appropriate, a comprehensive inventory of all high-risk automated decision systems that have been proposed for use, development, or procurement by, or are being used, developed, or procured by, any state agency. Existing law defines an “automated decision system” as a computational process derived from machine learning, statistical modeling, data analytics, or artificial intelligence that issues simplified output, including a score, classification, or recommendation, that is used to assist or replace human discretionary decisionmaking and materially impacts natural persons.

This bill would state the intent of the Legislature to enact legislation relating to commercial algorithms and artificial intelligence-enabled medical devices.

Digest Key

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NOYES  

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Bill Text

The people of the State of California do enact as follows:

SECTION 1.

 Section 111612 is added to the Health and Safety Code, to read:

111612.

 (a) For the purposes of this section, “medical device” means “device” as defined in subsection (h) of Section 321 of Title 21 of the United States Code.

(b) A medical device that satisfies the requirements of Section 111550 shall have a legible disclosure affixed on the product, packaging, or within informational materials included within the packaging for the device, or a combination thereof, that includes known limitations on the effectiveness of the device because of certain characteristics of the patient using the device or of the patient on which the medical device is being used, including, but not limited to, age, color, disability, ethnicity, gender, or race.

SEC. 2.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.

SECTION 1.

It is the intent of the Legislature to enact legislation relating to commercial algorithms and artificial intelligence-enabled medical devices.