Bill Text: DE SB362 | 2025-2026 | 153rd General Assembly | Draft
Bill Title: An Act To Amend Title 16 Of The Delaware Code Relating To A Parkinson's Disease Registry.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Introduced) 2026-10-30 - Introduced and Assigned to Executive Committee in Senate [SB362 Detail]
Download: Delaware-2025-SB362-Draft.html
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SPONSOR: |
Sen. Seigfried |
DELAWARE STATE SENATE
153rd GENERAL ASSEMBLY
SENATE BILL NO. 362
AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO A PARKINSON'S DISEASE REGISTRY.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
Section 1. Amend Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:
Chapter 32A. Parkinson’s Disease Registry
§ 3201A. Short title.
This chapter may be cited as the “Delaware Parkinson’s Disease Registry Act.”
§ 3202A. Purpose.
The intent of the General Assembly is to establish and maintain a central Parkinson’s disease registry for the State. Parkinson’s disease and Parkinsonisms are significant public health concerns affecting individuals, families, caregivers, and health-care systems. Because the number of affected individuals is projected to grow, Delaware needs reliable statewide data to plan for evolving health-care and support needs. To accomplish this purpose, the Department shall oversee the registry and shall contract with the University and DHIN to utilize their existing infrastructure and expertise to collect, analyze, and manage registry data. It is intended that the product of these efforts will be a central data bank of accurate, precise, and current information to inform public health planning and resource allocation, strengthen community-based support services for affected individuals and their families, and advance scientific research.
§ 3203A. Definitions.
As used in this chapter:
(1) "Department" means the Department of Health and Social Services established under Chapter 79 of Title 29.
(2) "DHIN" or "Delaware Health Information Network" means the Delaware Health Information Network established under Chapter 103 of Title 16.
(3) "Parkinson's disease" means a chronic, progressive neurological disorder characterized by the degeneration of dopamine-producing neurons in the brain and associated with motor and nonmotor symptoms.
(4) "Parkinsonisms" means neurological conditions that cause symptoms similar to those of Parkinson's disease and arise from a variety of underlying causes.
(5) "University" means the University of Delaware established under Chapter 51 of Title 14.
§ 3204A. Establishment and operation of the registry; mandatory reporting.
(a) The Department shall contract with the University and DHIN to perform the duties necessary to operate the registry. Under the terms of the agreement, the responsibilities must be allocated as follows:
(1) DHIN shall facilitate the collection and secure transfer of health information through its existing health information exchange infrastructure and health-care claims database.
(2) The University shall lead the organization, analysis, and management of registry data, prepare required reports, and evaluate scientific research proposals requesting access to de-identified registry data.
(b) The Department shall establish a statewide registry of Parkinson's disease and Parkinsonisms among Delaware residents and is authorized to adopt rules and regulations under Chapter 101 of Title 29 as necessary to implement and enforce the provisions of this chapter.
(c) Every occurrence of Parkinson's disease or Parkinsonisms diagnosed or treated in this State must be reported to the Department, through the University or DHIN, as the Department's designated agents, within 180 days of initial diagnosis or treatment. This subsection applies to all of the following:
(1) A neurologist, physician, or other health-care practitioner who diagnoses or provides treatment for Parkinson's disease or Parkinsonisms.
(2) A hospital, clinic, dispensary, or other public or private institution that diagnoses or provides treatment for Parkinson's disease or Parkinsonisms.
(3) A clinical laboratory that examines tissue, fluid, or clinical specimens disclosing the existence of Parkinson's disease or Parkinsonisms.
(d) Reports submitted under subsection (c) of this section must include patient demographic data, length of residency in Delaware, primary residential address in Delaware, location and nature of primary past employment, and any additional demographic or clinical information required by the Department by regulation, in consultation with the University and DHIN, to support public health planning and scientific research.
(e) The Department, in consultation with the University and DHIN, may maintain a voluntary, opt-in authorization process allowing an individual diagnosed with Parkinson's disease or Parkinsonisms to consent to contact regarding participation in research studies or clinical trials.
(f) This chapter does not apply to a person or private institution that, as an exercise of religious freedom, treats the sick or suffering by spiritual means through prayer alone.
§ 3205A. Confidentiality and data governance.
(a) A report of an occurrence of Parkinson's disease or Parkinsonisms made under this chapter is confidential and privileged. Information in a report may not be divulged or made public in a manner that discloses the identity of the person to whom it relates, except as authorized by the Department for approved research or inter-agency exchange under strict confidentiality safeguards.
(b) An individual or organization providing information to the Department, the University, or DHIN in accordance with this chapter is not liable for divulging confidential information.
(c) The Department, the University, and DHIN shall establish procedures to identify, document, and address deficiencies in data quality, completeness, confidentiality, and security.
§ 3206A. Annual reporting.
(a) The University, in coordination with the Department and DHIN, shall submit an annual report on the registry to the Governor, the General Assembly, and the Director and the Librarian of the Division of Legislative Services not later than January 1, 2029, and by January 1 of each subsequent year.
(b) The annual report must include all of the following:
(1) Aggregate estimates of the prevalence and incidence of Parkinson's disease and Parkinsonisms among Delaware residents.
(2) Geographic and demographic patterns in the occurrence of these conditions.
(3) Trends in the number of individuals identified in the registry over time.
(4) Findings concerning health-care utilization among individuals included in the registry to inform public health planning.
(5) A summary of registry activities in supporting qualified scientific research.
(c) The annual report may not include personally identifiable information and must comply with applicable privacy and confidentiality laws.
§ 3207A. Compliance, enforcement, and penalties.
(a) If a health-care provider, facility, or clinical laboratory fails to report in accordance with § 3204A of this title, the University or DHIN must issue a notice of noncompliance providing a reasonable opportunity to cure the deficiency within a specified timeframe. If the deficiency is not cured within the specified timeframe, the University or DHIN must notify the Department of the persistent noncompliance.
(b) Upon receiving notification of persistent noncompliance under subsection (a), the Department may assess an administrative penalty of $100 for each violation, with each day a violation continues constituting a separate violation, or refer the matter to the appropriate professional regulatory or licensing board for disciplinary action under Title 24.
Section 2. This Act is effective immediately and is to be implemented the earlier of the following:
(1) One year from the date of the Act’s enactment.
(2) Notice by the Department of Health and Social Services published in the Register of Regulations that final regulations to implement this Act have been promulgated.
SYNOPSIS
This Act establishes a statewide registry for Parkinson's disease and Parkinsonisms under the regulatory oversight of the Department of Health and Social Services, with operational responsibilities delegated to a partnership between the University of Delaware and the Delaware Health Information Network. To minimize administrative burdens on providers and leverage existing infrastructure, the Act mandates that healthcare practitioners, facilities, and clinical laboratories report occurrences of these conditions within 180 days of initial diagnosis or treatment. Furthermore, the legislation establishes strict data confidentiality protections, authorizes the sharing of de-identified data for qualified scientific research, requires an annual report to the General Assembly beginning January 1, 2029, and provides an enforcement mechanism through the Department for persistent noncompliance, which is a fine of $100 per day for each violation.
Author: Senator Seigfried
