PATH Study Privacy Impact Assessment (PIA)

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 7
PATH Study Privacy Impact Assessments (PIA)

06.1 HHS Privacy Impact Assessment / PATH IMS – No PII

Primavera ProSight

PIA SUMMARY

1
The following required questions with an asterisk (*) represent the information necessary to complete the PIA Summary for transmission to the Office of
Management and Budget (OMB) and public posting in accordance with OMB Memorandum (M) 03-22.
Note: If a question or its response is not applicable, please answer “N/A” to that question where possible. If the system hosts a website, the Website Hosting
Practices section is required to be completed regardless of the presence of personally identifiable information (PII). If no PII is contained in the system,
please answer questions in the PIA Summary Tab and then promote the PIA to the Senior Official for Privacy who will authorize the PIA. If this system
contains PII, all remaining questions on the PIA Form Tabs must be completed prior to signature and promotion.

2

Summary of PIA Required Questions

*Is this a new PIA?

Yes
If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

07/01/2012
*2. OPDIV Name:

National Institute on Drug Abuse (NIDA)
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200
*5. OMB Information Collection Approval Number:

TBD
*6. Other Identifying Number(s):

8954
*7. System Name (Align with system item name):

PATH IMS – Ancillary Support Systems
*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

Point of Contact Information

Dr. Kevin Paul Conway
NSC BG RM 5185
6001 EXECUTIVE BLVD
ROCKVILLE MD 20852
(301) 402-1817
[email protected]
*10. Provide an overview of the system:

The PATH IMS includes several ancillary support applications that do not collect, store, or display any personally identifiable information
(PII). The systems that will not contain personally identifiable information are a public information website, a SharePoint collaboration
site, a tobacco product image repository using the Alchemy image management application, a SAS® collaboration environment, a
biospecimen tracking tool called BEST, a technical support issue tracking tools called BMC Remedy Magic, a Learning Management
System hosted by ComplianceWire, an anonymous incentive payment management application hosted by Payoneer, and an inventory
tracking application called ITMS. The public website will be used to convey information about the study to the public. The SharePoint
site will be used for the partners in the study to collaborate and share ideas about the research. Alchemy is an image management

Page 1 of 17

system that will store images of tobacco products and ads. The SAS Collaboration Environment is an environment in which research
partners can access restricted use files that have had all personally identifiable information redacted. BEST tracks the shipping and
receipt of biospecimens collected from participants, but does not store any participant data, only sample ID’s which cannot be linked to
participants by an external party. The Remedy Magic technical support tool tracks system problem reports, but identifies staff only by
their business contact information, thus falling into the “federal contact data” category. The ComplianceWire application tracks training
and certification of staff, and also holds only federal contact information. The Payoneer application supports the payment of incentives to
study participants anonymously (participants are known to the application only by their debit card account number, not by any PII). ITMS
is an inventory management application that is used to track the consumption of forms and other supplies. ITMS carries no data about
participants or staff.
Note: According to OMB 07-16M, All agencies MUST participate in government-wide effort to eliminate unnecessary use of and explore alternatives to
agency use of Social Security Numbers as a personal identifier for both Federal employees and in Federal programs.
*13. Indicate if the system is new or an existing one being modified:

New
*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this
system?
Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the
Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by
mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If
the information contained in the system ONLY represents federal contact data (i.e., federal contact name, federal address, federal phone number, and
federal email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA Summary
is required). If the system contains a mixture of federal contact information and other types of PII, the response to Q.17 should be Yes (full PIA is required).

No
17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to
Q.17 should be No and only the PIA Summary must be completed.

Yes
*19. Are records on the system retrieved by 1 or more PII data elements?

No
*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

No
*23. If the system shares or discloses PII, please specify with whom and for what purpose(s):

N/A
*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system
ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information
contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

N/A
*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes
occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from
individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format
individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]):

N/A
*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of
the presence of PII)

Yes
*37. Does the website have any information or pages directed at children under the age of thirteen?

No
*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and
Destruction section in SORN)

Yes
*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

N/A

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PIA REQUIRED INFORMATION

1

HHS Privacy Impact Assessment (PIA)

The PIA determines if Personally Identifiable Information (PII) is contained within a system, what kind of PII, what is done with that information, and how that
information is protected. Systems with PII are subject to an extensive list of requirements based on privacy laws, regulations, and guidance. The HHS Privacy
Act Officer may be contacted for issues related to Freedom of Information Act (FOIA) and the Privacy Act. Respective Operating Division (OPDIV) Privacy
Contacts may be contacted for issues related to the Privacy Act. The Office of the Chief Information Officer (OCIO) can be used as a resource for questions
related to the administrative, technical, and physical controls of the system. Please note that answers to questions with an asterisk (*) will be submitted to the
Office of Management and Budget (OMB) and made publicly available in accordance with OMB Memorandum (M) 03-22.
Note: If a question or its response is not applicable, please answer “N/A” to that question where possible.

2

General Information

*Is this a new PIA?

Yes
If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

7/1/2012
*2. OPDIV Name:

National Institute on Drug Abuse (NIDA)
3. Unique Project Identifier (UPI) Number for current fiscal year (Data is auto-populated from the System Inventory form, UPI table):

TBD
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200
*5. OMB Information Collection Approval Number:

TBD
5a. OMB Collection Approval Number Expiration Date:

TBD
*6. Other Identifying Number(s):

Westat internal project ID 8954
*7. System Name: (Align with system item name)

PATH Ancillary Support Systems
8. System Location: (OPDIV or contractor office building, room, city, and state)

System Location:
OPDIV or contractor office building

Westat Inc.
1600 Research Blvd.

Room

Page 3 of 17

City

Rockville

State

MD

*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

Point of Contact Information
POC Name

Dr. Kevin Paul Conway

The following information will not be made publicly available:

POC Title
POC Organization

National Institute on Drug Abuse

POC Phone

(301) 402-1817

POC Email

[email protected]

*10. Provide an overview of the system: (Note: The System Inventory form can provide additional information for child dependencies if the system is a GSS.)

The PATH IMS includes several ancillary support applications that do not collect, store, or display any personally identifiable information
(PII). The systems that will not contain personally identifiable information are a public information website, a SharePoint collaboration
site, a tobacco product image repository using the Alchemy image management application, a SAS® collaboration environment, a
biospecimen tracking tool called BEST, a technical support issue tracking tools called BMC Remedy Magic, a Learning Management
System hosted by ComplianceWire, an anonymous incentive payment management application hosted by Payoneer, and an inventory
tracking application called ITMS. The public website will be used to convey information about the study to the public. The SharePoint
site will be used for the partners in the study to collaborate and share ideas about the research. Alchemy is an image management
system that will store images of tobacco products and ads. The SAS Collaboration Environment is an environment in which research
partners can access restricted use files that have had all personally identifiable information redacted. BEST tracks the shipping and
receipt of biospecimens collected from participants, but does not store any participant data, only sample ID’s which cannot be linked to
participants by an external party. The Remedy Magic technical support tool tracks system problem reports, but identifies staff only by
their business contact information, thus falling into the “federal contact data” category. The ComplianceWire application tracks training
and certification of staff, and also holds only federal contact information. The Payoneer application supports the payment of incentives to
study participants anonymously (participants are known to the application only by their debit card account number, not by any PII). ITMS
is an inventory management application that is used to track the consumption of forms and other supplies. ITMS carries no data about
participants or staff.
Note: According to OMB 07-16M, All agencies MUST participate in government-wide effort to eliminate unnecessary use of and explore alternatives to
agency use of Social Security Numbers as a personal identifier for both Federal employees and in Federal programs.

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SYSTEM CHARACTERIZATION AND DATA CATEGORIZATION

1

System Characterization and Data Configuration

11. Does HHS own the system?

Yes
11a. If no, identify the system owner:

12. Does HHS operate the system? (If the system is operated at a contractor site, the answer should be No)

No
12a. If no, identify the system operator:

Westat Inc.
1600 Research Blvd, Rockville, MD 20850
*13. Indicate if the system is new or an existing one being modified:

New
14. Identify the life-cycle phase of this system:

Acquisition/Development
15. Have any of the following major changes occurred to the system since the PIA was last submitted?

No

Please indicate “Yes” or “No” for each category below:

Yes/No

Conversions

No

Anonymous to Non-Anonymous

No

Significant System Management Changes

No

Significant Merging

No

New Public Access

No

Commercial Sources

No

New Interagency Uses

No

Internal Flow or Collection

No

Alteration in Character of Data

No

16. Is the system a General Support System (GSS), Major Application (MA), Minor Application (child) or Minor Application (stand-alone)?

Major application
*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this
system?

No
Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the
Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by
mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If
the information contained in the system ONLY represents business contact data (i.e., business contact name, business address, business phone number,
and business email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA
Summary is required). If the system contains a mixture of business contact information and other types of PII, the response to Q.17 should be Yes (full PIA is
required).
TIP: If the answer to Question 17 is “No” (indicating the system does not contain PII), only the PIA Summary tab questions need to be completed and
submitted. If the system does contain PII, the full PIA must be completed and submitted. (Although note that “Employee systems,” – i.e., systems that collect
PII “permitting the physical or online contacting of a specific individual … employed [by] the Federal Government” – only need to complete the PIA
Summary tab.)

Page 5 of 17

Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category
of PII.

Categories:

Yes/No

Name (for purposes other than contacting federal
employees)

No

Date of Birth

No

Social Security Number (SSN)

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

No

Personal Phone Numbers

No

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web Uniform Resource Locator(s) (URL)

No

Personal Email Address

No

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other

No

17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to
Q.17 should be No and only the PIA Summary must be completed.

Yes
18. Please indicate the categories of individuals about whom PII is collected, maintained, disseminated and/or passed through. Note: If the applicable PII
category is not listed, please use the Other field to identify the appropriate category of PII. Please answer "Yes" or "No" to each of these choices (NA in other
is not applicable).

Categories:

Yes/No

Employees

No

Public Citizen

No
Page 6 of 17

Patients

No

Business partners/contacts (Federal, state, local
agencies)

No

Vendors/Suppliers/Contractors

No

Other

No

*19. Are records on the system retrieved by 1 or more PII data elements?

No
Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category
of PII.

Categories:

Yes/No

Name (for purposes other than contacting federal
employees)

No

Date of Birth

No

SSN

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

No

Personal Phone Numbers

No

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

No

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other

No

20. Are 10 or more records containing PII maintained, stored or transmitted/passed through this system?

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N/A
*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

No
21a. If yes but a SORN has not been created, please provide an explanation.

N/A

Page 8 of 17

INFORMATION SHARING PRACTICES

1

Information Sharing Practices

22. Does the system share or disclose PII with other divisions within this agency, external agencies, or other people or organizations outside the agency?

No

Please indicate “Yes” or “No” for each category below:

Yes/No

Name (for purposes other than contacting federal
employees)

No

Date of Birth

No

SSN

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

No

Personal Phone Numbers

No

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

No

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other

*23. If the system shares or discloses PII please specify with whom and for what purpose(s):

NA
24. If the PII in the system is matched against PII in one or more other computer systems, are computer data matching agreement(s) in place?

No
25. Is there a process in place to notify organizations or systems that are dependent upon the PII contained in this system when major changes occur (i.e.,
revisions to PII, or when the system is replaced)?

Page 9 of 17

No
26. Are individuals notified how their PII is going to be used?

N/A
26a. If yes, please describe the process for allowing individuals to have a choice. If no, please provide an explanation.

N/A
27. Is there a complaint process in place for individuals who believe their PII has been inappropriately obtained, used, or disclosed, or that the PII is
inaccurate?

N/A
27a. If yes, please describe briefly the notification process. If no, please provide an explanation.

{notification text}
28. Are there processes in place for periodic reviews of PII contained in the system to ensure the data’s integrity, availability, accuracy and relevancy?

NA
28a. If yes, please describe briefly the review process. If no, please provide an explanation.

NA
29. Are there rules of conduct in place for access to PII on the system?

NA
Please indicate "Yes," "No," or "N/A" for each category. If yes, briefly state the purpose for each user to have access:

Users with access to PII

Yes/No/N/A

Purpose

User

NA {purpose text}

Administrators

NA

Developers

NA

Contractors

NA

Other

NA {purpose text}

*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system
ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information
contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

N/A
*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes
occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from
individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format
individuals will be given notice of consent [e.g., written notice, electronic notice, etc.])

{process text}

Page 10 of 17

WEBSITE HOSTING PRACTICES

1

Website Hosting Practices

*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of
the presence of PII)

Yes

Please indicate “Yes” or “No” for each Yes/ No
type of site below. If the system hosts
both Internet and Intranet sites,
indicate “Yes” for “Both” only.

If the system hosts an Internet site,
please enter the site URL. Do not
enter any URL(s) for Intranet sites.

Internet

Yes

Intranet

Yes

Both

Yes

Public website:
www.pathstudyinfo.gov
SharePoint collaboration site:
www.pathcollaboration.org

33. Does the system host a website that is accessible by the public and does not meet the exceptions listed in OMB M-03-22?
Note: OMB M-03-22 Attachment A, Section III, Subsection C requires agencies to post a privacy policy for websites that are accessible to the public, but
provides three exceptions: (1) Websites containing information other than "government information" as defined in OMB Circular A-130; (2) Agency intranet
websites that are accessible only by authorized government users (employees, contractors, consultants, fellows, grantees); and (3) National security systems
defined at 40 U.S.C. 11103 as exempt from the definition of information technology (see section 202(i) of the E-Government Act.).

Yes
34. If the website does not meet one or more of the exceptions described in Q. 33 (i.e., response to Q. 33 is "Yes"), a website privacy policy statement
(consistent with OMB M-03-22 and Title II and III of the E-Government Act) is required. Has a website privacy policy been posted?
(Note: A website privacy policy is required for Internet sites only.)

Yes
35. If a website privacy policy is required (i.e., response to Q. 34 is “Yes”), is the privacy policy in machine-readable format, such as Platform for Privacy
Preferences (P3P)?
(Note: Privacy policy in machine-readable format is required for Internet sites only.)

Yes
35a. If no, please indicate when the website will be P3P compliant:

36. Does the website employ tracking technologies?

Yes

Please indicate “Yes”, “No”, or “N/A” for each type of
cookie below:

Yes/No/N/A

Web Bugs

No

Web Beacons

No

Session Cookies

Yes

Persistent Cookies

No

Other

No

*37. Does the website have any information or pages directed at children under the age of thirteen?

No
37a. If yes, is there a unique privacy policy for the site, and does the unique privacy policy address the process for obtaining parental consent if any

Page 11 of 17

information is collected?

38. Does the website collect PII from individuals?

No

Please indicate “Yes” or “No” for each category below:

Yes/No

Name (for purposes other than contacting federal
employees)

No

Date of Birth

No

SSN

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver's License

No

Biometric Identifiers

No

Mother's Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

No

Personal Phone Numbers

No

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

No

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other: Employer Name, NIH commons ID, NIH account
ID, Job specialty

No

39. Are rules of conduct in place for access to PII on the website?

N/A
40. Does the website contain links to sites external to HHS that owns and/or operates the system?

Yes
40a. If yes, note whether the system provides a disclaimer notice for users that follow external links to websites not owned or operated by HHS.

Yes

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ADMINISTRATIVE CONTROLS

1

Administrative Controls

Note: This PIA uses the terms “Administrative,” “Technical” and “Physical” to refer to security control questions—terms that are used in several Federal
laws when referencing security requirements.
41. Has the system been certified and accredited (C&A)?

No
41a. If yes, please indicate when the C&A was completed (Note: The C&A date is populated in the System Inventory form via the responsible Security
personnel):

41b. If a system requires a C&A and no C&A was completed, is a C&A in progress?

A C&A is in progress.
42. Is there a system security plan for this system?

Yes
43. Is there a contingency (or backup) plan for the system?

Yes
44. Are files backed up regularly?

Yes
45. Are backup files stored offsite?

Yes
46. Are there user manuals for the system?

Yes
47. Have personnel (system owners, managers, operators, contractors and/or program managers) using the system been trained and made aware of their
responsibilities for protecting the information being collected and maintained?

Yes
48. If contractors operate or use the system, do the contracts include clauses ensuring adherence to privacy provisions and practices?

Yes
49. Are methods in place to ensure least privilege (i.e., “need to know” and accountability)?

Yes
49a. If yes, please specify method(s):

User roles are defined and individuals are assigned to one or more roles. These roles ensure that access privileges are narrowly defined,
and that only those staff members that need certain types of access are granted that access. In addition to limiting functions, physical
access controls limit access to the system.
Accountability is assured through authentication and authorization and the use of audit logs for applications, systems and network
infrastructure components.
*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention
and Destruction section in SORN):

N/A
50a. If yes, please provide some detail about these policies/practices:

N/A

Page 13 of 17

TECHNICAL CONTROLS

1

Technical Controls

51. Are technical controls in place to minimize the possibility of unauthorized access, use, or dissemination of the data in the system?

Yes

Please indicate “Yes” or “No” for each category below:

Yes/No

User Identification

Yes

Passwords

Yes

Firewall

Yes

Virtual Private Network (VPN)

Yes

Encryption

Yes

Intrusion Detection System (IDS)

Yes

Common Access Cards (CAC)

Yes

Smart Cards

No

Biometrics

No

Public Key Infrastructure (PKI)

Yes

52. Is there a process in place to monitor and respond to privacy and/or security incidents?

Yes
52a. If yes, please briefly describe the process:

The Westat systems group is responsible for monitoring and responding to any security incident in collaboration with the project. The
systems group employs various tools like network scanners and sniffers and regularly scheduled internal and external agency network
vulnerability scans etc. to stay on top of any security threat. All privacy and/or security incidents, or suspected incidents, must be
reported promptly by the project to the agency.

Page 14 of 17

PHYSICAL ACCESS

1

Physical Access

53. Are physical access controls in place?

Yes

Please indicate “Yes” or “No” for each category below:

Yes/No

Guards

Yes

Identification Badges

Yes

Key Cards

Yes

Cipher Locks

Yes

Biometrics

No

Closed Circuit TV (CCTV)

Yes

*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

Information is secured on the system through access controls, personnel security awareness and training, regular auditing of information
and information management processes, careful monitoring of a properly accredited information system, control of changes to the system,
by appropriate planning and testing of configuration management and contingency processes, by ensuring that all users of the information
system are properly identified and authorized for access and are aware of and acknowledge the system rules of behavior, by ensuring that
any contingency or incident is handled expeditiously, properly maintaining the system and regulating the environment it operates in, by
controlling media, by evaluating risks and planning for information management and information system operations, by ensuring that the
system and any exchange of information is protected, by maintaining the confidentiality and integrity of the information system, and by
adhering to the requirements established in the contract and statement of work.

Page 15 of 17

APPROVAL/DEMOTION
1

System Information

System Name:

2

PIA Reviewer Approval/Promotion or Demotion

Promotion/Demotion:
Comments:
Approval/Demotion Point
of Contact:
Date:

3

Senior Official for Privacy Approval/Promotion or Demotion

Promotion/Demotion:
Comments:

4

OPDIV Senior Official for Privacy or Designee Approval

Please print the PIA and obtain the endorsement of the reviewing official below. Once the signature has been collected,
retain a hard copy for the OPDIV's records. Submitting the PIA will indicate the reviewing official has endorsed it
This PIA has been reviewed and endorsed by the OPDIV Senior Official for Privacy or Designee (Name and Date):

Name: __________________________________

Date: ________________________________________

Name:
Date:

5

Department Approval to Publish to the Web

Approved for web publishing
Date Published:
Publicly posted PIA URL or no PIA URL explanation:

Page 16 of 17

PIA % COMPLETE
1

PIA Completion

PIA Percentage Complete:
PIA Missing Fields:

Page 17 of 17

06.1 HHS Privacy Impact Assessment / PATH IMS – Core Systems

Primavera ProSight

PIA SUMMARY

1
The following required questions with an asterisk (*) represent the information necessary to complete the PIA Summary for transmission to the Office of
Management and Budget (OMB) and public posting in accordance with OMB Memorandum (M) 03-22.
Note: If a question or its response is not applicable, please answer “N/A” to that question where possible. If the system hosts a website, the Website Hosting
Practices section is required to be completed regardless of the presence of personally identifiable information (PII). If no PII is contained in the system,
please answer questions in the PIA Summary Tab and then promote the PIA to the Senior Official for Privacy who will authorize the PIA. If this system
contains PII, all remaining questions on the PIA Form Tabs must be completed prior to signature and promotion.

2

Summary of PIA Required Questions

*Is this a new PIA?

Yes
If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

07/01/2012
*2. OPDIV Name:

National Institute on Drug Abuse (NIDA)
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200
*5. OMB Information Collection Approval Number:

TBD
*6. Other Identifying Number(s):

8954
*7. System Name (Align with system item name):

PATH IMS – Core Systems
*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

Point of Contact Information

Dr. Kevin Paul Conway
NSC BG RM 5185
6001 EXECUTIVE BLVD
ROCKVILLE MD 20852
(301) 402-1817
[email protected]
*10. Provide an overview of the system:

The PATH IMS includes a set of core applications that collect and store research and study operations data, including study participants’
PII as needed to identify, contact, and follow-up with participants. These applications include: the Home Office Management System
(HMS), the Basic Field Operating Systems (BFOS/IMS and BFOS/SMS), the Multi-Mode Manager (M3), Blaise® survey instruments, the
Blaise Editing System (BES), and the BMC Remedy Magic (Secure Instance). The HMS tracks overall information about the study sample,
the status of field activities, and the status of study participants as the study protocol unfolds. The BFOS/IMS (Interviewer Management
System) allows field interviewers to manage their cases, launch data collection instruments, record contacts and contact attempts, and
record study activity completion statuses. The BFOS/SMS (Supervisor Management System) allows field supervisors to assign cases to

Page 1 of 19

interviewers and track field activity in detail. The M3 is a data transport layer that allows flexible, secure communication between HMS,
BFOS, and other applications that collect or generate study data in different modes. Blaise is a commercial survey instrumentation
platform which Westat uses to develop and deploy the PATH data collection instruments. Blaise itself is a tool; it is the Blaise instruments
that collect the data, which is stored in secure databases. The BES is a back-end system used to review and clean data collected by the
Blaise instruments. The Magic application tracks questions, issues, and complaints reported by the public or by participants who call the
PATH 800 number or request information via the PATH website.
Note: According to OMB 07-16M, All agencies MUST participate in government-wide effort to eliminate unnecessary use of and explore alternatives to
agency use of Social Security Numbers as a personal identifier for both Federal employees and in Federal programs.
*13. Indicate if the system is new or an existing one being modified:

New
*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this
system?
Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the
Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by
mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If
the information contained in the system ONLY represents federal contact data (i.e., federal contact name, federal address, federal phone number, and
federal email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA Summary
is required). If the system contains a mixture of federal contact information and other types of PII, the response to Q.17 should be Yes (full PIA is required).

Yes
17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to
Q.17 should be No and only the PIA Summary must be completed.

No
*19. Are records on the system retrieved by 1 or more PII data elements?

Yes
*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

Yes
*23. If the system shares or discloses PII, please specify with whom and for what purpose(s):

N/A
*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system
ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information
contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

For PATH, Westat on behalf of NIDA will collect PII as necessary to identify, screen, enroll, and maintain contact with study participants
and potential participants. The data include name, address, telephone, and other contact information as well as some information critical
to informed consent and other PATH protocol procedures such as date of birth. PII will NOT be disseminated beyond the project in any
form; it is only used to conduct study operations. Any data analyzed by PATH investigators or other authorized investigators will have PII
removed and will have undergone appropriate non-disclosure review and modification. Any PII collected by PATH is strictly voluntary.
Study participants may refuse to answer any question, and may withdraw from participation at any time.
*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes
occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from
individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format
individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]):

Before participants enroll in the study, they are given a detailed written explanation of the study’s purpose, methods, and the uses to
which any information collected will be put. At this time they are asked to sign a written general consent to participate in the study, and
notified that they may withdraw at any time without penalty. Prior to specific study procedures, such as an in-home visit or a blood
collection, study participants are informed of the purpose of the activity and asked for consent again.
Participants will be notified of any substantive change to the system that would have any impact on the original consent(s), and will be
given an opportunity to withdraw their consent. If a participant withdraws from the study, he or she may request that all study data
collected about them up to that time be destroyed, and PATH will comply with that request.
*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of
the presence of PII)

Yes
*37. Does the website have any information or pages directed at children under the age of thirteen?

No
*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and
Destruction section in SORN)

Yes
*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

Page 2 of 19

The following levels of security controls protect PII in the PATH IMS core systems:
1. Only PATH supplied tablet computers with NIST and FIPS-compliant security controls, including whole disk encryption, can
be used to collect or access data in the field.
2. A valid PATH username and password is required to access any PATH core application.
3. Two-factor authentication is required to access central systems containing PII.
4. PII stored in the BFOS/SMS, M3, and HMS database is encrypted.
5. All PATH core applications generate audit logs that contain records for every access activity.
6. Access to the PATH data center is restricted by the Westat Corporate Officer for System Security.
7. A special keycard is required to open a cipher lock to gain access to the Data Center
8. There are video monitors that record activity in the data center.
9. Only authorized personnel who have passed the appropriate level of background investigation may access PII.
10. All PATH staff must take annual computer security awareness training, privacy awareness training, and human subjects
protection training.

Page 3 of 19

PIA REQUIRED INFORMATION

1

HHS Privacy Impact Assessment (PIA)

The PIA determines if Personally Identifiable Information (PII) is contained within a system, what kind of PII, what is done with that information, and how that
information is protected. Systems with PII are subject to an extensive list of requirements based on privacy laws, regulations, and guidance. The HHS Privacy
Act Officer may be contacted for issues related to Freedom of Information Act (FOIA) and the Privacy Act. Respective Operating Division (OPDIV) Privacy
Contacts may be contacted for issues related to the Privacy Act. The Office of the Chief Information Officer (OCIO) can be used as a resource for questions
related to the administrative, technical, and physical controls of the system. Please note that answers to questions with an asterisk (*) will be submitted to the
Office of Management and Budget (OMB) and made publicly available in accordance with OMB Memorandum (M) 03-22.
Note: If a question or its response is not applicable, please answer “N/A” to that question where possible.

2

General Information

*Is this a new PIA?

Yes
If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

7/1/2012
*2. OPDIV Name:

National Institute on Drug Abuse (NIDA)
3. Unique Project Identifier (UPI) Number for current fiscal year (Data is auto-populated from the System Inventory form, UPI table):

TBD
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200
*5. OMB Information Collection Approval Number:

TBD
5a. OMB Collection Approval Number Expiration Date:

TBD
*6. Other Identifying Number(s):

Westat internal project ID 8954
*7. System Name: (Align with system item name)

PATH IMS – Core Systems
8. System Location: (OPDIV or contractor office building, room, city, and state)

System Location:
OPDIV or contractor office building

Westat Inc.
1600 Research Blvd.

Room
City

Rockville

State

MD

*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

Point of Contact Information
POC Name

Dr. Kevin Paul Conway

Page 4 of 19

The following information will not be made publicly available:

POC Title

Deputy Director

POC Organization

National Institute on Drug Abuse

POC Phone

(301) 402-1817

POC Email

[email protected]

*10. Provide an overview of the system: (Note: The System Inventory form can provide additional information for child dependencies if the system is a GSS.)

The PATH IMS includes a set of core applications that collect and store research and study operations data, including study participants’
PII as needed to identify, contact, and follow-up with participants. These applications include: the Home Office Management System
(HMS), the Basic Field Operating Systems (BFOS/IMS and BFOS/SMS), the Multi-Mode Manager (M3), Blaise® survey instruments, the
Blaise Editing System (BES), and the BMC Remedy Magic (Secure Instance). The HMS tracks overall information about the study sample,
the status of field activities, and the status of study participants as the study protocol unfolds. The BFOS/IMS (Interviewer Management
System) allows field interviewers to manage their cases, launch data collection instruments, record contacts and contact attempts, and
record study activity completion statuses. The BFOS/SMS (Supervisor Management System) allows field supervisors to assign cases to
interviewers and track field activity in detail. The M3 is a data transport layer that allows flexible, secure communication between HMS,
BFOS, and other applications that collect or generate study data in different modes. Blaise is a commercial survey instrumentation
platform which Westat uses to develop and deploy the PATH data collection instruments. Blaise itself is a tool; it is the Blaise instruments
that collect the data, which is stored in secure databases. The BES is a back-end system used to review and clean data collected by the
Blaise instruments. The Magic application tracks questions, issues, and complaints reported by the public or by participants who call the
PATH 800 number or request information via the PATH website.
Note: According to OMB 07-16M, All agencies MUST participate in government-wide effort to eliminate unnecessary use of and explore alternatives to
agency use of Social Security Numbers as a personal identifier for both Federal employees and in Federal programs.

Page 5 of 19

SYSTEM CHARACTERIZATION AND DATA CATEGORIZATION

1

System Characterization and Data Configuration

11. Does HHS own the system?

Yes
11a. If no, identify the system owner:

12. Does HHS operate the system? (If the system is operated at a contractor site, the answer should be No)

No
12a. If no, identify the system operator:

Westat Inc.
1600 Research Blvd, Rockville, MD 20850
*13. Indicate if the system is new or an existing one being modified:

New
14. Identify the life-cycle phase of this system:

Acquisition/Development
15. Have any of the following major changes occurred to the system since the PIA was last submitted?

No

Please indicate “Yes” or “No” for each category below:

Yes/No

Conversions

No

Anonymous to Non-Anonymous

No

Significant System Management Changes

No

Significant Merging

No

New Public Access

No

Commercial Sources

No

New Interagency Uses

No

Internal Flow or Collection

No

Alteration in Character of Data

No

16. Is the system a General Support System (GSS), Major Application (MA), Minor Application (child) or Minor Application (stand-alone)?

Major application
*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this
system?

Yes
Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the
Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by
mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If
the information contained in the system ONLY represents business contact data (i.e., business contact name, business address, business phone number,
and business email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA
Summary is required). If the system contains a mixture of business contact information and other types of PII, the response to Q.17 should be Yes (full PIA is
required).
TIP: If the answer to Question 17 is “No” (indicating the system does not contain PII), only the PIA Summary tab questions need to be completed and
submitted. If the system does contain PII, the full PIA must be completed and submitted. (Although note that “Employee systems,” – i.e., systems that collect
PII “permitting the physical or online contacting of a specific individual … employed [by] the Federal Government” – only need to complete the PIA
Summary tab.)

Page 6 of 19

Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category
of PII.

Categories:

Yes/No

Name (for purposes other than contacting federal
employees)

Yes

Date of Birth

Yes

Social Security Number (SSN)

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

Yes

Personal Phone Numbers

Yes

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web Uniform Resource Locator(s) (URL)

No

Personal Email Address

Yes

Education Records

No

Military Status

Yes

Employment Status

No

Foreign Activities

No

Other

No

17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to
Q.17 should be No and only the PIA Summary must be completed.

No
18. Please indicate the categories of individuals about whom PII is collected, maintained, disseminated and/or passed through. Note: If the applicable PII
category is not listed, please use the Other field to identify the appropriate category of PII. Please answer "Yes" or "No" to each of these choices (NA in other
is not applicable).

Categories:

Yes/No

Employees

No

Public Citizen

Yes
Page 7 of 19

Patients

No

Business partners/contacts (Federal, state, local
agencies)

No

Vendors/Suppliers/Contractors

No

Other

No

*19. Are records on the system retrieved by 1 or more PII data elements?

Yes
Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category
of PII.

Categories:

Yes/No

Name (for purposes other than contacting federal
employees)

Yes

Date of Birth

No

SSN

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

Yes

Personal Phone Numbers

Yes

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

Yes

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other

No

20. Are 10 or more records containing PII maintained, stored or transmitted/passed through this system?

Page 8 of 19

Yes
*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

Yes
21a. If yes but a SORN has not been created, please provide an explanation.

N/A

Page 9 of 19

INFORMATION SHARING PRACTICES

1

Information Sharing Practices

22. Does the system share or disclose PII with other divisions within this agency, external agencies, or other people or organizations outside the agency?

No

Please indicate “Yes” or “No” for each category below:

Yes/No

Name (for purposes other than contacting federal
employees)

No

Date of Birth

No

SSN

No

Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

Photographic Identifiers

No

Driver’s License

No

Biometric Identifiers

No

Mother’s Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

No

Personal Phone Numbers

No

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

No

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other

No

*23. If the system shares or discloses PII please specify with whom and for what purpose(s):

N/A
24. If the PII in the system is matched against PII in one or more other computer systems, are computer data matching agreement(s) in place?

N/A
25. Is there a process in place to notify organizations or systems that are dependent upon the PII contained in this system when major changes occur (i.e.,
revisions to PII, or when the system is replaced)?

Page 10 of 19

N/A
26. Are individuals notified how their PII is going to be used?

Yes
26a. If yes, please describe the process for allowing individuals to have a choice. If no, please provide an explanation.

Before participants enroll in the study, they are given a detailed written explanation of the study’s purpose, methods, and the uses to
which any information collected will be put. At this time they are asked to sign a written general consent to participate in the study, and
notified that they may withdraw at any time without penalty. Prior to specific study procedures, such as an in-home visit or a blood
collection, study participants are informed of the purpose of the activity and asked for consent again.
Participants will be notified of any substantive change to the system that would have any impact on the original consent(s), and will be
given an opportunity to withdraw their consent. If a participant withdraws from the study, he or she may request that all study data
collected about them up to that time be destroyed, and PATH will comply with that request.
27. Is there a complaint process in place for individuals who believe their PII has been inappropriately obtained, used, or disclosed, or that the PII is
inaccurate?

Yes
27a. If yes, please describe briefly the notification process. If no, please provide an explanation.

Participants may at any time contact PATH using a toll-free telephone number, which is staffed by a dedicated Support Desk staff.
Complaints received from and issues reported by participants are escalated from the Support Desk to PATH study management and to
NIDA, depending on the nature of the report. Participants may also contact NIDA directly; this information is available on the PATH
website www.pathstudyinfo.gov.
At the NIH level, the Incident Response Team in OD CIO is responsible for the NIH-wide incident response capability. The IRT receives
incident reports from its intrusion detection server and from individuals. The IRT informs the appropriate technical staff in the affected
Institute or Center who take follow-up actions to investigate and respond to the incident.
28. Are there processes in place for periodic reviews of PII contained in the system to ensure the data’s integrity, availability, accuracy and relevancy?

No
28a. If yes, please describe briefly the review process. If no, please provide an explanation.

No data have yet been collected; the system is still in development and testing.
29. Are there rules of conduct in place for access to PII on the system?

Yes
Please indicate "Yes," "No," or "N/A" for each category. If yes, briefly state the purpose for each user to have access:

Users with access to PII

Yes/No/N/A

Purpose

User

Yes Users with specific roles, such as Data

Administrators

Yes Administrators, because of their role in

Collector or Field Supervisor, have access
to PII as needed for study operations (e.g.,
scheduling an appointment with a study
participant)
system operations, security, and network
administration, have privileges that would
allow them to access servers storing PII.
These individuals have all passed
background investigations, taken security
training over and beyond regular users,
and by policy may not use their access
privileges to examine any data other than
system operational data (e.g., error logs
and audit logs) necessary to perform thir
duties.

Page 11 of 19

Developers

Yes Certain developers may require access to

Contractors

Yes One subcontractor to Westat, Hooper

production data, including PII, in order to
diagnose and fix a problem that cannot be
reproduced in Test mode. These
developers are all cleared to see PII if
necessary, and have taken required
security and human subjects protection
training. By policy, these developers may
only access production systems when
requested by operations staff, and access
to production is only granted temporarily
for the duration of the diagnosis/fix/test
cycle.
Holmes, has limited access to participant
contact information for the purpose of
scheduling biospecimen collection visits.
These staff operate under the same
clearance, training, authorization, and
policy constraints that apply to Westat
staff.

Other

NA

*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system
ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information
contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

For PATH, Westat on behalf of NIDA will collect PII as necessary to identify, screen, enroll, and maintain contact with study participants
and potential participants. The data include name, address, telephone, and other contact information as well as some information critical
to informed consent and other PATH protocol procedures such as date of birth. PII will NOT be disseminated beyond the project in any
form; it is only used to conduct study operations. Any data analyzed by PATH investigators or other authorized investigators will have PII
removed and will have undergone appropriate non-disclosure review and modification. Any PII collected by PATH is strictly voluntary.
Study participants may refuse to answer any question, and may withdraw from participation at any time.
*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes
occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from
individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format
individuals will be given notice of consent [e.g., written notice, electronic notice, etc.])

Before participants enroll in the study, they are given a detailed written explanation of the study’s purpose, methods, and the uses to
which any information collected will be put. At this time they are asked to sign a written general consent to participate in the study, and
notified that they may withdraw at any time without penalty. They are given a copy of the consent brochure and the consent signature
page(s) indicating specifically what they have agreed to. Prior to specific study procedures, such as an in-home visit or a blood collection,
study participants are informed of the purpose of the activity and asked for consent again.
Participants will be notified of any substantive change to the system that would have any impact on the original consent(s), and will be
given an opportunity to withdraw their consent. If a participant withdraws from the study, he or she may request that all study data
collected about them up to that time be destroyed, and PATH will comply with that request.

Page 12 of 19

WEBSITE HOSTING PRACTICES

1

Website Hosting Practices

*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of
the presence of PII)

Yes

Please indicate “Yes” or “No” for each Yes/ No
type of site below. If the system hosts
both Internet and Intranet sites,
indicate “Yes” for “Both” only.

If the system hosts an Internet site,
please enter the site URL. Do not
enter any URL(s) for Intranet sites.

Internet

No

Intranet

Yes

Both

Yes

33. Does the system host a website that is accessible by the public and does not meet the exceptions listed in OMB M-03-22?
Note: OMB M-03-22 Attachment A, Section III, Subsection C requires agencies to post a privacy policy for websites that are accessible to the public, but
provides three exceptions: (1) Websites containing information other than "government information" as defined in OMB Circular A-130; (2) Agency intranet
websites that are accessible only by authorized government users (employees, contractors, consultants, fellows, grantees); and (3) National security systems
defined at 40 U.S.C. 11103 as exempt from the definition of information technology (see section 202(i) of the E-Government Act.).

No
34. If the website does not meet one or more of the exceptions described in Q. 33 (i.e., response to Q. 33 is "Yes"), a website privacy policy statement
(consistent with OMB M-03-22 and Title II and III of the E-Government Act) is required. Has a website privacy policy been posted?
(Note: A website privacy policy is required for Internet sites only.)

N/A
35. If a website privacy policy is required (i.e., response to Q. 34 is “Yes”), is the privacy policy in machine-readable format, such as Platform for Privacy
Preferences (P3P)?
(Note: Privacy policy in machine-readable format is required for Internet sites only.)

N/A
35a. If no, please indicate when the website will be P3P compliant:

36. Does the website employ tracking technologies?

Yes

Please indicate “Yes”, “No”, or “N/A” for each type of
cookie below:

Yes/No/N/A

Web Bugs

No

Web Beacons

No

Session Cookies

Yes

Persistent Cookies

No

Other

No

*37. Does the website have any information or pages directed at children under the age of thirteen?

No
37a. If yes, is there a unique privacy policy for the site, and does the unique privacy policy address the process for obtaining parental consent if any
information is collected?

Page 13 of 19

38. Does the website collect PII from individuals?

Yes

Please indicate “Yes” or “No” for each category below:

Yes/No

Name (for purposes other than contacting federal
employees)

Yes

Date of Birth

Yes

SSN
Note: According to OMB 07-16M, All agencies MUST participate in
government-wide effort to eliminate unnecessary use of and explore
alternatives to agency use of Social Security Numbers as a personal
identifier for both Federal employees and in Federal programs.

No

Photographic Identifiers

No

Driver's License

No

Biometric Identifiers

No

Mother's Maiden Name

No

Vehicle Identifiers

No

Personal Mailing Address

Yes

Personal Phone Numbers

Yes

Medical Records Numbers

No

Medical Notes

No

Financial Account Information

No

Certificates

No

Legal Documents

No

Device Identifiers

No

Web URLs

No

Personal Email Address

Yes

Education Records

No

Military Status

No

Employment Status

No

Foreign Activities

No

Other: Employer Name, NIH commons ID, NIH account
ID, Job specialty

No

39. Are rules of conduct in place for access to PII on the website?

Yes
40. Does the website contain links to sites external to HHS that owns and/or operates the system?

No
40a. If yes, note whether the system provides a disclaimer notice for users that follow external links to websites not owned or operated by HHS.

Yes

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ADMINISTRATIVE CONTROLS

1

Administrative Controls

Note: This PIA uses the terms “Administrative,” “Technical” and “Physical” to refer to security control questions—terms that are used in several Federal
laws when referencing security requirements.
41. Has the system been certified and accredited (C&A)?

No
41a. If yes, please indicate when the C&A was completed (Note: The C&A date is populated in the System Inventory form via the responsible Security
personnel):

41b. If a system requires a C&A and no C&A was completed, is a C&A in progress?

C&A is in progress.
42. Is there a system security plan for this system?

Yes
43. Is there a contingency (or backup) plan for the system?

Yes
44. Are files backed up regularly?

Yes
45. Are backup files stored offsite?

Yes
46. Are there user manuals for the system?

Yes
47. Have personnel (system owners, managers, operators, contractors and/or program managers) using the system been trained and made aware of their
responsibilities for protecting the information being collected and maintained?

Yes
48. If contractors operate or use the system, do the contracts include clauses ensuring adherence to privacy provisions and practices?

Yes
49. Are methods in place to ensure least privilege (i.e., “need to know” and accountability)?

Yes
49a. If yes, please specify method(s):

User roles are defined and individuals are assigned to one or more roles. These roles ensure that access privileges are narrowly defined,
and that only those staff members that need certain types of access are granted that access. In addition to limiting functions, physical
access controls limit access to the system.
Accountability is assured through authentication and authorization and the use of audit logs for applications, systems and network
infrastructure components.
*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention
and Destruction section in SORN):

Yes
50a. If yes, please provide some detail about these policies/practices:

PII is never released to the general public or research community at large. If a study participant decides to leave the study, he or she can
request that all his/her data be destroyed, including PII, and the NCS must comply with that request. All PII is encrypted so that even on
backup media, it cannot be accessed directly. Specific policies have not yet been formulated regarding the destruction of PII from the
PATH systems at the end of the study, but it is certain that those policies and procedures will comply with the Privacy Act, and with HHS
and NIH guidelines, and with IRB guidelines.

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TECHNICAL CONTROLS

1

Technical Controls

51. Are technical controls in place to minimize the possibility of unauthorized access, use, or dissemination of the data in the system?

Yes

Please indicate “Yes” or “No” for each category below:

Yes/No

User Identification

Yes

Passwords

Yes

Firewall

Yes

Virtual Private Network (VPN)

Yes

Encryption

Yes

Intrusion Detection System (IDS)

Yes

Common Access Cards (CAC)

Yes

Smart Cards

No

Biometrics

No

Public Key Infrastructure (PKI)

Yes

52. Is there a process in place to monitor and respond to privacy and/or security incidents?

Yes
52a. If yes, please briefly describe the process:

The Westat systems group is responsible for monitoring and responding to any security incident in collaboration with the project. The
systems group employs various tools like network scanners and sniffers and regularly scheduled internal and external agency network
vulnerability scans etc. to stay on top of any security threat. All privacy and/or security incidents, or suspected incidents, must be
reported promptly by the project to the agency.

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PHYSICAL ACCESS

1

Physical Access

53. Are physical access controls in place?

Yes

Please indicate “Yes” or “No” for each category below:

Yes/No

Guards

Yes

Identification Badges

Yes

Key Cards

Yes

Cipher Locks

Yes

Biometrics

No

Closed Circuit TV (CCTV)

Yes

*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

Information is secured on the system through access controls, personnel security awareness and training, regular auditing of information
and information management processes, careful monitoring of a properly accredited information system, control of changes to the system,
by appropriate planning and testing of configuration management and contingency processes, by ensuring that all users of the information
system are properly identified and authorized for access and are aware of and acknowledge the system rules of behavior, by ensuring that
any contingency or incident is handled expeditiously, properly maintaining the system and regulating the environment it operates in, by
controlling media, by evaluating risks and planning for information management and information system operations, by ensuring that the
system and any exchange of information is protected, by maintaining the confidentiality and integrity of the information system, and by
adhering to the requirements established in the contract and statement of work.

Page 17 of 19

APPROVAL/DEMOTION
1

System Information

System Name:

2

PIA Reviewer Approval/Promotion or Demotion

Promotion/Demotion:
Comments:
Approval/Demotion Point
of Contact:
Date:

3

Senior Official for Privacy Approval/Promotion or Demotion

Promotion/Demotion:
Comments:

4

OPDIV Senior Official for Privacy or Designee Approval

Please print the PIA and obtain the endorsement of the reviewing official below. Once the signature has been collected,
retain a hard copy for the OPDIV's records. Submitting the PIA will indicate the reviewing official has endorsed it
This PIA has been reviewed and endorsed by the OPDIV Senior Official for Privacy or Designee (Name and Date):

Name: __________________________________

Date: ________________________________________

Name:
Date:

5

Department Approval to Publish to the Web

Approved for web publishing
Date Published:
Publicly posted PIA URL or no PIA URL explanation:

Page 18 of 19

PIA % COMPLETE
1

PIA Completion

PIA Percentage Complete:
PIA Missing Fields:

Page 19 of 19