[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 rxl3@cdc.gov.
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
