Confidentiality

(A) A physician shall report, and abstractors shall collect, no more information than the Commissioner considers necessary and appropriate to conduct epidemiological surveys and to develop appropriate preventative treatment and control measures for congenital anomalies. Abstractors shall not collect, and a physician shall not report, social security numbers. To the extent that patient identifiers are necessary to eliminate duplicate reporting, the Department shall collect the minimum amount of data necessary to accomplish that task. (B) The contents of any reports, records or information submitted to the Congenital Anomalies Registry shall be solely for the use of the Department and shall not be open to public inspection or constitute a public record, or be disclosed except as specified in 105 CMR 302.070(D) and (G). (C) The Department shall maintain the confidentiality of reports or information submitted to the Congenital Anomalies Registry and shall not disclose such reports or any information or patient identifiers which because of name, identifying number, mark or description can be readily associated with a particular individual, except as specified in 105 CMR 302.070(D) and (G). (D) A report submitted to the Congenital Anomalies Registry concerning a particular individual and any other information that would indicate whether or not the named individual is listed in the Congenital Anomalies Registry shall be disclosed after redacting information pertaining to any third person other than the physician who made or reported the diagnosis: (1) to the particular individual upon: (a) receipt of a written request which is signed by the individual; and (b) presentation by the individual of identification deemed suitable by the Department; (2) if the individual is a minor, to the minor’s parent upon: (a) receipt of a written request which is signed by the parent; and (b) receipt of a certified copy of the individual’s birth certificate listing the requester as one of the child’s parents; and (c) presentation by the parent of identification deemed suitable by the Department; (3) if the particular individual has a court-appointed guardian, or if the individual is deceased, to the court-appointed guardian, or to the executor or administrator of the particular individual’s estate or to the decedent’s adult child upon: (a) receipt of a written request which is signed by the guardian or executor or administrator or child as applicable; and (b) receipt of a certified copy of the court order which appoints the guardian, executor, or administrator; and (c) presentation by the guardian, executor or administrator or child of identification deemed suitable by the Department; and (4) to an attorney designated by the individual, parent, court-appointed guardian, executor or administrator upon: (a) receipt of a written request and authorization for the release of information signed by the individual, parent, guardian, executor or administrator as applicable; and (b) presentation by the attorney of identification deemed suitable by the Department including in the case where the attorney is designated by a parent a certified copy of the individual’s birth certificate and in the case where the attorney is designated by a guardian, executor or administrator a certified copy of the court order which appoints the guardian, executor, or administrator. (E) Every written request for the disclosure of information submitted pursuant to 105 CMR 302.070(D) shall be signed by the person making the written request and such signature shall be either: (1) witnessed by an employee of the Department who has been designated to witness such requests; or (2) notarized by a notary public. (F) Any person required pursuant to 105 CMR 302.070(D) to present suitable identification shall present a valid, non-expired driver’s license; a valid, non-expired passport; or other valid, non-expired government-issued document which contains both a picture of the person and the signature or mark of the person. An adult child applying for information about a deceased parent under 105 CMR 302.070(D)(3) shall present documentaryevidence of the parent’s death and the parent-child relationship including: (1) a certified copy of the parent’s death record; and (2) a certified copy of the requestor’s own birth record listing the requestor’s parent; and (3) if names appearing on proffered identity documents and birth and death certificates differ or the parent-child relationship is not readily apparent from such documents due to intervening change(s) of name, documentary evidence of a change of legal name such as a certified copy of a certificate of marriage or an attested copy of a judicial change of name decree. (G) The Commissioner may disclose information maintained by the Congenital Anomalies Registry to the principal investigator of a study or research project authorized by the Commissioner to conduct an approved medical or scientific study for the purpose of the reduction of morbidity and mortality in the commonwealth, so long as the Commissioner and a duly constituted institutional review board first approves that study. Such study shall require approval pursuant to M.G.L. c. 111, § 24A. However, with respect to a pregnancy loss that is not a fetal death, the Department shall not disclose any medical record or individually identifiable health information or patient identifiers without written, informed consent of the patient. No such study or research project shall publish the name of any individual nor shall any such study or research project release any identifying number, mark or description which can be readily associated with an individual. (H) The Department shall maintain an audit trail that specifies each person who is given access to information from the Congenital Anomalies Registry under 105 CMR 302.070(D) and (G). The audit trail shall include the: (1) Name of the person authorizing access; (2) Name, title and organizational affiliation of each person given access; (3) Date(s) of access; and (4) Specific purpose for which the information was used. (I) The Department shall institute security procedures to prevent unauthorized individuals from accessing information maintained by the Congenital Anomalies Registry. (J) The Department shall comply with applicable statewide records retention schedules in the event that a decision is made that the information maintained or stored in connection with this registry is no longer needed. If destruction of information is authorized, all such destruction shall include standard sanitizing methods.