Cal. Code Regs. Tit. 11, § 820 - Definitions
(a) "Abuse"
means any use of an Applicable Controlled Substance that is not authorized in its
manner of use, purpose, quantity, or user.
(b) "Aggregated Data" means data that does not
include PII and is presented in summary counts, mitigating privacy risks and
attempts at re-identification.
(c)
"Animal Patient Entity" means a unique animal patient profile created from
dispensation records reported to CURES PDMP for each distinct combination of animal
name, animal owner first name, animal owner last name, animal owner date of birth,
animal owner gender, and animal owner address, and with which any subsequently
reported dispensations that match the same combination of animal patient data are
linked. A single animal patient may be associated with multiple Animal Patient
Entities due to variations in reported animal name, animal owner first name, animal
owner last name, animal owner date of birth, and animal owner address.
(d) "Annual Renewal" means the annual process by
which a User updates all applicable information contained within that User's CURES
profile.
(e) "Applicable Controlled
Substance" means a drug, substance, or immediate precursor that is listed in Health
and Safety Code section
11055,
11056,
11057,
or
11058.
(f) "Applicant Type" means the type of account for
which an applicant is applying for access to CURES, including only the following
types: Prescriber, Out-of-State Prescriber, Non-DEA Practitioner, Pharmacist,
Out-of-State Pharmacist, or Delegate.
(g) "Authorizing User" means a Prescriber-User,
Non-DEA Practitioner-User, or Pharmacist-User who delegates authority to a Delegate
to access data in CURES on behalf of that Prescriber-User, Non-DEA
Practitioner-User, or Pharmacist-User.
(h) "Authorized Health Care Provider" means an
individual who qualifies as a covered health care provider as defined in 45 Code of
Federal Regulations part 162.103 (10-1-20 Edition), incorporated by reference in
this chapter.
(i) "Bona Fide Research"
means research that is characterized by all of the following qualities:
(1) The identification, evaluation, or resolution
of a problem in a research field.
(2)
The intention to contribute to the knowledge of a research field.
(3) The utilization of scientific methods and
research methodologies.
(4) The
reasonable expectation that the final research product may support publication in a
peer-reviewed journal, program evaluation and quality improvement, public health
surveillance, or policy development.
(j) "Bona Fide Researcher" means a principal
investigator, or a public health officer, who conducts Bona Fide Research and meets
all of the following requirements:
(1) Has
possession of a Master of Science degree, Master of Arts degree, other master'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, accredited
universities, recognized research organizations, or public departments and
agencies.
(3) Has relevant research
experience at an accredited university or college, research entity, or public
agency.
(k) "Business
Associate" has the meaning set forth in 45 Code of Federal Regulations part 160.103
(10-1-20 Edition), incorporated by reference in this chapter.
(l) "Category of Licensure" means the title of the
license issued to an individual by that individual's Licensing Board or Out-of-State
Licensing Board.
(m) "Compliant
Password" means a password that meets the password security standards as set forth
by the application.
(n) "Connectivity
Fee" means the mandatory, one-time fee paid by an entity operating a HIT System
which covers the cost of connecting that HIT System to the Information Exchange Web
Service. The Connectivity Fee amount is $1,500.
(o) "Controlled Substance" has the meaning set
forth in Health and Safety Code section
11007,
unless otherwise specified.
(p) "Covered
Entity" has the meaning set forth in 45 Code of Federal Regulations part
160.103.
(q) "CURES" means the
Controlled Substance Utilization Review and Evaluation System.
(r) "CURES PDMP" means the Department's program
that administers CURES.
(s) "DEA" means
the United States Drug Enforcement Administration.
(t) "DEA Number" means the DEA Registration
Certificate number issued to an individual by the DEA.
(u) "DEA Registration Certificate" means the DEA
certificate of registration issued to an individual granting that individual federal
authority to handle controlled substances.
(v) "De-Identified Individual-Level Data" means
individually disaggregated data that does not include any PII.
(w) "Delegate" means an individual who meets the
eligibility requirements of section
824.1, subdivision (a), has entered
into an agreement that meets the requirements of section
824.2, subdivision (a), and is at least
18 years of age.
(x) "Delegate
Agreement" means an agreement between an Authorizing User and one or more Delegates
that meets the requirements of section
824.2, subdivision (a).
(y) "Delegate Audit Report" means a report
generated by CURES of the patient activity searches conducted by an individual who
is or was a Delegate-User of an Authorizing User. A Delegate Audit Report includes,
as applicable, the search date, search time, Authorizing User first name,
Authorizing User last name, Authorizing User State License Number, Delegate-User
first name, Delegate-User last name, patient first name, patient last name, patient
date of birth, patient gender, patient address, patient activity Search Period,
search mode, and generated Patient Entities or Animal Patient Entities.
(z) "Delegate-User" means a Delegate who is
registered to access CURES on behalf of an Authorizing User.
(aa) "Department" means the Department of Justice
of the State of California.
(bb)
"Department Investigative Team" means two or more Law Enforcement Agencies, one of
which is the Department, requesting access to CURES, or data from CURES, through the
Department, to assist that Department Investigative Team's efforts to control the
Diversion and Resultant Abuse of Applicable Controlled Substances.
(cc) "Diversion" means any redirection of an
Applicable Controlled Substance from a use that is authorized in its manner of use,
purpose, quantity, and user, toward any use that is not authorized in its manner of
use, purpose, quantity, or user.
(dd)
"Diversion and Resultant Abuse" means any redirection of an Applicable Controlled
Substance from a use that is authorized in its manner of use, purpose, quantity, and
user, toward any use that is not authorized in its manner of use, purpose, quantity,
or user, and any use of an Applicable Controlled Substance that is not authorized in
its manner of use, purpose, quantity, or user, that results, either directly or
indirectly, from that redirection.
(ee)
"Health Care Practitioner" means a licensee authorized under Health and Safety Code
section
11150 to
prescribe, order, administer, furnish, or dispense Controlled Substances, excluding
non-prescribing Pharmacists and non-prescribing Out-of-State Pharmacists, or a
Non-DEA Practitioner.
(ff) "Health
Information Technology System" or "HIT System" has the meaning set forth in Health
and Safety Code section
11165.1,
subdivision (g)(4).
(gg) "HIPAA" means
the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No.
104-191 , 110 Stat. 1936 (1996)).
(hh) "HIPAA Regulations" means the regulations
promulgated under HIPAA by the United States Department of Health and Human
Services, including, but not limited to, 45 Code of Federal Regulations parts 160
and 164, as are currently in effect or as later amended.
(ii) "Identified Individual-Level Data" means
individually disaggregated data that includes the PII of any patient to which that
data relates.
(jj) "Information Exchange
Web Service" means the method of system integration developed by the Department by
which approved Prescriber-Users and Pharmacist-Users may use a qualified HIT System
to request data from CURES.
(kk)
"Institutional DEA Number" means a unique number issued by the DEA to a licensed,
eligible institution that handles controlled substances.
(ll) "Interested Party" means a public or private
entity, Bona Fide Researcher, or Team Member.
(mm) "Interstate Non-DEA Practitioner" means an
individual who meets all of the following requirements:
(1) Has a license issued by an Out-of-State
Licensing Board that is equivalent to a Non-DEA Practitioner, and is engaged in the
professional practice authorized by that license.
(2) Does not have a DEA Registration
Certificate.
(3) Is an authorized user
of a PDMP of a state other than California, is in good standing with that PDMP, and
is authorized by that PDMP to request data from CURES.
(nn) "Interstate Pharmacist" means an Out-of-State
Pharmacist who is authorized to:
(1) Access the
PDMP of a state other than California, and is in good standing with that
PDMP.
(2) Request data from CURES from
that Interstate Pharmacist's PDMP.
(oo) "Interstate Prescriber" means an Out-of-State
Prescriber who is authorized to:
(1) Access the
PDMP of a state other than California, and is in good standing with that
PDMP.
(2) Request data from CURES from
that Interstate Prescriber's PDMP.
(pp) "Interstate-User" means an Interstate
Prescriber, Interstate Non-DEA Practitioner, or Interstate Pharmacist.
(qq) "Law Enforcement Agency" means an agency of
the United States, the State of California, or a public entity as defined in
Government Code section
811.2,
authorized to perform any of the following activities:
(1) Investigate or conduct an official inquiry
into a potential violation of law, including an investigation or official inquiry
into the manner, circumstances, or cause of death of a person, if the manner,
circumstances, or cause of death might have involved a violation of law.
(2) Prosecute or otherwise conduct a criminal or
civil proceeding arising from an alleged violation of law.
(3) Supervise criminal offenders
post-sentencing.
(rr) "Law
Enforcement Official" means a Law Enforcement Agency officer or employee who is
designated by that Law Enforcement Agency to access CURES, or request data from
CURES, on behalf of that Law Enforcement Agency.
(ss) "Law Enforcement-User" means a Law
Enforcement Official who is registered for access to CURES.
(tt) "Licensing Board" means each of the boards
and committees established within the California Department of Consumer Affairs and
identified in Business and Professions Code section
208,
subdivision (d).
(uu) "List of Patients"
means a List of Patients generated by CURES for whom a Prescriber-User or
Pharmacist-User is identified as the prescriber in CURES. A List of Patients
includes the prescriber DEA Number, prescriber last name, prescriber first name,
prescriber address, and the patient last name, patient first name, patient date of
birth, patient gender, animal name, animal owner last name, animal owner first name,
animal owner date of birth, animal owner gender, and patient address, as reported to
CURES PDMP.
(vv) "Non-DEA Practitioner"
means a California licensee who holds a physician's and surgeon's license and is
engaged in the professional practice authorized by that license under the
jurisdiction of the applicable Licensing Board, who does not have a DEA Registration
Certificate.
(ww) "Non-DEA
Practitioner-User" means a Non-DEA Practitioner who is registered for access to
CURES.
(xx) "Out-of-State Licensing
Board" means a licensing agency outside of California or a board or committee
established by a licensing agency outside of California.
(yy) "Out-of-State Pharmacist" means a pharmacist
licensed by an Out-of-State Licensing Board in a state or states of the United
States other than California, a territory or territories of the United States, or
the Commonwealth of Puerto Rico, and authorized under the laws of the Out-of-State
Licensing Board's jurisdiction to dispense Controlled Substances.
(zz) "Out-of-State Prescriber" means a prescriber
licensed by an Out-of-State Licensing Board in a state or states of the United
States other than California, a territory or territories of the United States, or
the Commonwealth of Puerto Rico, and authorized under the laws of the Out-of-State
Licensing Board's jurisdiction to prescribe Controlled Substances, and who possesses
a valid DEA Registration Certificate.
(aaa) "Patient Activity Report" means a report
generated by CURES of the Controlled Substance history of a patient, as reported to
CURES PDMP. A Patient Activity Report includes, as applicable, the patient last
name, patient first name, patient middle initial, patient date of birth, patient
gender, animal name, animal owner last name, animal owner first name, animal owner
middle initial, animal owner date of birth, animal owner gender, patient address,
contract provider name, contract provider contact number, contract expiration date,
date filled, date sold, drug name, refill number, number of authorized refills, drug
strength, drug form, days' supply, quantity, daily morphine milligram equivalency,
total morphine milligram equivalency, prescriber name, prescriber DEA Number,
prescriber city, pharmacy name, pharmacy license number, pharmacy address,
prescription form serial number, prescription form serial number status,
prescription number, payment method, total number of prescriptions, and total number
of active prescriptions.
(bbb) "Patient
Entity" means a unique patient profile created from dispensation records reported to
CURES PDMP for each distinct combination of patient first name, patient last name,
patient date of birth, patient gender, and patient address, and with which any
subsequently reported dispensations that match the same combination of patient data
are linked. A single patient may be associated with multiple Patient Entities due to
variations in reported patient first name, patient last name, patient date of birth,
and patient address.
(ccc) "Patient
Picklist" means a list of Patient Entities or Animal Patient Entities returned to a
User when that User submits the search criteria to initiate a Patient Activity
Report.
(ddd) "PDMP" means prescription
drug monitoring program.
(eee) "Peer
Review" means subjecting a researcher's scholarly work, research, or ideas to the
scrutiny of other researchers in the same field of research for either of the
following purposes:
(1) To ensure that the
scholarly work meets the accepted standards of the researcher's
discipline.
(2) To prevent the
dissemination of research that is compromised by unwarranted claims, unacceptable
interpretations, or personal views.
(fff) "Personal Identifying Information" or "PII"
has the meaning set forth in Penal Code section
530.55, subdivision
(b).
(ggg) "Pharmacist" has the meaning
set forth in Health and Safety Code section
11024.
(hhh) "Pharmacist Serialized Prescription Form
Report" means a report generated by CURES that a Pharmacist-User may initiate to
determine whether a prescription form serial number has been reported to CURES as
lost or stolen, and whether the prescription associated with that prescription form
serial number has been reported as filled in CURES. A Pharmacist Serialized
Prescription Form Report includes the prescription form serial number, prescription
form order type, prescriber last name, prescriber first name, prescriber DEA number,
prescriber phone number, prescription form serial number status, and number of
serialized prescription forms.
(iii)
"Pharmacist-User" means a Pharmacist or Out-of-State Pharmacist who is registered to
access CURES.
(jjj) "Pharmacy History
Report" means a report generated by CURES of the Controlled Substance dispensation
history of a pharmacy, as reported to CURES PDMP. A Pharmacy History Report includes
the pharmacy name, pharmacy license number, pharmacy address, total number of
prescriptions, patient last name, patient first name, patient date of birth, patient
gender, patient address, species, animal name, date filled, date sold, drug name,
refill number, number of authorized refills, drug strength, drug form, days' supply,
quantity, daily morphine milligram equivalency, total morphine milligram
equivalency, prescription number, prescription form serial number, prescription form
serial number status, payment method, prescriber name, prescriber DEA Number, and
prescriber address.
(kkk) "Prescriber"
means a Health Care Practitioner licensed in California who possesses a valid DEA
Registration Certificate.
(lll)
"Prescriber History Report" means a report generated by CURES of the Controlled
Substance prescribing history of a prescriber, as reported to CURES PDMP. A
Prescriber History Report includes the prescriber name, prescriber DEA Number,
prescriber address, total number of prescriptions, patient last name, patient first
name, patient date of birth, patient gender, patient address, species, animal name,
date filled, date sold, drug name, refill number, number of authorized refills, drug
strength, drug form, days' supply, quantity, daily morphine milligram equivalency,
total morphine milligram equivalency, prescription number, prescription form serial
number, prescription form status, payment method, pharmacy name, pharmacy license
number, and pharmacy address.
(mmm)
"Prescriber-User" means a Prescriber or Out-of-State Prescriber who is registered to
access CURES.
(nnn) "Prescription
History Report" means a Prescriber History Report, Pharmacy History Report, or
Serialized Prescription History Report.
(ooo) "Prescription Form Theft or Loss Report"
means the Web-form a Prescriber or Pharmacist is required to submit to the
Department under Health and Safety Code section
11165.3.
(ppp) "Protected Health Information" has the
meaning set forth in 45 Code of Federal Regulations part 160.103.
(qqq) "Regulatory Agency" means the Department of
Consumer Affairs, and the boards and committees identified in Business and
Professions Code section
208,
subdivision (d).
(rrr) "Regulatory
Agency Official" means a Regulatory Agency officer or employee who is designated by
that Regulatory Agency to access CURES, or request data from CURES, on behalf of
that Regulatory Agency.
(sss)
"Regulatory Agency-User" means a Regulatory Agency Official who is registered for
access to CURES.
(ttt) "Research
Purposes" means analysis on data to conduct a systematic investigation, including
research development, testing, or evaluation, which is designed to develop or
contribute to generalizable knowledge or education.
(uuu) "Search Period" means the requested date
range for which CURES is to be searched in relation to a Delegate Audit Report,
Patient Activity Report, Prescriber History Report, Pharmacy History Report,
Serialized Prescription History Report, Pharmacist Serialized Prescription Form
Report, Serialized Prescription Form Report, Prescription Form Theft or Loss Report,
or other report generated by CURES.
(vvv) "Security Question Answer" means an answer
used to verify the identity of a User.
(www) "Serialized Prescription Form Report" means
a report generated by CURES that a Regulatory Agency-User or Law Enforcement-User
may initiate to determine whether a prescription form serial number has been
reported to CURES as lost or stolen, and whether the associated prescription form
information has been reported to CURES by the applicable security printer. A
Serialized Prescription Form Report includes the prescriber last name, prescriber
first name, prescriber DEA Number, prescription form order type, prescription form
order delivery date, delivery recipient entity name, delivery recipient last name,
delivery recipient first name, starting prescription form serial number, ending
prescription form serial number, prescription form production date, prescription
form filled status, prescription form serial number status, security printer unique
record ID, security printer name, security printer file name, security printer file
submission date, security printer file processed date, security printer file
validation status, security printer file error code, security printer file error
description, and security printer file version number.
(xxx) "Serialized Prescription History Report"
means a report generated by CURES of the serialized prescription order information
associated with specified prescription form serial numbers, as reported to CURES
PDMP. A Serialized Prescription History Report includes, as applicable, starting
prescription form serial number, ending prescription form serial number,
prescription form order type, prescription form order delivery date, prescriber last
name, prescriber first name, prescriber DEA Number, total number of prescriptions,
patient last name, patient first name, patient date of birth, patient gender, animal
name, animal owner last name, animal owner first name, animal owner date of birth,
animal owner gender, patient address, date filled, date sold, drug name, refill
number, number of authorized refills, drug strength, drug form, days' supply,
quantity, daily morphine milligram equivalency, total morphine milligram
equivalency, prescriber address, pharmacy name, pharmacy license number, pharmacy
address, prescription form serial number, prescription form serial number status,
prescription number, and payment method.
(yyy) "State" means the State of
California.
(zzz) "State License Number"
means a licensee's professional license number assigned to that licensee by the
applicable Licensing Board or Out-of-State Licensing Board.
(aaaa) "Team Member" means an individual
authorized by the Department's Research Services, upon approval of a Data Request
Application, to access or analyze data obtained by a Bona Fide Researcher from
CURES.
(bbbb) "Terms and Conditions of
CURES" means all restrictions imposed by this chapter on the access and use of
CURES, or data from CURES, with which a User must comply. Any violation of these
Terms and Conditions of CURES, or any applicable State or federal law or regulation,
may result in prosecution.
(cccc)
"Ultimate User" has the meaning set forth in Health and Safety Code section
11030.
(dddd) "Under the Practitioner's Care," "Under the
Pharmacist's Care," and "Under Their Care," as used in Health and Safety Code
section
11165.1,
mean Under the Care of.
(eeee) "Under
the Care of" when used in this chapter to determine if a patient is Under the Care
of a Prescriber-User, Non-DEA Practitioner-User, Pharmacist-User, or
Interstate-User, means:
(1) With respect to a
Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate
Non-DEA Practitioner, when any of the following conditions exist:
(A) The patient has had a professional medical
consultation with the Prescriber-User, Non-DEA Practitioner-User, Interstate
Prescriber, or Interstate Non-DEA Practitioner, and has an ongoing provider-patient
relationship with that Prescriber-User, Non-DEA Practitioner-User, Interstate
Prescriber, or Interstate Non-DEA Practitioner.
(B) The patient has an appointment for a
professional medical consultation with the Prescriber-User, Non-DEA
Practitioner-User, Interstate Prescriber, or Interstate Non-DEA
Practitioner.
(C) The patient has not
had a professional medical consultation with the Prescriber-User, Non-DEA
Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner, but
the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate
Non-DEA Practitioner is part of the patient's "organized health care arrangement,"
as defined in 45 Code of Federal Regulations part 160.103, and the patient has a
provider-patient relationship with that Prescriber-User, Non-DEA Practitioner-User,
Interstate Prescriber, or Interstate Non-DEA Practitioner.
(D) The patient presents to an emergency
department for treatment and the Prescriber-User, Non-DEA Practitioner-User,
Interstate Prescriber, or Interstate Non-DEA Practitioner is involved in or oversees
the intake or professional medical consultation of that patient within the emergency
department.
(2) With respect
to a Pharmacist-User or Interstate Pharmacist, when both of the following conditions
exist:
(A) The patient, or an individual purporting
to be a patient, has presented a prescription for a Controlled Substance, or a
prescriber has ordered, or appears to have ordered, a prescription on behalf of that
patient, to a pharmacy where the Pharmacist-User or Interstate Pharmacist is
authorized to dispense Controlled Substances.
(B) The Pharmacist-User or Interstate Pharmacist
is involved in or oversees the ordering, compounding, filling, dispensing,
furnishing, or delivery of the Controlled Substance to that patient, or individual
purporting to be a patient.
(ffff) "User" means a type of CURES registrant,
including "Prescriber-User," "Non-DEA Practitioner-User," "Pharmacist-User,"
"Delegate-User," "Regulatory Agency-User," and "Law Enforcement-User."
(gggg) "User Profile Details Report" means a
report generated by CURES that a Regulatory Agency-User may initiate to request the
User profile details of a Prescriber-User, Non-DEA Practitioner-User,
Pharmacist-User, or Delegate-User. A User Profile Details Report includes, as
applicable, User first name, User last name, User ID, User Category of Licensure,
User License Number, User DEA Number, User role, User status, number of Delegate
associations, Delegate Agreement effective date, Delegate Agreement expiration date,
and Delegate association status.
(hhhh)
"Veterinary Workforce Member" means an employee, volunteer, trainee, or other person
whose conduct, in the performance of work for a veterinarian who is a
Prescriber-User, is under the direct control of that Prescriber-User.
(iiii) "Web-Based Application" means a
Department-administered Web site or Web application that is made available for the
purposes of accessing data in CURES or maintaining an account to access CURES.
Web-Based Application does not include the Information Exchange Web Service or a HIT
System.
(jjjj) "Workforce Member" means
an employee, volunteer, trainee, or other person whose conduct, in the performance
of work for an Authorized Health Care Provider, is under the direct control of that
Authorized Health Care Provider.
Notes
Note: Authority cited: Section 11165, Health and Safety Code. Reference: Sections 11030, 11165, 11165.1, 11165.3, 11165.4 and 11165.6, Health and Safety Code; and Sections 208 and 209, Business and Professions Code.
Note: Authority cited: Section 11165, Health and Safety Code. Reference: Sections 11030, 11165, 11165.1, 11165.3, 11165.4 and 11165.6, Health and Safety Code; and Sections 208 and 209, Business and Professions Code.
2. Change without regulatory effect amending chapter heading and redesignating subsections (tt)(A)-(B) as subsections (tt)(1)-(2) filed 2-2-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 6).
3. Amendment filed 8-15-2022; operative
4. Change without regulatory effect amending subsection (aaaa) filed 5-29-2024 pursuant to section 100, title 1, California Code of Regulations (Register 2024, No. 22).
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(a) "Abuse" means any use of an Applicable Controlled Substance that is not authorized in its manner of use, purpose, quantity, or user.
(b) "Aggregated Data" means data that does not include PII and is presented in summary counts, mitigating privacy risks and attempts at re-identification.
(c) "Animal Patient Entity" means a unique animal patient profile created from dispensation records reported to CURES PDMP for each distinct combination of animal name, animal owner first name, animal owner last name, animal owner date of birth, animal owner gender, and animal owner address, and with which any subsequently reported dispensations that match the same combination of animal patient data are linked. A single animal patient may be associated with multiple Animal Patient Entities due to variations in reported animal name, animal owner first name, animal owner last name, animal owner date of birth, and animal owner address.
(d) "Annual Renewal" means the annual process by which a User updates all applicable information contained within that User's CURES profile.
(e) "Applicable Controlled Substance" means a drug, substance, or immediate precursor that is listed in Health and Safety Code section 11055, 11056, 11057, or 11058.
(f) "Applicant Type" means the type of account for which an applicant is applying for access to CURES, including only the following types: Prescriber, Out-of-State Prescriber, Non-DEA Practitioner, Pharmacist, Out-of-State Pharmacist, or Delegate.
(g) "Authorizing User" means a Prescriber-User, Non-DEA Practitioner-User, or Pharmacist-User who delegates authority to a Delegate to access data in CURES on behalf of that Prescriber-User, Non-DEA Practitioner-User, or Pharmacist-User.
(h) "Authorized Health Care Provider" means an individual who qualifies as a covered health care provider as defined in 45 Code of Federal Regulations part 162.103 (10-1-20 Edition), incorporated by reference in this chapter.
(i) "Bona Fide Research" means research that is characterized by all of the following qualities:
(1) The identification, evaluation, or resolution of a problem in a research field.
(2) The intention to contribute to the knowledge of a research field.
(3) The utilization of scientific methods and research methodologies.
(4) The reasonable expectation that the final research product may support publication in a peer-reviewed journal, program evaluation and quality improvement, public health surveillance, or policy development.
(j) "Bona Fide Researcher" means a principal investigator, or a public health officer, who conducts Bona Fide Research and meets all of the following requirements:
(1) Has possession of a Master of Science degree, Master of Arts degree, other master'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, accredited universities, recognized research organizations, or public departments and agencies.
(3) Has relevant research experience at an accredited university or college, research entity, or public agency.
(k) "Business Associate" has the meaning set forth in 45 Code of Federal Regulations part 160.103 (10-1-20 Edition), incorporated by reference in this chapter.
(l) "Category of Licensure" means the title of the license issued to an individual by that individual's Licensing Board or Out-of-State Licensing Board.
(m) "Compliant Password" means a password that meets the password security standards as set forth by the application.
(n) "Connectivity Fee" means the mandatory, one-time fee paid by an entity operating a HIT System which covers the cost of connecting that HIT System to the Information Exchange Web Service. The Connectivity Fee amount is $1,500.
(o) "Controlled Substance" has the meaning set forth in Health and Safety Code section 11007, unless otherwise specified.
(p) "Covered Entity" has the meaning set forth in 45 Code of Federal Regulations part 160.103.
(q) "CURES" means the Controlled Substance Utilization Review and Evaluation System.
(r) "CURES PDMP" means the Department's program that administers CURES.
(s) "DEA" means the United States Drug Enforcement Administration.
(t) "DEA Number" means the DEA Registration Certificate number issued to an individual by the DEA.
(u) "DEA Registration Certificate" means the DEA certificate of registration issued to an individual granting that individual federal authority to handle controlled substances.
(v) "De-Identified Individual-Level Data" means individually disaggregated data that does not include any PII.
(w) "Delegate" means an individual who meets the eligibility requirements of section 824.1, subdivision (a), has entered into an agreement that meets the requirements of section 824.2, subdivision (a), and is at least 18 years of age.
(x) "Delegate Agreement" means an agreement between an Authorizing User and one or more Delegates that meets the requirements of section 824.2, subdivision (a).
(y) "Delegate Audit Report" means a report generated by CURES of the patient activity searches conducted by an individual who is or was a Delegate-User of an Authorizing User. A Delegate Audit Report includes, as applicable, the search date, search time, Authorizing User first name, Authorizing User last name, Authorizing User State License Number, Delegate-User first name, Delegate-User last name, patient first name, patient last name, patient date of birth, patient gender, patient address, patient activity Search Period, search mode, and generated Patient Entities or Animal Patient Entities.
(z) "Delegate-User" means a Delegate who is registered to access CURES on behalf of an Authorizing User.
(aa) "Department" means the Department of Justice of the State of California.
(bb) "Department Investigative Team" means two or more Law Enforcement Agencies, one of which is the Department, requesting access to CURES, or data from CURES, through the Department, to assist that Department Investigative Team's efforts to control the Diversion and Resultant Abuse of Applicable Controlled Substances.
(cc) "Diversion" means any redirection of an Applicable Controlled Substance from a use that is authorized in its manner of use, purpose, quantity, and user, toward any use that is not authorized in its manner of use, purpose, quantity, or user.
(dd) "Diversion and Resultant Abuse" means any redirection of an Applicable Controlled Substance from a use that is authorized in its manner of use, purpose, quantity, and user, toward any use that is not authorized in its manner of use, purpose, quantity, or user, and any use of an Applicable Controlled Substance that is not authorized in its manner of use, purpose, quantity, or user, that results, either directly or indirectly, from that redirection.
(ee) "Health Care Practitioner" means a licensee authorized under Health and Safety Code section 11150 to prescribe, order, administer, furnish, or dispense Controlled Substances, excluding non-prescribing Pharmacists and non-prescribing Out-of-State Pharmacists, or a Non-DEA Practitioner.
(ff) "Health Information Technology System" or "HIT System" has the meaning set forth in Health and Safety Code section 11165.1, subdivision (g)(4).
(gg) "HIPAA" means the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191 , 110 Stat. 1936 (1996)).
(hh) "HIPAA Regulations" means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 Code of Federal Regulations parts 160 and 164, as are currently in effect or as later amended.
(ii) "Identified Individual-Level Data" means individually disaggregated data that includes the PII of any patient to which that data relates.
(jj) "Information Exchange Web Service" means the method of system integration developed by the Department by which approved Prescriber-Users and Pharmacist-Users may use a qualified HIT System to request data from CURES.
(kk) "Institutional DEA Number" means a unique number issued by the DEA to a licensed, eligible institution that handles controlled substances.
(ll) "Interested Party" means a public or private entity, Bona Fide Researcher, or Team Member.
(mm) "Interstate Non-DEA Practitioner" means an individual who meets all of the following requirements:
(1) Has a license issued by an Out-of-State Licensing Board that is equivalent to a Non-DEA Practitioner, and is engaged in the professional practice authorized by that license.
(2) Does not have a DEA Registration Certificate.
(3) Is an authorized user of a PDMP of a state other than California, is in good standing with that PDMP, and is authorized by that PDMP to request data from CURES.
(nn) "Interstate Pharmacist" means an Out-of-State Pharmacist who is authorized to:
(1) Access the PDMP of a state other than California, and is in good standing with that PDMP.
(2) Request data from CURES from that Interstate Pharmacist's PDMP.
(oo) "Interstate Prescriber" means an Out-of-State Prescriber who is authorized to:
(1) Access the PDMP of a state other than California, and is in good standing with that PDMP.
(2) Request data from CURES from that Interstate Prescriber's PDMP.
(pp) "Interstate-User" means an Interstate Prescriber, Interstate Non-DEA Practitioner, or Interstate Pharmacist.
(qq) "Law Enforcement Agency" means an agency of the United States, the State of California, or a public entity as defined in Government Code section 811.2, authorized to perform any of the following activities:
(1) Investigate or conduct an official inquiry into a potential violation of law, including an investigation or official inquiry into the manner, circumstances, or cause of death of a person, if the manner, circumstances, or cause of death might have involved a violation of law.
(2) Prosecute or otherwise conduct a criminal or civil proceeding arising from an alleged violation of law.
(3) Supervise criminal offenders post-sentencing.
(rr) "Law Enforcement Official" means a Law Enforcement Agency officer or employee who is designated by that Law Enforcement Agency to access CURES, or request data from CURES, on behalf of that Law Enforcement Agency.
(ss) "Law Enforcement-User" means a Law Enforcement Official who is registered for access to CURES.
(tt) "Licensing Board" means each of the boards and committees established within the California Department of Consumer Affairs and identified in Business and Professions Code section 208, subdivision (d).
(uu) "List of Patients" means a List of Patients generated by CURES for whom a Prescriber-User or Pharmacist-User is identified as the prescriber in CURES. A List of Patients includes the prescriber DEA Number, prescriber last name, prescriber first name, prescriber address, and the patient last name, patient first name, patient date of birth, patient gender, animal name, animal owner last name, animal owner first name, animal owner date of birth, animal owner gender, and patient address, as reported to CURES PDMP.
(vv) "Non-DEA Practitioner" means a California licensee who holds a physician's and surgeon's license and is engaged in the professional practice authorized by that license under the jurisdiction of the applicable Licensing Board, who does not have a DEA Registration Certificate.
(ww) "Non-DEA Practitioner-User" means a Non-DEA Practitioner who is registered for access to CURES.
(xx) "Out-of-State Licensing Board" means a licensing agency outside of California or a board or committee established by a licensing agency outside of California.
(yy) "Out-of-State Pharmacist" means a pharmacist licensed by an Out-of-State Licensing Board in a state or states of the United States other than California, a territory or territories of the United States, or the Commonwealth of Puerto Rico, and authorized under the laws of the Out-of-State Licensing Board's jurisdiction to dispense Controlled Substances.
(zz) "Out-of-State Prescriber" means a prescriber licensed by an Out-of-State Licensing Board in a state or states of the United States other than California, a territory or territories of the United States, or the Commonwealth of Puerto Rico, and authorized under the laws of the Out-of-State Licensing Board's jurisdiction to prescribe Controlled Substances, and who possesses a valid DEA Registration Certificate.
(aaa) "Patient Activity Report" means a report generated by CURES of the Controlled Substance history of a patient, as reported to CURES PDMP. A Patient Activity Report includes, as applicable, the patient last name, patient first name, patient middle initial, patient date of birth, patient gender, animal name, animal owner last name, animal owner first name, animal owner middle initial, animal owner date of birth, animal owner gender, patient address, contract provider name, contract provider contact number, contract expiration date, date filled, date sold, drug name, refill number, number of authorized refills, drug strength, drug form, days' supply, quantity, daily morphine milligram equivalency, total morphine milligram equivalency, prescriber name, prescriber DEA Number, prescriber city, pharmacy name, pharmacy license number, pharmacy address, prescription form serial number, prescription form serial number status, prescription number, payment method, total number of prescriptions, and total number of active prescriptions.
(bbb) "Patient Entity" means a unique patient profile created from dispensation records reported to CURES PDMP for each distinct combination of patient first name, patient last name, patient date of birth, patient gender, and patient address, and with which any subsequently reported dispensations that match the same combination of patient data are linked. A single patient may be associated with multiple Patient Entities due to variations in reported patient first name, patient last name, patient date of birth, and patient address.
(ccc) "Patient Picklist" means a list of Patient Entities or Animal Patient Entities returned to a User when that User submits the search criteria to initiate a Patient Activity Report.
(ddd) "PDMP" means prescription drug monitoring program.
(eee) "Peer Review" means subjecting a researcher's scholarly work, research, or ideas to the scrutiny of other researchers in the same field of research for either of the following purposes:
(1) To ensure that the scholarly work meets the accepted standards of the researcher's discipline.
(2) To prevent the dissemination of research that is compromised by unwarranted claims, unacceptable interpretations, or personal views.
(fff) "Personal Identifying Information" or "PII" has the meaning set forth in Penal Code section 530.55, subdivision (b).
(ggg) "Pharmacist" has the meaning set forth in Health and Safety Code section 11024.
(hhh) "Pharmacist Serialized Prescription Form Report" means a report generated by CURES that a Pharmacist-User may initiate to determine whether a prescription form serial number has been reported to CURES as lost or stolen, and whether the prescription associated with that prescription form serial number has been reported as filled in CURES. A Pharmacist Serialized Prescription Form Report includes the prescription form serial number, prescription form order type, prescriber last name, prescriber first name, prescriber DEA number, prescriber phone number, prescription form serial number status, and number of serialized prescription forms.
(iii) "Pharmacist-User" means a Pharmacist or Out-of-State Pharmacist who is registered to access CURES.
(jjj) "Pharmacy History Report" means a report generated by CURES of the Controlled Substance dispensation history of a pharmacy, as reported to CURES PDMP. A Pharmacy History Report includes the pharmacy name, pharmacy license number, pharmacy address, total number of prescriptions, patient last name, patient first name, patient date of birth, patient gender, patient address, species, animal name, date filled, date sold, drug name, refill number, number of authorized refills, drug strength, drug form, days' supply, quantity, daily morphine milligram equivalency, total morphine milligram equivalency, prescription number, prescription form serial number, prescription form serial number status, payment method, prescriber name, prescriber DEA Number, and prescriber address.
(kkk) "Prescriber" means a Health Care Practitioner licensed in California who possesses a valid DEA Registration Certificate.
(lll) "Prescriber History Report" means a report generated by CURES of the Controlled Substance prescribing history of a prescriber, as reported to CURES PDMP. A Prescriber History Report includes the prescriber name, prescriber DEA Number, prescriber address, total number of prescriptions, patient last name, patient first name, patient date of birth, patient gender, patient address, species, animal name, date filled, date sold, drug name, refill number, number of authorized refills, drug strength, drug form, days' supply, quantity, daily morphine milligram equivalency, total morphine milligram equivalency, prescription number, prescription form serial number, prescription form status, payment method, pharmacy name, pharmacy license number, and pharmacy address.
(mmm) "Prescriber-User" means a Prescriber or Out-of-State Prescriber who is registered to access CURES.
(nnn) "Prescription History Report" means a Prescriber History Report, Pharmacy History Report, or Serialized Prescription History Report.
(ooo) "Prescription Form Theft or Loss Report" means the Web-form a Prescriber or Pharmacist is required to submit to the Department under Health and Safety Code section 11165.3.
(ppp) "Protected Health Information" has the meaning set forth in 45 Code of Federal Regulations part 160.103.
(qqq) "Regulatory Agency" means the Department of Consumer Affairs, and the boards and committees identified in Business and Professions Code section 208, subdivision (d).
(rrr) "Regulatory Agency Official" means a Regulatory Agency officer or employee who is designated by that Regulatory Agency to access CURES, or request data from CURES, on behalf of that Regulatory Agency.
(sss) "Regulatory Agency-User" means a Regulatory Agency Official who is registered for access to CURES.
(ttt) "Research Purposes" means analysis on data to conduct a systematic investigation, including research development, testing, or evaluation, which is designed to develop or contribute to generalizable knowledge or education.
(uuu) "Search Period" means the requested date range for which CURES is to be searched in relation to a Delegate Audit Report, Patient Activity Report, Prescriber History Report, Pharmacy History Report, Serialized Prescription History Report, Pharmacist Serialized Prescription Form Report, Serialized Prescription Form Report, Prescription Form Theft or Loss Report, or other report generated by CURES.
(vvv) "Security Question Answer" means an answer used to verify the identity of a User.
(www) "Serialized Prescription Form Report" means a report generated by CURES that a Regulatory Agency-User or Law Enforcement-User may initiate to determine whether a prescription form serial number has been reported to CURES as lost or stolen, and whether the associated prescription form information has been reported to CURES by the applicable security printer. A Serialized Prescription Form Report includes the prescriber last name, prescriber first name, prescriber DEA Number, prescription form order type, prescription form order delivery date, delivery recipient entity name, delivery recipient last name, delivery recipient first name, starting prescription form serial number, ending prescription form serial number, prescription form production date, prescription form filled status, prescription form serial number status, security printer unique record ID, security printer name, security printer file name, security printer file submission date, security printer file processed date, security printer file validation status, security printer file error code, security printer file error description, and security printer file version number.
(xxx) "Serialized Prescription History Report" means a report generated by CURES of the serialized prescription order information associated with specified prescription form serial numbers, as reported to CURES PDMP. A Serialized Prescription History Report includes, as applicable, starting prescription form serial number, ending prescription form serial number, prescription form order type, prescription form order delivery date, prescriber last name, prescriber first name, prescriber DEA Number, total number of prescriptions, patient last name, patient first name, patient date of birth, patient gender, animal name, animal owner last name, animal owner first name, animal owner date of birth, animal owner gender, patient address, date filled, date sold, drug name, refill number, number of authorized refills, drug strength, drug form, days' supply, quantity, daily morphine milligram equivalency, total morphine milligram equivalency, prescriber address, pharmacy name, pharmacy license number, pharmacy address, prescription form serial number, prescription form serial number status, prescription number, and payment method.
(yyy) "State" means the State of California.
(zzz) "State License Number" means a licensee's professional license number assigned to that licensee by the applicable Licensing Board or Out-of-State Licensing Board.
(aaaa) "Team Member" means an individual authorized by the Department's Research Services, upon approval of a Data Request Application, to access or analyze data obtained by a Bona Fide Researcher from CURES.
(bbbb) "Terms and Conditions of CURES" means all restrictions imposed by this chapter on the access and use of CURES, or data from CURES, with which a User must comply. Any violation of these Terms and Conditions of CURES, or any applicable State or federal law or regulation, may result in prosecution.
(cccc) "Ultimate User" has the meaning set forth in Health and Safety Code section 11030.
(dddd) "Under the Practitioner's Care," "Under the Pharmacist's Care," and "Under Their Care," as used in Health and Safety Code section 11165.1, mean Under the Care of.
(eeee) "Under the Care of" when used in this chapter to determine if a patient is Under the Care of a Prescriber-User, Non-DEA Practitioner-User, Pharmacist-User, or Interstate-User, means:
(1) With respect to a Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner, when any of the following conditions exist:
(A) The patient has had a professional medical consultation with the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner, and has an ongoing provider-patient relationship with that Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner.
(B) The patient has an appointment for a professional medical consultation with the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner.
(C) The patient has not had a professional medical consultation with the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner, but the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner is part of the patient's "organized health care arrangement," as defined in 45 Code of Federal Regulations part 160.103, and the patient has a provider-patient relationship with that Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner.
(D) The patient presents to an emergency department for treatment and the Prescriber-User, Non-DEA Practitioner-User, Interstate Prescriber, or Interstate Non-DEA Practitioner is involved in or oversees the intake or professional medical consultation of that patient within the emergency department.
(2) With respect to a Pharmacist-User or Interstate Pharmacist, when both of the following conditions exist:
(A) The patient, or an individual purporting to be a patient, has presented a prescription for a Controlled Substance, or a prescriber has ordered, or appears to have ordered, a prescription on behalf of that patient, to a pharmacy where the Pharmacist-User or Interstate Pharmacist is authorized to dispense Controlled Substances.
(B) The Pharmacist-User or Interstate Pharmacist is involved in or oversees the ordering, compounding, filling, dispensing, furnishing, or delivery of the Controlled Substance to that patient, or individual purporting to be a patient.
(ffff) "User" means a type of CURES registrant, including "Prescriber-User," "Non-DEA Practitioner-User," "Pharmacist-User," "Delegate-User," "Regulatory Agency-User," and "Law Enforcement-User."
(gggg) "User Profile Details Report" means a report generated by CURES that a Regulatory Agency-User may initiate to request the User profile details of a Prescriber-User, Non-DEA Practitioner-User, Pharmacist-User, or Delegate-User. A User Profile Details Report includes, as applicable, User first name, User last name, User ID, User Category of Licensure, User License Number, User DEA Number, User role, User status, number of Delegate associations, Delegate Agreement effective date, Delegate Agreement expiration date, and Delegate association status.
(hhhh) "Veterinary Workforce Member" means an employee, volunteer, trainee, or other person whose conduct, in the performance of work for a veterinarian who is a Prescriber-User, is under the direct control of that Prescriber-User.
(iiii) "Web-Based Application" means a Department-administered Web site or Web application that is made available for the purposes of accessing data in CURES or maintaining an account to access CURES. Web-Based Application does not include the Information Exchange Web Service or a HIT System.
(jjjj) "Workforce Member" means an employee, volunteer, trainee, or other person whose conduct, in the performance of work for an Authorized Health Care Provider, is under the direct control of that Authorized Health Care Provider.
Notes
Note: Authority cited: Section 11165, Health and Safety Code. Reference: Sections 11030, 11165, 11165.1, 11165.3, 11165.4 and 11165.6, Health and Safety Code; and Sections 208 and 209, Business and Professions Code.
Note: Authority cited: Section 11165, Health and Safety Code. Reference: Sections 11030, 11165, 11165.1, 11165.3, 11165.4 and 11165.6, Health and Safety Code; and Sections 208 and 209, Business and Professions Code.
2. Change without regulatory effect amending chapter heading and redesignating subsections (tt)(A)-(B) as subsections (tt)(1)-(2) filed 2-2-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 6).
3. Amendment filed 8-15-2022; operative
4. Change without regulatory effect amending subsection (aaaa) filed 5-29-2024 pursuant to section 100, title 1, California Code of Regulations (Register 2024, No. 22).