Mass. Gen. Laws ch. 111 § 243

Current through Chapters 1 to 249 and Chapters 253 to 255 of the 2024 Legislative Session
Section 111:243 - Parkinson's Parkinsonisms cases registry
(a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:

"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, characterized by tremor at rest, slow movements, muscle rigidity, stooped posture and unsteady or shuffling gait.

"Parkinsonisms", related conditions that cause a combination of the movement abnormalities seen in Parkinson's disease, including 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; provided, however, that "Parkinsonisms" shall include, but not be limited to: Multiple System Atrophy, Dementia with Lewy Bodies, Corticobasal Degeneration and Progressive Supranuclear Palsy.

(b) The department shall, subject to appropriation, establish a registry to record cases of Parkinson's and Parkinsonisms that occur in residents of the commonwealth and such information concerning these cases as it shall deem necessary and appropriate in order to determine the incidence and prevalence of such diseases.
(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 shall be provided a written and oral notice regarding the collection of information and patient data on Parkinson's disease and related Parkinsonisms. 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 required to participate in this registry and patients may change their data collection 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. The department shall designate Parkinson's disease and related Parkinsonisms as diseases required to be reported in the commonwealth or any part of the commonwealth.

All cases of Parkinson's disease and related Parkinsonisms diagnosed or treated in the commonwealth shall be reported to the department; provided, however, that the mere incidence of a patient with Parkinson's disease or a related Parkinsonism 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. The list shall include, but not be limited to, necessary triggering diagnostic conditions, consistent with the latest World Health Organization's International Statistical Classification of Diseases and Related Health Problems and resulting case data including, but not limited to, diagnosis, treatment and survival.

The department may implement and administer this subsection 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 not less than 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 may 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; provided, however, that 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:
(i) obtain approval of their committee for the protection of human subjects established in accordance with 45 C.F.R. 46 ; and
(ii) provide documentation to the department that demonstrates to the department's satisfaction that the entity has established the procedures and has the 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. To ensure privacy, the department shall promulgate a coding system that removes any identifying information about the patient.
(j) Notwithstanding any general or special law to the contrary, 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.

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 such 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 under this section. The record shall include:
(i) the name of the person authorizing access;
(ii) the name, title, address and organizational affiliation of persons given access;
(iii) dates of access; and
(iv) the specific purpose for which such confidential 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 general or special law to the contrary, confidential information under this section shall not be available for subpoena and shall not be disclosed, subject to discovery or compelled to be produced in any civil, criminal, administrative or other proceeding. Such confidential information shall not be deemed admissible as evidence in any civil, criminal, administrative or other tribunal or court for any reason.

This subsection shall not prohibit the publication by the department of reports and statistical compilations that do not 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 such information.

(m) This section shall not preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with Parkinson's disease or related Parkinsonisms to maintain their own facility-based Parkinson's disease or Parkinsonisms registries.
(n) Annually, the department shall report to the house and senate committees on ways and means and the joint committee on public health, a program summary update on the incidence and prevalence of Parkinson's and related Parkinsonisms in the commonwealth, delineated by county, and including the number of records that have been included and reported into the registry and demographic information such as patients, by age, gender and race. The report shall be published in a downloadable format on the department's webpage or on a dedicated webpage for the registry.
(o)

[Effective 1/1/2025]

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, the yearly program summary required by this section and any other relevant or helpful information related to the registry. This information may be published in any form deemed appropriate by the department.

Mass. Gen. Laws ch. 111, § 111:243

Amended by Acts 2024, c. 238,§ 225, eff. 11/20/2024 and 1/1/2025.
Added by Acts 2021 , c. 24, § 45, eff. 7/1/2021.