Security and Privacy Language for Information and Information Technology Procurements.docx

Security and Privacy Guide for Information Technology Acquisition v2 Page 1

Security and Privacy Language for Information and Information Technology Procurements Version 2.2 September 7, 2017

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information. Contractor personnel who need to be on-site to perform service and maintenance must be escorted and monitored at all times. A NDA must be signed if services and maintenance requires access PII/PHI or sensitive government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

· Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

· Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

· Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [x] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ x ] Low [ ] Moderate [ ] High

4) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

5) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of

HHS Security and Privacy Language for Information and Information Technology Procurements v2

HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Crimi1nal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

6) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6). .

7) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

8) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

9) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

11) System Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU). Systems that interconnect exchange or share sensitive information need to meet the OMB A-130 requirement that "written management authorization (often in the form of a Memorandum of Understanding or Agreement,) be obtained prior to connecting with other systems and/or sharing sensitive data/information. The written authorization shall detail the rules of behavior and controls that must be maintained by the interconnecting systems." To meet this requirement it is required a System Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) focused on protecting the data exchanged.

An MOU and/or ISA will be required for any remote vendor access the NIHnet in order to ensure adequate security and the protection of the NIHnet.

NIH ISA Template and NIH MOU Template are available at https://ocio.nih.gov/InfoSecurity/Policy/Pages/NIH_ISA_Templates.aspx

1. Requirements for Procurements Involving Privacy Act Records

3.A. Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals.

The disposition to be made of the Privacy Act records upon completion of contract performance is: [OpDiv insert records disposition instructions the contractor and any subcontractor must follow upon completion of contract performance. Needs input from Tricia Coffey who is CC Records Management Liaison for CC.].

3.B. Privacy Incident Handling and Notification

The Contractor (and/or any subcontractor) shall obtain notification instructions and approval from the Contracting Officer prior to notifying individuals whose PII resided in the Contractor (and/or any subcontractor) IT system at the time of the incident. The method and content of any notification by the Contractor shall be compliant with HHS Privacy Incident Response Team (PIRT) Standard Operating Procedures (SOP) (http://intranet.hhs.gov/it/cybersecurity/docs/incident_mgmt/PIRTSOP/pirt_sop.pdf ) and NIH Guidance as well as coordinated and approved by the HHS PIRT in consultation with the Contracting Officer, the NIH SAOP (or his or her designee), and/or Computer Security Incident Response Team (CSIRT). Upon receiving notification and approval from the agency Contracting Officer, the Contractor shall send notifications to affected individuals within [NIH Specific timeline].

(Note: The Contractor (and/or any subcontractor) shall not proceed with any notification to individuals unless the Contracting Officer, in consultation with the HHS PIRT and NIH SAOP, has determined in writing that the Contractor notification is appropriate.)

3.B.1. All determinations related to privacy incidents, including response activities, notifications to affected individuals and/or federal agencies, and related services (e.g., credit monitoring and identity protection) will be made in writing by the Contracting Officer in consultation with the HHS PIRT, NIH CIO, and SAOP (or his or her designee) and in compliance with HHS and/or NIH Guidance.

3.B.2. The Contractor (and/or any subcontractor) shall provide full access and cooperation for all activities determined by the Government to be required to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. Incident response activities determined to be required by the Government may include, but are not limited to, the following:

1. Inspections,

2. Investigations,

3. Forensic reviews, and

4. Data analysis and processing.

3.C. Privacy Act

3.C.1. Privacy Act Notification (FAR Clause 48 CFR § 52.224-1). The Contractor (and/or any subcontractor) shall comply with FAR Clause 48 CFR § 52.224-1 requirements, which can be located at: https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html

3.C.2. Privacy Act (FAR Clause 48 CFR § 52.224-2). The Contractor (and/or any subcontractor) shall comply with FAR Clause 48 CFR § 52.224-2 requirements, which can be located at: https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html

3.C.3. Privacy Act (HHSAR Clause 48 CFR §352.224-70). The Contractor (and/or any subcontractor) shall comply with HHSAR Clause 48 CFR §352.224-70 requirements, which can be located at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-70

1. Standards

1.1 HHS Encryption Standard

All encryption solutions used throughout the Department and referenced throughout this document must be Federal Information Processing Standard (FIPS) 140-2 validated.6 NIH shall ensure FIPS 140-2 validated encryption solutions are available to all users to ensure sensitive data are appropriately secure while at rest and in transit.

2.1.1 Device Encryption

1) Servers that authenticate, store, process, and/or transmit sensitive information shall be encrypted. If server encryption is not technically feasible, all folders and/or files containing sensitive information must be encrypted. The implemented level of encryption must be sufficient to mitigate the risk severity.7

HHS Standard for Encryption of Computing Devices and Information

2.1.2 Information Encryption

All sensitive information at rest and in transit shall be encrypted to safeguard the confidentiality and integrity of information. If encrypting such information is not technically feasible or demonstrably affects the ability of NIH to carry out their respective missions, functions, or operations, the NIH Authorizing Official, in consultation with the Senior Agency Official for Privacy (SAOP) (as applicable)14 must accept the risk and demonstrate that compensatory controls have been implemented to protect sensitive information.

Data at Rest

Sensitive data stored either on GFE or non-GFE (contractor owned) shall be safeguarded in accordance with NIST guidance15 and the HHS Information Security and Privacy Policy (IS2P), as amended, including but not limited to:

· Folders/files containing sensitive PII or other sensitive data stored in shared drive shall be encrypted and the folders configured to restrict access on a need-to-know basis;

· Data backups shall be encrypted and securely transported/filed/archived.

· For high-impact systems, cryptographic mechanisms shall be employed to protect the integrity of audit information (e.g. log, and audit tools).16

Data in Transit

1) Confidentiality and integrity of remote access sessions and sensitive information shall be protected with end-to-end encryption commensurate with the sensitivity level of the data.

2) Email and any attachment that contains sensitive information when transmitted inside and outside of HHS premises shall be encrypted using the user’s Personal Identity

2 Data such as device passwords, configuration settings, or processed jobs may appear to be unreadable but are exploitable if it is not encrypted. See NISTIR 8023 Risk Management for Replication Devices, page 8 for additional information.

3 MDM capabilities include, but are not limited to user administration, geo-location services, remote lock services, remote wipe services, application installation, records retention, eDiscovery, legal hold, and FOIA search and preserve capability.

4 The OMB Circular A-130 Managing Federal Information as a Strategic Resource, https://www.whitehouse.gov/sites/default/files/omb/assets/OMB/circulars/a130/a130revised.pdf.

5 NIST SP 800-111 Guide to Storage Encryption Technologies for End User Devices, November 2007, http://csrc.nist.gov/publications/PubsSPs.html.

6 See HHS IS2P, AU-9(3).

Verification (PIV) card when possible.17 If PIV encryption is not feasible, a FIPS 140-2 validated solution must be employed:

· Password protection of files are recommended to add an additional layer of data protection but shall not be used in lieu of encryption solutions.

· Password and/or encryption key shall not be included in the same email that contains sensitive information or in separate email. Password/encryption key shall be provided to the recipient separately via text message or verbally.

1.2 Websites and Web Services

1) All publicly accessible federal websites and web services shall employ secure connections, such as Hypertext Transfer Protocol Secure (HTTPS). HTTPS may be employed on Intranets but is not explicitly required.21

7 HHS Cybersecurity Program - Encryption, Guide to Outlook Email Encryption Using an HHS PIV card, http://intranet.hhs.gov/it/cybersecurity/enterprise_security/Encryption/index.html.

8 NIST SP 800-56A Recommendation for Pair-Wise Key Establishment Schemes Using Discrete Logarithm Cryptography; SP 800-57 Recommendation for Key Management, NIST SP 800-131A Transitions: Recommendations for Transitioning the Use of Cryptographic Algorithms and Key Lengths; and NIST SP 800-175B Guideline for Using Cryptographic Standards in the Federal Government: Cryptographic Mechanisms; and HHS policy Public Key Infrastructure, http://www.hhs.gov/ocio/securityprivacy/publickey/pki.html.

9 HHS Enterprise Public Key Infrastructure (PKI), http://intranet.hhs.gov/security-pki/index.html#_Enterprise_PKI_Services. 20 OMB Circular A-130, https://www.whitehouse.gov/sites/default/files/omb/assets/OMB/circulars/a130/a130revised.pdf.

21 OMB Memorandum M-15-13 Policy to Require Secure Connections across Federal Websites and Web Services, https://www.whitehouse.gov/sites/default/files/omb/memoranda/2015/m-15-13.pdf.

2) HTTPS is a combination of HTTP and the network protocol Transport Layer Security (TLS), which establishes an encrypted connection to an authenticated peer over an untrusted network. NIH shall use the most current TLS version. TLS shall be implemented and configured in accordance with the recommendation of NIST SP 800-5222 as amended. NIH shall monitor the HHS OCIO website, intranet and other public resources to keep apprised of current best practices.

3) NIH websites and services shall deploy HTTPS in a manner that allows for rapid updates to certificates, cipher choices protocol versions, and other configuration elements.

4) Websites and services available over HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS going forward. This reduces the number of unsecure redirects and protects users against attacks that attempt to downgrade connections to plain HTTP. Once HSTS is in place, domains can be submitted to a “preload list” used by all major browsers to ensure the HSTS policy is in effect at all times.

5) Allowing HTTP connections for the sole purpose of redirecting clients to HTTPS connections shall be acceptable and encouraged. HSTS headers must specify a max- age of at least 1 year.23

1.3 HHS Contracts

All HHS contracts shall include encryption language to ensure contractors and third-party service providers, handling, storing and/or processing government sensitive information, protect such information in accordance with the Federal Acquisition Regulation (FAR), the HHS Acquisition Regulation,24 this Standard, and other HHS policies

1.4 Incident Handling

1) All security and privacy incidents shall be immediately reported to the NIH Security Incident Response Team (CSIRT) and/or NIH Helpdesk. The NIH CSIRT or Help Desk will notify the HHS Computer Security Incident Response Center (CSIRC) after assessing the situation, responding to any immediate requirements, and collecting essential information about the incident.25 These include, but are not limited to:

· Loss or theft of any equipment that contains sensitive information, even if the information and device are encrypted;

· Loss of PIV card or compromised key; and,

· Unencrypted email containing sensitive information is accidently/intentionally transmitted or received.

2) All sensitive incident-related information shall be encrypted at all times.

22 NIST SP 800-52 Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations, http://csrc.nist.gov/publications/PubsSPs.html.

23 OMB M-15-13.

24HHS Acquisition Policies and Guidance Portal, available at: http://intranet.hhs.gov/abouthhs/contracts-grants- support/acquisition/.

25 HHS Computer Security Incident Response Center (CSIRC), http://intranet.hhs.gov/it/cybersecurity/hhs_csirc/index.html.

1.5 Deviations

1) All deviations from these standards must be documented using a risk-based decision and/or waiver request and submitted to and approved by the NIH CISO. Documentation must state a business need for the deviation and the compensating security controls implemented to secure the device and/or information.

2) If government data on mobile computers/devices is determined to be non-sensitive and does not require encryption, determination shall be done in writing by the business/data owner and approved by the NIH CISO or Senior Official for Privacy (SOP).26

26 OMB M-06-16 Protection of Sensitive Agency Information, https://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2006/m06-16.pdf.

1 CC Remote Access Options The following options and associated processes described below are acceptable and approved methods of remote access into Clinical Center IT and medical systems. Responsible parties requesting remote access must meet all required security requirements as listed per the selected option.

Option 1: Non-Persistent Remote Access (e.g. GoToMeeting, WebEx) This option is for ad-hoc or as needed communications that may be needed within NIH or between NIH and external parties where a persistent/continuous connection is not required.

Requirements:

· CC staff must initiate the connection with the external party, monitor activities, retain a log of the external party’s name, date/time and purpose of the connection, and terminate the connection when activities are completed

· NIH technical representative will need to be available for initiating and terminating the connection.

· No ISA/MOU is needed

· PIV or NIH Active Directory (AD) account is NOT required

Option 2: CC CITRIX (Casper) The CC Casper/Citrix option meets NIH Remote Access Standards and can be used for remote access to CC systems. CC Citrix can be accessed via: https://cccasper.cc.nih.gov. No local desktop storage or local printing options are allowed using Citrix remotely. Data can be stored/saved on assigned shared drives if needed.

Requirements:

· Must be sponsored for PIV card, obtain NIH AD Account, and have background investigation completed (see Option 3 for details). In addition, NIH Clinical Center Administrative Account (AA) request must be obtained for remote administration of CC servers (follow CC AA Process).

· If using government furnished equipment (GFE), contact the User Support Team (UST) to obtain PIV card reader for user’s workstation/laptop, and configure workstation

· For Non-GFE personal computers, guidance for configuration of PIV readers and installation of Active Identity is available at https://ocio.nih.gov/Smartcard/Pages/default.aspx

· Must install Citrix Client Software (Citrix Receiver)

· Must contact CC Citrix Team to put user in appropriate group to allow for Citrix use for non-CC users

· May use Citrix to Remote Desktop Protocol (RDP) to access local workstation/server

· ISA/MOU required for vendor remote access to CC systems

Option 3: NIH Virtual Private Network (VPN) The NIH VPN can be used to provide a secure, encrypted connection to the NIH network and resources.

Requirements:

· Must be sponsored by Administrative Officer (AO) to utilize the NIH VPN Identity Services Engine (ISE)

· Must be sponsored for PIV card (through the AO) and obtain NIH AD Account. In addition, NIH Clinical Center Administrative Account (AA) request must be obtained for remote administration of CC servers (follow CC AA Process).

· Must have background investigation completed.

· For general access to the NIH network, users will need Level 1 Non-Sensitive (OPM National Agency Check with Inquiries (NACI) Background Check). Cost is approximately $103 for contract staff. Department sponsoring the contractor is responsible for funding.

· For remote system maintenance and administration, a Level 5 Moderate Risk Public Trust will be necessary. Cost is approximately $2,500 for contract staff.

· Department sponsoring the contractor is responsible for funding.

Note: Background Investigation costs may vary and/or change. Please check with your AO on exact costs.

· Must complete security training: Secure Your Remote Computers training, Annual Security & Privacy refresher training

· GFE (e.g. Laptop) must be issued to the contractor.

· May use NIH VPN to RDP to access local workstation/server

· ISA/MOU is required for vendor remote access to CC systems

Option 4: CC VPN The CC VPN, managed by the CC DCRI Network Administrator team, is used to allow remote administration of CC servers that are behind the Clinical Center firewall(s)\.

Requirements:

· Must be sponsored for PIV card, obtain NIH AD Account, and have background investigation completed (see Option 3 for details)

· GFE (e.g. laptop) must be issued to contractor

· PMO office and/or senior management will validate or sponsor any vendor request and will send the request to the DCRI Network Admin team to provide remote CC VPN access.

· Specific background configuration of the CC managed firewall(s) by the DCRI Network Admin team is needed to allow access to resources. All devices are not given access to CC VPN by default.

· ISA/MOU is required for vendor remote access to CC systems

Option 5: Vendors with larger maintenance support staff (over 10 or more) for use of NIH VPN (Option 3) or CC VPN (Option 4) This option is for vendors who have a large rolling staff that would like to use NIH VPN (Option

3) or CC VPN (Option 4).

· Vendor selects limited staff members (2 to 5 contractors) to support Clinical Center systems

· Vendor limited staff members must be sponsored by Administrative Officer (AO) as stated in Option 3 or 4.

· Vendor limited staff members must access NIH system via option 2, 3 or 4 (as defined above)

· Vendor limited staff members must initiate the connection

· Vendor limited staff members must monitor all actions

· Vendor limited staff members must terminate the connection

· Vendor limited staff members will be held responsible for any actions taken by other vendor staff during that session

· Vendor limited staff members must keep a log of the name, role, and actions taken by the other vendor staff; this log may be requested at any time by the NIH

Option 6: Waiver Process Deviations to this policy and the NIH Remote Access Standard shall be addressed through the CC Waiver process.

1. System owner shall email the CC Information Security Office (ccsecurity@mail.nih.gov) for a review of the CC Waiver Process.

2. System owner shall write a summary that includes a review of each of the options and a justification of why Options 1-5 are not possible for the respective system. The summary shall include alternate proposed remote access solution(s).

3. System owner shall schedule a meeting with the CC CISO and the C CIO to review the written summary.

4. If a temporary waiver is approved, the system owner shall follow the CC Waiver Process to create and complete the waiver.

5.

APPENDIX A: NIH Remote Access Standard

NIH Remote Access Standard

Purpose: This standard establishes requirements to ensure that NIH information technology (IT) resources are appropriately protected when authorized staff remotely access the NIH network.

Scope: All NIH IT resources, whether maintained by the NIH or by a contractor on behalf of the NIH; the NIH enterprise remote access service; IC-managed remote access solutions that have been approved (as exceptions) by the NIH Chief Information Security Officer (CISO); and wireless remote access to the NIH network via laptops (which must also meet the requirements in the NIH Wireless Network Security Standard). Mobile devices such as smart phones and tablets are addressed under the NIH Mobile Device Security Standard.

Standard:

1. The NIH enterprise remote access service is preferred, and is available for all Institutes and Centers (IC).

2. If the IC has a business need that cannot be satisfied by the NIH enterprise method, the IC may establish a remote access method (with approval by the CISO) that meets the following requirements: a. The remote access service must require Personal Identity Verification (PIV) authentication for connection.

b. The remote access service must reside in a public-facing network segment or DMZ.

c. All remote access logs must be forwarded to the NIH enterprise logging solution.

Compliance: Where deviations from this standard are necessary, requests for exceptions should be submitted through the IRT Portal at https://irtportal.ocio.nih.gov/, and will be evaluated by the NIH CISO.

APPENDIX B: System Monitoring by External Vendors The NIH Clinical Center recognizes the need to enable system monitoring by external vendors to support and maintain medical devices and/or other systems for performance, health checks, or other reasons to ensure the availability of critical equipment for patient care.

The purpose of the document above, NIH Clinical Center Policy for Remote Access to IT & Medical Systems Policy, is to establish streamlined and acceptable methods of remote access by vendors into internal NIH resources for maintenance and troubleshooting purposes when human intervention is required.

This document was developed to establish acceptable methods of monitoring system health and status on NIH CC systems via vendor systems where the connection is purely from CC systems to vendor systems and no human intervention is required. The options listed below ensure the security posture of the NIH network, while enabling system monitoring from an external site to CC systems.

Figure 1 Site to Site VPN

Option 1: Site-to-Site VPN for Bi-directional Communication This option is for a business need to have persistent bi-lateral communication between Clinical Center systems and external vendor systems

Requirements:

· Must have Interconnection Security Agreements (ISAs) and Memorandum of Understanding (MOUs) prior to VPN activation

· The agreement with the vendor must specify any reporting caveats and explicitly state that the connection is strictly System-to-System for monitoring device health and status

· Must have an approved firewall waiver on file to open ports to the external vendor

· Source and destination of the traffic must be limited to a specific IP address, IP range, ports, and/or VLAN

· The connections must utilize FIPS 140-2 validated encryption and restricted to specific ports, as well as direction

· Remote access logs must be forwarded to the NIH enterprise Security Information and Event Management (SIEM) solution

· The vendor must limit access to NIH data stored on vendor systems to authorized personnel with a valid need to view/access the data

· The vendor must ensure all NIH data stored on vendor systems are protected and secured adequately based on the classification of the data

· Information transmitted outside the NIH network must be minimized to include only the necessary data required for monitoring

· System Owner shall consult with the CC Information Security Office if transmitting sensitive, PHI, or PII data outside the NIH network

Figure 2 One-directional Connection

Option 2: One-directional Remote Monitoring and/or Alerting Remote system monitoring using agents or third party software to transmit health, status and/or alert information.

Requirements:

· Internal component (agent or third party utility) sends status/health check type of information to a specific vendor destination/system

· Must have an approved firewall waiver on file to open specific ports to the external vendor

· Source and destination of the traffic must be limited to a specific IP address, IP range, port, and/or VLAN

· Traffic must be one way (from internal NIH to the vendor), utilize Federal Information Processing Standards (FIPS) 140-2 validated encryption and restricted to specific ports

· Remote access logs must be forwarded to the NIH enterprise Security Information and Event Management (SIEM) solution

· The vendor must limit access to NIH data stored on vendor systems to authorized personnel with a valid need to view/access the data

· The vendor must ensure all NIH data stored on vendor systems are protected and secured adequately based on the classification of the data

· Information transmitted outside the NIH network must be minimized to include only the necessary data required for monitoring

· System Owner shall consult with the CC Information Security Office if transmitting sensitive, PHI, or PII data outside the NIH network

Figure 3 Intermediary Repository Connection

Option 3: Intermediary Repository for Hosting System Monitoring Data Use of an intermediate repository, located behind the NIH perimeter firewall, to receive and store the system monitoring data from the NIH CC medical device. The vendor system is responsible for initiating the connection to view the information from the NIH CC repository system.

Requirements:

· Internal component (agent or third party utility) must be able to write system health and monitoring data to a repository

· Vendor must be able to use secure authentication to view data from CC repository system located behind the NIH perimeter firewall (preferably in the CC DMZ)

· Must have an approved firewall waiver on file to open ports to the external vendor

· Source and destination of the traffic must be limited to a specific IP address, IP range, ports, and/or VLAN

· The connections must utilize FIPS 140-2 validated encryption and restricted to specific ports, as well as direction

· Remote access logs must be forwarded to the NIH enterprise Security Information and Event Management (SIEM) solution

· The vendor must limit access to NIH data stored on vendor systems to authorized personnel with a valid need to view/access the data

· The vendor must ensure all NIH data stored on vendor systems are protected and secured adequately based on the classification of the data

· Information transmitted outside the NIH network must be minimized to include only the necessary data required for monitoring

· System Owner shall consult with the CC Information Security Office if transmitting sensitive, PHI, or PII data outside the NIH network image2.png image3.png image3.jpeg image9.jpeg image1.jpeg image4.jpeg image5.jpeg image6.jpeg image60.jpeg image7.jpeg image70.jpeg