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[Federal Register Volume 63, Number 81 (Tuesday, April 28, 1998)]
[Notices]
[Pages 23289-23291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11185]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Vaccine Program Office Meetings

    The National Vaccine Program Office, Centers for Disease Control 
and Prevention (CDC) announces the following meeting:

    Name: National Vaccine Advisory Committee (NVAC) Immunization 
Registries Workgroup on Ensuring Provider Participation.
    Time and date: 8:30 a.m.-12:30 p.m., May 13, 1998.

    Name: NVAC Immunization Registries Workgroup on Resource Issues.
    Time and date: 1:30 p.m.-5:30 p.m., May 13, 1998.

    Name: NVAC Immunization Registries Workgroup on Privacy and 
Confidentiality.
    Time and date: 8:30 a.m.-12:30 p.m., May 14, 1998.

    Name: NVAC Immunization Registries Workgroup on Technological 
and Operational Challenges.
    Time and date: 1:30 p.m.-5:30 p.m., May 14, 1998.

    Place: Omni Shoreham Hotel, Ambassador Ballroom, 2500 Calvert 
Street, NW., Washington, DC, telephone (202) 234-0700.
    Status: Open to the public, limited only by space availability. 
The meeting room accommodates approximately 200 people.

    Purpose: During a White House Ceremony on July 23, 1997, the 
President directed the Secretary of Health and Human Services (HHS) 
to work with the States on integrated immunization registries. As a 
result, NVAC has formed workgroups, staffed by the National 
Immunization Program (NIP), that will gather information for 
development of a National Immunization Registry Plan of Action.
    To assist in the formulation of a work plan, a series of public 
meetings relating to (1) privacy and confidentiality; (2) resource 
issues; (3) technological and operational challenges; and (4) 
ensuring provider participation, will be held throughout the Nation. 
These meetings will provide an opportunity for input from all 
partners which include state and local public health agencies, 
professional organizations of private health agencies, managed care 
organizations (MCOs), employer-funded health care plans, vaccine 
manufacturers and developers, vendors and developers of medical 
information systems, information standards development 
organizations, parents, social welfare agencies, law enforcement 
agencies, legislators, privacy and consumer interest groups, and 
other representatives of the public at large.
    For each meeting, the Workgroup is inviting experts to address 
the four specific issues outlined above. Expert speakers are being 
asked to respond to the questions outlined below in writing, make 
brief oral presentations, and to respond to additional questions 
from the Workgroup.
    Members of the public who wish to provide comments may do so in 
the form of written statements, to be received by the completion of 
the last meeting, addressed as follows: NIP/CDC, Data Management 
Division, 1600 Clifton Road, NE., M/S E-62, Atlanta, Georgia, 30333.
    There will be a period of time during the agenda for members of 
the public to make oral statements, not exceeding 3 minutes in 
length, on the issues being considered by the Workgroup. Members of 
the public who wish to speak are asked to place their names on a 
list at the registration table on the day of the meeting. The number 
of speakers will be limited by the time available and speakers will 
be heard once in the order in which they place their names on the 
list. Written comments are encouraged; please provide 20 copies.
    Based on the outcome of these meetings, a National Immunization 
Registry Plan of Action will be developed and proposed to NVAC for 
their deliberation and approval. This plan will identify registry 
barriers and solutions, strategies to build a registry network, 
resource requirements and commitments, and a target date for network 
completion.

[[Page 23290]]

    Matters to be discussed: Agenda items will include an overview 
of the Initiative on Immunization Registries and current 
immunization registry efforts and testimonies by organizational 
representatives on the following issues relevant to immunization 
registries: privacy and confidentiality, resources, technological 
and operational challenges, and ensuring provider participation.
    Agenda items are subject to change as priorities dictate.

Resource Issues Questions To Be Considered

    1. What approaches have been successful in securing funding to 
support registries?
    2. What approaches to secure funding have been tried but failed?
    3. What cost-sharing arrangements would your organization view 
as reasonable and fair to ensure long-term sustainability of a 
registry?
    4. Would you be willing to share costs through a fee-for-service 
arrangement and how much would you be willing to pay?
    5. Would you be willing to support a vaccine surcharge and at 
what rate?
    6. What types of resources and/or in-kind support do you receive 
and from whom?
    7. What types of resources and/or in-kind support do you 
provide?
    8. What types of resources are you willing and able to provide 
over the short-term and/or long-term to ensure registry 
sustainability?
     9. Are you willing to provide resources or in-kind support 
toward linking your existing registries with state and local 
registries?
    10. What are the costs of implementing/operating an immunization 
registry?
    11. What are the costs of not having an immunization registry 
(e.g., looking up immunization histories, generating school 
immunization records, etc.)?
    12. How should immunization registries be integrated with larger 
patient information systems and how should their component costs be 
ascertained?
    13. Do you feel there is a need for the Federal Government to 
provide leadership in developing state and community-based 
immunization registries? What should the role of the Federal 
Government be in this effort?

Technological and Operational Questions To Be Considered

    1. How can universal, interactive, real-time, secure 
immunization record exchange between immunization providers be 
implemented?
    2. How does your system implement record exchange?
    A. Can a provider get an up-to-date immunization history for a 
patient sitting in his or her office?
    B. How is this function implemented?
    3. How can it be assured that the most complete and up-to-date 
copy of an immunization record is always retrieved by a requesting 
provider?
    4. How does your system identify the definitive record?
    5. How can existing practice management systems achieve 
connectivity with immunization registries efficiently, without dual 
systems, redundant processes, and multiple interfaces?
    6. What software systems can your system interface with?
    7. How are connections between your system and existing systems 
implemented?
    8. How can registries be used to measure immunization rates, 
accurately and routinely, at county, state, and national levels, 
without counting any individual more than once?
    9. How can the functionality of immunization registries be 
standardized without compromising registries' ability to customize 
and extend that functionality?
    10. What immunization registry functions should be standardized?
    11. Who should provide leadership in such a standardization 
effort?
    12. How will/should standards be implemented in immunization 
registries?
    13. How can the cost of operating immunization registries be 
reduced to a level at which immunization providers themselves would 
be willing to support them? [crossover with cost issue]
    14. What sorts of inter-organizational arrangements and legal 
structures need to be in place to provide an environment in which 
immunization registry data can flow as needed? [crossover with 
privacy & confidentiality issue]
    15. Do you feel that there is a need for the Federal Government 
to provide leadership in developing state and community-based 
immunization registries? What should the role of the Federal 
Government be in this effort?
    16. How can duplication of records be minimized?
    17. How can existing billing/encounter information systems be 
modified to provide appropriate immunization registry functions?
    18. How can immunization registries be broadened to provide 
other important functions in patient monitoring (e.g., well-child 
assessments, metabolic/hearing screening, etc.)?
    19. What mechanisms are needed to detect and prevent 
unauthorized access to registry data?
    20. What data capture technology (e.g., bar codes, voice 
recognition, etc.) can minimize the negative impact on workflow?
    21. What techniques (e.g., standard knowledge representation 
such as Arden Syntax) can be used to disseminate vaccination 
guidelines to individual registries quickly and with a minimum of 
new programming required to update automated reminder/recall and 
forecasting based on the guidelines?

Privacy and Confidentiality Questions To Be Considered

    Terminology: Privacy--The right of an individual to limit access 
by others to some aspect of the person. Confidentiality--The 
treatment of information that an individual has disclosed in a 
relationship of trust and with the expectation that it will not be 
divulged to others in ways that are inconsistent with the 
understanding of the original disclosure. Individually identifiable 
information--Information that can reasonably be used to identify an 
individual (by name or by inference).
    1. Should immunization data have different privacy requirements 
than the rest of the medical record?
    2. How can the disclosure and re-disclosure of immunization 
information be controlled through policies, procedures, and 
legislation?
    3. Should consent to participate be implied or required? In what 
form?
    4. Should different levels of disclosure be possible? What 
levels should be available to what groups?
    5. Who should have access to immunization registry data?
    6. What information should be disclosed to an immunization 
registry?
    7. What other uses can immunization registry data have?
    8. Would ability to produce a legal record be a desirable 
function for the registry?
    9. What fair information practices should be implemented (e.g., 
ability to correct the record, notice of being put in registry to 
parent)?
    10. How long should information be kept in a registry?
    11. How will privacy issues affect the following groups: 
parents, immigrants, religious groups, HIV-positive and other 
immunocompromised health conditions, law enforcement, victims of 
domestic violence, and custodial parents?
    12. How should registries ensure that privacy policies are 
followed?
    13. Do you have any comment or recommendation for NVAC/CDC/HHS 
related to the implementation of the network of state and community-
based registries and do you have any concerns?
    14. Do you feel there is a need for the Federal Government to 
provide leadership in developing state and community-based 
immunization registries? What should the role of the Federal 
Government be in this effort?
    15. Given the mandate of Health Insurance Portability and 
Accountability Act to create a unique health identifier, how should 
that goal be achieved while minimizing the probability of 
inappropriate use of the identifier?
    16. What steps can be taken to prevent unauthorized re-
disclosure of information already provided to an organization or 
person?
    17. What legal barriers exist which prevent data sharing by MCOs 
and how can they be obviated?
    18. What mechanism should be available to allow parents to opt 
out of the registry?
    19. What agency/organization should be responsible for 
maintaining registry information?
    20. How should consent for inclusion in an immunization registry 
be obtained? Should it be implicit or explicit?
    21. What information should be included in an immunization 
registry?
    22. Should registries include (and release) information on 
contraindications, adverse events, etc.?
    23. Who should have access to immunization registry data and how 
can restricted access be assured?
    24. What information should be available to persons other than 
the client/patient and the direct health care provider (e.g., 
schools)?
    25. What is the best way to protect privacy and ensure 
confidentiality within a registry?

[[Page 23291]]

    26. How should individuals/parents have access to registry 
information on themselves/their children?
    27. Should data maintained in a state and community-based 
immunization registry be considered public information?
    28. Would national privacy and confidentiality standards help 
ensure that data maintained in an immunization registry is 
protected?

Ensuring Provider Participation Questions To Be Considered

    1. What type of resources (e.g., hardware, staff, etc.) are 
needed for you (provider/organization) to participate in a 
computerized registry?
    2. What are the cost-related barriers that keep you (provider/
organization) from participating in an immunization registry?
    3. What cost should providers be responsible for, pertaining to 
participation in immunization registry systems?
    4. What are the cost savings you would anticipate as a result of 
participating in a computerized registry (e.g., increased return 
visit form reminders, less personnel paperwork for preschool exams, 
etc.)?
    5. How much time would you be willing to invest per patient 
visit (e.g., additional 1, 5, 7, 10 minutes) in the overall success 
of an immunization registry?
    6. What type of user support would be needed in order for you 
(provider/organization) to participate in an immunization registry?
    7. How would you (provider/organization) encourage providers and 
consumers in your community to participate in an immunization 
registry?
    8. What community support would be necessary for you to 
participate in the immunization registry?
    9. What benefits/value (e.g., immunization reminders, quick 
access to immunization histories, etc.) would a registry provide 
that would encourage your (provider/organization) participation?
    10. What incentives should be offered to providers/organizations 
to participate in an immunization registry?
    11. What barriers have you (provider/organization) encountered 
that have prevented you from participating in an immunization 
registry?
    12. Is provider liability (e.g, disclosure of sensitive patient 
information) a barrier to participating in an immunization registry? 
Why?
    13. How would an immunization registry impact your practice/
organization?
    14. Do you currently share immunization data with other 
providers electronically? For what purpose (e.g., billing, share 
group data, etc.)?
    15. How (e.g., electronic record, paper record) is medical 
information maintained in your practice/organization?
    16. Who should retain ownership of immunization records as they 
are distributed throughout an immunization registry?
    17. How would you (provider/organization) use the data 
maintained in an immunization registry?
    18. What type of quality control process would you (provider/
organization) perform to ensure the accuracy and completeness of the 
immunization data entered into an immunization registry?
    19. What type of security policies and procedures need to be in 
place for you to be confident that data are secure?
    20. What functions should a registry perform in your office in 
order for you (provider/organization) to participate?
    21. Do you have any advice or recommendations for NVAC/CDC/HHS 
related to the implementation of the network of state and community-
based registries and do you have any concerns?
    22. Do you feel that there is a need for the Federal Government 
to provide leadership in developing state and community-based 
immunization registries? What should the role of the Federal 
Government be in this effort?
    23. Have you received training on the use and maintenance of 
computerized medical information? Do you feel this training is 
needed to fully support the development and maintenance of 
immunization registries?
    Contact Person for More Information: Robb Linkins, M.P.H., 
Ph.D., Chief, Systems Development Branch, Data Management Division, 
NIP, CDC, 1600 Clifton Road, NE, M/S E-62, Atlanta, GA 30333, 
telephone (404) 639-8728, e-mail [email protected].

    Dated: April 22, 1998.
Joseph E. Salter,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-11185 Filed 4-27-98; 8:45 am]
BILLING CODE 4163-18-P
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