Establishes State Parkinson's disease registry.

A1155

ASSEMBLY, No. 1155

STATE OF NEW JERSEY

222nd LEGISLATURE

�

PRE-FILED FOR INTRODUCTION IN THE 2026 SESSION

Sponsored by:

Assemblyman JOE DANIELSEN

District 17 (Middlesex and Somerset)

SYNOPSIS

���� Establishes State Parkinson's disease registry.

CURRENT VERSION OF TEXT

���� Introduced Pending Technical Review by Legislative
Counsel.

��

An Act
concerning Parkinson�s disease and supplementing Title
26 of the Revised Statutes.

����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:

���� 1.��� As used in this act:

���� �Advisory committee� means the
Parkinson�s disease registry advisory committee established pursuant to section
3 of this act.

���� �Commissioner� means the
Commissioner of Health.

���� �Department� means the
Department of Health.

���� �Health care provider� means a
health care facility licensed pursuant to P.L.1971, c.163 (C.26:2H-1 et seq.)
or an individual licensed or certified to practice a health care profession
pursuant to Title 45 of the Revised Statutes.

���� �Parkinson�s disease� means a
chronic and progressive neurologic disorder resulting from deficiency of the
neurotransmitter dopamine as the consequence of specific degenerative changes
in the area of the brain called the basal ganglia. Parkinsonisms are related
movement abnormalities and conditions that may overlap with or evolve from
Parkinson�s disease.

���� �Registry� means the
Parkinson�s disease registry established pursuant to section 2 of this act.

���� 2.��� a. The department shall
establish a Statewide population-based Parkinson's disease registry.

���� b.��� The department shall
collect data on the incidence of Parkinson's disease within the State. The
registry, data collection, and dissemination of information shall be under the
direction of the commissioner, who may enter into contracts, grants, or other agreements
as are necessary for the conduct of the registry.

���� c.���� (1) In consultation
with the advisory committee, the department shall establish a system for the
collection and dissemination of information concerning the incidence and
prevalence of Parkinson's disease and Parkinsonisms. The system shall be
designed in a way that prevents the inclusion of duplicate registry records for
a single individual.

���� (2)�� Subject to the
provisions of subsection e. of this section, all cases of Parkinson�s disease
that are diagnosed or treated in the State, including cases of Parkinson�s
disease that were diagnosed prior to the effective date of this act, shall be
reported to the department in a form and manner as the department requires.

���� (3)�� The department shall
establish, review, and revise as needed a list of mandatory and advisory data
points for the purposes of reporting Parkinson's disease and Parkinsonisms
under this section. Such list shall include, but not be limited to, necessary
triggering diagnostic conditions, consistent with the latest International
Statistical Classification of Diseases and Related Health Problems, and
resulting case data including, but not limited to, diagnosis, treatment,� and�
survival;� and� may� include� appropriate� patient

demographic information concerning
the individual�s age, gender, race, and ethnicity, to the extent the individual
chooses to disclose such demographic information.

���� d.��� Subject to the
provisions of subsection e. of this section, a health care provider that
diagnoses an individual with Parkinson�s disease or Parkinsonisms or that is
the primary treatment provider for an individual diagnosed with Parkinson's
disease or Parkinsonisms shall report each unique case of Parkinson's disease
or Parkinsonisms to the registry. The department may enter into data sharing
contracts with data reporting entities and associated electronic medical record
systems vendors to securely and confidentially receive information related to
Parkinson's disease testing, diagnosis, and treatment.

���� e.���� An individual may opt
out of the registry at any time by providing a written opt-out form to the
health care provider seeking to enroll the individual in the registry, or by
submitting a request to the department to be removed from, or not to be
included in, the registry. The department shall develop a written opt-out
request form for use by health care providers for the purposes of this
paragraph, and shall establish a written or online opt-out request form for
requests submitted directly to the department. If an individual chooses not to
participate in the registry, the only required information to be collected
shall be the incidence of Parkinson's disease or Parkinsonisms, and no further
data shall be reported to the registry for that individual. At such time as a
health care provider seeks to enroll an individual in the registry, the health
care provider shall provide the individual with written notice, in a form and
manner developed by the department, of the individual�s right to opt-out of
participation in the registry.

���� f.���� The Department shall
provide notification of the mandatory reporting of Parkinson�s disease and
Parkinsonism on its website and may also provide that information to
professional associations representing physicians, nurse practitioners, and
hospitals at least 90 days prior to requiring information be reported.

���� g.��� All registry information
collected pursuant to this section shall be confidential. To protect against
disclosure of personal identifying information and confidential health
information, the department shall establish a coding system that removes any
identifying information about individuals included in the registry.

���� h.��� The department may enter
into agreements to furnish data collected in the registry to other states'
Parkinson's disease registries, federal Parkinson's disease control agencies,
local health officers, or health researchers for the study of Parkinson's disease.
In addition to the requirements of subsection h. of this section, before
registry information is disclosed to an agency, officer, researcher, or out-of-
State registry, the requesting entity shall agree in writing to maintain the
confidentiality of the information, and in the case of a researcher, shall:

���� (1)�� obtain approval from the
researcher�s Committee for the Protection of Human Subjects (CPHS) established
in accordance with 45 CFR Part 46; and

���� (2)�� provide documentation to
the department that demonstrates, to the department�s satisfaction, that the
researcher has established procedures, and has the ability, to maintain the
confidentiality of the information.

���� i.���� (1) Notwithstanding any
other provision of law to the contrary, registry information provided to a
requester pursuant to subsection g. of this section shall include only the
information necessary for the stated purpose outlined in the request, and shall
not be used by the requester for any purpose other than the purpose outlined in
the request. Unless approved by the department in writing, an entity that is
provided registry information pursuant to subsection g. of this section shall
not furnish the registry information to any other entity for any purpose.

���� (2)�� Notwithstanding any
other provision of law to the contrary, registry information shall not be
subject to subpoena or otherwise subject to disclosure, discovery, or compelled
production in any civil, criminal, administrative, or other proceeding.
Registry information shall not be deemed admissible as evidence in any civil,
criminal, administrative, or other tribunal or court for any reason.

���� (3)�� The department shall
maintain an accurate record of all persons who are provided registry
information pursuant to subsection

g. of this section. The record
shall include: the name of the person authorizing access; the name, title,
address, and organizational affiliation of the requester; the date the registry
information was provided to the requester; and the specific purpose for which
the registry information is provided. Records of access maintained pursuant to
this paragraph shall be open to public inspection during normal operating hours
of the department.

���� (4)�� Nothing in this
subsection shall be construed to prohibit the department from publishing
reports and statistical compilations that do not in any way identify individual
cases or individual sources of information included in the registry.

���� (5)�� An individual whose
information is included in the registry shall have access to the individual�s
own registry information.

���� j.���� Commencing 18 months
after the effective date of this act, and annually thereafter, the department
shall prepare and submit a report to the Governor and, pursuant to section 2 of
P.L.1991, c.164 (C.52:14-19.1), to the Legislature, which shall provide information
and statistics concerning: (1) the incidence and prevalence of Parkinson's
disease and Parkinsonisms in the State, by county; (2) the overall number of
cases of Parkinson�s disease and Parkinsonisms included in the registry and the
number of new enrollments in the registry during the reporting period; and (3)
demographic information for individuals enrolled in the registry, to the extent
such demographic information is disclosed by individuals enrolled in the
registry, which demographic information may include, but shall not be limited
to, age, gender, race, and ethnicity.

���� k. The department shall create
and maintain on its internet website a publicly-accessible webpage dedicated to
the State Parkinson's disease registry, which shall include information related
to the registry, a yearly program summary, copies of the annual reports
prepared pursuant to subsection j. of this section, and any other relevant or
helpful information related to the registry as the department, in consultation
with the advisory council, deems necessary and appropriate.

���� 3.��� a. The department shall
establish a Parkinson�s disease registry advisory council, which advisory
council shall assist in the development and administration of the registry,
including determining what data is collected and maintained in the registry and
generally advising the department concerning the implementation of this act.

���� b.��� Members of the advisory
council shall be appointed by, and shall serve at the pleasure of, the
commissioner. at a minimum, the membership of the advisory council shall
include:

���� (1)�� a neurologist;

���� (2)�� a movement disorder
specialist;

���� (3)�� a primary care provider;

���� (4)�� a physician
informaticist;

���� (5)�� a patient living with
Parkinson�s disease;

���� (6)�� a public health
professional;

���� (7)�� a population health
researcher familiar with registries;

���� (8)�� a Parkinson�s disease
researcher; and

���� (9)�� any other members as the
commissioner deems necessary.

���� c.���� Members of the advisory
council shall serve without compensation but may be reimbursed for reasonable
expenses incurred in the performance of their official duties, subject to the
availability of funds made available to the advisory council for this purpose.

���� d.��� The commissioner shall
appoint a chair and a vice-chair of the advisory council. The chair may appoint
a secretary, who need not be a member of the advisory council.

���� e.���� The advisory council
shall meet at least quarterly at such times and places as are determined by the
chair. The advisory council shall additionally meet at the call of the
commissioner or of the chair.

���� 4.��� The Commissioner of
Health may adopt rules and regulations, in accordance with the �Administrative
Procedure Act,� P.L.1968, c.410 (C.52:14B-1 et seq.), if necessary to
effectuate the provisions of this act.

���� 5.��� This act shall take
effect immediately.

STATEMENT

���� This bill requires the
Department of Health (DOH) to establish a State Parkinson�s disease registry.
Parkinson�s disease is a chronic and progressive neurologic disorder resulting
from deficiency of the neurotransmitter dopamine as the consequence of specific
degenerative changes in the area of the brain called the basal ganglia.�
Parkinson�s disease is characterized by tremor at rest, slow movements, muscle
rigidity, stooped posture, and unsteady or shuffling gait. Parkinsonisms are
related movement abnormalities and conditions that may overlap with or evolve
from Parkinson�s disease.

���� Under this bill, the DOH is to
oversee the creation and management of a Statewide Parkinson�s disease
registry. The registry will collect data on the incidence of Parkinson's
disease and Parkinsonisms within the State. Health care providers, including hospitals
and other health care facilities and health care practitioners, such as
physicians, physician assistants, and advanced practice nurses, that diagnose
or treat people diagnosed with Parkinson's disease or Parkinsonisms will be
required to report each unique case of Parkinson's disease or Parkinsonisms to
the registry. The DOH will determine the specific mandatory and permissive data
points to be collected in the registry.

���� Registry information will
generally be deemed confidential, but may be made available to various
entities, including other Parkinson�s disease registries, public health
entities, and researchers, under certain circumstances.� Patients will have the
opportunity to opt out of inclusion in the registry, in which case only the
incidence of a Parkinson�s diagnosis will be reported.

���� The DOH will be required to
prepare an annual report concerning registry information and will be required
to maintain a publicly- accessible webpage providing information about the
registry and links to the DOH�s annual reports.

���� The DOH will additionally be
required to establish a Parkinson�s disease registry advisory council to assist
in the development of the registry, determine what data will be collected, and
advise the DOH as to the implementation of the bill.

���� Public health agencies have
long recognized that population-based data registries are required to estimate
the incidence and prevalence of non-communicable chronic diseases. Registries
have been developed throughout the world for the purpose of surveillance of
these diseases to inform public health agencies and the public on the extent of
the disease and to identify trends amidst population centers to support the
development of public health interventions.

���� States that have adopted
statewide Parkinson�s disease registries include California, Nebraska, Utah,
and Washington. A population- based registry is necessary to generate the basic
data that will help researchers, treatment providers, and legislators determine
the causes of the disease, evaluate the efficacy of treatment, uncover
inequities in Parkinson�s disease healthcare, and make decisions about the
allocation of resources for prevention and treatment. It is the sponsor�s
belief that a State Parkinson�s disease registry will enable the State to
better understand the full, diverse, and heterogeneous nature of Parkinson�s
disease among New Jerseyans and ensure that the regional nuances and trends are
captured in effort to minimize over or underrepresentation.