To enact sections 3705.30, 3705.31, 3705.32, 3705.33, 3705.34, and 3705.35 of the Revised Code to require the Director of Health to establish a Birth Defects Information System and to repeal section 3705.34 four years after the effective date of this act in compliance with agency sunset provisions.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Sec. 3705.30. THE DIRECTOR OF HEALTH SHALL ESTABLISH A STATEWIDE BIRTH DEFECTS INFORMATION SYSTEM FOR THE COLLECTION OF INFORMATION CONCERNING CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS.

(A) THE DIRECTOR MAY REQUIRE EACH HOSPITAL CLASSIFIED AS A GENERAL HOSPITAL UNDER SECTION 3701.07 OF THE REVISED CODE AND EACH FREESTANDING BIRTHING CENTER, AS DEFINED IN SECTION 3702.51 of the Revised Code, TO REPORT TO THE SYSTEM INFORMATION CONCERNING ALL PATIENTS UNDER FIVE YEARS OF AGE WITH A PRIMARY DIAGNOSIS OF A CONGENITAL ANOMALY OR ABNORMAL CONDITION.

(B) ON REQUEST, EACH GENERAL HOSPITAL AND FREESTANDING BIRTHING CENTER SHALL GIVE THE DIRECTOR OR APPROPRIATE EMPLOYEES OF THE DEPARTMENT OF HEALTH ACCESS TO THE MEDICAL RECORDS OF ANY PATIENT DESCRIBED IN DIVISION (A) OF THIS SECTION. THE DEPARTMENT SHALL PAY THE COSTS OF COPYING ANY MEDICAL RECORDS PURSUANT TO THIS DIVISION.

(C) THE DIRECTOR MAY REVIEW VITAL STATISTICS RECORDS AND SHALL CONSIDER EXPANDING THE LIST OF CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS REPORTED ON BIRTH CERTIFICATES PURSUANT TO SECTION 3705.08 of the Revised Code.

(D) A HOSPITAL OR BIRTHING CENTER THAT PROVIDES INFORMATION TO THE SYSTEM PURSUANT TO THIS SECTION SHALL NOT BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY FOR PROVIDING THE INFORMATION.

Sec. 3705.31. THE BIRTH DEFECTS INFORMATION SYSTEM ESTABLISHED UNDER SECTION 3705.30 OF THE REVISED CODE MAY BE USED FOR ALL OF THE FOLLOWING PURPOSES:

(A) TO IDENTIFY AND DESCRIBE CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS;

(B) TO DETECT TRENDS AND EPIDEMICS IN CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS;

(C) TO QUANTIFY MORBIDITY AND MORTALITY OF CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS;

(D) TO STIMULATE EPIDEMIOLOGICAL RESEARCH REGARDING CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS;

(E) TO IDENTIFY RISK FACTORS FOR CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS;

(F) TO FACILITATE INTERVENTION IN AND PREVENTION OF CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS;

(G) TO FACILITATE ACCESS TO TREATMENT FOR CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS;

(H) TO INFORM AND EDUCATE THE PUBLIC ABOUT CONGENITAL ANOMALIES, STILLBIRTHS, AND ABNORMAL CONDITIONS OF NEWBORNS.

Sec. 3705.32. (A) EXCEPT AS PROVIDED IN THIS SECTION, INFORMATION ASSEMBLED BY THE BIRTH DEFECTS INFORMATION SYSTEM PURSUANT TO SECTION 3705.30 OF THE REVISED CODE IS CONFIDENTIAL.

(B)(1) THE DIRECTOR OF HEALTH MAY USE INFORMATION ASSEMBLED BY THE SYSTEM TO NOTIFY PARENTS, GUARDIANS, AND CUSTODIANS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL CONDITIONS OF MEDICAL CARE AND OTHER SERVICES AVAILABLE FOR THE CHILD AND FAMILY.

(2) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE SYSTEM WITH THE WRITTEN CONSENT OF THE PARENT OR LEGAL GUARDIAN OF THE CHILD WHO IS THE SUBJECT OF THE INFORMATION.

(C)(1) ACCESS TO INFORMATION ASSEMBLED BY THE SYSTEM SHALL BE LIMITED TO THE FOLLOWING PERSONS AND GOVERNMENT ENTITIES:

(a) THE DIRECTOR OF HEALTH;

(b) APPROPRIATE EMPLOYEES OF THE DEPARTMENT OF HEALTH;

(c) QUALIFIED PERSONS OR GOVERNMENT ENTITIES THAT ARE ENGAGED IN DEMOGRAPHIC, EPIDEMIOLOGICAL, OR SIMILAR STUDIES RELATED TO HEALTH AND HEALTH CARE PROVISION.

(2) THE DIRECTOR SHALL GIVE A PERSON OR GOVERNMENT ENTITY DESCRIBED IN DIVISION (C)(1)(c) OF THIS SECTION ACCESS TO THE SYSTEM ONLY IF THE PERSON OR A REPRESENTATIVE OF THE PERSON OR GOVERNMENT ENTITY SIGNS AN AGREEMENT TO MAINTAIN THE SYSTEM'S CONFIDENTIALITY.

(3) THE DIRECTOR SHALL MAINTAIN A RECORD OF ALL PERSONS AND GOVERNMENT ENTITIES GIVEN ACCESS TO THE INFORMATION IN THE SYSTEM THE RECORD SHALL INCLUDE ALL OF THE FOLLOWING INFORMATION:

(a) THE NAME OF THE PERSON WHO AUTHORIZED ACCESS TO THE SYSTEM;

(b) THE NAME, TITLE, AND ORGANIZATIONAL AFFILIATION OF THE PERSON OR GOVERNMENT ENTITY GIVEN ACCESS TO THE SYSTEM;

(c) THE DATES THE PERSON OR GOVERNMENT ENTITY WAS GIVEN ACCESS TO THE SYSTEM;

(d) THE SPECIFIC PURPOSE FOR WHICH THE PERSON OR GOVERNMENT ENTITY INTENDS TO USE THE INFORMATION.

(4) THE RECORD MAINTAINED PURSUANT TO DIVISION (C)(3) OF THIS SECTION IS A PUBLIC RECORD, AS DEFINED IN SECTION 149.43 OF THE REVISED CODE.

(5) A PERSON WHO VIOLATES AN AGREEMENT DESCRIBED IN DIVISION (C)(2) OF THIS SECTION MAY BE DENIED FURTHER ACCESS TO CONFIDENTIAL INFORMATION MAINTAINED BY THE DIRECTOR.

(D) THE DIRECTOR MAY DISCLOSE INFORMATION ASSEMBLED BY THE SYSTEM IN SUMMARY, STATISTICAL, OR OTHER FORM THAT DOES NOT IDENTIFY PARTICULAR INDIVIDUALS OR INDIVIDUAL SOURCES OF INFORMATION.

Sec. 3705.33. A CHILD'S PARENT OR LEGAL GUARDIAN WHO WANTS INFORMATION CONCERNING THE CHILD REMOVED FROM THE BIRTH DEFECTS INFORMATION SYSTEM SHALL REQUEST FROM THE CHILD'S PHYSICIAN A FORM PREPARED BY THE DIRECTOR OF HEALTH. ON REQUEST, A PHYSICIAN SHALL PROVIDE THE FORM TO THE CHILD'S PARENT OR LEGAL GUARDIAN AND DISCUSS WITH THE CHILD'S PARENT OR LEGAL GUARDIAN THE INFORMATION CONTAINED IN THE SYSTEM. IF THE CHILD'S PARENT OR LEGAL GUARDIAN SIGNS THE FORM, THE PHYSICIAN SHALL FORWARD IT TO THE DIRECTOR. ON RECEIPT OF THE SIGNED FORM, THE DIRECTOR SHALL REMOVE ALL INFORMATION CONCERNING THE CHILD FROM THE SYSTEM.

Sec. 3705.34. THE DIRECTOR OF HEALTH SHALL APPOINT A COUNCIL TO ADVISE ON THE IMPLEMENTATION OF THE BIRTH DEFECTS INFORMATION SYSTEM.

(A) THE COUNCIL SHALL INCLUDE, AT A MINIMUM, PERSONS REPRESENTING EACH OF THE FOLLOWING INTERESTS:

(1) OBSTETRICS AND GYNECOLOGY;

(2) PEDIATRICS;

(3) GENETICS;

(4) EPIDEMIOLOGY;

(5) BIOSTATISTICS;

(6) HOSPITAL ADMINISTRATION;

(7) THE DEPARTMENT OF MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES;

(8) THE DEPARTMENT OF EDUCATION;

(9) THE DEPARTMENT OF HUMAN SERVICES;

(10) PARENTS OF CHILDREN WITH CONGENITAL ANOMALIES OR ABNORMAL CONDITIONS;

(11) THE PUBLIC.

(B)(1) THE COUNCIL SHALL CONVENE FOR ITS FIRST MEETING NO LATER THAN THIRTY DAYS AFTER THE EFFECTIVE DATE OF THIS SECTION. IN CONSULTATION WITH AND WITH THE APPROVAL OF THE COUNCIL, THE DIRECTOR SHALL APPOINT, AT THE FIRST MEETING OF THE COUNCIL, THE CHAIRPERSON AND VICE-CHAIRPERSON OF THE COUNCIL FROM AMONG THE MEMBERS OF THE COUNCIL. THE CHAIRPERSON MAY CALL ADDITIONAL MEETINGS AS THE CHAIRPERSON CONSIDERS APPROPRIATE.

(2) THE COUNCIL MAY ESTABLISH RULES OF PROCEDURE AS NECESSARY TO FACILITATE THE COUNCIL'S ORDERLY CONDUCT OF BUSINESS.

(3) COUNCIL MEMBERS SHALL SERVE WITHOUT COMPENSATION BUT SHALL BE REIMBURSED FOR THEIR ACTUAL AND NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF THEIR DUTIES.

(C) THE COUNCIL SHALL RECOMMEND TO THE DIRECTOR A LIST OF CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM.

Sec. 3705.35. WITHIN NINETY DAYS AFTER THE EFFECTIVE DATE OF THIS SECTION, THE DIRECTOR OF HEALTH SHALL ADOPT RULES IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE TO DO ALL OF THE FOLLOWING:

(A) IMPLEMENT THE BIRTH DEFECTS INFORMATION SYSTEM;

(B) SPECIFY THE TYPES OF CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS TO BE REPORTED TO THE SYSTEM UNDER SECTION 3705.30 OF THE REVISED CODE;

(C) ESTABLISH REPORTING REQUIREMENTS FOR INFORMATION CONCERNING DIAGNOSED CONGENITAL ANOMALIES AND ABNORMAL CONDITIONS OF NEWBORNS;

(D) ESTABLISH STANDARDS THAT MUST BE MET BY PERSONS OR GOVERNMENT ENTITIES THAT SEEK ACCESS TO THE SYSTEM;

(E) ESTABLISH A FORM FOR USE BY PARENTS OR LEGAL GUARDIANS WHO SEEK TO HAVE INFORMATION REGARDING THEIR CHILDREN REMOVED FROM THE SYSTEM AND A METHOD OF DISTRIBUTING THE FORM TO PHYSICIANS.