[Federal Register Volume 60, Number 3 (Thursday, January 5, 1995)]
[Notices]
[Pages 1788-1791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-268]



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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