SECTION 1. Chapter 111 of the General Laws is hereby amended by striking Section 243 and inserting in place thereof the following new section: -
Section 243: Parkinson’s disease registry
(a) As used in this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:
“Parkinson’s disease”, 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. It is characterized by tremor at rest, slow movements, muscle rigidity, stooped posture, and unsteady or shuffling gait.
“Parkinsonisms”, related conditions that causes a combination of the movement abnormalities seen in Parkinson's disease — such as tremor at rest, slow movement, muscle rigidity, impaired speech or muscle stiffness — which often overlap with and can evolve from what appears to be Parkinson’s disease. Example Parkinsonisms of particular interest include, but are not exclusive to, the following: Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB), Corticobasal Degeneration (CBD), and Progressive Supranuclear Palsy (PSP).
(a) The department shall establish a Parkinson's disease registry for the collection of information necessary to determine the incidence and prevalence of Parkinson's disease and Parkinsonisms in the commonwealth.
(b) There shall be within the department a Parkinson's disease registry advisory committee to advise and assist in the development, implementation and progress of the Parkinson's disease registry established in subsection (a). The committee shall review and submit recommendations on: (i) what data shall be collected, including, but not limited to, demographic information and data by areas and regions of the commonwealth, with specific data from urban, low and median income communities and minority communities of the commonwealth; (ii) the means of collecting and disseminating such data; (iii) how to ensure privacy and confidentiality of such data; (iv) the purpose, design and functionality of the registry; and (v) the implementation of the registry. The committee shall recommend to the department any information deemed necessary and appropriate for the statistical identification and planning for treatment and education of health care providers and persons diagnosed with Parkinson's disease.
The committee shall consist of the commissioner, or a designee, and 10 members to be appointed by the commissioner as follows: 3 physicians, 1 of whom shall be a general neurologist, 1 of whom shall be a movement disorder specialist and 1 of whom shall be a primary care physician; 1 health informaticist; 2 population health researchers familiar with registries; 2 Parkinson's disease researchers; and 2 persons diagnosed with Parkinson's disease. The committee shall meet at least bi-annually to assess registry progress and recommend changes.
(c) The registry and system of 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 program.
(d) All patients diagnosed with Parkinson’s disease or related Parkinsonisms, as advised by an Advisory Committee, shall be provided a notice in writing and orally regarding the collection of information and patient data on Parkinson’s disease. Patients who do not wish to participate in the collection of data for purposes of research in this registry shall affirmatively opt-out in writing after an opportunity to review the documents and ask questions. No patient shall be forced to participate in this registry. Patients may change their participation status at any time by submitting a request in writing.
(e) The department shall establish a system for the collection and dissemination of information determining the incidence and prevalence of Parkinson’s disease and related Parkinsonisms, as advised by the advisory committee. The department shall designate Parkinson’s disease and related Parkinsonisms as advised by the advisory committee as diseases required to be reported in the state or any part of the state.
All cases of Parkinson’s disease diagnosed or treated in the commonwealth shall be reported to the department. However, the mere incidence of a patient with Parkinson’s shall be the sole required information for this registry for any patient who chooses not to participate. For the subset of patients who choose not to participate, no further data shall be reported to the registry.
The department may create, review and revise a list of data points required as part of mandated Parkinson’s disease reporting under this Section.
i. This 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.
ii. The department may implement and administer this subdivision through a bulletin, or similar instruction, to providers without taking regulatory action.
(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) Any hospital, facility, physician, surgeon, physician assistant or nurse practitioner who diagnoses or is responsible for providing primary treatment to Parkinson’s disease or Parkinsonism patients shall report each case of Parkinson’s disease and Parkinsonisms, as required by subsection (e), to the department in a format prescribed by the department. The Department shall be authorized to enter into data sharing contracts with data reporting entities and their associated electronic medical record systems vendors to securely and confidentially receive information related to Parkinson’s disease testing, diagnosis and treatment.
(h) The department may enter into agreements to furnish data collected in this 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. 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:
i. 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; and
ii. 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
(i) 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. To ensure privacy, the department shall promulgate a coding system that removes any identifying information about the patient.
(j) Notwithstanding any other 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.
i. Provided the security of confidentiality has been documented, 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.
(k) 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.
(l) Notwithstanding any other law, confidential information shall not be available for subpoena, shall not be disclosed, discoverable or compelled to be produced in any civil, criminal, administrative or other proceeding. Confidential information shall not be deemed admissible as evidence in any civil, criminal, administrative or other tribunal or court for any reason.
This subsection 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.
Notwithstanding the restrictions in this subsection, the individual to whom the information pertains shall have access to his or her own information.
(m) 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.
SECTION 2. On or before December 21, 2024, and every year thereafter, the Department shall report to the House Committee on Ways and Means, the Senate Committee on Ways and Means, and the Joint Committee on Public Health, a yearly program summary update on the incidents and prevalence of Parkinson’s in the state by county, how many records have been included and reported into the registry, and demographic information such as patients by age, gender and race. This yearly report shall also be published in a downloadable format on the Department’s webpage or designated Massachusetts Parkinson’s Research Registry webpage.
SECTION 3. The Department shall create and maintain a webpage titled “an overview from the Massachusetts Parkinson’s Research Registry” within the Department’s public information website to allow public access to information related to the registry, a yearly program summary, and any other relevant or helpful information related to the registry as deemed necessary by the Parkinson’s Disease Registry Advisory Committee. This information may be published in any form deemed appropriate by the Department.
This section will take effect January 1, 2025.
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