Section 840.30  Availability of Registry Information

a)         All reports issued by the Department that are aggregated or recorded to make it impossible to identify any patient or reporting physician or facility, including the annual report, shall be made available to the public pursuant to the Department's Freedom of Information rules (2 Ill. Adm. Code 1126) and the Freedom of Information Act.

b)         All requests by medical or epidemiologic researchers for confidential Registry data must be submitted in writing to the Department.  The request must include a study protocol that contains:  objectives of the research; rationale for the research, including scientific literature justifying the current proposal; overall study methods, including copies of study forms, questionnaires, and consent forms used by researchers to contact facilities, physicians or study subjects; methods for documenting compliance with 42 CFR 2a.4(a)-(j), 2a.6(a)-(b), 2a.7(a)-(b)(1); methods for processing data; storage and security measures taken to ensure confidentiality of patient-identifying information; time frame of the study; a description of the funding source of the study (e.g., federal contract); the curriculum vitae of the principal investigator and collaborators.  In addition, the research request must include a copy of the current IRB approval from the researcher's institution, signed assurance forms for all parties participating in the project and a completed application for the Department's IRB review.

c)         All requests to conduct research and modifications to approved research proposals involving the use of data that includes patient or facility identifying information shall be subject to a review to determine compliance with the following conditions:

1)         The request for patient or facility identifying information contains stated goals or objectives.

2)         The request documents the feasibility of the study design in achieving the stated goals and objectives.

3)         The request documents the need for the requested data or interventions to achieve the stated goals and objectives.

4)         The requested data can be provided within the time frame set forth in the request.

5)         The request documents that the researcher has qualifications relevant to the type of research being conducted.

6)         The research will not duplicate other research already underway using the same registry data when both require the contact of a patient, reporting facility or physician about an individual patient involved in the previously approved concurrent research.

7)         Other such conditions relevant to the need for the patient or facility identifying information and the patient's confidentiality rights because the Department will only release the patient or facility identifying information that is necessary for the research.

8)         Appropriate exemptions, IRB approvals and waivers have been obtained.

9)         The request documents the researcher's commitment to provide updated reports.

d)         Research Agreements

1)         The Department will enter into research agreements for all approved research requests.  These agreements shall specify exactly what information is being released and how it can be used in accordance with the standards in subsection (c).  In addition, the researcher shall include an assurance that:

A)        use of data is restricted to the specifications of the protocol;

B)        any and all data that may lead to the identity of any patient, research subject, physician, other person, or hospital is strictly privileged and confidential and agrees to keep all such data strictly confidential at all times;

C)        all officers, agents and employees will keep all such data strictly confidential, will communicate the requirements of this Section to all officers, agents, and employees, will discipline all persons who may violate the requirements of this Section, and will notify the Department in writing within 48 hours after any violation of this Section, including full details of the violation and corrective actions to be taken;

D)        all data provided by the Department pursuant to this agreement may be used only for the purposes named in this agreement and that any other or additional use of the data may result in immediate termination of this agreement by the Department;

E)         all data provided by the Department pursuant to this agreement is the sole property of the Department and may not be copied or reproduced in any form or manner and agrees to return all data and all copies and reproduction of the data to the Department upon termination of this agreement.

2)         Any departures from the approved protocol must be submitted in writing and approved by the Director in accordance with subsection (c) prior to initiation.  No patient or facility identifying information may be released by a researcher to a third party.

e)         The Department shall disclose individual patient or facility information to the reporting facility that originally supplied that information to the Department, upon written request of the facility.

f)          The Department, by signed and reciprocating agreement, may disclose individual patient information concerning residents of another state to the registry in the individual's state of residence only if the recipient of such information is legally required to hold such information in confidence and provides protection from disclosure of patient-identifying information equivalent to the protection afforded by the Illinois law.

g)         The patient-identifying information submitted to the Department by those entities required to submit information under the Act and this Part is to be used in the course of medical study under Part 21 of Article 8 of the Code of Civil Procedure. Therefore, this information is privileged from disclosure by Part 21 of Article 8 of the Code of Civil Procedure.

h)         The identity, or any group of facts that tends to lead to the identity, of any facility or of any person whose condition or treatment is submitted to the Illinois Health and Hazardous Substances Registry is confidential and shall not be open to public inspection or dissemination. Such information shall not be available for disclosure, inspection or copying under the Freedom of Information Act or the State Records Act.  Information for specific research purposes may be released in accordance with procedures established by the Department in this Section.  (Section 4(d) of the Act)

i)          Hospitals, laboratories, other facilities or physicians shall not be held liable for the release of information or confidential data in accordance with the Act.  The Department shall protect any information made confidential or privileged under law.  (Section 4(e) of the Act)

j)          Every reporting facility shall provide the Department or entities authorized to represent the Department with access to information from all medical, pathological, and other pertinent records and logs related to reportable registry information in order for the Department to conduct rapid case ascertainment; death certificate clearance; patient follow-up; or any other review that is required to ensure data completeness, quality, and timeliness.  The mode of access and the time during which this access will be provided shall be by mutual agreement between the facility and the Department (see Section 10 of the Act).

k)         Every reporting facility shall provide access to diagnostic, treatment, follow-up and survival information regarding specified patients or other patients specified through rapid case ascertainment for research studies conducted by the Department.  Any disputes as to access to information shall be resolved by the reporting facility in consultation with the Department within 30 days after requests for access have been denied.

l)          The Department shall disclose individual patient or facility APORS information obtained from each Regional Perinatal Network facility to the Regional Perinatal Network's Perinatal Center, upon written request of that particular Perinatal Center's Clinical Director.  The patient and facility identifying information submitted to the Perinatal Center by the Department as required under this Part is to be used in the course of medical study under Part 21 of Article 8 of the Code of Civil Procedure and is, therefore, privileged from disclosure.  The Perinatal Center's request for APORS data should clearly indicate the purpose for which the data will be used.  The Department shall release data only for internal quality control or medical study for the purpose of reducing morbidity or mortality, or for improving patient care.  The Department shall provide a copy of the original request and the data that are released to the hospital that originally reported these data.

m)        The Department shall disclose summary and statistical reports containing information that identifies individual patients or individual hospitals to the hospital that reported the patient, to the Perinatal Center with which it is affiliated, and to the local health agency designated by the Department to provide follow-up services to patients. Such reports may contain information provided by the referring hospital and information provided by the follow-up agency.  Patient and reporting facility specific data provided to the appropriate designee under this Section are confidential and shall not be otherwise disclosed.

(Source:  Amended at 31 Ill. Reg. 12207, effective August 2, 2007)