EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb0703*
HOUSE BILL 703
J1 3lr1884
CF SB 584
By: Delegate Kerr
Introduced and read first time: February 6, 2023
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
Public Health – Parkinson’s Disease Registry – Established 2
FOR the purpose of establishing a Parkinson’s Disease Registry in the Maryland 3
Department of Health; requiring the Department to collect certain data for the 4
Registry; authorizing the Department to share certain information in the Registry 5
with certain entities under certain conditions; providing for the confidentiality of 6
information collected under this Act; requiring the Department to maintain a record 7
of individuals granted access to confidential information in the Registry; and 8
generally relating to the establishment of a Parkinson’s Disease Registry. 9
BY repealing and reenacting, with amendments, 10
Article – Health – General 11
Section 18–1201 and 18–1203 12
Annotated Code of Maryland 13
(2019 Replacement Volume and 2022 Supplement) 14
BY repealing 15
Article – Health – General 16
Section 18–1202 17
Annotated Code of Maryland 18
(2019 Replacement Volume and 2022 Supplement) 19
BY adding to 20
Article – Health – General 21
Section 18–1202 and 18–1204 through 18–1210 22
Annotated Code of Maryland 23
(2019 Replacement Volume and 2022 Supplement) 24
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 25
That the Laws of Maryland read as follows: 26
2 HOUSE BILL 703
Article – Health – General 1
18–1201. 2
(a) In this subtitle the following words have the meanings indicated. 3
(b) “Advisory Committee” means the Parkinson’s Disease Registry Advisory 4
Committee. 5
(c) (1) “PARKINSONISMS ” MEANS CONDITIONS RELATED TO 6
PARKINSON’S DISEASE THAT CAUSE A COMBINATION OF THE MOVEMENT 7
ABNORMALITIES SEEN I N PARKINSON’S DISEASE. 8
(2) “PARKINSONISMS ” INCLUDES MULTIPLE SYSTEM ATROPHY, 9
DEMENTIA WITH LEWY BODIES, CORTICOBASAL DEGENERATION , AND PROGRESSIVE 10
SUPRANUCLEAR PALSY. 11
(D) “Parkinson’s disease” means a chronic and progressive disorder resulting from 12
deficiency of the neurotransmitter dopamine as the consequence of specific degenerative 13
changes in the area of the brain called the basal ganglia, characterized by tremors at rest, 14
slow movements, muscle rigidity, stooped posture, and unsteady or shuffling gait. 15
(E) “REGISTRY” MEANS THE PARKINSON’S DISEASE REGISTRY. 16
[18–1202. 17
There is a Parkinson’s Disease Registry Advisory Committee in the Department.] 18
18–1202. 19
THERE IS A PARKINSON’S DISEASE REGISTRY IN THE DEPARTMENT . 20
18–1203. 21
(A) THERE IS A PARKINSON’S DISEASE REGISTRY ADVISORY COMMITTEE 22
IN THE DEPARTMENT . 23
[(a)] (B) The Advisory Committee shall: 24
(1) Assist in the development and implementation of a Parkinson’s Disease 25
Registry; 26
(2) Determine what data shall be collected and be stored in a Parkinson’s 27
Disease Registry and the methods to ensure the privacy and confidentiality of data collected 28
and stored in the registry; and 29 HOUSE BILL 703 3
(3) Advise the Department on Parkinson’s disease and maintaining a 1
Parkinson’s Disease Registry. 2
[(b)] (C) (1) The Secretary shall appoint individuals to serve on the Advisory 3
Committee, including: 4
(i) A neurologist; 5
(ii) A movement disorder specialist; 6
(iii) A primary care provider; 7
(iv) A physician informaticist; 8
(v) A patient with Parkinson’s disease; 9
(vi) A public health professional; 10
(vii) A population health researcher familiar with disease registries; 11
(viii) A Parkinson’s disease researcher; and 12
(ix) Any other individuals the Secretary determines are necessary. 13
(2) The Secretary shall establish: 14
(i) The duration of term limits for members of the Advisory 15
Committee; 16
(ii) The frequency of meetings of the Advisory Committee; 17
(iii) Rules and procedures for conducting business of the Advisory 18
Committee; and 19
(iv) Any other rules necessary for the Advisory Committee to 20
function effectively. 21
18–1204. 22
(A) THE DEPARTMENT SHALL COLL ECT DATA FOR THE REGISTRY, 23
INCLUDING DATA ON THE IN CIDENCE OF PARKINSON’S DISEASE IN THE STATE AND 24
RELATED EPIDEMIOLOGI CAL DATA. 25
(B) THE ADVISORY COMMITTEE, IN CONSULTATION WITH THE 26
DEPARTMENT , SHALL: 27 4 HOUSE BILL 703
(1) IDENTIFY CATEGORIES OF DATA TO BE COLLECTED FOR THE 1
REGISTRY RELATED TO: 2
(I) PATIENT DEMOGRAPHICS , INCLUDING GEOGRAPHY ; AND 3
(II) DIAGNOSES; AND 4
(2) PERIODICALLY REVIEW T HE DATA COLLECTED FOR THE 5
REGISTRY TO ASSESS WHETHER THE : 6
(I) DATA INCLUDES SUFFICI ENT INFORMATION TO E NSURE 7
THERE ARE NO DUPLICA TED PATIENT RECORDS IN THE REGISTRY; AND 8
(II) CATEGORIES OF DATA CO LLECTED SHOULD BE AL TERED. 9
18–1205. 10
(A) (1) UNLESS OTHERWISE PROV IDED IN THIS SUBTITL E, ALL 11
INFORMATION COLLECTE D FOR THE REGISTRY UNDER THIS S UBTITLE SHALL BE 12
CONFIDENTIAL . 13
(2) THE DEPARTMENT SHALL IMPLEMENT A CODING S YSTEM THAT 14
REMOVES ANY PERSONAL LY IDENTIFIABLE INFO RMATION OF AN INDIVI DUAL FROM 15
COLLECTED DATA . 16
(B) THE DEPARTMENT , IN CONSULTATION WITH THE ADVISORY 17
COMMITTEE, SHALL ESTABLISH A SY STEM FOR THE COLLECT ION OF DATA FOR THE 18
REGISTRY AND DISSEMINATION OF INFORMATION DETERMIN ING THE INCIDENCE 19
AND PREVALENCE OF PARKINSON’S DISEASE AND RELATE D PARKINSONISMS . 20
(C) (1) THE DEPARTMENT , IN CONSULTATION WITH THE ADVISORY 21
COMMITTEE, SHALL: 22
(I) NOTIFY, IN WRITING AND ORALL Y, ALL INDIVIDUAL S IN THE 23
STATE DIAGNOSED WITH PARKINSON’S DISEASE OR RELATED PARKINSONISMS 24
ABOUT THE CREATION O F THE REGISTRY, DATA COLLECTION ASSO CIATED WITH 25
THE REGISTRY, AND THE RIGHT TO OPT OUT OF PARTICIPATION IN THE REGISTRY; 26
AND 27
(II) PROVIDE AN OPPORTUNIT Y TO OPT OUT OF PARTICIPAT ION 28
IN THE REGISTRY. 29
HOUSE BILL 703 5
(2) (I) AN INDIVIDUAL WITH PARKINSON’S DISEASE OR RELATED 1
PARKINSONISMS MAY OPT OUT OF PARTI CIPATING IN THE REGISTRY BY 2
SUBMITTING WRITTEN N OTICE TO THE DEPARTMENT . 3
(II) IF AN INDIVIDUAL OPTS OUT OF PARTICIPA TION IN THE 4
REGISTRY, THE DEPARTMENT : 5
1. SHALL RECORD AN INCID ENCE OF A PATIENT WI TH 6
PARKINSON’S DISEASE; AND 7
2. MAY NOT RECORD ANY AD DITIONAL INFORMATION 8
ABOUT THE INDIVIDUAL . 9
(D) THE DEPARTMENT MAY : 10
(1) CREATE, REVIEW, AND REVISE A LIST OF DATA POINTS REQUIRED 11
AS PART OF MANDATED PARKINSON’S DISEASE REPORTING UNDER THIS SECTION , 12
INCLUDING NECESSARY TRIGGERING DIAGNOSTI C CONDITIONS THAT AR E 13
CONSISTENT WITH THE LATEST INTERNATIONAL STATISTICAL CLASSIFICATION OF 14
DISEASES AND RELATED HEALTH PROBLEMS; AND 15
(2) IMPLEMENT THE COLLECT ION OF DATA POINTS O N THE LIST 16
CREATED UNDER ITEM (1) OF THIS SUBSECTION T HROUGH A BULLETIN , OR SIMILAR 17
INSTRUCTION, TO NURSE PRACTITIONE RS, PHYSICIANS, AND PHYSICIAN 18
ASSISTANTS. 19
(E) AT LEAST 180 DAYS BEFORE THE DEPARTMENT ADOPTS MANDA TORY 20
REPORTING OF PARKINSON’S DISEASE AND RELATE D PARKINSONISMS , THE 21
DEPARTMENT SHALL PROV IDE NOTIFICATION OF THE MANDATORY REPORT ING OF 22
PARKINSON’S DISEASE AND RELATE D PARKINSONISMS : 23
(1) ON THE DEPARTMENT ’S WEBSITE; 24
(2) DIRECTLY TO ASSOCIATIONS REPR ESENTING HOSPITALS , 25
HEALTH CARE PROFESSI ONALS, AND OTHER HEALTH CAR E PROVIDERS IN THE 26
STATE; AND 27
(3) DIRECTLY TO THE STATE BOARD OF NURSING AND THE STATE 28
BOARD OF PHYSICIANS. 29
(F) (1) A NURSE PRACTITIONER , PHYSICIAN, OR PHYSICIAN AS SISTANT 30
WHO DIAGNOSES PATIEN TS WITH PARKINSON’S DISEASE AND RELATE D 31
PARKINSONISMS SHALL REPORT EACH CASE OF PARKINSON’S DISEASE AND 32 6 HOUSE BILL 703
RELATED PARKINSONISM S TO THE REGISTRY IN A FORMAT DETERMINED BY THE 1
DEPARTMENT . 2
(2) THE DEPARTMENT MAY U SE EXISTING REPORTING PROCEDURES 3
TO IMPLEMENT THE REQ UIREMENT UNDER PARAG RAPH (1) OF THIS SUBSECTION 4
FOR DIAGNOSIS REPORT ING AND DATA SUBMISS ION BY A NURSE PRACTITIONER , 5
PHYSICIAN, OR PHYSICIAN ASSISTA NT. 6
18–1206. 7
(A) THE DEPARTMENT MAY ENTER INTO AGREEMENTS TO P ROVIDE DATA 8
COLLECTED IN THE REGISTRY WITH PARKINSON’S DISEASE REGISTRIES IN OTHER 9
STATES, FEDERAL PARKINSON’S DISEASE CONTROL AG ENCIES, LOCAL HEALTH 10
DEPARTMENTS , OR HEALTH RESEARCHER S FOR THE STUDY OF PARKINSON’S 11
DISEASE AND RELATED PARKINSONISMS . 12
(B) (1) BEFORE CONFIDENTIAL I NFORMATION IS DISCLO SED UNDER 13
SUBSECTION (A) OF THIS SECTION , THE DEPARTMENT SHALL RECE IVE A WRITTEN 14
AGREEMENT FROM THE P ARTNERING ENTITY TO MAINTAIN THE CONFIDE NTIALITY 15
OF THE INFORMATION . 16
(2) IF THE ENTITY RECEIVI NG CONFIDENTIAL DATA FROM THE 17
REGISTRY IS A RESEARC H ENTITY, THE RESEARCH ENTITY SHALL: 18
(I) OBTAIN APPROVAL FROM THE COMMITTEE AT THE 19
RESEARCH ENTITY THAT NORMALLY REVIEW S RESEARCH PROJECTS FOR THE 20
PROTECTION OF HUMAN SUBJECTS ESTABLISHED IN ACCORDANCE WITH TITLE 45 21
OF THE CODE OF FEDERAL REGULATIONS; AND 22
(II) PROVIDE DOCUMENTATION TO THE DEPARTMENT THAT 23
DEMONSTRATES , TO THE DEPARTMENT ’S SATISFACTION , THAT THE RESEARCH 24
ENTITY HAS ESTABLISH ED PROCEDURES AND TH E ABILITY TO MAINTAI N THE 25
CONFIDENTIALITY OF T HE DISCLOSED INFORMATION . 26
(C) THE DEPARTMENT SHALL ESTA BLISH PROCEDURES TO REVIEW AND 27
APPROVE REQUESTS TO USE REGISTRY DATA FOR SCI ENTIFIC RESEARCH . 28
18–1207. 29
(A) NOTWITHSTANDING ANY O THER PROVISION OF LA W OR RULE OF 30
PROCEDURE OR EVIDENC E IN THE MARYLAND RULES: 31
(1) A DATA DISCLOSURE AUTH ORIZED BY THIS SUBTI TLE MAY NOT: 32 HOUSE BILL 703 7
(I) INCLUDE INFORMATION O THER THAN THE INFORM ATION 1
NECESSARY FOR THE PU RPOSE OF THE DISCLOS URE; 2
(II) BE USED FOR A PURPOSE OTHER THAN THE PURPO SE FOR 3
THE DISCLOSURE ; OR 4
(III) BE FURTHER DISCLOSED ; 5
(2) THE CONFIDENTIAL INFO RMATION COLLECTED FO R THE 6
REGISTRY MAY NOT BE M ADE AVAILABLE FOR SU BPOENA, DISCLOSED, 7
DISCOVERABLE , OR COMPELLED TO BE P RODUCED IN ANY CIVIL , CRIMINAL, 8
ADMINISTRATIVE , OR OTHER PROCEEDING ; AND 9
(3) THE CONFIDENT IAL INFORMATION COLL ECTED FOR THE 10
REGISTRY MAY NOT BE D EEMED ADMISSIBLE AS EVIDENCE IN ANY CIVI L, CRIMINAL, 11
ADMINISTRATIVE , TRIBUNAL, OR OTHER PROCEEDING . 12
(B) (1) THIS SECTION DOES NOT PREEMPT THE AUTHORIT Y OF A HEALTH 13
CARE PROVIDER , AS DEFINED IN § 19–132 OF THIS ARTICLE , PROVIDING 14
DIAGNOSTIC SERVICES OR TREATMENT TO PATI ENTS WITH PARKINSON’S DISEASE 15
OR RELATED PARKINSON ISMS TO MAINTAIN A PARKINSON’S DISEASE REGISTR Y. 16
(2) THIS SECTION DOES NOT PROHIBIT THE PUBLICA TION OF 17
REPORTS AND STATISTI CAL COMPIL ATIONS THAT DO NOT I DENTIFY INDIVIDUALS 18
WITH PARKINSON’S DISEASE OR RELATED PARKINSONISMS OR IND IVIDUAL 19
SOURCES OF INFORMATI ON. 20
18–1208. 21
(A) THE DEPARTMENT SHALL MAINTAIN A RECORD OF INDIVIDUALS 22
GRANTED ACCESS TO CO NFIDENTIAL INFORMATI ON FROM THE REGISTRY. 23
(B) THE DEPARTMENT MAY NOT DE NY A REQUEST FOR INS PECTION OF THE 24
RECORD MAINTAINED UN DER SUBSECTION (A) OF THIS SECTION UNDER TITLE 4 OF 25
THE GENERAL PROVISIONS ARTICLE. 26
(C) THE RECORD MAINTAINED UNDER SUBSECTION (A) OF THIS SECTION 27
SHALL INCLUDE THE ACCESSING INDIVI DUAL’S: 28
(1) NAME; 29
(2) TITLE; 30 8 HOUSE BILL 703
(3) ADDRESS; 1
(4) ORGANIZATIONAL AFFILI ATION; 2
(5) DATES OF ACCESS; AND 3
(6) PURPOSE FOR ACCESSING THE INFORMATION . 4
18–1209. 5
THE DEPARTMENT SHALL ADOP T REGULATIONS NECESS ARY TO CARRY OUT 6
THIS SUBTITLE. 7
18–1210. 8
(A) ON OR BEFORE DECEMBER 1 EACH YEAR, BEGINNING IN 2023, THE 9
ADVISORY COMMITTEE SHALL REPOR T TO THE SECRETARY OF HEALTH AND, IN 10
ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, THE SENATE 11
FINANCE COMMITTEE AND THE HOUSE HEALTH AND GOVERNMENT OPERATIONS 12
COMMITTEE ON THE REGISTRY AND THE PREV ALENCE OF PARKINSON’S DISEASE IN 13
THE STATE. 14
(B) THE DEPARTMENT SHALL POST THE REPORT REQUIRED UNDER 15
SUBSECTION (A) OF THIS SECTION ON A DEDICATED WEBSITE AC CESSIBLE TO THE 16
PUBLIC. 17
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 18
October 1, 2023. 19