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Privacy Impact Assessment Form
v 1.21
Status
Form Number
Form Date
Question
Answer
1
OPDIV:
CDC
2
PIA Unique Identifier:
TBD
2a Name:
12/05/2023
National Healthcare Safety Network (Cloud) (NHSN2)
General Support System (GSS)
Major Application
3
The subject of this PIA is which of the following?
Minor Application (stand-alone)
Minor Application (child)
Electronic Information Collection
Unknown
3a
Identify the Enterprise Performance Lifecycle Phase
of the system.
Development
Yes
3b Is this a FISMA-Reportable system?
4
Does the system include a Website or online
application available to and for the use of the general
public?
5
Identify the operator.
6
Point of Contact (POC):
7
Is this a new or existing system?
8
Does the system have Security Authorization (SA)?
8b Planned Date of Security Authorization
No
Yes
No
Agency
Contractor
POC Title
Branch Chief
POC Name
Andrea Benin
POC Organization NCEZID/DHQP
POC Email
[email protected]
POC Phone
404-498-1186
New
Existing
Yes
No
12/1/2023
Not Applicable
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8c
10
Briefly explain why security authorization is not
required
N/A
Describe in further detail any changes to the system
that have occurred since the last PIA.
The National Healthcare Safety Network (Cloud) (NHSN2) is a
cloud-based system migrated from the National Healthcare
Safety Network (NHSN) on-prem system, which has an
approved PIA. Migration to the cloud is a significant system
management change which will result in new privacy risks.
11 Describe the purpose of the system.
The National Healthcare Safety Network (Cloud) (NHSN2) is a
cloud-based system migrated from the National Healthcare
Safety Network (NHSN) system. The major purpose of NHSN2 is
to equip participating healthcare facilities to enter data
associated with healthcare safety events, such as surgical site
infections, anti-microbial use and resistance, bloodstream
infections, and healthcare worker vaccinations. NHSN2
provides analysis tools that generate reports using the
aggregated data (reports about infection rates, national and
local comparisons, etc.). Participating NHSN2 healthcare
facilities can access web-based screens that allow them to
enter data associated with healthcare safety events. These data
are captured in a relational database at the CDC. Participants
can then use NHSN2 analysis tools to generate reports that are
displayed on their web browser.
NHSN2 addresses data collection from healthcare facilities to
permit valid estimation of adverse events among patients or
residents and healthcare personnel. Similarly, it provides
facilities with risk-adjusted metrics that can be used for interfacility comparisons and local quality improvement activities.
NHSN2 also allows for the opportunity of collaborative
research studies with participating facilities that describe the
epidemiology of emerging health care-associated infections
(HAIs) and pathogens, assess the importance of potential risk
factors, further characterize HAI pathogens and their
mechanisms of resistance, and evaluate alternative surveillance
and prevention strategies. The NHSN2 Agreement ensures
compliance with legal requirements – including state or federal
laws, regulations, or other requirements – for mandatory
reporting of facility-specific adverse event, prevention practice
adherence, and other public health data. NHSN2 enables
healthcare facilities to report data to the Centers for Medicare
& Medicaid Services (CMS) of the U.S. Department of Health
and Human Services (DHHS) in fulfillment of CMS’s quality
measurement reporting requirements for those data.
Considering the Coronavirus Disease (COVID-19) Pandemic,
CDC created the capability for COVID-19 surveillance in NHSN2,
enabling data collection reported by Long-Term Care Facilities
(LTCFs) and Outpatient Dialysis Facilities. This data is reported
through different pathways within the NHSN2 COVID-19
Modules for LTCFs and Outpatient Dialysis Facilities.
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The type of information the NHSN2 system collects is described
below:
Patients: Patient identification number (may be a medical
record number), gender and date of birth. For some patients,
birth weight is required.
Healthcare workers: Healthcare worker identification number,
gender, date of birth, work location, and occupation.
Facilities: Facility name, address, county, city, state , zip code,
telephone number, identifying number (i.e., CMS provider
number and/or American Hospital Association identification
number and/or Veterans Administration station code), type,
ownership category, affiliation with a medical school (y/n), and
bed-size characteristics.
Describe the type of information the system will
Users: Name, address (if different from facility), telephone
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask number, and email address.
Optional information that may be reported to NHSN2:
about the specific data elements.)
Patients: Social security number, secondary identification
number, name, ethnicity, and race.
Healthcare workers: Name, address, work and home phone
numbers, email address, born in United States (y/n), ethnicity,
race, and date of employment.
Users: Fax number, pager number, and title.
NHSN2 external users are authenticated through CDC Secure
Access Management System (SAMS), which is covered by a
separate Privacy Impact Assessment (PIA). NHSN2 internal
users access the system via Active Directory (AD) which is a
separate system covered by its own PIA.
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.
NHSN2 data is used by CDC for improving and tracking public
health; by CMS for public reporting, payment, and regulatory
programs; by Facilities, Systems, and Collaboratives for
improving care; and by States and local health departments
and Hospital Associations for public health safety reporting.
The data is used to provide state and local health departments
with information that identifies the facilities in their state that
participate in NHSN2 and to provide to state and local health
departments, at their request, facility-specific, NHSN2 data for
surveillance, prevention, or mandatory public reporting. Any
U.S. healthcare institution including hospitals, outpatient
centers, and Long-Term Care Facilities (LTCF) may enroll in
NHSN2 provided they have access to the Internet. The NHSN2
Registration server provides healthcare administrators with a
way to register their facility in NHSN2. After registering their
facility, they will be given instructions on how to get a digital
certificate and begin using the main NHSN2 application. This
registration application also provides a way for users to accept
the NHSN2 Rules of Behavior before accessing the main NHSN2
application.
NHSN2 external users are authenticated through CDC Secure
Access Management System (SAMS), which is covered by a
separate PIA. NHSN2 internal users access the system via
Active Directory (AD) which is a separate system covered by its
own PIA.
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Yes
14 Does the system collect, maintain, use or share PII?
Indicate the type of PII that the system will collect or
15
maintain.
No
Social Security Number
Date of Birth
Name
Photographic Identifiers
Driver's License Number
Biometric Identifiers
Mother's Maiden Name
Vehicle Identifiers
E-Mail Address
Mailing Address
Phone Numbers
Medical Records Number
Medical Notes
Financial Account Info
Certificates
Legal Documents
Education Records
Device Identifiers
Military Status
Employment Status
Foreign Activities
Passport Number
Taxpayer ID
Birth weight
Ethnicity and Race
Work Identification Number
Titles
Gender
Employees
Public Citizens
16
Indicate the categories of individuals about whom PII
is collected, maintained or shared.
Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other
17 How many individuals' PII is in the system?
18 For what primary purpose is the PII used?
19
Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)
1,000,000 or more
Data from NHSN2 is used for tracking of healthcare-associated
infections, antibiotic use and resistance, and surveillance of
COVID-19.
Data from NHSN2 is also used as a guide for infection
prevention activities that protect patients.
20 Describe the function of the SSN.
SSNs are vital to the overall operation of NHSN2 because
hospitals whose data is entered into NHSN2 may use NHSN2 to
track a patient by SSN. Also state public health officials who
have been granted access to the data in their state by their
constituent hospitals may require access to patient SSNs. The
state of Pennsylvania for example requires by law the
reporting of Healthcare Associated Infections using NHSN2 and
as part of the state mandate requires the records to be
identified by SSNs. This allows Pennsylvania to download data
from NHSN2 about patients in their state and link that data to
payment information.
20a Cite the legal authority to use the SSN.
E.O. 9397, November 22, 1943 (as Amended by E.O. 13478, 18
November 2008)
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Public Health Service Act, Section 301, "Research and
Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d)
Identify legal authorities governing information use which discuss authority to maintain data and provide
21
and disclosure specific to the system and program.
assurances of confidentiality for health research and related
activities (42 U.S.C. 242 b, k, and m(d)).
5 U.S.C. 301, 40 U.S.C. 486(c).
22
Yes
Are records on the system retrieved by one or more
PII data elements?
Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.
No
Published:
09-20-0136: Epidemiologic Studies and Surveilla
Published:
09-90-2001: Records Used for Surveillance and S
Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources
23
Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other
Identify the sources of PII in the system.
Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a
Identify the OMB information collection approval
number and expiration date.
OMB No. 0920-0666, expiration Date: 2023-12-31
Yes
24 Is the PII shared with other organizations?
No
CMS for required COVID-19
ureporting and with HHS for
Other Federal
Federal Emergency Management
Agency/Agencies Agency (FEMA), Administration for
State or Local
Select Healthcare facilities in the U.S.
Agency/Agencies
Within HHS
24a
Identify with whom the PII is shared or disclosed and
for what purpose.
Private Sector
Some corporate healthcare entities
and quality improvement
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Information and the NHSN Data Use Agreement document can
be found at http://www.cdc.gov/hai/surveillance/DUAannouncment.html. Each state or local jurisdiction has
requested access to different data—you can read each state’s
specifics by clicking on the state at http://www.cdc.gov/HAI/
state-based/index.html. Each facility can only see it's own data.
Health Departments (HD) with NHSN DUAs:
Chicago Department of Public Health
Harris County Health Department
Houston Health Department
Los Angeles County Department of Public Health
Maricopa County Department of Public Health (Phoenix, AZ)
New York City DOH & Mental Hygiene
Southern Nevada Health District
San Diego (County of San Diego Health & Human Services
Describe any agreements in place that authorizes the Agency)
Orange County Health Department
information sharing or disclosure (e.g. Computer
Arizona Department of Health Services
24b Matching Agreement, Memorandum of
Florida Department of Health
Understanding (MOU), or Information Sharing
Idaho Department of Health and Welfare
Agreement (ISA)).
Indiana State Department of Health
Kansas Department of Health and Environment
Kentucky Department of Public Health
Louisiana Department of Health, Infectious Disease
Epidemiology Section
Minnesota Department of Health ("MDH")
Montana Department of Public Health and Human Services
Nevada Division of Public and Behavioral Health
New York State Department of Health
North Dakota Department of Health
Ohio Department of Health
South Dakota Department of Health
Texas Department of State Health Services(TXDSHS)
Vermont Department of Health
Washington State Dept of Health
(Territory) Guam Department of Public Health and Social
Services
24c
Describe the procedures for accounting for
disclosures
Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.
26
Is the submission of PII by individuals voluntary or
mandatory?
It is the responsibility of the facility and Electronic Health
Record (EHR) vendor to notify patients of any data collected on
their behalf. Requests from patients for data submitted to
NHSN would be tracked by established processes that are
specific to that healthcare facility.
N/A; data in NHSN2 is not collected directly from the individual
but rather provided from the facilities. It is the responsibility of
the facility and Electronic Health Record (EHR) vendor to notify
patients of any data collected on their behalf.
Voluntary
Mandatory
Describe the method for individuals to opt-out of the
N/A; because facilities submit data on behalf of patients.
collection or use of their PII. If there is no option to
27
Patients do not submit data directly into NHSN2, but rather
object to the information collection, provide a
NHSN users (facilities) do so on their behalf.
reason.
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Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.
Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.
Facilities that participate in NHSN2 are responsible for letting
individuals know if their PII is being used and as such any
concerns regarding this should be directed to the facility.
Facilities that participate in NHSN2 are responsible for letting
individuals know if their PII is being used and as such any
concerns regarding this should be directed to the facility.
No umbrella process is in place to ensure the accuracy of the
PII contained in the system. Facilities participating in NHSN2
are responsible for the submission and verification of PII in
NHSN2.
Users
Administrators
Identify who will have access to the PII in the system
and the reason why they require access.
Users will have access to the PII in the
system for Epidemiologic Analysis.
Administrators will have access to the
PII in the system for data management
Developers will have access to the PII
in the system for NHSN2 Development
Direct Contractors with Personal
Contractors
Identity Verification (PIV) cards need
Epidemiologic Analysis by approved
Others
CDC staff and guest researchers.
All users must be approved by the Business Steward based on
Describe the procedures in place to determine which their role, duties and responsibilities prior to gaining access to
32 system users (administrators, developers,
the data. Role Based Access Control (RBAC) is utilized. The roles
contractors, etc.) may access PII.
are predefined and users are assigned those roles as
appropriate.
31
Developers
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.
The least privilege model is utilized to allow those with
access to PII to only access the minimum amount of
information necessary to perform their job.
Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.
All CDC personnel are required to complete annual Security
and Privacy Awareness training.
Describe training system users receive (above and
35 beyond general security and privacy awareness
training).
Users are required to acknowledge Rules of Behavior attesting
to their understanding of the privacy requirements.
Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?
Yes
No
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Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.
CDC Records Control Policy applies. Records are retained and
disposed of in accordance with the CDC Records Control
Schedule for NHSN2 records. Records are retained for various
periods of time depending upon how useful they are
considered to be, in accordance with NHSN2 policy. Some
records of users may be maintained indefinitely. Disposal
methods include burning or shredding hard copy and erasing
computer tapes and disks.
NHSN2 record schedule adhere to N1-442-09-001, item 1
Administrative controls include Federal, HHS, and CDC specific
Privacy, Risk Assessment, and Incident Management Policies,
annual system privacy impact assessments; and mandatory
annual security & privacy awareness training.
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.
Technical controls include application level role based access
controls; encryption of PII at rest and in transit; standard
baseline configurations for IT assets; server audit and
accountability measures; and continuous monitoring of system
resources to identify vulnerabilities and ensure adherence to
organizationally defined minimum security requirements. In
addition, the system is protected by residing within SAMS and
requires each user to have CDC-approved identity proofing in
order to access the system.
Physical controls surrounding the system's data centers include
gated campuses with 24-hour security guards to enforce
access restriction; key card access to campus buildings; and
access control lists further limiting physical access to sensitive
areas such as the data centers.
REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.
Reviewer Questions
1
Are the questions on the PIA answered correctly, accurately, and completely?
Answer
Yes
No
Reviewer
Notes See email re concerns: Qs 4, 12-13, 24-25, 27, & 39-43. Please address concerns.
2
Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?
Yes
Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?
Yes
No
Reviewer
Notes
3
No
Reviewer
Notes
4
Does the PIA appropriately describe the PII quality and integrity of the data?
Yes
No
Reviewer
Notes
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Reviewer Questions
5
Answer
Yes
Is this a candidate for PII minimization?
No
Reviewer
Notes
6
Does the PIA accurately identify data retention procedures and records retention schedules?
Yes
No
Reviewer
Notes
7
Are the individuals whose PII is in the system provided appropriate participation?
Yes
No
Reviewer
Notes See email for concerns re Qs 24-25 &27
8
Does the PIA raise any concerns about the security of the PII?
Yes
No
Reviewer
Notes
9
Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?
Yes
No
Reviewer
Notes
10
Is the PII appropriately limited for use internally and with third parties?
Yes
No
Reviewer
Notes
11
Does the PIA demonstrate compliance with all Web privacy requirements?
Yes
No
Reviewer
Notes
12
Were any changes made to the system because of the completion of this PIA?
Yes
No
Reviewer
Notes
General Comments
OPDIV Senior Official
for Privacy Signature
SOP/CPO signature of this version of the revised PIA is ONLY for the purpose of approval of the eRAP
associated with this system; not the ATO. It is expected that the program will continue to expediently
collaborate with the CDC Privacy Team to gain approval of the final PTA/PIA using the ARCHER GRC tool
Once that PIA is finalized in ARCHER (including HHS approval), it will be used for the ATO.
Beverly E.
Walker -S
Digitally signed by
Beverly E. Walker -S
Date: 2023.12.05
16:17:46 -05'00'
HHS Senior
Agency Official
for Privacy
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File Type | application/pdf |
File Modified | 2023-12-05 |
File Created | 2013-03-29 |