[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17447-17450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07444]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Privacy Act of 1974; System of Records Notice

AGENCY: Office of the Secretary (OS), Department of Health and Human 
Services (HHS).

ACTION: Notice to establish a new system of records and delete an 
existing system of records.

-----------------------------------------------------------------------

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, as amended (5 U.S.C. 552a), HHS is establishing a new department-
wide system of records, ``Records about Restricted Dataset 
Requesters,'' System Number 09-90-1401, to cover records about 
individuals within and outside HHS who request restricted datasets and 
software products from HHS (e.g., for health-related scientific 
research and study purposes), when HHS maintains the requester records 
in a system from which they are retrieved directly by an individual 
requester's name or other personal identifier. The System of Records 
Notice (SORN) previously published at 78 FR 32654 for ``Online 
Application Ordering for Products from the Healthcare Cost and 
Utilization Project (HCUP),'' System Number 09-35-0003, is being 
deleted and replaced by this new department-wide SORN.

DATES: Effective Dates: The department-wide SORN proposed in this 
Notice is effective upon publication, with the exception of the routine 
uses. The routine uses will be effective 30 days after publication of 
this Notice, unless comments are received that warrant revisions to 
this Notice. Written comments on the routine uses should be submitted 
within 30 days. The deletion of System Number 09-35-0003 will be 
effective 30 days after publication of this Notice.

ADDRESSES: The public should address written comments to: Beth Kramer, 
HHS Privacy Act Officer, Mary E. Switzer Building--Room 2210, 330 C 
Street SW., Washington, DC 20201, [email protected]. Comments will be 
available for public viewing at the same location. To review comments 
in person, please contact Beth Kramer at [email protected] or (202) 
690-6941.

FOR FURTHER INFORMATION CONTACT: Beth Kramer, HHS Privacy Act Officer, 
Mary E. Switzer Building--Room 2210, 330 C Street SW., Washington, DC 
20201, [email protected].

SUPPLEMENTARY INFORMATION: The new system of records will cover records 
about individuals within and outside HHS who request restricted 
datasets and software products from HHS, when HHS maintains the 
requester records in a system from which they are retrieved directly by 
an individual requester's name or other personal identifier. 
``Restricted'' datasets and software products are those that HHS makes 
affirmatively available to qualified members of the public but provides 
subject to restrictions, because they contain identifiable data and/or 
anonymized data that has the potential, when combined with other data, 
to identify the particular individuals, such as patients or providers, 
whose information is represented in the data. The datasets and products 
are made available through an on-line or paper-based ordering and 
delivery system that provides them to qualified requesters 
electronically or by mail.
    The restrictions are necessary to protect the privacy of 
individuals whose information is represented in the datasets or 
software products. The restrictions typically limit the data requester 
to using the data for research, analysis, study, and aggregate 
statistical reporting; prohibit any attempt to identify any individual 
or establishment represented in the data; and require specific security 
measures to safeguard the data from unauthorized access. HHS is 
required by law to impose, monitor, and enforce the restrictions (see, 
for example, provisions in the Confidential Information Protection and 
Statistical Efficiency Act of 2002 (CIPSEA), 44 U.S.C. 3501 at note). 
To impose and enforce the restrictions, it is necessary to collect 
information about the data requesters.
    Currently, this system of records covers data requester records in 
ordering and delivery systems administered by three HHS Operating 
Divisions, but only to the extent that the records pertain to 
requesters seeking restricted datasets. These ordering and delivery 
systems retrieve requester records directly by personal identifier:

[[Page 17448]]

     Agency for Healthcare Research and Quality (AHRQ) ``Online 
Application Ordering for Products from the Healthcare Cost and 
Utilization Project (HCUP).'' HCUP is an online system established in 
2013; it makes restricted databases and software available for 
qualified applicants to purchase for scientific research and public 
health use. Applicants may be researchers, patients, consumers, 
practitioners, providers, policy makers, or educators. The HCUP 
databases are annual files containing anonymous information from 
hospital discharge records for inpatient care and certain components of 
outpatient care. The HCUP software tools enhance the use of the data. 
The online system supports AHRQ's mission of promoting improvements in 
health care quality.
     Centers for Medicare & Medicaid Services (CMS) ``Data 
Agreement & Data Shipping Tracking System (DADSS).'' DADSS was 
established in 2004 to track authorization, payment status, shipping 
status, and ownership of restricted and unrestricted data extracts 
between CMS, its contractors, and other authorized entities. DADSS is 
slated to be replaced in 2015 with an electronic information system 
designed to provide a traceable record of CMS' data disclosures.
     Substance Abuse and Mental Health Services Administration 
(SAMHSA) ``Online Application for the Data Portal (SAMHDA).'' This 
online data portal was established in 2013 to more efficiently make 
restricted datasets from SAMHSA available to designated, approved 
researchers. The Data Portal and all applications are maintained 
through the Substance Abuse and Mental Health Data Archive (SAMHDA). 
Currently, data from the Drug Abuse Warning Network (DAWN), DAWN 
Medical Examiner/Coroner component, National Survey on Drug Use and 
Health (NSDUH), and NSDUH Adult Clinical Interview data are available 
through the portal. Data recipients must complete a web-based 
application process and receive project approval from SAMHSA's Center 
for Behavioral Health and Statistics and Quality (CBHSQ), and can use 
the datasets for statistical purposes only. No fees are charged for the 
datasets. The online portal supports SAMHSA's mission to make substance 
use and mental disorder information and research more accessible.
    Note that this system of records does not include:
     Records about requesters who seek unrestricted datasets, 
publications, or other information products from an HHS on-line or 
paper-based ordering and delivery system. Unrestricted materials are 
also proactively made available to the public by HHS, but are released 
without restrictions (though some may be subject to terms or conditions 
of use and require registration for an account and payment of a fee). 
Because the requests or order forms collect minimal information about 
the requester (i.e., the requester's name, mailing address or email 
address, telephone number, or other contact or delivery information, 
and payment information if a fee is imposed) they would be adequately 
covered by other SORNs (for example, ``Correspondence Tracking 
Management System (CTMS)'' SORN #09-70-3005; ``Consumer Mailing List'' 
SORN #09-90-0041; and ``Unified Financial Management System (UFMS)'' 
SORN #09-90-0024 if a fee is involved), if a SORN is required (i.e., if 
the records are retrieved directly by an individual requester's name or 
other personal identifier). Examples include records about requesters 
who order materials online from AHRQ's Publications Online Store & 
Clearinghouse or by mail from AHRQ's Publications Clearinghouse, which 
provide only unrestricted publications and other information products; 
and records about requesters ordering unrestricted datasets from CMS's 
current DADSS system and its successor, which processes orders for both 
restricted and unrestricted datasets.
     Records about data requesters that are not retrieved 
directly by an individual requester's name or other personal 
identifier. These records are not subject to the Privacy Act and are 
not required to be covered in a SORN, even when they are associated 
with a restricted dataset and include additional information about the 
requester (such as, the requester's intended research purpose, 
qualifications, signed Data Use Agreement, and confidentiality training 
certificate). An example would be requester records that are retrieved 
first by a dataset name and/or a requesting entity's name, and then by 
an individual researcher's or record custodian's name.
    The Privacy Act (5 U.S.C. 552a) governs the means by which the U.S. 
Government collects, maintains, and uses information about individuals 
in a system of records. A ``system of records'' is a group of any 
records under the control of a federal agency from which information 
about an individual is retrieved by the individual's name or other 
personal identifier. The Privacy Act requires each agency to publish in 
the Federal Register a system of records notice (SORN) identifying and 
describing each system of records the agency maintains, including the 
purposes for which the agency uses information about individuals in the 
system, the routine uses for which the agency discloses such 
information outside the agency, and how individual record subjects can 
exercise their rights under the Privacy Act.
    A report on the proposed new system of records has been sent to OMB 
and Congress in accordance with 5 U.S.C. 552a(r).
SYSTEM NUMBER:
    09-90-1401

SYSTEM NAME:
    Records About Restricted Dataset Requesters

SECURITY CLASSIFICATION:
    Unclassified

SYSTEM LOCATIONS:
    Electronic files are maintained at the following server locations:

     AHRQ: Social & Scientific Systems Data Center, Ashburn, 
Virginia
     CMS: CMS Data Center, Baltimore, Maryland
     SAMHSA: Substance Abuse and Mental Health Data Archive, 
Rockville, Maryland

    Hard-copy files are maintained at the System Manager locations; see 
``System Manager(s)'' section below.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals within and outside HHS who request restricted datasets 
and software products that HHS makes proactively available to qualified 
members of the public, usually for health-related scientific research 
and study purposes. Examples include individual researchers and records 
custodians, project officers, or other representatives of entities such 
as universities, government agencies, and research organizations.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Categories of records include:
    1. Request records, containing the requester's name and contact 
information (telephone number, mailing address, email address), 
affiliated entity (e.g., if making the request as a records custodian 
or other employee), and a description of the dataset requested.
    2. Order fulfillment records, containing user registration 
information such as email address and IP address (if the requester is 
provided access to the dataset electronically through a public access 
web portal or link) or mailing information (if the dataset is mailed to 
the requester on a disk or other media), and tracking information 
(providing proof of delivery).

[[Page 17449]]

    3. Data use restriction records, containing the requester's 
identification, contact, and affiliated entity information, 
qualifications, intended use of the data (e.g., study name, contract 
number), confidentiality training documentation (e.g., a coded number 
indicating the individual completed required confidentiality training), 
signed and notarized data use agreement documents (e.g., Affidavit of 
Nondisclosure; Declaration of Nondisclosure; Confidential Data Use and 
Nondisclosure Agreement (CDUNA); Individual Designations of Agent; DUA 
number and expiration date), tracking information, and any on-site 
inspection information.
    4. Payment records (if a fee is charged), consisting of the 
requester's credit card account name, number, and billing address, or 
bank routing number and checking account name, address, and number.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    AHRQ: 42 U.S.C. 299-299a; 42 U.S.C. 299c-2
    CMS: 5 U.S.C. 552a(e)(10); 45 CFR 164.514(e); 44 U.S.C. 3544; 42 
U.S.C. 1306
    SAMHDA: 42 U.S.C. 290aa(d)(1); 44 U.S.C. 3501(8)
    See also: CIPSEA, codified at 44 U.S.C. 3501 note.

PURPOSE(S) OF THE SYSTEM:
    The purposes of this system of records is to provide restricted 
datasets and software products to qualified data requesters in a timely 
and efficient manner and consistent with applicable laws, and to enable 
HHS to enforce data requesters' compliance with use and security 
restrictions that apply to the data. Relevant HHS personnel use the 
records on a need-to-know basis for those purposes; specifically:
     Contact and user registration information is used to 
communicate with the requester, enable the requester to access 
requested data electronically (for example, the requester's email 
address would be used to register the requester to use a public access 
web portal or link, and to notify the requester when data has been 
delivered electronically to his registered account), locate the 
requester (e.g., for on-site inspections or to otherwise check 
compliance with the data use agreement), and deliver and track data 
provided by mail (e.g., to document receipt for enforcement purposes 
and report lost shipments to security personnel).
     Qualifications, planned use of the data, confidentiality 
training information, signed data use agreement, data receipt 
information, on-site inspection information, and information about data 
breaches or contract violations is used to grant the request 
(consistent with data use restrictions) or deny the request, bind the 
requester to the applicable data use restrictions and other security 
requirements, conduct on-site inspections or otherwise check the 
requester's compliance with the data use agreement, enforce the 
agreement if breached, and share information about data breaches and 
contract violations with other HHS components administering restricted 
dataset requests involving the same requesters.
     Payment information is used to collect any applicable fee. 
Any payment information shared with HHS accounting and debt collection 
systems is also covered under the accounting and debt collection 
systems' SORNs and is subject to the routine uses published in those 
SORNs (see, e.g., United Financial Management System, SORN #09-90-0024; 
and Debt Management and Collection System, SORN #09-40-0012).

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES:
    Information about an individual data requester may be disclosed to 
parties outside HHS without the individual's prior, written consent 
pursuant to the following routine uses:
    1. Disclosures may be made to federal agencies and Department 
contractors that have been engaged by HHS to assist in accomplishment 
of an HHS function relating to the purposes of this system of records 
and that have a need to have access to the records in order to assist 
HHS in performing the activity. Any contractor will be required to 
comply with the requirements of the Privacy Act.
    2. Records may be disclosed to student volunteers, individuals 
working under a personal services contract, and other individuals 
performing functions relating to the purposes of this system of records 
for the Department but technically not having the status of agency 
employees, if they need access to the records in order to perform their 
assigned agency functions.
    3. CMS records may be disclosed to a CMS contractor (including but 
not limited to Medicare Administrative Contractors, fiscal 
intermediaries, and carriers) that assists in the administration of a 
CMS-administered health benefits program, or to a grantee of a CMS-
administered grant program, when disclosure is deemed reasonably 
necessary by CMS to prevent, deter, discover, detect, investigate, 
examine, prosecute, sue with respect to, defend against, correct, 
remedy, or otherwise combat fraud, waste, or abuse in such program.
    4. Records may be disclosed to another federal agency or an 
instrumentality of any governmental jurisdiction within or under the 
control of the United States (including any state or local governmental 
agency) that administers federally funded programs, or that has the 
authority to investigate, potential fraud, waste or abuse in federally 
funded programs, when disclosure is deemed reasonably necessary by HHS 
to prevent, deter, discover, detect, investigate, examine, prosecute, 
sue with respect to, defend against, correct, remedy or otherwise 
combat fraud, waste or abuse in such programs.
    5. When a record on its face, or in conjunction with other records, 
indicates a violation or potential violation of law, whether civil, 
criminal or regulatory in nature, and whether arising by general 
statute or particular program statute, or by regulation, rule, or order 
issued pursuant thereto, disclosure may be made to the appropriate 
public authority, whether federal, foreign, state, local, tribal, or 
otherwise, responsible for enforcing, investigating or prosecuting the 
violation or charged with enforcing or implementing the statute, rule, 
regulation, or order issued pursuant thereto, if the information 
disclosed is relevant to the enforcement, regulatory, investigative, or 
prosecutorial responsibility of the receiving entity.
    6. Information may be disclosed to the U.S. Department of Justice 
(DOJ) or to a court or other tribunal, when:
    a. The agency or any component thereof, or
    b. any employee of the agency in his or her official capacity, or
    c. any employee of the agency in his or her individual capacity 
where DOJ has agreed to represent the employee, or
    d. the United States Government, is a party to litigation or has an 
interest in such litigation and, by careful review, HHS determines that 
the records are both relevant and necessary to the litigation and that, 
therefore, the use of such records by the DOJ, court or other tribunal 
is deemed by HHS to be compatible with the purpose for which the agency 
collected the records.
    7. Records may be disclosed to a federal, foreign, state, local, 
tribal, or other public authority of the fact that this system of 
records contains information relevant to the hiring or retention of an 
employee, the retention of a security clearance, the letting of a 
contract, or the issuance or retention of

[[Page 17450]]

a license, grant or other benefit. The other agency or licensing 
organization may then make a request supported by the written consent 
of the individual for further information if it so chooses. HHS will 
not make an initial disclosure unless the information has been 
determined to be sufficiently reliable to support a referral to another 
office within the agency or to another federal agency for criminal, 
civil, administrative, personnel, or regulatory action.
    8. Information may be disclosed to a Member of Congress or 
Congressional staff member in response to a written inquiry of the 
Congressional office made at the written request of the constituent 
about whom the record is maintained. The Congressional office does not 
have any greater authority to obtain records than the individual would 
have if requesting the records directly.
    9. Records may be disclosed to the U.S. Department of Homeland 
Security (DHS) if captured in an intrusion detection system used by HHS 
and DHS pursuant to a DHS cybersecurity program that monitors Internet 
traffic to and from federal government computer networks to prevent a 
variety of types of cybersecurity incidents.
    10. Disclosures may be made to appropriate federal agencies and 
Department contractors that have a need to know the information for the 
purpose of assisting the Department's efforts to respond to a suspected 
or confirmed breach of the security or confidentiality of information 
maintained in this system of records, when the information disclosed is 
relevant and necessary to that assistance.
    Information about an individual data requester may also be 
disclosed from this system of records to parties outside HHS without 
the individual's consent for any of the uses authorized directly in the 
Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM--
STORAGE:
    Records are stored in electronic databases and hard-copy files. 
DADSS, and its successors', records may also be stored on portable 
media.

RETRIEVABILITY:
    Records are retrieved by the data requester's name, registrant/user 
name, User ID number, or data use agreement (DUA) number.

SAFEGUARDS:
    Records are safeguarded in accordance with applicable laws, rules 
and policies, including the HHS Information Technology Security Program 
Handbook, all pertinent National Institutes of Standards and Technology 
(NIST) publications, and OMB Circular A-130, Management of Federal 
Resources. Records are protected from unauthorized access through 
appropriate administrative, physical, and technical safeguards. 
Safeguards conform to the HHS Information Security and Privacy Program, 
http://www.hhs.gov/ocio/securityprivacy/. The safeguards include 
protecting the facilities where records are stored or accessed with 
security guards, badges and cameras, securing hard-copy records in 
locked file cabinets, file rooms or offices during off-duty hours, 
limiting access to electronic databases to authorized users based on 
roles and the principle of least privilege, and two-factor 
authentication (user ID and password), using a secured operating system 
protected by encryption, firewalls, and intrusion detection systems, 
using an SSL connection for secure encrypted transmissions, requiring 
encryption for records stored on removable media, and training 
personnel in Privacy Act and information security requirements.

RETENTION AND DISPOSAL:
    Records needed to enforce data use restrictions are retained for 20 
years by AHRQ (see DAA-0510-2013-0003-0001) and 5 years by CMS (see N1-
440-10-04) after the agreement is closed, and may be kept longer if 
necessary for enforcement, audit, legal, or other purposes. The 
equivalent SAMHSA records will be retained indefinitely until a 
disposition schedule is approved by the National Archives and Records 
Administration (NARA). SAMHSA anticipates proposing a 5 year retention 
period to NARA. Records of payments made electronically are transmitted 
securely to a Payment Card Industry-compliant payment gateway for 
processing and are not stored. Records of payments made by check, 
purchase order, or wire transfer are disposed of once the funds have 
been received.
    Records are disposed of using destruction methods prescribed by 
NIST SP 800-88.

SYSTEM MANAGER(S) AND ADDRESS(ES):
     AHRQ: HCUP Project Officer, Center for Delivery, 
Organization, and Markets, 540 Gaither Road, Rockville, MD 20850; 
Telephone: 301-427-1410; [email protected].
     CMS: DADSS and its successor, Division of Data and 
Information Dissemination, Data Development and Services Group, Office 
of Enterprise Data and Analytics, Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Mailstop: B2-29-04, Office Location: 
B2-03-37, Baltimore, MD 21244-1870.
     SAMHSA: SAMHDA Project Officer, CBHSQ, 1 Choke Cherry 
Road, Rockville, MD 20857.

NOTIFICATION PROCEDURE:
    An individual who wishes to know if this system of records contains 
records about him or her should submit a written request to the 
relevant System Manager at the address indicated above. The individual 
must verify his or her identity by providing either a notarized request 
or 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 Privacy Act, subject to a 
five thousand dollar fine.

RECORD ACCESS PROCEDURE:
    Same as notification procedure.

CONTESTING RECORD PROCEDURES:
    An individual seeking to amend the content of information about him 
or her in this system should contact the relevant System Manager and 
reasonably identify the record, specify the information contested, 
state the corrective action sought, and provide the reasons for the 
amendment, with supporting justification.

RECORD SOURCE CATEGORIES:
    Information in this system of records is obtained directly from the 
individual data requester to whom it applies, or is derived from 
information supplied by the individual or provided by HHS officials.

EXEMPTIONS CLAIMED FOR THIS SYSTEM:
    None.

Celeste Dade-Vinson,
Health Insurance Specialist, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07444 Filed 3-31-15; 8:45 a.m.]
 BILLING CODE 4120-03-P