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06.1 HHS Privacy Impact Assessment (Form) / NIH NINDS Clinical
Information Management System (CIMS) (Item)
Form Report, printed by: Wright, Verle, Nov 27, 2012
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?
No
If this is an existing PIA, please provide a reason for revision:
PIA Validation
*1. Date of this Submission:
Aug 24, 2012
*2. OPDIV Name:
NIH
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):
09-25-200
*5. OMB Information Collection Approval Number:
N/A
*6. Other Identifying Number(s):
N/A
*7. System Name (Align with system item name):
Clinical Information Management System (CIMS)
*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
Quang Hoang
*10. Provide an overview of the system:
CIMS supports the Clinical Research program of NINDS. It consists of two subsystems, the Clinical Study Information System (CSIS) and
the Protocol Tracking and Management System (PTMS), that store information relevant to the Clinical Research studies of NINDS and
patients involved in those research studies.
*13. Indicate if the system is new or an existing one being modified:
Existing
*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?
TIP: If the answer to Question 17 is “No” (indicating the system does not contain PII), only the remaining 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.)
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.
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*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):
Does not share or disclose PII.
*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:
CIMS supports the Clinical Research program of NINDS. It consists of two subsystems, the Clinical Study Information System (CSIS) and
the Protocol Tracking and Management System (PTMS), that store information relevant to the Clinical Research studies of NINDS and
patients involved in those research studies. Some PII information may be maintained by the CSIS subsystem, but not by PTMS. Submission
of a minimal amount of personal information is required for patients who have volunteered to participate in the clinical studies.
*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.]):
Participants in clinical studies volunteer to participate in the studies and give their written consent to provide PII and medical information.
They are notified of such study requirements when they volunteer for the studies, and they are given information on how the study
information may be used. It is not feasible to obtain further consent for any later changes in the CIMS system.
*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:
Role based security, using authorized user name and password for network access to CIMS. System resides behind a firewall and is in a
server room with no external access. All personal not having card key access are escorted.
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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?
No
If this is an existing PIA, please provide a reason for revision:
PIA Validation
*1. Date of this Submission:
Aug 24, 2012
*2. OPDIV Name:
NIH
3. Unique Project Identifier (UPI) Number for current fiscal year (Data is auto-populated from the System Inventory form, UPI table):
*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):
09-25-200
*5. OMB Information Collection Approval Number:
N/A
5a. OMB Collection Approval Number Expiration Date:
*6. Other Identifying Number(s):
N/A
*7. System Name: (Align with system item name)
Clinical Information Management System (CIMS)
8. System Location: (OPDIV or contractor office building, room, city, and state)
System Location:
OPDIV or contractor office building
NIH Building CRC
Room
CRC/B25750
City
Bethesda
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
Quang Hoang
The following information will not be made publicly available:
POC Title
C&A Manager
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POC Organization
NINDS/DIR/ITP
POC Phone
301-443-2902
POC Email
hoangq@ninds.nih.gov
*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)
CIMS supports the Clinical Research program of NINDS. It consists of two subsystems, the Clinical Study Information System (CSIS) and
the Protocol Tracking and Management System (PTMS), that store information relevant to the Clinical Research studies of NINDS and
patients involved in those research studies.
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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:
Name: Donna Stephenson
Component: National Institutes of Health
Address:
Phone:
Email: Stephedo@nih.ninds.gov
FAX:
12. Does HHS operate the system? (If the system is operated at a contractor site, the answer should be No)
Yes
12a. If no, identify the system operator:
*13. Indicate if the system is new or an existing one being modified:
Existing
14. Identify the life-cycle phase of this system:
Operations/Maintenance
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)?
Minor Application (child)
*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
TIP: If the answer to Question 17 is “No” (indicating the system does not contain PII), only the remaining 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.)
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
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Date of Birth
Yes
Social Security Number (SSN)
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
Yes
Medical Notes
Yes
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
No
Employment Status
No
Foreign Activities
No
Other
None
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.
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
Patients
Yes
Business partners/contacts (Federal, state, local
agencies)
No
Vendors/Suppliers/Contractors
No
Other
None
*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
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Name (for purposes other than contacting federal
employees)
Yes
Date of Birth
Yes
SSN
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
Yes
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
None
20. Are 10 or more records containing PII maintained, stored or transmitted/passed through this system?
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.
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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
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
None
*23. If the system shares or discloses PII please specify with whom and for what purpose(s):
Does not share or disclose PII.
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?
Not Applicable
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)?
Yes
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.
Patients for clinical studies are all volunteers
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?
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Yes
27a. If yes, please describe briefly the notification process. If no, please provide an explanation.
Individuals can contact the coordinator for their study to request changes or file complaints.
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?
Yes
28a. If yes, please describe briefly the review process. If no, please provide an explanation.
The users of CIMS periodically reveiw their information for correctness
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
To support their clinical studies
Administrators
Yes
Only as necessary to support the system
Developers
Yes
Only as necessary to support system
development
Contractors
No
Other
No
*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:
CIMS supports the Clinical Research program of NINDS. It consists of two subsystems, the Clinical Study Information System (CSIS) and
the Protocol Tracking and Management System (PTMS), that store information relevant to the Clinical Research studies of NINDS and
patients involved in those research studies. Some PII information may be maintained by the CSIS subsystem, but not by PTMS. Submission
of a minimal amount of personal information is required for patients who have volunteered to participate in the clinical studies.
*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.])
Participants in clinical studies volunteer to participate in the studies and give their written consent to provide PII and medical information.
They are notified of such study requirements when they volunteer for the studies, and they are given information on how the study
information may be used. It is not feasible to obtain further consent for any later changes in the CIMS system.
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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 type of site below. If the system
hosts both Internet and Intranet
sites, indicate “Yes” for “Both” only.
Yes/ No
Internet
No
Intranet
Yes
Both
No
If the system hosts an Internet site,
please enter the site URL. Do not
enter any URL(s) for Intranet sites.
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?
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)?
Yes
35a. If no, please indicate when the website will be P3P compliant:
36. Does the website employ tracking technologies?
No
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
No
Persistent Cookies
No
Other
*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?
38. Does the website collect PII from individuals?
Yes
Please indicate “Yes” or “No” for each category below:
Yes/No
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Name (for purposes other than contacting federal
employees)
Yes
Date of Birth
Yes
SSN
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
Yes
Medical Notes
Yes
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
None
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.
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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)?
Yes
41a. If yes, please indicate when the C&A was completed:
Jun 5, 2009
41b. If a system requires a C&A and no C&A was completed, is a C&A in progress?
Not Applicable
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):
Audit trails
*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:
NINDS follows the HHS and NIH policies found in:
NIH POLICY MANUAL
2805 - NIH Web Page Privacy Policy
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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)
No
Smart Cards
No
Biometrics
No
Public Key Infrastructure (PKI)
No
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 NINDS SOC monitors and responds to privacy and security incidents, and NINDS follows the NIH IRT's policies and guidelines.
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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
No
Biometrics
No
Closed Circuit TV (CCTV)
No
*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:
Role based security, using authorized user name and password for network access to CIMS. System resides behind a firewall and is in a
server room with no external access. All personal not having card key access are escorted.
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APPROVAL/DEMOTION
1
System Information
System Name:
2
Clinical Information Management System (CIMS)
PIA Reviewer Approval/Promotion or Demotion
Promotion/Demotion:
Promote
Comments:
Approval/Demotion Point
of Contact:
Joellen Harper Austin, Executive Officer, NINDS 301-496-4697
Date:
Aug 24, 2012
3
Senior Official for Privacy Approval/Promotion or Demotion
Promotion/Demotion:
Promote
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:
Karen Plá
Date:
5
Sep 28, 2012
Department Approval to Publish to the Web
Approved for web publishing
Date Published:
No
Sep 1, 2009
Publicly posted PIA URL or no PIA URL explanation:
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PIA % COMPLETE
1
PIA Completion
PIA Percentage Complete:
100.00
PIA Missing Fields:
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| File Type | application/pdf |
| File Title | https://sport.hhs.gov/prosight/Forms/FormsPrint.aspx?ExportPrin |
| Author | wrightve |
| File Modified | 2016-09-26 |
| File Created | 2016-09-26 |