Montana’s Statewide Immunization Information System - imMTrax
Immunization information systems (IIS) are population-based and confidential computerized databases that record all immunization doses administered by participating providers to persons residing within a given area. Montana’s system is called imMTrax.
 IIS systems provide complete immunization histories at the point-of-care for healthcare providers to determine appropriate client immunizations
 The systems provide data for use in determining immunization coverage levels
 Quick and convenient access to immunization records is often required for attendance in childcare, school, or work settings
 Use of an IIS assists state and local public health departments and healthcare providers to improve immunization coverage, preventing outbreaks of disease
 Montana is one of only three states requiring persons to “opt-in” the IIS by providing explicit consent
 The Centers for Disease Control and Prevention (CDC) in 2012 indicated 50 IIS programs either allow or mandate collection of immunization information unless the person elects to “opt-out”. Only 3 IIS programs, including Montana, require explicit consent to participate.
As healthcare providers and state and local public health departments work to improve immunization coverage to prevent outbreaks of disease, modernization of laws related to the IIS is needed. The proposal below outlines advantages of an “opt-out” system.
Currently, participation in imMTrax requires consent for release of immunization information to the IIS for use of authorized users, including public health agencies, healthcare providers, and school administration. Authorization can be revoked and immunization history can be removed at any time if requested by the individual or guardian.
 The process of obtaining consent may be time consuming and burdensome by healthcare providers, schools, and childcare facilities,
 Very few persons, less than 4%, decline consent
 Presents unique challenges to implementing electronic data transfers from electronic health records (EHR) due to the fact that the majority of state systems do not require consent for inclusion of immunization data

As noted above, vast majorities of state systems have “opt-out” models.
 Demonstrated as cost- and time-savings
 Simplifies the consent process for providers and patients
 Still allows personal choice regarding participation in the IIS
The following two-part proposal is suggested to streamline the process for consent and sharing immunization information with authorized users.
1) Language explicitly allowing healthcare providers to share immunization information with the IIS unless a patient or patient representative “opts-out” of participation.
2) Language explicitly authorizing the sharing of immunization information among authorized users of this information (healthcare providers, schools, childcare facilities, and public health agencies) when required for attendance or to ensure continuity of care. Persons opting out of the IIS would not be impacted by this provision because their immunization information would not be stored in a database.
December   2014

6901-07-003
0343
Harwell
_______________
Domitrovich
______________________________
Allow Immunization Information System (IIS) to Collect and Disclose
Information
Amend 50-16-530, MCA. This proposal would provide the opportunity to "opt-out" of having a child’s immunization records included in the Montana Immunization Information
System (imMTrax). A structure that records vaccinations unless parents "opt-out" will improve efficiency, help health care providers and parents keep children up to date on vaccinations, prevent unnecessary shots, provide a convenient place to obtain immunization records, document contraindications, and allow public health agencies to monitor and improve vaccination efforts.
Montana is one of only three states in the nation that requires someone receiving a vaccine to "opt-in" to a state’s Immunization Information System.
Adds Department's imMTrax system to permissible disclosures of health care information that do not require patient authorization by a health care provider not subject to
HIPAA. Provides for patient opt-out.
Allows Department to disclose immunization records in imMTrax to local public health agencies, health care providers, child care facilities and schools.
Corrects statutory cross-reference to 50-16-603, MCA, to reflect addition of new subsection.
Adds Department's imMTrax system to permissible disclosures of health care information that do not require patient authorization by a health care provider subject to HIPAA.
Provides for patient opt-out.
______________________________________________________________________________
1

64th Legislature HB0073.01
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HOUSE BILL NO. 73
INTRODUCED BY C. SCHREINER
BY REQUEST OF THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES
A BILL FOR AN ACT ENTITLED: "AN ACT ALLOWING LIMITED DISCLOSURE OF A PATIENT'S
IMMUNIZATION RECORD WITHOUT THE PATIENT'S AUTHORIZATION FOR THE PURPOSES OF THE
STATE IMMUNIZATION INFORMATION SYSTEM; ALLOWING A PATIENT TO OPT OUT OF DISCLOSURE
OF THE INFORMATION; AND AMENDING SECTIONS 50-16-530, 50-16-603, 50-16-605, AND 50-16-805,
MCA."
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
Section 1.
Section 50-16-530, MCA, is amended to read:
"50-16-530. Disclosure without patient's authorization.
A health care provider may disclose health care information about a patient without the patient's authorization if the disclosure is:
(1) directory information, unless the patient has instructed the health care provider not to make the disclosure;
(2) to federal, state, or local public health authorities, to the extent the health care provider is required by law to report health care information or when needed to protect the public health;
(3) to federal, state, or local law enforcement authorities to the extent required by law;
(4) to a law enforcement officer about the general physical condition of a patient being treated in a health care facility if the patient was injured on a public roadway or was injured by the possible criminal act of another;
(5) in response to a request of the office of victims services for information under 53-9-104(2)(b);
(6) pursuant to compulsory process in accordance with 50-16-535 and 50-16-536;
(7) pursuant to 50-16-712; or
(8) to the department of public health and human services for inclusion in the state immunization information system unless the patient or the patient's parent or guardian, if the patient is under 18 years of age, has completed and filed with the provider a form prohibiting disclosure of the information; or
(8)(9) to the state medical examiner or a county coroner for use in determining cause of death. The information is required to be held confidential as provided by law."
- 1 Authorized Print Version - HB 73

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Section 2.
Section 50-16-603, MCA, is amended to read:
"50-16-603. Confidentiality of health care information -- exceptions.
Health (1) Except as provided in this section, health care information in the possession of the department, a local board, a local health officer, or the entity's authorized representatives may not be released except:
(1)(a) for statistical purposes, if no identification of individuals can be made from the information released;
(2)(b) when the health care information pertains to a person who has given written consent to the release and has specified the type of information to be released and the person or entity to whom it may be released;
(3)(c) to medical personnel in a medical emergency as necessary to protect the health, life, or well-being of the named person;
(4)(d) as allowed by Title 50, chapters 17 and 18;
(5)(e) to another state or local public health agency, including those in other states, whenever necessary to continue health services to the named person or to undertake public health efforts to prevent or interrupt the transmission of a communicable disease or to alleviate and prevent injury caused by the release of biological, chemical, or radiological agents capable of causing imminent disability, death, or infection;
(6)(f) in the case of a minor, as required by 41-3-201 or pursuant to an investigation under 41-3-202 or if the health care information is to be presented as evidence in a court proceeding involving child abuse pursuant to Title 41, chapter 3. Documents containing the information must be sealed by the court upon conclusion of the proceedings.
(7)(g) to medical personnel, the department, a local health officer or board, or a district court when necessary to implement or enforce state statutes or state or local health rules concerning the prevention or control of diseases designated as reportable pursuant to 50-1-202, if the release does not conflict with any other provision contained in this part.
(2) The department may share information in the state immunization information system with:
(a) a local public health agency as defined in 50-1-101;
(b) a health care provider for a patient being treated by the health care provider; or
(c) a child-care facility or school for a child enrolled in the facility or school."
Section 3.
Section 50-16-605, MCA, is amended to read:
- 2 Authorized Print Version - HB 73

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"50-16-605. Judicial, legislative, and administrative proceedings -- testimony.
(1) An officer or employee of the department may not be examined in a judicial, legislative, administrative, or other proceeding about the existence or content of records containing individually identifiable health care information, including the results of investigations, unless all individuals whose names appear in the records give written consent to the release of information identifying them.
(2) Subsection (1) does not apply if the health care information is to be released pursuant to
50-16-603(6) and (7) 50-16-603(1)(f) or (1)(g)."
Section 4.
Section 50-16-805, MCA, is amended to read:
"50-16-805. Disclosure of information allowed for certain purposes.
(1) To the extent provided in
39-71-604 and 50-16-527, a signed claim for workers' compensation or occupational disease benefits authorizes disclosure to the workers' compensation insurer, as defined in 39-71-116, by the health care provider.
(2) A health care provider may disclose health care information about an individual for law enforcement purposes if the disclosure is to:
(a) federal, state, or local law enforcement authorities to the extent required by law; or
(b) a law enforcement officer about the general physical condition of a patient being treated in a health care facility if the patient was injured by the possible criminal act of another.
(3) A health care provider may disclose a patient's immunization information to the department of public health and human services for inclusion in the state immunization information system unless the patient or the patient's parent or guardian, if the patient is under 18 years of age, has completed and filed with the provider a form prohibiting disclosure of the information.
(3)(4) A health care provider may disclose health care information to a fetal, infant, child, and maternal mortality review team for the purposes of 50-19-402 [and to the Montana suicide review team for the purposes of 53-21-1105 through 53-21-1110]. (Bracketed language terminates June 30, 2016--sec. 16, Ch. 353, L. 2013.)"
- END -
- 3 Authorized Print Version - HB 73

Montana Immunization Information System (imMTrax)
Disclosure to Patient/Parent/Legal Guardian
Decline to Participate in imMTrax
Background
An immunization information system (IIS) is a confidential, computerized, population-based system that collects and consolidates vaccination data from vaccine providers and provides tools for designing and sustaining effective immunization strategies at the provider and program levels. Among the capabilities of an IIS are the capacity to inform vaccine providers of upcoming patient vaccination needs; generate vaccination coverage reports, patient reminders, or recalls for past due vaccinations; and interface with electronic health record (EHR) systems.
Who can see immunization records?
These healthcare providers are able to use imMTrax: primary care physicians, nurses, pharmacists, school nurses and other appropriate health care providers or public health entities. Providers who have completed imMTrax training and received personal log-in credentials can see shot records and use imMTrax to help their patients get the shots that are needed.
What kind of personal information may be found in imMTrax?

Name

Date of birth

Race/Ethnicity

Name of responsible person (for example, parent or guardian)

Contact information for patient or a child’s responsible person (for example, address, phone, email)

Record of shots received

Medical conditions that could influence a decision whether to give a shot
What are patients’ rights?

Patients may review a personal shot record, or child’s record

Patients may inform providers about mistakes and/or missing information

Patients may choose to receive or not receive reminders about getting shots that are due

Patients may choose to personally keep track of their (or their children’s) shots and decline to have one or more shots recorded in imMTrax (decline to participate)
Who do I talk to about my shot record or my questions?
Talk to your healthcare provider:
 to ask for a copy of your shot record or your child’s shot record
 to report errors or missing information in a shot record
 to provide information about “historical shots” (received in some other state), for inclusion in imMTrax
Contact the Montana Immunization Program about concerns or
problems with an imMTrax record: (406) 444-5580

Montana Immunization Information System (imMTrax)
Decline to Participate in imMTrax
I have read the Montana Immunization Information System Disclosure to Patient/Parent/Legal Guardian. I understand that I have the right to decline to participate in imMTrax, which means no immunization records should be created in imMTrax.
By declining to participate for myself or my child, I am aware that my healthcare provider may not have access to my (my child’s) entire immunization history unless my healthcare provider is the only one who has given me
(my child) all lifetime immunizations.
Please Print CLEARLY in the spaces provided below:
Patient’s First Name:______________________________________________________
Patient’s Last Name:______________________________________________________
Parent/Legal Guardian First Name:___________________________________________
Parent/Legal Guardian Last Name:___________________________________________
Today’s Date:___________________
By signing below, I designate that I understand the consequences of declining to participate and I agree that I am responsible for my decision and any consequences.
I swear (or affirm) that all of the forgoing statements are true to the best of my information, knowledge, and belief.
____________________________________________________________________________________
The original, signed Decline to Participate form should be completed and given to your (your child’s) healthcare provider at the time of immunization administration.
Each time that an immunization is offered or administered to you (your child), you may complete this form and
Decline to Participate which means your healthcare provider will not record the immunization record(s) in the imMTrax.

imMTrax
If your provider participates in imMTrax, they will be able to add any newly administered or past immunizations into imMTrax.
You have the right to opt out or decline participation in imMTrax on behalf of yourself or your child.
To learn more visit us at: www.dphhs.mt.gov/publichealth/imMTrax.aspx
American Academy of Pediatrics (AAP)
American Medical Association (AMA)
American Public Health Association (APHA)
American School Health Association (ASHA)
Gerber Foundation
All Kids Count (AKC)
Robert Wood Johnson Foundation “Please join me in our mission to assure that all of America's children are fully immunized on time by calling your local health department to inquire about how you can sign up to share data with the registry.”
Rosalynn Carter
Former First Lady & Co-Founder,
Every Child By Two
National School Boards Association (NSBA)
National Association of School Nurses (NASN)
National Association of Pediatrics
Nurse Associates and Practitioners (NAPNAP)
National Association of County & City Health
Officers (NACCHO)
Working To
IMMUNIZE
On Time,
Every Time!
Montana Immunization Program
1400 Broadway St
Helena, MT 59601
406-444-5580 TEL http://www.dphhs.mt.gov/publichealth/imMTrax.aspx
**Persons featured in this publication are models and for illustrative purposes only**
1,750 copies of this public document were published at an estimated cost of $.16 per copy, for a total cost of $280.00, which includes $280.00 for printing & $0.00 for distribution.
Montana Immunization Program

imMTrax
Yes . Only authorized professionals can access imMTrax records. imMTrax has several built-in security features to ensure patient confidentiality. imMTrax uses data encryption for all data going to and from the system and is compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
imMTrax , Montana’s immunization information system or IIS, contains official immunization records for participating
Montanans. imMTrax is a free program administered by the Montana Department of
Public Health and Human Services that electronically preserves a patient’s immunization record. imMTrax brings together records from multiple immunization providers (public and private) and parental
“shot cards” to form one complete record. imMTrax Records Include:
 Your child’s name
 Birth date
 Gender
 Vaccinations received
 Vaccine administration dates
 Vaccine lot numbers
 Vaccine manufacturers
By condensing partial records into a complete immunization record, imMTrax provides health professionals with the information necessary to accurately assess your child’s immunization status , thereby preventing under- or overimmunization.
imMTrax ensures that your child’s immunization record remains accessible even if your family relocates to a different city, changes healthcare providers, or misplaces its personal “shot cards.” imMTrax
Authorized health professionals, such as your primary care provider or health department, can easily print out your child’s immunization history, a Montana school entry form, or documentation for child care facilities .
imMTrax assists health professionals in making sure your child receives their immunizations on time . imMTrax also helps health professionals generate immunization reminders so that you are contacted when your child’s next immunization is due. imMTrax is a helpful tool used to ensure your child is immunized on time, every time!

LWW/JPHMP JPHMP-D-14-00100 June 6, 2014 4:30
Lloyd F. Novick, MD, MPH r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r
Four articles on immunization information systems are being published ahead of print by the Journal of Public
Health Management and Practice.
Three of these articles are related to findings of a recent systematic review by the Community Preventive Services Task Force. A fourth article, from the Centers of Disease Control and
Prevention, by Daniel Martin “Immunization Information Systems: A Decade of Progress in Law and Policy” is a study of laws, regulations, and policies governing
Immunization Information Systems (IIS), also known as immunization registries.
A Community Guide systematic review, “Immunization Information Systems to Increase Vaccination
Rates,” synthesized evidence from studies that evaluated IIS capabilities to (1) create or support interventions to increase vaccination rates; (2) identify patient vaccination status to inform health care decisions; (3) aid population-based responses to vaccine-preventable disease; and (4) provide other information relevant to vaccine administration and aid vaccine management.
Review of 240 papers and abstracts demonstrated a positive association between IIS activities and improvements in vaccination coverage.
A companion article from the Community Preventive Services Task Force, “Recommendations for Use of Immunization Information Systems to Increase Vaccination Rates,” concluded that there was strong evidence that immunization information systems are
“effective in increasing vaccination rates and reducing vaccine preventable disease” based on the findings from 108 published articles and 132 conference abstracts.
Another Community Guide systematic review,
“Economic Review of Immunization Information Systems to Increase Vaccination Rates,” evaluated the costs and benefits associated with using these systems. IIS require funding for implementing and operating the system and providers and the IIS incur costs for data exchange. The benefits include reduced duplicative vaccination, improved vaccination coverage, fewer administrative burdens, and allocation of less public and private resources to administer vaccines. Economic evaluations, including those published in this study, are complex because of the speed of technology change, including growing use of electronic health records.
Although IIS functions and features and available technologies continue to expand, it is anticipated that benefits to providers, public health and the general population will outweigh costs associated with these advancements.
In addition to traditional immunization partners such as vaccination providers and schools, the rise in electronic data exchange and other technologies has expanded the number and type of entities interfacing with IIS (eg, health information exchanges, pharmacy networks, etc). In addition, federal agencies such as
Centers for Medicare and Medicaid Services and Office of the National Coordinator, which support the management and execution of Meaningful Use initiatives, are interested in IIS capacity to support clinical and public health data exchange. Expanded stakeholder involvement in IIS has increased the need for standardization of both IIS operations and technical capacities. Publication of HL7 implementation guides for immunization messaging, Clinical Decision Support for immunization guidelines, and the adoption of
2-dimensional barcode technology for recording vaccination information in electronic health records and IIS are examples of standardization movements. The adoption and implementation of such standards only serves to further increase the number of IIS stakeholders and the ability of these partners to use IIS information to benefit the health of the public.
J Public Health Management Practice , 2014, 00(00), 1–2
Copyright
C
2014 Wolters Kluwer Health | Lippincott Williams & Wilkins
Author Affiliation: Lloyd F. Novick, MD, MPH, Program, Brody School of
Medicine, Greenville, North Carolina (NOVICKL@ecu.edu).
The author declares no conflicts of interest.
Correspondence: Lloyd F. Novick, MD, MPH, Program, Brody School of
Medicine, Hardy Bldg, Greenville, NC 27834 (NOVICKL@ecu.edu).
DOI: 10.1097/PHH.0000000000000111
1
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

LWW/JPHMP JPHMP-D-14-00100 June 6, 2014 4:30
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Journal of Public Health Management and Practice
Begun in the 1970s, IIS now operate in all but one
US state and most serve children, adolescents, and adults. The articles now being published demonstrate substantial progress in participation of patient and immunization provider in IIS and enhanced system functionalities that serve a broad set of immunization stakeholders. As new technology develops, standards for data exchange and data use are established and implemented, and IIS stakeholders expand, the effectiveness of IIS to serve the immunization needs of clinicians, public health, the general population of all ages will also increase.
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Copyright c Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Julie A. Boom, Leila C. Sahni, Cynthia S. Nelson, Anna C. Dragsbaek, and Luisa Franzini r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r
I mmunization information systems (IISs) are confidential, population-based systems that contain immunization data for children, and, in some cases, adults, within a geographic area. There are generally two models for participation in an IIS, termed voluntary exclusion or “opt-out” and voluntary inclusion or “opt-in.” Using the Texas opt-in consent system and statewide IIS (ImmTrac), we describe the costs associated with obtaining opt-in consent in hospitals as part of the birth registration process and in provider offices for children without prior consent. We also estimate the costs associated with a hypothetical opt-out system. Between October
2006 and August 2007, project staff conducted on-site time studies for patients in 8 birthing hospitals ( n
=
281), 16 provider offices ( n = 131), and ImmTrac state offices in Austin, Texas
( n
=
100). Total costs per child and costs per year were estimated using a time-and-motion study in which the time associated with discussing ImmTrac and obtaining ImmTrac consent was measured. The annual costs associated with obtaining consent for Texas’ opt-in IIS are estimated at
$1 389 804.61. The average per child cost associated with
ImmTrac consent completed at birth is $2.00, whereas the per child cost for consent completed in provider offices is $2.64. The annual costs of operating an alternative, opt-out system are estimated at $110 714.03, or $0.29 per child. This cost analysis demonstrated that the proposed opt-out costs were substantially less than the actual opt-in model currently utilized. Changing to an opt-out system could redirect limited healthcare funding to more critical areas such as vaccine purchasing and administration.
KEY WORDS: consent, cost analysis, immunization information system
J Public Health Management Practice , 2010, 1–8
Copyright
C
2010 Wolters Kluwer Health
|
Lippincott Williams & Wilkins
Immunization information systems (IISs) are confidential, population-based computerized systems that contain immunization data for children, and, in some cases, adults, within a geographic area.
1 These systems are currently under development or are actively being used in almost every state in the United States.
2,3
They can assist medical providers in accessing and consolidating children’s immunization histories, deciding which immunizations children need, contacting children who are due or overdue for immunizations, determining immunization coverage levels, generating official immunization histories for school or day care entry, identifying pockets of need, and avoiding underor overimmunization.
1
This study was funded by a donation from St David’s Foundation, Austin, Texas, and by in-kind contributions from Texas Children’s Hospital, Houston.
The authors thank Anne Frug ´e and Alessia Bhargava for their capable work in collecting data; Jack Sims, Immunization Branch, Texas Department of State
Health Services, for assistance in obtaining institutional review board approval from Texas Department of State Health Services; Mark Ritter, MHA, Centers for
Disease Control and Prevention Senior Public Health Advisor, Texas Department of State Health Services, and Jack Sims for assistance in procuring Texas VFC data; St David’s Foundation for its generous monetary support of this study; Dr
Virginia Moyer, Baylor College of Medicine, Therese Hoyle, Hoyle Consulting, Inc,
Gary Urquhart, MPH, Centers for Disease Control and Prevention, and Dr Alan
Hinman, Public Health Informatics Institute, Task Force for Global Health, for editorial comments.
Corresponding Author: Julie Boom, MD, Texas Children’s Hospital, 6701
Fannin St CC1540, Houston, TX 77030 (jboom@bcm.edu).
q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q q
Julie A. Boom, MD, is Director, Immunization Project, Texas Children’s Hospital;
Director, Infant and Childhood Vaccines, Center for Vaccine Awareness and Research,
Texas Children’s Hospital; and Associate Professor, Section of Academic General
Pediatrics, Department of Pediatrics, Baylor College of Medicine, Houston, Texas.
Leila C. Sahni, MPH, is Immunization Action Plan Coordinator, Immunization Project,
Texas Children’s Hospital, Houston.
Cynthia S. Nelson, MPH, is Instructor and Physician Assistant, Pediatric Critical
Care Section, Baylor College of Medicine, Houston, Texas.
Anna C. Dragsbaek, JD, is President/Chief Executive Officer, The Immunization
Partnership, Houston, Texas.
Luisa Franzini, PhD, MS, is Associate Professor, Management, Policy, and
Community Health Division, University of Texas Health Science Center Houston
School of Public Health, Houston.
1

Copyright c Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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Journal of Public Health Management and Practice
Across the United States, there are generally two models for participation in an IIS. The first is voluntary exclusion (also known as “opt-out”). In this model, consent is automatic or assumed unless a parent or individual chooses to exclude themselves or their children from participation. The second model is voluntary inclusion, or “opt-in,” and requires parents or individuals to actively indicate a willingness to participate in an IIS. State legislatures generally determine the model that is used by a state. Many issues are considered by legislators before selecting one model or another. Deliberations typically include issues such as privacy, administrative burden, cost, and sociopolitical acceptance. Of the 56 IISs in the United States, 8
IISs in 6 states (Idaho, Illinois, Kansas, Massachusetts,
Texas, and Virginia) employ opt-in consent procedures
(G. Urquhart, MPH, Centers for Disease Control and
Prevention, personal communication, January 2009); the remaining 48 IISs in 44 states and Washington, DC, employ opt-out systems.
2–4 When comparing participation rates in states that utilize opt-in consent versus those that have opt-out consent, parental refusal to participate is generally less than 10 percent, regardless of the nature of the consent process.
2 In other words, in an opt-in system, all parents must be approached and consent procedures must be completed to facilitate the inclusion of 90 percent or more of children. Conversely, in an opt-out system, all parents are informed of their child’s automatic participation in the IIS and exclusion procedures are completed for the less than 10 percent who chose to decline participation.
Although consent for IIS participation is primarily completed at birth, parents may consent or exclude their children at any age. For this reason, all medical providers and their staff members who offer care to children must be knowledgeable about the consent procedures in their state and approach parents whose children are not in the IIS. As the number of children seen in medical provider offices and birthing hospitals can be variable, the knowledge and efficiency with which these procedures are completed can differ.
On the basis of these observations, we hypothesized that opt-in procedures for IIS participation may be labor-intensive and costly. This study describes the estimated costs to hospitals and medical provider offices associated with an opt-in system, using the Texas IIS,
ImmTrac, as an example. ImmTrac is an established IIS that has been used statewide since its implementation in 1998. The costs to the state of Texas associated with operating an opt-in consent process are also included.
For comparison, we also estimated the costs associated with a hypothetical opt-out system.
●
To assess the financial impact of maintaining an optin consent process, we conducted a cost-analysis study to determine the expenses associated with obtaining
ImmTrac consent. Institutional review board approvals were obtained from Baylor College of Medicine, Texas
Department of State Health Services, and six additional institutions where data were collected.
Between October 2006 and August 2007, we conducted time-motion studies in birthing hospitals and medical provider offices in both the public and private health sectors in the Greater Houston area and in
ImmTrac state offices in Austin, Texas. Trained project staff conducted time studies on-site by using a standardized time log. Only the time associated with discussing ImmTrac and obtaining ImmTrac consent was measured. All other time associated with immunization procedures, such as time spent discussing a specific vaccine or vaccine administration, was excluded. Consent for participation in ImmTrac can be granted by a child’s parent/guardian either during the birth registration process or later in life in a medical provider’s office.
Using the consent form provided by the state, parents are required to blacken the appropriate circle to indicate that they are permitting or denying consent for their child’s immunization record to be included in
ImmTrac. These consent forms are sent to ImmTrac offices at the state health department for processing. If the form was either incomplete or illegible, the form is rejected and the child is excluded from ImmTrac regardless of parental consent. Conversely, consent forms completed later in life in medical provider offices are only for children whose parents/guardians grant consent for inclusion in ImmTrac. These forms are also sent to ImmTrac offices for processing and are rejected if they are illegible or incomplete. Depending on parental choice, the accuracy with which consent forms are completed, and the decision by the medical provider to offer consent, consent procedures may occur multiple times, although it is required only once during a child’s life.
To determine the cost associated with ImmTrac consent gathered in birthing hospitals, time studies ( n =
106) were conducted at three large, publicly funded
(safety net) birthing hospitals and five large, private birthing hospitals ( n = 175). We selected a convenience sample of hospitals that was intended to include a wide variety of hospital types. At the time of data collection, annual births at these hospitals ranged from 1 142 to
8 085. The studies conducted captured the additional time required to obtain ImmTrac consent as part of the birth registration process; time spent on any other part of the birth registration process was excluded.

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Immunization Information System Opt-In Consent
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3
We then determined the costs associated with Imm-
Trac consent collection in provider offices. Ten time studies were conducted at each of 10 different public health clinics ( n
= 100). Because ImmTrac consent was not routinely being offered in most provider offices, the number of time studies obtained at each of six private provider offices varied between 1 and 11 ( n = 31).
To determine the costs associated with state-level procedures such as processing consent documents, establishing records, and verifying consent, project staff conducted time study analyses at ImmTrac offices. The consent procedures for 100 randomly selected individuals were evaluated at ImmTrac to determine the related costs for all study groups.
Unrelated costs to the state of Texas associated with operating and maintaining ImmTrac were not included in the analysis.
Analysis
Time costs associated with each stage of the consent process were calculated by multiplying the average minutes elapsed per child during the completion of the specific portion of the consent process by the compensation per minute of the employee completing the task.
The total cost to the state for the entire consent process was computed, including the direct expenses and the time costs associated with obtaining and documenting consent. Direct costs included the cost of equipment used for storing and processing consent forms; fixed costs such as facility costs were not included. The costs of maintaining equipment used exclusively for processing, storing, and maintaining ImmTrac consent forms, such as bar codes, fax machines, and scanners, were obtained from ImmTrac staff and included.
The mean time for consent procedures completed in hospitals and the mean time for consent collected in provider offices were calculated by averaging costs in the public and private sectors, using as weights the proportion of consents obtained in the public and private sectors. The overall cost per child was obtained by dividing the total annual cost of consent by the number of children for whom consent was obtained. Opt-out costs were estimated by modeling the opt-out process and associated costs using time estimates on the basis of time-and-motion studies.
We calculated the hypothetical costs of using an optout system on the basis of the assumption that up to 10 percent of parents/guardians might chose to exclude their children from an IIS.
2 One birth registrar observed consistently spent 1 minute introducing and explaining
ImmTrac to parents, whereas birth registrars observed at the seven other hospitals spent between 15 and 30 seconds introducing ImmTrac and completing the parental portion of the consent process. On the basis of these time study data collected, we estimated that birth registrars would spend a nominal amount of time (20 seconds) per child introducing, explaining, and verifying interest in IIS participation to the parents/guardians of 90 percent of the birth cohort. The full opt-out process, as described earlier, would be completed for parents/ guardians of 10 percent of the birth cohort who refuse consent. ImmTrac-related costs were included for 10 percent of the birth cohort, as were the cost of letters to parents completing the process to confirm exclusion from the IIS for 10 percent of the birth cohort.
●
Costs associated with ImmTrac consent collection at birth
Of the 106 time studies conducted at three large publicly funded (safety net) birthing hospitals, consent procedures completed at birth required an average of 3 minutes 5.3 seconds of the birth registrar’s time. The average annual salary (including 23% fringe) for a birth registrar employed by a Texas public hospital totals $41 881.01 (confidential, unpublished data, January
2007). Therefore, the time costs associated with birth registrar effort for obtaining consent for a child in the public birth setting were $1.04 per child (Table 1).
Of the 175 time studies conducted in five large private birthing hospitals, the consent procedures required on average 2 minutes 40.8 seconds of the birth registrar’s time. The average annual salary (including 23% fringe) for a birth registrar employed by a private hospital totals $50 528.40 (confidential, unpublished data January 2009). Therefore, the time cost associated with birth registrar effort for obtaining consent for a child in the private setting was $1.08 per child.
Time studies conducted at ImmTrac offices revealed that an additional 0.03 seconds of ImmTrac staff time were required to process birth consent forms that had been received by the state. Consent forms from birth registrars are received and processed using an electronic interface and are manually reviewed by ImmTrac staff only when an electronic error occurs. This time,
0.03 seconds, with an associated cost of $0.01, is a per consent form average of the time spent on reviewing the subset of consent forms that requires manual review. In addition, ImmTrac staff send verification letters to new parents who complete the birth registration process; the cost of printing and mailing these letters was determined to be $0.56 per letter. All consent forms received are stored electronically by ImmTrac staff. The storage and maintenance of these forms and the annual cost of the necessary equipment required added an additional
$0.09 for each consent form processed. ImmTrac staff also provide ongoing training and education to birth

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Journal of Public Health Management and Practice
● Costs associated with ImmTrac a consent collection at birth
Stage in consent process Person completing task Time per consent Cost per consent
ImmTrac consent collected as part of the birth registration process
ImmTrac processing
Letters to new parents
Consent form storage
Ongoing birth registrar training and outreach
Total cost per consent
Birth registrar
ImmTrac and Vital Statistics staff
External agency
ImmTrac staff
ImmTrac staff
3 min 5.3 s (public)
2 min 40.8 s (private)
0 min 0.3 s
$1.04 (public)
$1.08 (private)
$1.07 (weighted mean) b
$0.01
$0.56
$0.09
$0.27
$1.97 (public)
$2.01 (private)
$2.00 (weighted mean) b a
The Texas statewide Immunization Information System (IIS).
b
Public and private time costs were averaged on the basis of 21.4% of consents collected in public birthing hospitals and 78.6% collected in private birthing hospitals.
registrars across the state who complete consent procedures; the costs associated with travel and training added an additional $0.27 per consent form received.
The total costs to gather, process, and maintain information for each consent collected at birth were $1.97 at public birthing hospitals and $2.01 at private birthing hospitals. The number of public and private hospitals in Texas was used to determine the percentage of children for whom newborn consent procedures are completed in public and private birthing hospitals. In
2005, 388 285 births occurred in Texas hospitals. Of these, 83 093 (21.4%) births occurred in public hospitals whereas 305 192 (78.6%) occurred in private hospitals.
5
Using this weighting, the average cost per child for consent collected at birth is $2.00.
Costs associated with ImmTrac consent collection in provider offices
Of the 100 time studies conducted at 10 different public health clinics, consent procedures required an average of 3 minutes 24.6 seconds. At all public health clinics, registered nurses (RNs) were the staff assigned to obtain ImmTrac consent. On the basis of an average annual salary (including 23% fringe) of $93 151.34 for an
RN employed in a public health clinic (confidential, unpublished data, January 2007), the time costs associated with nursing effort for obtaining consent were $2.55 per child (Table 2).
Of the 31 time studies conducted at six different private provider offices, consent procedures required an average of 4 minutes 53.2 seconds. In comparison with public health settings, medical assistants or licensed vocational nurses (LVNs) were generally responsible for obtaining ImmTrac consent. On the basis of an average annual salary (including 23% fringe) of $49 556.21 for an LVN employed in the private sector (confidential, unpublished data, January 2009), the time cost associated with staff effort for gathering consent was $1.94
per child.
In addition to the medical provider staff time, 63.4
seconds of ImmTrac staff time were required to process each consent form received. Unlike consent forms that are received from birth registrars via an electronic interface, consent forms obtained from medical provider offices require manual review to eliminate duplicate records and prevent data entry error. When the costs incurred by ImmTrac at the state level for storing and
● Costs associated with ImmTrac a consent collection in provider offices
Stage in consent process Person completing task Time per consent Cost per consent
ImmTrac consent collected in medical provider offices
ImmTrac processing
Consent form storage
Total cost per consent
RN
Medical assistant or licensed vocational nurse
ImmTrac staff
ImmTrac staff
3 min 24.6 s (public)
4 min 53.2 s (private)
4 min 08.9 s (mean)
1 min 03.4 s
$2.55 (public)
$1.94 (private)
$2.08 (weighted mean) b
$0.47
$0.09
$3.11 (public)
$2.50 (private)
$2.64 (weighted mean) b a
The Texas statewide Immunization Information System (IIS).
b
Public and private time costs were averaged on the basis of 23.5% of consents collected in public clinics or health centers and 76.5% collected in private provider offices.

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Immunization Information System Opt-In Consent
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5 maintaining consent forms (as described earlier) were added to these costs, the total costs for obtaining consent for a child were $3.11 for consent procedures completed in public clinics and $2.50 for consent procedures completed in private medical provider offices. Costs associated with training clinical staff who collect ImmTrac consent in provider offices were not included because no training is currently provided by ImmTrac.
To determine the number of children for whom consent is obtained in public health clinics, receipt of publicly funded vaccine through the Texas Vaccines for
Children (VFC) program was used. This program supplies vaccine to children and adolescents less than 18 years of age who are underinsured or uninsured or who meet other inclusion criteria.
6 Although the vaccine itself is publicly funded, it is administered in both public and private health settings. For the purpose of this study, the proportion of Texas children who received
VFC vaccine in a public clinic was used to determine the percentage of Texas children who are treated in the public health sector and thus complete ImmTrac consent procedures in the public sector. Similarly, the proportion of Texas children who received private vaccine or VFC vaccine in a private provider office was used to determine the percentage of Texas children who complete ImmTrac consent procedures in the private sector. In 2008, 23.5 percent ( n = 54 468) of Texas children were served in a public clinic or health center, whereas 76.5 percent ( n = 177 312) were served in a private provider’s office (M. Ritter, Centers for Disease
Control and Prevention, personal communication, January 14, 2009). This breakdown assumes that children received vaccine in either the public health sector or the private health sector and did not migrate between the two. Therefore, the average cost per child for consent collected in provider offices is $2.64.
Total costs
In 2005, 388 285 births occurred in Texas hospitals. As part of the Texas electronic birth registration process, these infants should all be offered ImmTrac consent.
Under the current opt-in system, the consent process completed by parents and birth registrars is the same regardless of parental decision to include their child.
For the purpose of this study, 21.4 percent ( n
= 83 093) of newborn consent forms received were attributed to public birthing hospitals and 78.6 percent ( n = 305 192) were attributed to private birthing hospitals.
5 This results in annual costs of $163 693.21 and $613 435.92 to the public and private sectors, respectively, for the collection, processing, and storage of ImmTrac consent forms collected at birth (Table 3).
ImmTrac state offices receive an average of 19 315 consent forms from Texas provider offices each month, for an annual total of 231 780 consent forms. Using the previously described breakdown, 54 468 consent forms are received from public clinics and health centers whereas 177 312 consent forms are received from private provider offices. This results in annual costs of $169 395.48 and $443 280.00 to the public and private sectors, respectively, for the collection, processing, and storage of ImmTrac consent forms completed in provider offices.
Therefore, the total annual costs associated with obtaining, processing, and maintaining ImmTrac consent at birth and in provider offices are $1 389 804.61. Using the total number of consent forms received from birth registrars and provider offices, an average per child cost of $2.24 is obtained.
ImmTrac receives and processes more than 620 000 consent forms each year, which greatly exceeds the annual birth cohort. This difference is due, in part, to the completion of duplicate consent forms for children.
Although ImmTrac requests that providers verify patients’ ImmTrac consent status before completing consent procedures for patients, many providers ask all new patients to complete the consent process. In addition, some consent forms collected at birth cannot be processed because of completion or processing errors: multiple consent forms may be completed for these children during their lifetime. Finally, in-migration
● Consent costs for the current Texas opt-in system for ImmTrac a participation
Consent obtained at birth b Consent obtained in a clinic c
Number of consent forms, n (%)
Cost per consent
Cost per year
Public
83 093 (21.4)
$1.97
$163 693.21
Private
305 192 (78.6)
$2.01
$613 435.92
Public
54 468 (23.5)
$3.11
$169 395.48
Private
177 312 (76.5)
$2.50
$443 280.00
Total
. . .
$2.24
d
$1 389 804.61
a
The Texas statewide Immunization Information System (IIS).
b
Based on the 388 285 births occurring in Texas hospitals in 2005.
c
Based on annual completion of 231 780 consent forms in provider offices.
d
Weighted mean based on the annual receipt of 620 065 consent forms and the breakdown of forms received from the public and private sectors for both birthing hospitals and provider offices/clinics.

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Journal of Public Health Management and Practice
● Costs associated with a hypothetical opt-out system
Stage in consent process Person completing task Time per consent Cost per consent
Introduction and explanation of ImmTrac to new parents a
Completion of opt-out process
ImmTrac processing d
Letters to new parents
Consent form storage
Total cost per child c c
Birth registrar
Birth registrar
ImmTrac and Vital Statistics staff
External agency
ImmTrac staff
0 min 20.00 s
3 min 05.3 s (public)
2 min 40.8 s (private)
0 min 00.03 s
. . .
. . .
$0.11 (public)
$0.13 (private)
$0.11 (weighted mean) b
$1.04 (public)
$1.08 (private)
$1.07 (weighted mean) b
$0.01
$0.56
$0.09
$0.28 (public)
$0.31 (private)
$0.29 (weighted mean) b a
Ninety percent of Texas birth cohort.
b
Public and private time costs were averaged on the basis of 21.4% of consents collected in public birthing hospitals and 78.6% collected in private birthing hospitals.
c
For 10% of parents who opt out.
d
ImmTrac processing completed for 10% of parents who opt out.
also contributes to the number of consent forms received.
Opt-out costs
Using the previously described opt-out system and the number of children born in Texas hospitals in 2005, the annual costs associated with birth registrar time to exclude 10 percent of all children born, were calculated at
$86 249.95. When the additional statewide costs of processing, electronically storing, and maintaining these records and the cost of confirmatory letters to parents who excluded their child from ImmTrac are added to the costs incurred in the hospitals, the total annual cost of maintaining an opt-out system for 10 percent of all newborns was calculated at $110 714.03, or $0.29 per child (Table 4).
●
Our study found that the costs for ImmTrac consent were significant, ranging from $1.97 to consent a child in a public birthing hospital up to $3.11 to consent a child in a public health clinic. The difference in costs can be attributed to several factors including less time required for consent procedures in private birthing hospitals, use of RNs instead of medical assistants or LVNs in public health clinics, and differences in salaries between the public and private health sectors. Averaging the public and private hospital costs, as previously described, and using the entire yearly birth cohort yields an annual cost of $777 129.13 for ImmTrac consent collected at birth. Similarly, when medical provider office costs are combined, the total annual cost is $612 675.48
for ImmTrac consent collected in provider offices. Thus, the total annual costs of the current opt-in system to all involved are more than $1.3 million. In comparison, the total annual costs of the hypothetical opt-out system suggest a much lower cost of $110 714.03. On a per child basis, the hypothetical opt-out system costs $0.29; approximately one-tenth of the current opt-in cost of
$2.24 per child to consent all newborns and children in clinical settings.
The costs of the proposed opt-out model presented are based on parental refusal to participate for 10 percent of the birth cohort. Analysis of IIS participation suggests that nationwide, opt-out rates vary from less than 1 percent of the population to approximately 10 percent.
2 Under the current opt-in system in Texas, approximately 5 percent of parents chose to exclude their children from ImmTrac 2 ; therefore, the costs of an optout system could be substantially lower than those proposed earlier.
Because this study is the first published cost analysis of an opt-in system for an IIS, it is unlikely that cost estimates played a significant role during legislative debate prior to consent implementation. It is likely that more weight was given to other concerns such as privacy and sociopolitical acceptance. Over the past decade, acceptance for IISs may have improved as the general public has become more familiar with the use of electronic systems, such as on-line banking and physician electronic medical records (EMRs). Conversely, concerns about vaccine safety have continued to grow over recent years. Many vaccine-concerned parent groups worry about the privacy of their children’s vaccination records. As such, privacy remains a sensitive

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Immunization Information System Opt-In Consent
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7 issue. However, with rapidly developing privacy tools, these concerns can be remedied through the use of encryption technology and cohesive standards for data exchange.
Although this study focused on the costs associated with IIS consent, it has implications for other aspects of patient care. Given the emergence of EMRs and health information exchanges, the time spent obtaining patient consent is an important consideration not only for policy makers when contemplating the privacy concerns of their constituents but also for administrators when implementing new electronic health systems.
Given that the vast majority of individuals consent to participate in an IIS, this new information about the estimated cost of opt-out consent warrants a reevaluation of cost, privacy, and political acceptance.
Finally, this cost analysis is unique to Texas and may not be generalizable to other states with opt-in IIS consent procedures or to other forms of health information.
Furthermore, the salary information used to determine the costs presented in this study is representative of public and private facilities in the Greater Houston area and may not be generalizable to other areas in Texas or to other states. Minor differences in consent procedures could have major cost implications. Despite the potential variability in consent processes among other states with opt-in laws for IIS participation, this unique study provides an estimate of the costs of maintaining an opt-in system and could serve as a reference against which future studies in other states are validated. Furthermore, conducting similar studies in states with optout consent procedures already in place would provide a more accurate assessment of the actual costs associated with operating an opt-out system.
Limitations
This study had several limitations. First, we found a limited number of private providers in the Greater
Houston area who regularly completed ImmTrac consent procedures. This made it difficult to conduct time studies. The relatively small number of studies conducted may have resulted in an inaccurate estimate of the clinic portion of the time required to obtain consent.
However, the consistency within times collected from
11 different clinics makes this unlikely.
Second, time data collected for each step of the Imm-
Trac consent process were assumed to be separate and distinct. In reality, some of these times may represent shared times and tasks that apply to multiple activities, thus increasing the costs associated with obtaining
ImmTrac consent. However, this increase in cost was applied to both the actual opt-in costs and the hypothetical opt-out system.
The costs associated with obtaining consent in provider offices assumed that children received vaccine in either the public sector or the private sector and did not migrate between the two. In reality, the two sectors are not mutually exclusive and some children may be treated by providers in both sectors.
In addition, there is no way to accurately assess the number of children in the opt-out system who may opt out later in life. These may be children whose parents granted consent for ImmTrac participation at birth and later changed their minds, or it may also include children who were born outside Texas and first have the opportunity to opt-out during a clinic visit.
These factors would increase the costs associated with maintaining an opt-out system. Furthermore, as with the current opt-in system, some parents may complete opt-out processes multiple times during their child’s life, further increasing costs associated with an opt-out system.
Implications and policy recommendations
Given national concerns regarding rising healthcare costs, it becomes increasingly important to carefully scrutinize how public and private healthcare dollars are being spent. As IISs continue to mature and prove to be reliable sources of confidential immunization information 7,8 reconsidering the efficiency and costs associated with consent procedures for populating these systems and other electronic health record systems is essential. Furthermore, the costs associated with consent will be a factor as EMRs become widespread and health information becomes easier to exchange in electronic format with other providers. Because the proposed opt-out costs were demonstrated in this study to be substantially less than the actual opt-in model currently utilized, changing to an opt-out IIS could redirect limited healthcare funding to more critical areas such as vaccine purchasing, administration, and education.
REFERENCES
1. Centers for Disease Control and Prevention. Vaccines and immunizations: What is IIS? http://www.cdc.gov/ vaccines/programs/iis/what-iis.htm. Accessed January 15,
2009.
2. Urquhart G. Immunization information systems: current status and plans for the future. http://www.
stdavidsfoundation.org/programs immtech materials.htm.
Accessed January 15, 2009.
3. Horlick GA, Feikema Beeler S, Linkins RW. A review of state legislation related to immunization registries.
Am J Prev Med.
2001;20(3):208–213.
4. American Immunization Registry Association. http://www.
immregistries.org. Accessed January 15, 2009.

Copyright c Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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5. Texas Department of State Health Services.
Vital Statistics
2005 Occurrent Births, Preliminary Facilities Data . Austin: Texas
Department of State Health Services; 2009.
6. Immunization Branch, Texas Department of State Health Services. Overview of Vaccines for Children program. http:// www.dshs.state.tx.us/immunize/toolkit/kit1.shtm# overview. Accessed April 24, 2009.
7. Boom JA, Dragsbaek AC, Nelson CS. The success of an immunization information system in the wake of Hurricane
Katrina.
Pediatrics.
2007;119(6):1213–1217.
8. Urquhart G, Williams W, Tobias J, Welch FJ. Immunization information system use during a public health emergency in the United States.
J Public Health Manag Pract.
2007;13(5):481–
485.

Daniel W. Martin, MSPH; N. Elaine Lowery, JD, MSPH; Bill Brand, MPH; Rebecca Gold, JD;
Gail Horlick, MSW, JD r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r r
T his article reports on a study of laws, regulations, and policies governing Immunization Information Systems (IIS, also known as “immunization registries”) in states and selected urban areas of the United States. The study included a search of relevant statutes, administrative codes and published attorney general opinions/findings, an online questionnaire completed by immunization program managers and/or their staff, and follow-up telephone interviews.
The legal/regulatory framework for IIS has changed considerably since 2000, largely in ways that improve IIS’ ability to perform their public health functions while continuing to maintain strict confidentiality and privacy controls. Nevertheless, the exchange of immunization data and other health information between care providers and public health and between entities in different jurisdictions remains difficult due in part to ongoing regulatory diversity.
To continue to be leaders in health information exchange and facilitate immunization of children and adults, IIS will need to address the challenges presented by the interplay of federal and state legislation, regulations, and policies and continue to move toward standardized data collection and sharing necessary for interoperable systems.
KEY WORDS: electronic data interchange, health information exchange, immunization information system, informatics
Electronic exchange of patient health information is a major component of the United States national strategy to improve health care quality, improve population health outcomes, and reduce costs.
1 Making health information on a patient available to clinicians when and where needed allows both the clinician and the
J Public Health Management Practice , 2013, 00(00), 1–8
Copyright
C
2013 Wolters Kluwer Health | Lippincott Williams & Wilkins patient to be supported in making the right decision.
2
Consolidating information from multiple sources enables public health authorities to better monitor, assess, and respond to changing needs in the population.
Immunization Information Systems (IIS), also known as “Immunization Registries,” have made patients’ health information available to growing numbers of immunization providers for more than
20 years.
3,4 Using secure database technology, IIS consolidate the fragmented immunization records of patients who seek care from multiple providers 5-7 and
Author Affiliations: Immunization Information Systems Support Branch,
Immunization Services Division, National Center for Immunization and
Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta,
Georgia (Mr Martin); Public Health Informatics Institute, Decatur, Georgia
(Ms Lowery); Public Health Informatics Institute, Decatur, Georgia (Mr Brand);
National Center for Immunization and Respiratory Diseases, Centers for Disease
Control and Prevention, Atlanta, Georgia (Ms Gold); and Office of the Associate
Director for Science, Centers for Disease Control and Prevention, Atlanta,
Georgia (Ms Horlick).
The authors thank the Immunization Information System managers, immunization program managers, and other staff of the immunization programs in the state and urban health departments who responded to their surveys to provide the raw data for this study. In addition, the authors thank Janet Kelly, MPH, RN, for her participation in the planning phase of this project.
The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.
Data gathering and analysis were conducted by the Public Health Informatics Institute, Decatur, Georgia, under cooperative agreement no. HM08-
080502CONT12 from the Centers for Disease Control and Prevention.
This is an open-access article distributed under the terms of the Creative
Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
All authors report they have no financial or other conflicts of interest to disclose.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.JPHMP.com).
Correspondence: Daniel W. Martin, MSPH, Immunization Information Systems
Support Branch, Immunization Services Division, NCIRD, Centers for Disease
Control and Prevention, 1600 Clifton Road, Mailstop A-19, Atlanta, GA 30333
(dwm5@cdc.gov).
DOI: 10.1097/PHH.0000000000000040
1
Copyright © 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

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Journal of Public Health Management and Practice provide clear clinical guidance in the context of increasingly complex immunization recommendations.
8,9
Many IIS now receive a growing proportion of their data through interfaces with Electronic Health Record
(EHR) systems rather than through direct-entry or paper record submission. Both the Medicare and
Medicaid EHR Incentive Programs (which incentivize the adoption and “Meaningful Use” of EHR systems in clinical practice) 10 and Centers for Disease Control and Prevention (CDC) assistance of more than $40 million nationwide (CDC, unpublished data, 2012) have supported this trend.
Since the early 1990s, states have enhanced legal and policy support for IIS. A survey of states that examined state laws, regulations, and policies in 2000 found that
36% of states had laws or rules specifically addressing
IIS for children.
11 A more recent study in 2010/2011 found an increased number of states (66%) with laws specifically authorizing the operation of an IIS.
12
The legal framework goes beyond simply authorization of registry operations. A variety of laws and regulations define the balance between public health authority and individuals’ rights to privacy and consent with regard to their own data. These include not only state and local law but also the federal Health
Insurance Portability and Accountability Act (HIPAA)
Privacy Rule.
13-15 This complex patchwork of federal, state, and local laws and policies presents challenges for both intra- and interstate exchange of immunization information.
Complicating this patchwork of laws even more are new entities created to facilitate health information exchange, alternatively called Health Information
Organizations, Health Information Exchanges (HIE), or Health Information Service Providers (collectively referred to in this paper as “HIEs”). HIEs often have specific statutory authorities and duties, including requirements for patient consent, which may or may not be consistent with those governing IIS. For example, a state may have a law that mandates provider reporting of pediatric immunizations to an IIS without need for parental consent, but the laws for HIE require written patient consent for participation. Such a situation effectively means that the provider cannot fulfill a mandate to report immunizations without either violating the HIE consent requirement or bypassing the HIE for nonconsented patients.
●
The objective of this study was to obtain information relating to legislation, regulations, rules, and policies
(collectively referred to as “laws”) that enable, support, or constrain the ability of an IIS to receive or disclose immunization information for both children and adults and to assess trends with regard to these laws.
●
The initial target population included all domestic recipients of federal Section 317 immunization grant funding administered by the CDC: 50 states, 5 municipalities, and the District of Columbia. Houston discontinued operation of its IIS in 2010 and Chicago does not operate an IIS. Both municipalities were excluded from this study. At the time of this study, New
Hampshire did not operate an IIS and was excluded.
The final study population was 49 states, 3 municipalities (New York City, Philadelphia, and San Antonio, each of which operates an IIS independent of its respective state), and the District of Columbia, for a total of
53 participants.
●
Online survey
A self-reported, online survey was pilot tested by
3 state immunization program manager volunteers.
Prior to administration, this survey was reviewed by the CDC National Center for Immunization and
Respiratory Diseases Human Subjects Advisor and determined not to involve human subjects and, therefore, exempt from institutional review board monitoring.
After the pilot, all participant programs were asked to complete the final 36-question survey on SurveyMonkey during February and March 2012. Respondents were directed to refer to state statutes and laws, municipal ordinances if applicable, state and local rules and regulations, state and local written policies, and written findings/opinions of attorney general or general counsel. The immunization program manager was asked to provide answers in consultation with other appropriate individuals, including IIS managers or other program/IT staff. The response rate was 100%.
Legal research
In October and November 2011, the study team conducted a WestLaw search of relevant statutes, administrative codes, and published attorney general opinions/findings.
16 Results of the legal research were examined by members of the study team who are attorneys to restrict the scope to citations addressing
IIS, as opposed to laws regulating non-IIS issues such as clinical practice, outbreak control, health officer emergency powers, and school attendance.
Follow-up telephone interviews
In March and April 2012, 1 member of the study team conducted a 30-minute telephone follow-up interview
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Immunization Information Systems—Law and Policy
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3 with every program in the study. Interviews addressed any inconsistent or unclear answers and allowed participants to elaborate on any of their responses to the online survey, including any apparent discrepancies between survey responses and the study team’s legal research. Participants on the follow-up calls varied and included immunization program managers, IIS managers, CDC Public Health Advisors, legal counsel, and
IIS vendors.
thority rather than explicit authorization to operate an
IIS for children (Figure 1).
Taken together, these findings represent a total of
43 of 53 (81%) jurisdictions that directly provided legal authority for public health to operate an IIS.
These numbers contrast with the legal authority for
IIS reported in 2000: 24 (47%) IIS-specific, 9 (18%) immunization-information, and 3 (6%) general public health authority 11 (see Supplemental Digital Content
Figure 1A, available at http://links.lww.com/JPHMP/
A69), or the only 9 (18%) states with any IIS authorization reported in 1995.
3
Validation
Modifications of the original online responses were made as a result of the follow-up telephone interviews; the modified responses and the study team’s reclassification of “Other” responses were validated with the respondents through a second round of e-mail and telephone communication in February 2013.
Comparative data for trends
When possible, data gathered in this study were compared with Horlick’s 11 review of IIS-related legislation.
The data in Horlick were gathered in 2000, so this is the year used for reference in any comparisons made. The study by Horlick in 2000 did not address the details of adult versus childhood records in IIS, nor did it include municipal IIS, so not all data were comparable.
Type of authority to operate an IIS for adults
Of the 51 IIS programs that were authorized to operate an IIS for adults, 27 (52.9%) had laws that specifically authorized operation of IIS, 8 (15.7%) had laws that authorized sharing of immunization information, but did not specifically authorize the operation of IIS, 3 (5.9%) had laws allowing the sharing of health care information, but did not refer to immunization information explicitly, and 13 (25.5%) relied on general public health statutes or regulations to operate IIS for adults.
●
A complete line-listing of data is summarized in Supplemental Digital Content Survey Data, available at http://links.lww.com/JPHMP/A72.
Lifelong or childhood IIS
Fifty-one (96.2%) of the 53 IIS programs were authorized to collect immunization records for all age groups (also known as a lifelong IIS). For 2 (3.8%) programs, the IIS was limited to immunization records for children only.
Type of authority to operate an IIS for children
Thirty-six (68%) of the IIS programs studied collected immunization data for children (age ranges vary by state) on the basis of laws specifically authorizing
IIS, another 6 (11%) on the basis of immunization information-sharing laws (which did not mention an
IIS), and 1 (2%) on the basis of laws allowing the sharing of general health information. The remaining
10 (18.9%) programs relied on general public health au-
Mandate to report immunizations
Thirty-one (58.5%) jurisdictions mandated at least
1 type of provider or entity to report immunizations and 22 (41.5%) had no mandate to report immunizations (Figure 2). By contrast, in 2000 11 only 12 states had mandated reporting (see Supplemental Digital Content
Figure 2A, available at http://links.lww.com/JPHMP/
A70).
A mandate to report may be limited to certain age groups or certain vaccines (eg, publicly funded vaccines). Of the 31 IIS programs with some type of mandate to report immunizations, 21 (67.7%) mandated all immunization providers to report, 27 (87.1%) mandated public health providers to report, 23 (74.2%) mandated Vaccines for Children (a federal vaccine-purchase program) providers to report, 21 (67.7%) mandated private providers to report, and 22 (71%) mandated pharmacies/pharmacists to report.
Among the 31 IIS programs with some type of mandate to report immunizations, 12 (38.7%) mandated that immunizations for all age groups be reported and 17 (54.8%) mandated that immunizations for children/adolescents/young adults (with upper age limits ranging from 18 to 26 years of age) be reported but not immunizations for adults. Only 2 (6.3%) programs mandated reporting of immunizations for only young children (with upper age limits of 6 or 7 years of age). Among the 31 programs with some type of mandate to report immunizations, 26 (83.9%) mandated
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● Legal Basis for IIS Operation, United States, 2012
Chicago
New York
Philadelphia
Washington
San Antonio
Houston
Authorization type (children’s data)
Law specifically authorizing IIS
Law addressing sharing of immunization information
Law addressing sharing of health information
Authorization derived from general public health authority
No IIS that the report be to the IIS, 3 (9.7%) mandated that the report be to local public health, and 2 (6.3%) mandated that the report be to both local public health and the IIS. For San Antonio, the mandate was to report to either the San Antonio IIS or the state of
Texas IIS.
Of the 31 IIS programs with some type of mandate to report immunizations, 21 (67.7%; 39.6% of total participants) had a mechanism to enforce the mandate.
The authorized enforcement mechanism was a penalty or fine in 4 (12.9%) locations. Fourteen (45.2%) programs had authority to enforce a mandate by limiting the amount of public vaccine a provider can order if that provider fails to report immunizations. Four (12.9%) programs were authorized to enforce a mandate to report immunizations both through a penalty/fine and by restricting orders of public vaccine.
Of the 21 IIS programs with a mechanism to enforce the reporting mandate, 4 (19%) reported that they enforced it through feedback to the noncompliant provider and did not use penalties, fines, or limitation of vaccine orders. Eleven (52.3%) enforced reporting by limiting the amount of public vaccine a nonreporting provider could order. One (4.8%) program used both limitation on the amount of public vaccine and feedback to noncompliant providers. Five (23.8%) did not enforce the mechanism.
Consent for vital records
Forty-six IIS (86.8%) received information on births in their jurisdiction from vital records or from birthing hospitals. Of those 46, 21 (45.7%) imported the birth record into the IIS on the basis of implied consent;
5 (10.9%) had no consent requirement, but the parent or guardian had the right to opt out of having his or her child’s information in the IIS; 15 (32.6%) imported the birth record without consent and there was no right to opt out; and in the remaining 5 (10.9%), written consent was required to share birth record information with the IIS.
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● IIS Reporting Mandate, United States, 2012
Immunization Information Systems—Law and Policy
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5
Chicago
New York
Philadelphia
Washington
San Antonio
Houston
Mandate
Mandate has no age restrictions
Childhood/adolescent/young adult
Young childhood
No mandate
No IIS
Consent to share childhood immunization information
For 36 (67.9%) IIS programs, childhood immunization information could be included in and shared by the
IIS on the basis of implied consent, with a right to exclude or remove immunization information from the IIS (“opt out”). In 14 (26.4%) programs, childhood immunization information could be shared with the
IIS without any consent, with no right to opt out in 12 jurisdictions and with a right to opt out in 2 (Figure 3).
In Oregon and Florida, the right to opt out was very restricted. In Oregon, the parent had to prove that disclosure of immunizations would disclose a medical condition or provide an affidavit that disclosure would present a potential safety issue such as domestic abuse.
(Because of the restriction, Oregon was classified as
“no right to opt out” in this study). In Florida, the parent could restrict the sharing of information by the IIS but could not prevent inclusion in the IIS.
Explicit consent was required to share childhood immunization information with the IIS in 3 (7.5%) IIS programs (written consent was required in 2 of these 3).
As shown in Supplemental Digital Content Figure 3A, available at http://links.lww.com/JPHMP/A71, there has been a notable reduction in jurisdictions requiring explicit consent since 2000.
Consent to share adult immunization information
Of the 51 programs with authority to operate an
IIS for adults, 34 (66.6%) relied upon implied consent to share adult immunization information with the IIS, with a right to opt out. For 9 (17.6%) programs, adult immunization information could be shared without any consent, with no right to opt out in 8 of these programs and with a right to opt out in 1. Explicit consent was required to share adult immunization information in 8 (15.9%) jurisdictions (written consent was required in 5).
In the District of Columbia, no consent was required to share information for adults immunized with publicly purchased vaccine, but consent was implied with a right to opt out for adults (older than 26 years) immunized with privately purchased vaccine. In Arizona,
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● IIS Consent Requirements, United States, 2012
Chicago
New York
Philadelphia
Washington
San Antonio
Houston
Consent to include children’s data
Mandatory, with no right to opt out
Mandatory, with right to opt out
Implicit consent with opt out
Explicit consent
No IIS explicit consent was required before sharing adult vaccination information, except for immunizations administered by pharmacists for which there was implicit consent with right to opt out.
25 (47.2%) were considered to not be covered entities under HIPAA, and 4 (7.5%) respondents did not know whether the IIS was considered to be a covered entity under HIPAA.
Withdrawal of consent
Consent to retain information in the IIS could not be withdrawn in 7 (13.2%) jurisdictions. In the remaining 46 (86.8%) jurisdictions, if consent to retain information in the IIS was withdrawn: all data were retained and access was limited or prohibited in
32 (69.6%), all data were removed in 7 (14.6%), and limited identifying demographic information was retained in 6 (12.5%). One program was in the process of upgrading its IIS and reported that its existing system could not adequately address withdrawal of consent.
Health Insurance Portability and Accountability Act
Twenty-four (45.3%) IIS were considered by their programs to be covered entities under HIPAA,
Interaction with HIEs
Fifty (94.3%) IIS programs reported that sharing of immunization data between their IIS and HIEs was implemented or contemplated. Thirty-six (67.9%) programs already had authority to exchange data with
HIEs in their jurisdiction. Of the 36 with authority to exchange data, in 15 (41.7%) the authority was derived from a data exchange agreement only, in
13 (36%) the authority was derived from general public health laws, and in 9 (25%) the authority was derived from a specific statute or regulation. Seven
(19.4%) programs reported that they did not know whether they had authority to share immunization information with HIEs in their jurisdiction and 1 program responded that the question was not applicable because the HIE was merely a conduit for data transmission.
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Immunization Information Systems—Law and Policy
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Authority to transmit or allow access to data across state borders
Thirty-six (67.9%) IIS programs had authority to transmit or allow access to immunization data across state borders. Of the 36 with authority to transmit or allow access across state borders, in 15 (41.7%) the authority was derived from a data exchange agreement only, in
11 (30.6%) the authority was derived from general public health laws, and in 10 (27.8%) the authority was derived from a specific statute or regulation. Two
(3.8%) IIS programs responded that they did not know whether they had authority to transmit or allow access to data across state borders. New York State had legislative authority to transmit or allow access to data across state borders and also required a data-sharing agreement. Twenty-nine (54.7%) programs responded that they currently transmit or allow access to data in the
IIS across state borders and 24 (45.3%) did not conduct such transmission or access.
●
There is a long-standing recognition of the need for appropriate legal/regulatory support for IIS. Linkins and Feikema 8 proposed several categories of “registryfriendly” legislation addressing authorization, mandate to report, privacy/confidentiality, and the sharing of health information. Although national IIS-like systems have been discussed, 12,17 the states remain the locus of such legislation.
Notwithstanding the variability documented in this study, there is much progress to report. The fact that
43 jurisdictions have directly addressed IIS authorization through some form of law or regulation versus
36 in 2000 suggests that legislative bodies have been increasingly supportive of IIS activities.
There is a similar trend with regard to a mandate to report to IIS. The finding that 31 jurisdictions report some form of mandate today versus only 12 jurisdictions in 2000 may indicate increased recognition among legislative bodies of the utility of IIS to public health.
Although another recent study 12 reported only 46% of states with a reporting mandate, the difference may be due to methodology. Hedden’s text analysis approach included only published laws and regulations. Our interview methodology included written policies, which
Hedden did not analyze.
Privacy and consent
Privacy, confidentiality, and consent have been consistent themes in IIS policy from the inception of electronic immunization reporting.
3,8,11,18-20 ing such policies in place.
21
All states report hav-
There is considerable variability regarding whether inclusion of an individual’s record in IIS, and the sharing of that record with authorized users, requires the consent of the individual or his/her parent/ guardian. State IIS policies and laws range from highly restrictive—that is, the record is only included on an opt-in basis—to mandatory inclusion with no opportunity to opt out of the IIS. The majority of jurisdictions either mandated reporting or used implied consent, in which the patient or parent/guardian is notified of the provider’s requirement to report and offered the opportunity to opt out. In the case of IIS with a provision to opt out, there is further variation as to whether the record of an individual who opts out is completely deleted from the system, or whether access to that individual’s record is restricted (eg, to public health and the original reporting health provider).
National public health experts recommend opt out consent policies when feasible in order to lower the barrier to comprehensive reporting to IIS.
8,18 Such policies respect an individual’s right to privacy, including the right to exclude information from public health databases, while maximizing the availability of needed data for quality care and public health.
It has been suggested that switching from opt in to opt out could save more than $1 million per year in
1 state, 22 and at least 1 study has suggested that opt out policies may correlate with improved immunization coverage.
23
Health Information Exchange
There remain important barriers to successful interoperation of HIE systems with IIS. Although the overwhelming majority (50/53, 94%) of IIS programs reported intent to exchange immunization information with HIEs, differences in consent requirements could present an impediment to successful exchange, for example, between an opt in HIE and an opt out IIS. Interstate information exchange is particularly hampered by the variation in consent laws.
9
Immunization Information Systems have in many ways blazed the trail for HIEs, addressing issues of data quality, interoperability, and even interstate data exchange.
22 Immunization Information Systems by definition are intended to facilitate the exchange of immunization information between authorized entities such as health care providers. Such exchange can fully be realized only when other information systems, such as
EHRs and other health databases, can interoperate with
IIS 10 in a standardized manner.
24
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Journal of Public Health Management and Practice
Limitations
The study is based on self-reported data and is not a comprehensive review of the law. Biases inherent in self-reported information were minimized through the collection and review of laws, regulations, and published attorney general opinions.
●
Immunization Information Systems have been in the forefront of electronic health information exchange efforts and can serve as “building blocks” to a more mature national health information exchange.
24 Over the past decade, legislation, regulation, and policies concerning immunization data have become more conducive to full participation in IIS and to sharing and using the information outside the IIS, for example, with HIEs. To continue to be leaders in health information exchange and facilitate immunization of children and adults, IIS will need to address the challenges presented by the interplay of federal, state, and local legislation, regulations, and policies and continue to move toward standardized data collection and sharing necessary for interoperable systems. While the expanded use of EHRs and HIEs will continue to facilitate the exchange of immunization information, this expansion may challenge IIS’ continuing efforts to protect privacy and confidentiality and to enhance system security in order to maintain the trust of individuals, providers, and the public.
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