105 CMR 302.005
Definitions
Abstractor means an official or agent of the Department authorized by the Commissioner to
abstract and record individually identifiable health information from patient medical records for
the Congenital Anomalies Registry.
Birth Defect see congenital anomaly.
Commissioner means the Commissioner of the Department of Public Health.
Congenital Anomaly or Birth Defect means structural, functional or biochemical abnormality,
regardless of cause, and irrespective of any known genetic or environmental association(s),
whether manifest prenatally, at delivery or at a later date three years of age or younger, and that
may interfere with normal growth or development.
Congenital Anomalies Registry means the central data bank containing collected, classified and
coded stored data relating to reported diagnoses of congenital anomalies.
Department means the Department of Public Health.
Diagnosis means a physician’s opinion, derived from physician observation, procedures or tests
of a patient, which identifies a congenital anomaly or birth defect.
Fetal Death means a death that is required to be reported to the Department pursuant to
M.G.L. c.111, § 202.
Health Care Facility means any facility or institution located in the commonwealth, whether
public or private, proprietary or not for profit, including but not limited to hospitals and other
outpatient facilities such as clinics that provide treatment, diagnostic services, or both to any or
all of the following: pregnant women, newborns and children three years of age or younger.
Incidence means the frequency of a new occurrence of a congenital anomaly over a period of
time and in relation to the population in which it occurs. Incidence is expressed as a rate,
commonly a number of new cases during a prescribed time in a unit of population.
(MA REG. # 1325, Dated 11-4-16)
Individually Identifiable Health Information means information that is a subset of health
information, including demographic information, and is created or received by the Department
and relates to the past, present, or future physical or mental health or condition of an individual,
the provision of health care to an individual, or the past, present, or future payment for the
provision of health care to an individual, and that identifies the individual or with respect to
which there is a reasonable basis to believe the information can be used to identify the individual.
Patient Identifiers means confidential information that can be attributed to a specific individual
including but not limited to name, date of birth, address, geocode, telephone number, medical
record number, health plan beneficiary number, and health identification number.
Physician means any licensed physician who makes a diagnosis.
Report means an official notice to the Department of a diagnosis of a congenital anomaly in
writing, by facsimile, or by electronic means.