National Vaccine Advisory Committee; Notice of Meeting

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

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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?

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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 [email protected].

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