Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 270.000 - Blood Screening Of Newborns For Treatable Diseases And Disorders
Section 270.011 - Confidentiality of Newborn Screening Test Results and Information

Universal Citation: 105 MA Code of Regs 105.270

Current through Register 1531, September 27, 2024

(A) The Newborn Blood Screening Program shall maintain the confidentiality of testing results generated by the Program and information submitted to the Program for purposes of newborn screening and follow-up of newborn testing.

(B) Other than as required for routine notification of newborn blood testing as described in 105 CMR 270.009, the Newborn Blood Screening Program shall not disclose newborn screening results or any information or patient identifiers which because of name, identifying number, mark or description can be readily associated with a particular individual or the individual's parents/guardians, or any newborn screening information that could be used in combination with other information to identify an individual, except to:

(1) that individual;

(2) the individual's parents or guardians if a minor;

(3) the executor or administrator of the individual's estate;

(4) anyone authorized in writing by that individual or the individual's legal representative;

(5) authorized Department and New England Newborn Screening Program personnel;

(6) authorized staff at other state newborn screening programs responsible for the follow up of the particular newborn;

(7) anyone authorized to receive such information pursuant to a court order; or

(8) any researcher approved by the Department to conduct a specific study pursuant to M.G.L. c. 111, § 24A, and when approved by the Department's or the University of Massachusetts Medical School's Institutional Review Board. Except as provided in 105 CMR 270.011(C), newborn screening information or data that could be used to identify an individual shall not be disclosed to a researcher without the written consent of a parent or guardian.

(C) The Newborn Screening Program may provide a Limited Data Set, as defined in the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR §164.514(e)), of newborn screening results or information to researchers upon approval from the Department and subject to the terms of a written data use agreement.

(D) All individually identifiable testing results and information, as defined by the Department, shall be considered confidential and shall not be available as a public record under M.G.L. c. 66.

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