Bill Text: CA SB1442 | 2023-2024 | Regular Session | Amended
Bill Title: Point-of-care tests for fentanyl.
Spectrum: Slight Partisan Bill (Democrat 2-1)
Status: (Engrossed) 2024-05-23 - In Assembly. Read first time. Held at Desk. [SB1442 Detail]
Download: California-2023-SB1442-Amended.html
|
Amended
IN
Senate
March 18, 2024 |
| Introduced by |
February 16, 2024 |
LEGISLATIVE COUNSEL'S DIGEST
Existing law requires the State Public Health Officer to establish a statewide system for the collection of information determining the incidence of Parkinson’s disease, and requires the officer, commencing on specified dates, to phase in statewide Parkinson’s disease reporting regions, county or regional registries, and the statewide Parkinson’s disease reporting system. Existing law requires the officer, on or before June 1, 2005, to submit an implementation and funding schedule to the Legislature.
This bill would repeal those provisions.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOBill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 127697.1 is added to the Health and Safety Code, to read:127697.1.
(a) CHHSA may enter into partnerships for the manufacture or purchase of any United States Food and Drug Administration (FDA)-approved point-of-care tests for fentanyl. Partnerships entered into pursuant to this section may allow the development, manufacturing, or distribution of FDA-approved point-of-care tests for fentanyl by any entity that is authorized to do so under federal or state law.(a)The department may designate any demographic parts of the state as regional Parkinson’s disease incidence reporting areas and may establish regional Parkinson’s disease registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide to the department, on a timely basis, Parkinson’s disease incidence data as designated by the department. The department may contract with an agency, including, but not limited to, a health systems agency, single-county health department, multicounty health department grouping, or nonprofit professional association, representing a designated Parkinson’s disease reporting region for the purposes of collecting and collating Parkinson’s disease incidence data.
(b)The director shall designate Parkinson’s disease as a disease required to be reported in the state or any demographic parts of the state in which Parkinson’s disease information is collected under this section. All cases of Parkinson’s disease diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the Parkinson’s disease data, or any individual, agency, or organization designated to cooperate with that representative.
(c)(1)A hospital or other facility providing therapy to Parkinson’s disease patients within an area designated as a Parkinson’s disease reporting area shall report each case of Parkinson’s disease to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other facility shall reimburse the department or the authorized representative for its costs to access and report the information.
(2)A
physician and surgeon, pharmacist, or other health care practitioner diagnosing or providing treatment for Parkinson’s disease patients shall report each Parkinson’s disease case to the department or the authorized representative of the department except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnosis or treatment of that instance of Parkinson’s disease.
(d)All physicians, hospitals, outpatient clinics, and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with Parkinson’s disease shall grant to the department or the
authorized representative access to all records that would identify cases of Parkinson’s disease or would establish characteristics of Parkinson’s disease, treatment of Parkinson’s disease, or medical status of any identified Parkinson’s disease patient. Willful failure to grant access to those records shall be punishable by a civil penalty of up to five hundred dollars ($500) each day access is refused. Any civil penalties collected pursuant to this subdivision shall be deposited by the department in the General Fund.
(e)(1)Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For
purposes of this section, this information shall be referred to as “confidential information.”
(2)The department and any regional Parkinson’s disease registry designated by the department shall use the information to determine the sources of Parkinson’s disease.
(3)Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.
(4)The department and any regional Parkinson’s disease registry designated by the department may enter into agreements to furnish confidential information to other states’ Parkinson’s disease registries, federal Parkinson’s disease control agencies, local
health officers, or health researchers for the purposes of determining the sources of Parkinson’s disease and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:
(A)Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.
(B)Provide documentation to the department that demonstrates to the department’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.
(5)Notwithstanding any other provision of law, a disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.
(6)The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(7)The department shall maintain an accurate record of all persons who
are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.
(8)Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
(9)This
subdivision does not prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.
(10)Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to
the individual’s own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
(f)For the purpose of this section, “Parkinson’s disease” means a chronic and progressive neurologic disorder resulting from deficiency of the neurotransmitter dopamine as the consequence of degenerative, vascular, or inflammatory changes in the area of the brain called the basal ganglia. It is characterized by tremor at rest, slow movements, rigidity of movement, droopy posture, muscle weakness, and unsteady or shuffling gait.
(g)This section does not preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with Parkinson’s disease to maintain their own facility-based Parkinson’s disease registries.
