Iowa Admin. Code r. 641-7.11 - Statewide registry
(1)
Statewide registry. The department shall maintain a statewide
immunization and health screening registry. Enrolled users are responsible for
purchasing and maintaining all computer hardware related to use of the registry
and for providing an Internet connection to transfer information between the
user's computer and the registry.
(2)
Purpose and permitted uses of
registry.
a. The registry shall
contain immunization and health screening information, including identifying
and demographic data, to allow enrolled users to maintain and access a database
of immunization and health screening histories for purposes of ensuring that
patients are fully immunized and screened.
b. The registry may be used to track
inventory or utilization of pharmaceutical agents identified by the department
to prepare for or respond to an emergency event.
c. Enrolled users shall not use information
obtained from the registry to market services to patients or nonpatients, to
assist in bill collection services, or to locate or identify patients or
nonpatients for any purpose other than those expressly provided in this
rule.
d. The registry shall contain
health screening data, including screening results and follow-up
information.
(3)
Release of information to the registry. Enrolled users shall
provide immunization and health screening information, including identifying
and demographic data, to the registry. Information provided may include, but is
not limited to, the following:
a. Name of
patient;
b. Gender of
patient;
c. Date of
birth;
d. Race;
e. Ethnicity;
f. Birth state and birth country;
g. Address;
h. Parents' names;
i. Mother's maiden name;
j. Type of vaccination
administered;
k. Dose or series
number of vaccine;
l. Date
vaccination was administered;
m.
Lot number;
n. Date of health
screening;
o. Health screening
results;
p. Source of health
screening;
q. Health screening
follow-up information;
r. Patient
comments;
s. Provider name,
license, and business address; and
t. Patient history, including previously
unreported doses.
(4)
Confidentiality of registry information. Immunization and
health screening information, including identifying and demographic data
maintained on the registry, is confidential and may not be disclosed except
under the following limited circumstances:
a.
The department may release information from the registry to the following:
(1) The person or the parent or legal
guardian of the person immunized or screened.
(2) Enrolled users of the registry who have
completed an enrollment form that specifies the conditions under which the
registry can be accessed and who have been issued an organization code and user
name by the department;
(3) Persons
or entities requesting immunization or health screening data in an aggregate
form that does not identify an individual either directly or
indirectly.
(4) Agencies that
complete an agreement with the department which specifies conditions for access
to registry data and how that data will be used. Agencies shall not use
information obtained from the registry to market services to patients or
nonpatients, to assist in bill collection services, or to locate or identify
patients or nonpatients for any purposes other than those expressly provided in
this rule.
(5) A representative of
a state or federal agency, or entity bound by that state or federal agency, to
the extent that the information is necessary to perform a legally authorized
function of that agency or the department. The state or federal agency is
subject to confidentiality regulations that are the same as or more stringent
than those in the state of Iowa. State or federal agencies shall not use
information obtained from the registry to market services to patients or
nonpatients, to assist in bill collection services, or to locate or identify
patients or nonpatients for any purposes other than those expressly provided in
this rule.
(6) The admitting
official of a licensed child care center, elementary school, secondary school,
or postsecondary school; or medical or health care providers providing
continuity of care.
(7) Enrolled
users from other states or jurisdictions who have signed and completed
enrollment in the state's or jurisdiction's immunization registry.
b. Enrolled users shall not
release data obtained from the registry except to the person or the parent or
legal guardian of the person immunized or screened, admitting officials of
licensed child care centers and schools, medical or health care providers
providing continuity of care, and other enrolled users of the registry.
(5)
Suspend or
terminate access. The department may suspend or terminate an enrolled
user's access consistent with department policy if the user violates this
chapter, the IRIS Authorized Site Agreement-Organization, the IRIS Authorized
Individual User Agreement, or the IRIS Security and Confidentiality Policy. The
department shall approve, suspend, terminate, and reinstate user access in
accordance with this chapter and department policy.
Notes
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