Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.120 - Confidentiality and Access to Data in Newborn Screening Registries

Current through Register Vol. 48, No. 28, July 12, 2024
a) The Department
				will maintain confidentiality of information that would identify individual
				patients. All data in the Registry or Registries obtained directly from
				medical, intervention or parent-reported records of individual patients shall
				be for the confidential use of the Department and those authorized users
				designated by the Department to view the individual patient records as
				described in Section 661.110(g).
				Information contained in the Registry or Registries shall be confidential and
				not subject to inspection by persons other than authorized users designated.
				(Section 23 of the EHDI Act)
b) The
				Department will disclose individual patient test results or patient information
				to the reporting facility that originally supplied that information to the
				Department, and to the primary care providers and consulting medical
				specialists caring for the child. Test results may also be disclosed to the
				parent or legal guardian and to the patient when 18 years of age or
				older.
c) Only the minimum
				information necessary for the intended purpose will be disclosed. Disclosure
				may take place using secure electronic means, including, but not limited to,
				email, text, or secure portal, compliant with HIPAA and FERPA security and
				privacy standards. A person or institution to whom information is furnished, or
				to whom access to records has been given, shall not divulge any part of the
				records so as to disclose the identity of the person or persons to whom the
				information or records relate, except as necessary for the person's diagnosis,
				treatment and interventions.
d)
				Identifiable data may be released to the extent necessary for the diagnosis,
				treatment, interventions, or public health surveillance for
the purpose
				of
care coordination,
follow-up services and to assess
				long-term outcomes
. Identifiable data may be shared for conditions of
				public health significance, i.e., as permitted by HIPAA or FERPA regulations,
				the Medical Studies Act, and the Health Statistics Act and in accordance with
				established agreements with entities such as the CDC. As described in the
				Health Statistics Act, a Department-approved Institutional Review Board or its
				equivalent on the protection of human subjects in research shall review and
				approve requests from researchers for individually identifiable data.
e) The Registry or Registries shall be
				accessible to authorized users who have completed a user agreement and are
				approved by the Department for access. Authorized users can search, submit, and
				obtain information related to newborn blood spot, newborn hearing and newborn
				heart screening.
f) The Registry or
				Registries may only be used for the provision of services under this Part as
				described in Section 661.120(d).
				Authorized users who engage in any prohibited use of the Registry may be denied
				further access to the Registry, in addition to any other penalties provided by
				law.