Office of the Assistant Secretary for Health; Privacy Act of 1974; New System of Records

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Office of the Assistant Secretary for Health; Privacy Act of

1974; New System of Records

AGENCY: Public Health Service, HHS.

ACTION: Notification of a new system of records.

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SUMMARY: In accordance with the requirements of the Privacy Act, the

Public Health Service (PHS) is publishing a notice of a new system of

records, 09-37-0024, ``Studies of Preventive Medicine, Health

Promotion, and Disease Prevention, HHS/OASH/ODPHP.'' records. We are

also proposing routine uses for this new system.

DATES: PHS invites interested parties to submit comments on the

proposed routine use on or before (30 days after publication). PHS has

sent a Report of New System of Records to the Congress and to the

Office of Management and Budget (OMB) on December 28, 1994. The system

of records will be effective 40 days after the date of publication

unless PHS receives comments that [[Page 1789]] would result in a

contrary determination.

ADDRESSES: Please submit comments to: PHS Privacy Act Officer, Room 17-

45, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857,

Telephone: 301-443-2055 (This is not a toll-free number).

Comments received will be available for inspection at the above

address from 8:30 a.m. to 4 p.m. Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Dr. Hurdis M. Griffith, Senior Policy Advisor, Office of Disease

Prevention and Health Promotion, 2132 Switzer Building, 330 C Street,

SW, Washington, DC 20201, 202-205-8660 (This is not a toll-free

number).

SUPPLEMENTARY INFORMATION: PHS proposes to establish a new system of

records: 09-37-0024, ``Studies of Preventive Medicine, Health

Promotion, and Disease Prevention, HHS/OASH/ODPHP.'' This system of

records will be used by the Office of Disease Prevention and Health

Promotion (ODPHP) in the Office of the Assistant Secretary for Health

(OASH) to study the impact of preventive medicine interventions and

public education efforts on health service delivery, patient behavior,

and health outcome.

The system will contain records of patients of the clinicians

participating in these studies, as well as normal volunteers, relatives

of the patients, and the providers of services. Examples of the

information collected are: Patient or provider name, study

identification number, address, relevant telephone numbers, Social

Security Number (voluntary), date of birth, weight, height, sex, race;

medical, psychological and dental information, laboratory and

diagnostic testing results; registries; social, economic and

demographic data; health services utilization; immunization status;

insurance and hospital cost data, employers; characteristics and

activities of health care providers.

The records in this system will be maintained in a secure manner

commensurate with their content and use. The System Manager will

control access to the data. Access to identifiers and to link files is

strictly limited to the authorized personnel whose duties require such

access. Procedures for determining authorized access to identified data

are established as appropriate for each location. Personnel, including

contractor personnel, who may be so authorized include those directly

involved in data collection and in the design of research studies,

e.g., interviewers and interviewer supervisors; project managers; and

statisticians involved in designing sampling plans. Other one-time and

special access by other employees is granted on a need-to-know basis as

specifically authorized by the System Manager. Researchers authorized

to conduct research will typically access the system through the use of

encrypted identifiers sufficient to link individuals with records in

such a manner that does not compromise confidentiality of the

individual. The collection and maintenance of data is consistent with

legislation and regulations regarding the protection of human subjects,

informed consent, and confidentiality.

The proposed routine uses are compatible with the stated purposes

of the system. The first routine use permits the disclosure of

information to researchers under carefully controlled conditions. The

second routine use permits the disclosure of information to a member of

Congress when a constituent has requested assistance. The third routine

use permits HHS to disclose information to the Department of Justice in

the event of litigation. The fourth routine use permits disclosure of

information to a contractor for the purpose of analyzing or refining

the data. The fifth routine use permits disclosure of information for

the purpose of quality assessment, audit, or utilization review. The

sixth routine use permits disclosure to Federal and State agencies, and

private organizations for the purpose of locating individuals for

follow-up studies. The seventh routine use permits the disclosure of

information to student volunteers who need the records to carry out

their official functions.

The following notice is written in the present, rather than the

future tense, to avoid the unnecessary expenditures of public funds for

republishing the notice after the system has become effective.

Dated: December 30, 1994.

Ellen Wormser,

Director, Office of Organization and Management Systems.

09-37-0024

Studies of Preventive Medicine, Health Promotion, and Disease

Prevention, HHS/OASH/ODPHP.

None.

Records are located at the Office of Disease Prevention and Health

Promotion (ODPHP) and Contractor research facilities that collect or

provide research data for this system. Primary record storage sites are

listed in Appendix I. A current list of additional contractor sites is

available by writing to the System Manager at the address below.

Patients (adults and children) of the clinicians participating in

these studies; individuals who are representative of the general

population or of special groups including, but not limited to: Normal

controls, normal volunteers, family members and relatives; providers of

services.

The system contains records about individuals as relevant to these

studies: (1) Medical records (treatment, laboratory screening and

diagnostic tests, and preventive services); (2) clinician surveys (use

of screening, counseling and preventive services); and (3) patient

surveys (height, weight, race/ethnicity, health behavior, health

conditions). Examples of information include, but are not limited to:

Patient or provider name, study identification number, address,

relevant telephone numbers, Social Security Number (voluntary), date of

birth, weight, height, sex, race; medical, psychological and dental

information, laboratory and diagnostic testing results; registries;

social, economic and demographic data; health services utilization;

immunization status; insurance and hospital cost data, employers;

characteristics and activities of health care providers.

Authorization to collect these data is provided under section 301

of the Public Health Service Act (42 U.S.C. 241), General Powers and

Duties of Public Health Service.

The purpose of this system of records is to enable the study of the

impact of preventive medicine interventions and public education

efforts of health service delivery, patient behavior, and health

outcome. Information from the system of records will be shared within

the Department of Health and Human Services (DHHS) with such Public

Health Service (PHS) agencies as the Centers for Disease Control and

Prevention (CDC) including the National Center for Health Statistics

(NCHS), the Health Resource Services Administration (HRSA), the Indian

Health Service (IHS), the National Institutes for Health (NIH), the

Agency for Health Care Policy and Research [[Page 1790]] (AHCPR), and

the Health Care Financing Administration (HCFA).

1. A record may be disclosed for a research purpose, when the

Department: (A) Has determined that the use or disclosure does not

violate legal or policy limitations under which the record was

provided, collected, or obtained; e.g., disclosure of alcohol or drug

abuse patient records will be made only in accordance with the

restrictions of confidentiality statutes and regulations (42 U.S.C. 290

(dd-2), 42 U.S.C. 241 and 405, 42 CFR part 2), and where applicable, no

disclosures will be made inconsistent with an authorization of

confidentiality under 42 U.S.C. 242a and 42 CFR part 2a; (B) has

determined that the research purpose (1) cannot be reasonably

accomplished unless the record is provided in individually identifiable

form, and (2) warrants the risk to the privacy of the individual that

additional exposure of the record might bring; (C) has required the

recipient to (1) establish reasonable administrative, technical, and

physical safeguards to prevent unauthorized use or disclosure of the

record, (2) remove or destroy the information that identifies the

individual at the earliest time at which removal or destruction can be

accomplished consistent with the purpose of the research project,

unless the recipient has presented adequate justification of a research

or health nature for retaining such information, and (3) make no

further use or disclosure of the record except (a) in emergency

circumstances affecting the health or safety of any individual, (b) for

use in another research project, under these same conditions, and with

written authorization of the Department, (c) for disclosure to a

properly identified person for the purpose of an audit related to the

research project, if information that would enable research subjects to

be identified is removed or destroyed at the earliest opportunity

consistent with the purpose of the audit, or (d) when required by law;

and (D) has secured a written statement attesting to the recipient's

understanding of, and willingness to abide by, these provisions.

Examples of organizations and agencies of which records from this

system may be disclosed include, but are not limited to Health

Maintenance Organizations (HMOs) and other service providers

participating in the studies and various federal and state agencies,

such as the Veteran's Administration, branches of the Armed Forces, and

state and local health department.

2. Disclosure may be made to a congressional office from the record

of an individual in response to a verified inquiry from a congressional

office made at the written request of that individual.

3. In the event of litigation, where the defendant is (a) the

Department, any component of the Department, or any employee of the

Department in his or her official capacity; (b) the United States where

the Department determines that the claim, if successful, is likely to

directly affect the operations of the Department or any of its

components; or (c) any Department employee in his or her individual

capacity where the Justice Department has agreed to represent such

employee, for example, in defending a claim against the Public Health

Service, based upon an individual's mental or physical condition and

alleged to have arisen because of activities of the Public Health

Service in connection with such an individual, the Department may

disclose such records as it deems desirable or necessary to the

Department of Justice to enable that Department to present an effective

defense, provided such disclosure is compatible with the purpose for

which the records were collected.

4. ODPHP may contract with a private firm for the purpose of

collecting, analyzing, aggregating, or otherwise refining records in

this system. Relevant records may be disclosed to such contractor. The

contractor shall be required to maintain Privacy Act safeguards with

respect to such records.

5. Disclosure may be made to organizations deemed qualified by the

Secretary to carry out quality assessments, medical audits or

utilization review.

6. Information from this system may be disclosed to Federal

agencies, State agencies (including the Motor Vehicle Administration

and State vital statistics offices), private organizations, and other

third parties (such as current or prior employers, acquaintances,

relatives), in order to obtain information on morbidity and mortality

experiences and to locate individuals for follow-up studies. Social

Security numbers may be disclosed to the Social Security Administration

to ascertain disabilities and/or location of participants. Social

Security numbers may also be given to other Federal agencies, and State

and local agencies for purposes of locating individuals for

participation in follow-up studies.

7. Records may be disclosed to student volunteers, individuals

working under a personal services contract, and other individuals

performing functions for PHS who do not technically have the status of

agency employees, if they need the records in the performance of their

agency functions.

Records may be stored in hard copy, index cards, file folders,

computer tapes and disks (including optical disks), photography media,

microfiche, microfilm, and audio and video tapes. Typically, factual

data with study code numbers are stored on computer tape or disk, while

the key to personal identifiers is stored separately, without factual

data, in locked paper files.

During data collection stages and follow-up retrieval is by

personal identifier (e.g., name, Social Security Number, medical record

or study identification number etc.). During the data analysis stage,

data are normally retrieved by the variables of interest (e.g.,

diagnosis, age, occupation).

1. Authorized Users: Access to identifiers and to link files is

strictly limited to the authorized personnel whose duties require such

access. Procedures for determining authorized access to identified data

are established as appropriate for each location. Personnel, including

contractor personnel, who may be so authorized include those directly

involved in data collection and in the design of research studies,

e.g., interviewers and interviewer supervisors; project managers, and

statisticians involved in designing sampling plans.

Other one-time and special access by other employees is granted on

a need-to-know basis as specifically authorized by the System Manager.

Researchers authorized to conduct research will typically access

the system through the use of encrypted identifiers sufficient to link

individuals with records in such a manner that does not compromise

confidentiality of the individual.

2. Physical Safeguards: Records are stored in locked rooms, locked

file cabinets, and/or secured computer facilities. Personal identifiers

and link files are separated as much as possible and stored in locked

files. Computer data access is limited through the use of key words

known only to authorized personnel.

A separate key list linking ID codes to respondents will be

maintained by the contractor conducting the survey,

[[Page 1791]] during the data collection period in order to permit

follow-up with non-respondents. This key list will be kept in a locked

file when not actively in use. As soon as data cleaning is completed

this key list will be destroyed. No data that could be used to identify

respondents will be entered on the computer database.

Likewise the name of individual settings will not appear on data

collection forms or the computerized database. Again a separate key

matching the ID code to the hospital name will be maintained during the

course of data collection in order to permit follow-up of non-

respondents. They key listing will be kept in a secure location when

not actively in use, and destroyed as soon as the data cleaning is

completed.

3. Procedural Safeguards: Collection and maintenance of data is

consistent with legislation and regulations regarding the protection of

human subjects, informed consent, and confidentiality. When anonymous

data is provided to research scientists for analysis, study numbers

which can be matched to personal identifiers will be eliminated,

scrambled, or replaced by the agency or contractor with random numbers

which cannot be matched. Contractors who maintain records in this

system are instructed to make no further disclosure of the records.

Privacy Act requirements are specifically included in contracts for

survey and research activities related to this system. The ODPHP

project officers and contract officers oversee compliance with these

requirements.

The records are maintained with individual identifiers only until

analysis and follow-up are completed, generally a two- to three-year

period. Removal or disposal of identifiers will be done according to

the storage medium (e.g., erase computer tape, shred, pulp or burn

paper records etc.). A staff person designated by the System Manager or

an authorized Contractor will oversee and confirm the disposal in

writing. Long-term retention is only in aggregate form without

individual identifiers in accordance with the OASH Records Disposition

Schedule.

Senior Policy Advisor, Office of Disease Prevention and Health

Promotion, 2132 Switzer Building, 330 C Street, SW, Washington, DC

20201.

To determine if a record exists, write to the System Manager listed

above. Notification requests should include: individual's name; current

address; date of birth; date, place and nature of participation in the

research study; address at the time of participation. The System

Manager may accept a written certification that the requester is who he

or she claims to be and understands that the knowing and willful

request for acquisition of a record pertaining to an individual under

false pretenses is a criminal offense under the Act, subject to a five

thousand dollar fine.

An individual who requests notification of, or access to, a

medical/dental record shall, at the time the request is made, designate

in writing a responsible representative who will be willing to review

the record and inform the subject individual of its contents at the

representative's discretion. The representative may be a physician, or

other health professional, or other responsible individual. The subject

individual will be granted direct access unless it is determined that

such access is likely to have a adverse effect on him or her. In this

case, the medical/dental record will be sent to the designated

representative.

Individuals will be informed in writing if the record is sent to

the representative.

A parent or guardian who requests notification of, or access to, a

child's or incompetent person's medical record shall designate a family

physician or other health professional (other than a family member) to

whom the record, if any, will be sent. The parent or guardian must

verify relationship to the child or incompetent person as well as his

or her own identity.

Same as notification procedures. Requesters should also reasonably

specify the record contents being sought. An individual may also

request an accounting of disclosures of his/her record, if any.

Contact the appropriate official at the address specified under

Notification Procedures above and reasonably identify the record,

specify the information being contested, and state the corrective

action sought and the reason(s) for requesting the correction, along

with supporting justification to show how the record is inaccurate,

incomplete, untimely, or irrelevant.

The system contains information obtained directly from the subject

individual by interview (face-to-face or telephone), written

questionnaire, or observations. Information is also obtained from other

sources, including but not limited to: referring physicians; hospitals;

State and local health agencies; relatives; guardians; schools,

employers; and clinical research records.

None.

Appendix I: System Location sites

Office of Disease Prevention and Health Promotion (ODPHP), 2132

Switzer Building, 330 C Street, SW, Washington, DC 20201

Battelle Memorial Institute, Centers for Public Health Research and

Evaluation, 2101 Wilson Boulevard, Suite 800, Arlington, VA 22201

Battelle Memorial Institute, Centers for Public Health Research and

Evaluation, Room 100E, 505 King Avenue, Columbus, OH 43201-2693

Battelle/SRA, 401 North Lindbergh Boulevard, Suite 330, St. Louis,

MO 63141-7816

[FR Doc. 95-268 Filed 1-4-95; 8:45 am]

BILLING CODE 4160-17-M