[Federal Register Volume 63, Number 128 (Monday, July 6, 1998)]
[Notices]
[Pages 36411-36413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17763]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Vaccine Advisory Committee; Notice of Meeting
Name: National Vaccine Advisory Committee (NVAC) Immunization
Registries Workgroup on Privacy and Confidentiality.
Time and Date: 8:30 a.m.-12:30 p.m., July 16, 1998.
Name: NVAC Immunization Registries Workgroup on Technical and
Operational Challenges.
Time and Date: 1:30 p.m.-5:30 p.m., July 16, 1998.
Name: NVAC Immunization Registries Workgroup on Ensuring Provider
Participation.
Time and Date: 8:30 a.m.-12:30 p.m., July 17, 1998.
Name: NVAC Immunization Registries Workgroup on Resource Issues.
Time and Date: 1:30 p.m.-5:30 p.m., July 17, 1998.
Place: Marriott Marquis, 265 Peachtree Center, Atlanta, Georgia,
telephone (404) 521-0000.
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 a Workgroup, 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) technical 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, 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
[[Page 36412]]
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.
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 issues, technical 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?
Technical 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?
[[Page 36413]]
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?
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, Georgia 30333, telephone
(404) 639-8728, e-mail rxl3@cdc.gov.
Dated: June 29, 1998.
Carolyn J. Russell,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 98-17763 Filed 7-2-98; 8:45 am]
BILLING CODE 4163-18-P
