HomeMy WebLinkAboutRES 19-139RESOLUTION NO. 19-139
BE IT RESOLVED BY THE CITY COUNCIL OF THE
CITY OF BEAUMONT:
THAT the City Manager or the Chief Financial Officer be and they are hereby authorized
to execute a Memorandum of Understanding between the City of Beaumont and the
Texas Department of State Health Services (DSHS) in an effort to establish the roles
and responsibilities regarding medications available through DSHS Inventory Tracking
Electronic Asset Management System (ITEAMS) platform for the outpatient treatment of
sexually transmitted diseases (STD) and Tuberculosis (TB) services. The Memorandum
of Understanding is substantially in the form attached hereto as Exhibit "A" and made a
part hereof for all purposes.
The meeting at which this resolution was approved was in all things conducted in
strict compliance with the Texas Open Meetings Act, Texas Government Code, Chapter
551.
PASSED BY THE CITY COUNCIL of the City of Beaumont this the 9th day of
July, 2019.
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DEPARTMENT OF STATE HEALTH SERVICES
MEMORANDUM OF UNDERSTANDING
This Memorandum of Understanding, (the "MOU"), is entered into by and between the
Department of State Health Services ("DSHS"), an agency of the State of Texas, and the
Beaumont Public Health Department ("Clinic"), (collectively, the "Parties"), in the effort to set
out the roles and responsibilities between the Parties regarding medications available through
DSHS Inventory Tracking Electronic Asset Management System (1TEAMS) platform to treat
and control the spread of infectious disease across Texas to achieve improved public health
outcomes.
RECI'T'ALS
WHEREAs, DSHS purchases medications with state and federal funds allocated to DSHS for
specific public health purposes, and are to be administered or dispensed in compliance with
federal program regulations;
WHEREAS, the Clinic obtains medications through the rMAMS platform for the outpatient
treatment of sexually transmitted diseases (STD) or for tuberculosis (TB) services; and
WHEREAS, for the TB medications, this MOU only applies to local health departments and
entities who are pre -authorized to order medications for TB services.
Now THEREFORE, in consideration of the mutual promises set forth herein and other good and
valuable consideration, the sufficiency of which is hereby acknowledged, the Parties agree as
follows:
A. The Clinic must ensure medications are used only for the treatment of STDs and TB;
B. The Clinic must ensure STD medications are used only for uninsured or underinsured
patients as defined by DSHS;
C. The Clinic must distribute medications at no charge to the patient;
D. The Clinic must not seek third party reimbursement, including Medicaid reimbursement,
for the medications that are provided at no cost to the clinic;
EXHIBIT "A"
E. The Clinic must ensure that medications are not sold or exchanged for profit to another
individual or entity for any reason
F. The Clinic must have a Class D Pharmacy license. Clinics without a Class D Pharmacy
license are only permitted to order medications under a physician's license for direct
administration to patients onsite in the clinic.
G. The Clinic must have a designate staff member who oversees the ordering, provision,
reconciliation, and reporting of medications obtained through the ITEAMS platform.
Reconciliation of medications must occur on a monthly basis, as defined by the DSHS
Pharmacy Branch
H. The Clinic must have manual or electronic tracking procedures to demonstrate that all
ITEAMS medications administered or dispensed have been appropriately provided to an
eligible recipient of clinical services in an outpatient setting.
I. The Clinic must maintain records containing information that would establish appropriate
use of medications can be requested and audited in an internal review at any time to ensure
compliance. Records include, but are not limited to, billing records, medication tracking
logs, and relevant patient records.
J. The Clinic must ensure medications for the treatment of STDs comply with current policies
and procedures outlined by the DSHS HIV/STD Program, which can be accessed at:
https://www.dshs.texas.gov/liivstd/Solig LI.
K. The Clinic must ensure medication for TB services must comply with current policies and
procedures outlined by the DSHS Tuberculosis and Hansen's Disease Branch in the Texas
Tuberculosis Work Plan, which can be accessed at:
haps•//www dshs texas gzov/idcu/disease/tb/policies/.
I. Term of the MOU.
This MOU begins upon the first date on which it has been executed by both Parties and ends
on August 31, 2021
H. Authority.
DSHS enters into this MOU under the authority of Health and Safety Code, Chapter 1001.
III. Amendments.
Amendments to this MOU shall be in writing and signed by the Parties.
IV. Termination of MOU.
V.
VI.
Either Department of State Health Services or Beaumont Public Health Department may
terminate this MOU with written notice of thirty days prior to the date of termination.
Confidentiality.
Information exchanged pursuant to this MOU will be exchanged only in accordance to the
attached DUA.
Primary Contacts.
All communications between the Parties shall be made through the primary contacts or their
designees to the maximum extent possible. The primary contacts are:
For: Department of State Health Services
Pharmacy Branch
DSHS Medications
Phone: 512-776-7500
STD Nurse Consultant
Pamela Mathie, MSN, RN
Phone: (512) 533-3118
Email: pamela mathie(cr)dshs.texas.gov
TB Contract Manager
Ebony White
Phone: (512) 776-2152
Email: ebony whitePdshs.texas.gov
Department of State Health Services
PO Box 149347
Austin, TX 78714
VII. Entire Agreement.
For: Beaumont Public Health
Department
STD Nurse
Kathryn Williams
Phone: (409) 654-3618
Email:
kathryn,williams@beaumonttexas.gov
TB Nurse
Kathryn Williams
Phone: (409) 654-3618
Email:
kathryn.williams@beaumonttexas.gov
Beaumont Public Health Department
3040 College Street
Beaumont, TX 77701
The parties acknowledge that this MOU, including the incorporated attachments, is the entire
agreement of the Parties and that there are no agreements or understandings, written or oral,
between them with respect to the subject matter of this MOU, other than as set forth in this
MOU.
By signing below, the Parties acknowledge that they have read the MOU and agree to its
terms, and that the persons whose signatures appear below have the requisite authority to
execute this MOU on behalf of the named party.
DEPARTMENT OF STATE HEALTH
SERVICES
By:
Signature of Authorized Official
BEAUMONT PUBLIC HEALTH DEPARTMENT
By:
Signature of Authorized Official
Date Date
AHS DATA USE AGREEMENT
This Data Use Agreement ("DUA"), effective as of the date the Base Contract into which
it is incorporated is signed ("Effective Date"), is entered into by and between a Texas Health and.
Human Services Enterprise agency ("HHS"), and the Contractor identified in the Base Contract, a
political subdivision of the State of Texas ("CONTRACTOR.
ARTICLE 1.
PURPOSE; APPLICABILITY; ORDER OF PRECEDENCE
The purpose of this DUA is to facilitate creation, receipt, maintenance, use, disclosure or
access to Confidential Information with CONTRACTOR, and describe CONTRACTOR's rights
and obligations with respect to the Confidential Information. 45 CFR 164.504(e)(1)-(3). This DUA
also describes HHS's remedies in the event of CONTRACTOR's noncompliance with its
obligations under this DUA. This DUA applies to both Business Associates and contractors who
are not Business Associates who create, receive, maintain, use, disclose or have access to
Confidential Information on behalf of HHS, its programs or clients as described in the Base
Contract.
As of the Effective Date of this DUA, if any provision of the Base Contract, including any
General Provisions or Uniform Terms and Conditions, conflicts with this DUA, this DUA controls.
ARTICLE 2.
DEFINITIONS
For the purposes of this DUA, capitalized, underlined terms have the meanings set forth in
the following: Health Insurance Portability and Accountability Act of 1996, Public Law 104-191(42
U.S.C. §1320d, et seq.) and regulations thereunder in 45 CFR Parts 160 and 164, including all
amendments, regulations and guidance issued thereafter; The Social Security Act, including Section
1137 (42 U.S.C. §§ 1320b-7), Title XVI of the Act; The Privacy Act of 1974, as amended by the
Computer Matching and Privacy Protection Act of 1988, 5 U.S.C. § 552a and regulations and
guidance thereunder; Internal Revenue Code, Title 26 of the United States Code and regulations and
publications adopted under that code, including IRS Publication 1075; OMB Memorandum 07-18;
Texas Business and Commerce Code Ch. 521; Texas Government Code, Ch. 552, and Texas
Government Code §2054.1125. In addition, the following terms in this DUA are defined as follows:
"Authorized Purpose" means the specific purpose or purposes described in the Statement
of Work of the Base Contract for CONTRACTOR to fulfill its obligations under the Base Contract,
or any other purpose expressly authorized by HHS in writing in advance.
"Authorized User" means a Person:
(1) Who is authorized to create, receive, maintain, have access to, process, view,
handle, examine, interpret, or analyze Confidential Information pursuant to this DUA;
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(2) For whom CONTRACTOR warrants and represents has a demonstrable need to
create; receive, maintain, use, disclose or have access to the Confidential Information; and
(3) Who has agreed in writing to be bound by the disclosure and use limitations
pertaining to the Confidential Information as required by this DUA.
"Confidential Information" means any communication or record (whether oral, written,
electronically stored or transmitted, or in any other form) provided to or made available to
CONTRACTOR, or that CONTRACTOR may, for an Authorized Purpose, create, receive, maintain,
use, disclose or have access to, that consists of or includes any or all of the following:
(1) Client Information;
(2) Protected Health Information in any form including without limitation, Electronic
Protected Health Information or Unsecured Protected Health Information (herein "PHP');
(3) Sensitive Personal Information defined by Texas Business and Commerce Code
Ch. 521;
(4) Federal Tax Information;
(5) Individually Identifiable Health Information as related to HIPAA, Texas HIPAA
and Personal Identifying; Information under the Texas Identity Theft Enforcement and Protection
Act;
(6) Social Security Administration Data, including, without limitation, Medicaid
information;
(7) All privileged work product;
(8) All information designated as confidential under the constitution and laws of the
State of Texas and of the United States, including the Texas Health & Safety Code and the Texas
Public Information Act, Texas Government Code, Chapter 552.
"Legally Authorized Representative" of the Individual, as defined by Texas law, including
as provided in 45 CFR 435.923 (Medicaid); 45 CFR 164.502(g)(1) (HIAA); Tex. Occ. Code §
151.002(6); Tex. H. & S. Code § 166.164; and Estates Code Ch. 752.
ARTICLE 3.
CONTRACTOR'S DUTIES REGARDING CONFIDENTIAL INFORMATION
3.01 Obligations of CONTRACTOR
CONTRACTOR agrees that:
(A) CONTRACTOR will exercise reasonable care and no less than the same
degree of care CONTRACTOR uses to protect its own confidential, proprietary and trade
secret information to prevent any portion of the Confidential Information from being used in
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a manner that is not expressly an Authorized Purpose under this DUA or as Required by Law.
45 CFR 164.502(b)(1); 45 CFR 164.514(d)
(B) Except as Required by Law, CONTRACTOR will not disclose or allow access
to any portion of the Confidential Information to any Person or other entity, other than
Authorized User's Workforce or Subcontractors (as defined in 45 CFR. 160.103) of
CONTRACTOR who have completed training in confidentiality, privacy, security and the
importance of promptly reporting any Event or Breach to CONTRACTOR's management, to
carry out CONTRACTOR's obligations in connection with the Authorized Purpose.
HHS, at its election, may assist CONTRACTOR in training and education on specific or
unique HHS processes, systems and/or requirements. CONTRACTOR will produce
evidence of completed training to HHS upon request. 45 C.F.R. 164.308(a)(5)(i); Texas
Health & Safety Code §181.101
(C) CONTRACTOR will establish, iwnplement and maintain appropriate
sanctions against any member of its Workforce or Subcontractor who fails to comply with this
DUA, the Base Contract or applicable law. CONTRACTOR will maintain evidence of
sanctions and produce it to HHS upon request.45 C.F.R. 164.308(a)(1)Cd)(C); 164.530(e);
164.410(h); 164.530(h)(1)
(D) CONTRACTOR will not, except as otherwise permitted by this DUA,
disclose or provide access to any Confidential Information on the basis that such act is
Required by Law without notifying either HHS or CONTRACTOR's own legal counsel to
determine whether CONTRACTOR should object to the disclosure or access and seek
appropriate relief. CONTRACTOR will maintain an accounting of all such requests for
disclosure and responses and provide such accounting to HHS within 48 hours of HHS'
request. 45 CFR 164.504(e)(2)(ui)(A)
(E) CONTRACTOR will not attempt to re-identify or further identify
Confidential Information or De-identified Information, or attempt to contact any Individuals
whose records are contained in the Confidential Information except for an Authorized
ose, without express written authorization from HHS or as expressly permitted by the
Base Contract. 45 CFR 164.502(d)(2) (iand (U) CONTRACTOR will not engage in
prohibited marketing or sale of Confidential Information. 45 CFR 164.501, 164.508(a)(3)
and (4); Texas Health & Safety Code Ch.181.002
(F) CONTRACTOR will not permit, or enter into any agreement with a
Subcontractor to, create, receive, maintain, use, disclose, have access to or transmit
Confidential information to carry out CONTRACTOR's obligations in connection with the
Authorized Purpose on behalf of CONTRACTOR, unless Subcontractor agrees to comply
with all applicable laws, rules and regulations. 45 CFR 164.502(e)(1)(ii); 164.504(e)(1)r)
and (2).
(G) CONTRACTOR is directly responsible for compliance with, and enforcement
of, all conditions for creation, maintenance, use, disclosure, transmission and Destruction of
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Confidential Information and the acts or omissions of Subcontractors as may be reasonably
necessary to prevent unauthorized use. 45 CFR 164.504(e)(5); 42 CFR 431.300, et seq.
(M If CONTRACTOR maintains PHI in a Designated Record Set which is
Confidential Information and subject to this Agreement, CONTRACTOR will make PHI
available to HHS in a Designated Record Set upon request. CONTRACTOR will provide PHI
to an Individual, or Legally Authorized Representative of the Individual who is requesting
PHI in compliance with the requirements of the HIPAA Privacy RegWations.
CONTRACTOR will release PHI in accordance with the HIPAA Privac�Regulations upon
receipt of a valid written authorization. CONTRACTOR will make other Confidential
Information in CONTRACTOR's possession available pursuant to the requirements of
HIPAA or other applicable law upon a determination of a Breach of Unsecured PHI as defined
in HIPAA. CONTRACTOR will maintain an accounting of all such disclosures and provide
it to HHS within 48 hours of HHS' request. 45 CFR 164, 524and 164.504(e)(2)(Y)(E).
(n If PHI is subject to this Agreement, CONTRACTOR will make PER as
required by HIPAA available to HHS for review subsequent to CONTRACTOR's
incorporation of any amendments requested pursuant to HIPAA. 45 CFR
164 504(e)(2)(U)(E) and (F),
(J) • If PHI is subject to this Agreement, CONTRACTOR will document and make
available to HHS the PHI required to provide access, an accounting of disclosures or
amendment in compliance with the requirements ofthe H1PAA Privacy Regulations, 45 CFR
164.504(e)(2)(U)(G) and 164528.
(K) If CONTRACTOR receives a request for access, amendment or accounting
of PHI from an individual with a right of access to information subject to this DUA, it will
respond to such request in compliance with the HIPAA Privacy Regulations.
CONTRACTOR will maintain an accounting of all responses to requests for access to or
amendment of PHI and provide it to HHS within 48 hours of HHS' request. 45 CFR
164.504(e)(2).
(L) CONTRACTOR will provide, and will cause its Subcontractors and agents
to provide, to HHS periodic written certifications of compliance with controls and
provisions relating to information privacy, security and breach notification, including
without limitation information related to data transfers and the handling and disposal of
Confidential Information. 45 CFR .164.308; 164.530(c); 1 TAC 202.
(NI) Except as otherwise limited by this DUA, the Base Contract, or law
applicable to the Confidential Information, CONTRACTOR may use PHI for the proper
management and administration of CONTRACTOR or to carry out CONTRACTOR's
legal responsibilities. Except as otherwise limited by this DUA, the Base Contract, or law
applicable to the Confidential Information, CONTRACTOR may disclose PHI for the
proper management and administration of CONTRACTOR, or to carry out
CONTRACTOR's legal responsibilities, if: 45 CFR 164.504(e)(4)(A).
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(1) Disclosure is Required bylaw, provided that CONTRACTOR complies with
Section 3.01(D); or
(2) CONTRACTOR obtains reasonable assurances from the person or entity to
which the information is disclosed that the person or entity will: '
(a)Maintain the confidentiality of the Confidential Information in accordance
with this DUA;
(b) Use or further disclose the information only as Required by Law or for
the Authorized Purpose for which it was disclosed to the Person; and
(c)Notify CONTRACTOR in accordance with Section 4.01 of any Event or
Breach of Confidential Information of which the Person discovers or should have
discovered with the exercise of reasonable diligence. 45 CFR
164.504(e)(4)(ii)(B).
(l) Except as otherwise limited by this DUA, CONTRACTOR will, if required
by law and requested by HHS, use commercially reasonable efforts to use PHI to provide data
aggregation services to HHS, as that term is defined in the HIPAA, 45 C.F.R. § 164.501 and
permitted by HIPAA. 45 CFR 164 504(e)(2)(1)(B)
(0) CONTRACTOR will, on the termination or expiration of this DUA or the
Base Contract, at its expense, send to HHS or Destroy, at HHS's election and to the extent
reasonably feasible and permissible by law, all Confidential Information received from HHS
or created or maintained by CONTRACTOR or any of CONTRACTOR 's agents or
Subcontractors on HHS's behalf if that data contains Confidential Information.
CONTRACTOR will certify in writing to HHS that all the Confidential Information that has
been created, received, maintained, used by or disclosed to CONTRACTOR, has been
Destroyed or sent to HHS, and that CONTRACTOR and its agents and Subcontractors have
retained no copies thereof Notwithstanding the foregoing, HHS acknowledges and agrees
that CONTRACTOR is not obligated to send to HHSC and/or Destroy any Confidential
Information if federal law, state law, the Texas State Library and Archives Commission
records retention schedule, and/or a litigation hold notice prohibit such delivery or
Destruction. If such delivery or Destruction is not reasonably feasible, or is impermissible by
law, CONTRACTOR will immediately notify HHS of the reasons such delivery or
Destruction is not feasible, and agree to extend indefinitely the protections of this DUAto the
Confidential Information and limit its further uses and disclosures to the purposes that make
the return delivery or Destruction of the Confidential Information not feasible for as long as
CONTRACTOR maintains such Confidential Information. 45 CFR 164.504(e)(2)(U)(J)
(P) CONTRACTOR will create, maintain, use, disclose, transmit or Destro
Confidential Information in a secure fashion that protects against any reasonably anticipated
threats or hazards to the security or integrity of such information or unauthorized uses. 45
CFR 164.306;164.530(c)
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(Q) If CONTRACTOR accesses, transmits, stores, and/or maintains Confidential
Information, CONTRACTOR will complete and return to HHS at
infosecurity&hse.state.tx.us the HHS information security and privacy initial inquiry (SPI)
at Attachment 1 . The SPI identifies basic privacy and security controls with which
CONTRACTOR must comply to protect HEIS Confidential Information. CONTRACTOR
will comply with periodic security controls compliance assessment and monitoring by HHS
as required by state and federal law, based on the type of Confidential Information
CONTRACTOR creates, receives, maintains, uses, discloses or has access to and the
Authorized Purpose and level of risk. CONTRACTOR's security controls will be based on
the National Institute of Standards and Technology (NIST) Special Publication 800-53.
CONTRACTOR will update its security controls assessment whenever there,are significant
changes in security controls for HHS Confidential Information and will provide the updated
document to HHS. HHS also reserves the right to request updates as needed to satisfy state
and federal monitoring requirements. 45 CFR 164.306.
(R) CONTRACTOR will establish, implement and maintain reasonable
procedural, administrative, physical and technical safeguards to preserve and maintain the
confidentiality, integrity, and availability of the Confidential Information, and with respect to
PHI, as described in the HIPAA Privacy and Security Reppulations, or other applicable laws
or regulations relating to Confidential Informationto prevent any unauthorized use or
disclosure of Confidential Information as long as CONTRACTOR has such Confidential
Information in its actual or constructive possession. 45 CFR 164.308 (administrative
safeguards); 164.310 (physical , safeguards); 164.312 (technical safeguards);
164.530(c)(privacy safeguards),
(S) CONTRACTOR will designate and identify, a Person or Persons, as Privacy
Official 45 CFR 164.530(a)(1) and Information Security Official, each of whom is authorized
to act on behalf of CONTRACTOR and is responsible for the development and
implementation of the privacy and security requirements in this DUA. CONTRACTOR will
provide name and current address, phone number and e-mail address for such designated
officials to HHS upon execution of this DUA and prior to any change. If such persons fail to
develop and implement the requirements of the DUA, CONTRACTOR will replace them
upon HHS request. 45 CFR 164.308(a)(2).
(T) CONTRACTOR represents and warrants that its Authorized Users each have
a demonstrated need to know and have access to Confidential Information solely to the
minimum extent necessary to accomplish the Authorized Purpose pursuant to this DUA and
the Base Contract, and further, that each has agreed in writing to be bound by the disclosure
and use limitations pertaining to the Confidential Information contained in this DUA. 45
CFR 164.502;164 514(d).
([J) CONTRACTOR and its Subcontractors will maintain an updated, complete,
accurate and numbered list of Authorized Userstheir signatures, titles and the date they
agreed to be bound by the terms of this DUA, at all times and supply it to HHS, as directed,
upon request.
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(V) CONTRACTOR will implement, update as necessary, and document
reasonable and appropriate policies and procedures for privacy, security and Breach of
Confidential Information and an incident response plan for an Event or Breach, to comply
with the privacy, security and breach notice requirements of this DUA prior to conducting
work under the Statement of Work. 45 CFR 164.308,164.316; 164.514(d); 164.530(i)(1).
(W) CONTRACTOR will produce copies of its information security and privacy
policies and procedures and records relating to the use or disclosure of Confidential
Information received from, created by, or received, used or disclosed by CONTRACTOR for
an Authorized Purpose for HHS's review and approval within 30 days of execution of this
DUA and upon request by HHS the following business day or other agreed upon time frame.
45 CFR 164.308, 164.514(d).
(X) CONTRACTOR will make available to HHS any information HHS requires
to fulfill HHS's obligations to provide access to, or copies of, PHI in accordance with HIPAA
and other applicable laws and regulations relating to Confidential Information.
CONTRACTOR will provide such information in a time and manner reasonably agreed upon
or as designated by the Secretary of the U.S. Department of Health and Human Services, or
other federal or state law. 45 CFR 164.504(e)(2)(i)(7).
(Y) CONTRACTOR will only conduct secure transmissions of Confidential
Information whether in paper, oral or electronic form, in accordance with applicable rules,
regulations and laws. A secure transmission of electronic Confidential Information in motion
includes, but is not limited to, Secure File Transfer Protocol (SFTP) or Encryption at an
appropriate level. If required by rule, regulation or law, HHS Confidential Information at rest
requires Encryption unless there is other adequate administrative, technical, and physical
security. All electronic data transfer and communications of Confidential Information will be
through secure systems. Proof of system, media or device security and/or Encryption must be
produced to HHS no later than 48 hours after HHS's written request in response to a
compliance investigation, audit or the Discovery of an Event or Breach. Otherwise, requested
production of such proof will be made as agreed upon by the parties. De -identification of HHS
Confidential Information is a means of security. With respect to de -identification of PHI,
"secure" means de -identified according to HIPAAPrivacy standards and regulatory guidance.
45 CFR 164.312;164.530(d).
(Z) For each type of Confidential Information CONTRACTOR creates, receives,
maintains, uses, discloses, has access to or transmits in the performance of the Statement of
Work, CONTRACTOR will comply with the following laws rules and regulations, only to
the extent applicable and required by law:
Title 1, Part 10, Chapter 202, Subchapter B, Texas Administrative Code;
The Privacy Act of 1974;
OMB Memorandum 07-16;
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• The Federal Information Security Management Act of 2002 (FISMA);
• The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
as defined in the DUA;
• Internal Revenue Publication 1075 — Tax Information Security Guidelines
for Federal, State and Local Agencies;
• National Institute of Standards and Technology (NIST) Special Publication
800-66 Revision I — An Introductory Resource Guide for Implementing the
Health Insurance Portability and Accountability Act (HIPAA) Security
Rule;
• NIST Special Publications 800-53 and 800-53A — Recommended Security
Controls for Federal Information Systems and Organizations, as currently
revised;
• NIST Special Publication 800-47 — Security Guide for Interconnecting
Information Technology Systems;
• NIST Special Publication 800-88, Guidelines for Media Sanitization;
• NIST Special Publication 800-111, Guide to Storage of Encryption
Technologies for End User Devices containing PHI; and
Any other State or Federal law, regulation, or administrative rule relating to the specific HHS
program area that CONTRACTOR supports on behalf of HHS.
(AA) Notwithstanding anything to the contrary herein, CONTRACTOR will treat
any Personal Identifying Information it creates, receives, maintains, uses, transmits, destroys
and/or discloses in accordance with Texas Business and Commerce Code, Chapter 521 and
other applicable regulatory standards identified in Section 3.01(Z), and Individually
Identifiable Health Information CONTRACTOR creates, receives, maintains, uses,
transmits, destroys and/or discloses in accordance with HWAA and other applicable
regulatory standards identified in Section 3.01(2).
ARTICLE 4.
BREACH NOTICE, REPORTING AND CORRECTION REQUIREMENTS
4.01 Breach or Event Notification to HHS. 45 CFR 164.400414.
(A) CONTRACTOR will cooperate fully with HISS in investigating, mitigating to
the extent practicable and issuing notifications directed by HHS, for any Event or Breach of
Confidential Information to the extent and in the manner determined by HHS.
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(B) CONTRACTOR'S obligation begins at the Discovery of an Event or Breach
and continues as long as related activity continues, until all effects of the Event are mitigated
to HHS's reasonable satisfaction (the "incident response period"). 45 CFR 164.404.
(C) Breach Notice:
(1) Initial Notice.
(a) For federal information, including without limitation, Federal
Tax Information, Social SegDAyAdministration Data. and Medicaid Client
Information, within the first, consecutive clock hour of Discovery and for
all other types of Confidential Information not more than 24 hours after
Discovery or in a timeframe otherwise approved by HHS in writing, initially
report to HHS's Privacy and Security Officers via email at:
privacy@HHSC.state.tx.us and to the HHS division responsible for this
DUA; and IRS Publication 1075; Privacy Act of 1974, as amended by the
Computer Matching and Privacy Protection Act of 1988, 5 U.S.C. § 552a;
OMB Memorandum 07-16 as cited in BHHSSC-CMS Contracts for
information exchange.
(b) Report all information reasonably available to
CONTRACTOR about the Event or Breach of the privacy or security of
Confidential Information. 45 CFR 164.410.
(c) Name, and provide contact information to HHS for,
CONTRACTOR's single point of contact who will communicate with HHS
both on and off business hours during the incident response period.
(2) Formal Notice. No later than two business days after the Initial Notice
above, provide formal notification to privacy@HHSC.state.tx.us and to the HEIS
division responsible for this DUA, including all reasonably available information
about the Event or Breach, and CONTRACTORS investigation, including without
limitation and to the extent available: For (a) - (m) belo3v: 45 CFR 164.400414.
(a) The date the Event or Breach occurred;
(b) The date of CONTRACTOR' and, if . applicable,
Subcontractor's Discovery;
(c) A brief description of the Event or Breach; including how it
occurred and who is responsible (or hypotheses, if not yet determined);
(d) A brief description of CONTRACTORSs investigation and the
status of the investigation;
(e) A description of the types and amount of Confidential
Information involved;
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(f) Identification of and number of all Individuals reasonably
believed to be affected, including fust and last name of the Individual and if
applicable the, Legally Authorized Representative, last known address,
age, telephone number, and email address if it is apreferred contact method,
to the extent known or can be reasonably determined by CONTRACTOR at
that time;
(g) CONTRACTOR's initial risk assessment of the Event or
Breach demonstrating whether individual or other notices are required by
applicable law or this DUA for HHS approval, including an analysis of
whether there is a low probability of compromise of the Confidential
Information or whether any legal exceptions to notification apply;
(h) CONTRACTOR's recommendation for HHS's approval as to
the steps Individuals and/or CONTRACTOR on behalf of Individuals,
should take to protect the Individuals from potential harm, including without
limitation CONTRACTOR's provision of notifications, credit protection,
claims monitoring, and any specific protections for a Legally Authorized
Representative to take on behalf of an Individual with special capacity or
circumstances;
(i) The steps CONTRACTOR has taken to mitigate the harm or
potential harm caused (including without limitation the provision of
sufficient resources to mitigate);
0) The steps CONTRACTOR has taken, or will take, to prevent
or reduce the likelihood of recurrence of a similar Event or Breach;
(k) Identify, describe or estimate the Persons, Workforce,
Subcontractor, or Individuals and any law enforcement that may be involved
in the Event or Breach;
0) A reasonable schedule for CONTRACTOR to provide regular
updates during normal business hours to the foregoing in the future for
response to the Event or Breach, but no less than every three (3) business
days or as otherwise directed by HHS, including information about risk
estimations, reporting, notification, if any, mitigation, corrective action, root
cause analysis and when such activities are expected to be completed; and
(m) Any reasonably available, pertinent information, documents or
reports related to an Event or Breach that HHS requests following
Discovery.
4.02 Investigation, Response and Mitigation. 45 CFR 164.308, 310 and 312;164.530
(A) CONTRACTOR will immediately conduct a full and complete investigation,
respond to the Event or Breach, commit necessary and appropriate staff and resources to
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expeditiously respond, and report as required to and by HHS for incident response purposes
and for purposes of HMS's compliance with report and notification requirements, to the
reasonable satisfaction of HHS.
(B) CONTRACTOR will complete or participate in a risk assessment as directed
by HHS following an Event or Breach, and provide the final assessment, corrective actions
and mitigations to HHS for review and approval.
(C) CONTRACTOR will fully cooperate with HHS to respond to inquiries and/or
proceedings by state and federal authorities, Persons and/or Individuals about the Event or
Breach.
(D) CONTRACTOR will fully cooperate with HMS's efforts to seek appropriate
injunctive relief or otherwise prevent or curtail such Event or Breach, or to recover or protect
any Confidential Information, including complying with reasonable corrective action or
measures, as specified by HHS in a Corrective Action Plan if directed by HHS under the Base
Contract.
4.03 Breach Notification to Individuals and Reporting to Authorities. Tex. Bus. &
Comm. Code §521.053; 45 CFR 164.404 (Individuals), 164.406 (Media); 164.408
(Authorities)
(A) ' HHS may direct CONTRACTOR to provide Breach notification to
Individuals, regulators or third parties, as specified by HHS following a Breach.
(B) CONTRACTOR shall give HHS an opportunity to review and provide
feedback to CONTRACTOR and to confirm that CONTRACTOR's notice meets all
regulatory requirements regarding the time, manner and content of any notification to
Individuals, regulators or third -parties, or any notice required by other state or federal
authorities. HHS shall have ten (10) business days to provide said feedback to
CONTRACTOR. Notice letters will be in CONTRACTOR's name and on CONTRACTOR's
letterhead, unless otherwise directed by HHS, and will contain contact information, including
the name and title of CONTRACTOR's representative, an email address and a toll-free
telephone number, if required by applicable law, rule, or regulation, for the Individual to obtain
additional information.
(C) CONTRACTOR will provide HHS with copies of distributed and approved
communications.
(D) CONTRACTOR will have the burden of demonstrating to the reasonable
satisfaction of HISS that any notification required by HHS was timely made. If there are delays
outside of CONTRACTOR's control, CONTRACTOR will provide written documentation of
the reasons for the delay.
(E) If HHS delegates notice requirements to CONTRACTOR, HHS shall, in the
time and manner reasonably requested by CONTRACTOR, cooperate and assist with
CONTRACTOR's information requests in order to make such notifications and reports.
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ARTICLE 5.
STATEMENT OF WORK
"Statement of Work" means the services and deliverables to be performed or provided by
CONTRACTOR, or on behalf of CONTRACTOR by its Subcontractors or agents for HHS that are
described in detail in the Base Contract. The Statement of Work, including any future amendments
thereto, is incorporated by reference in this DUA as if set out word-for-word herein.
ARTICLE 6.
GENERAL PROVISIONS
6.01 Oversight of Confidential Information
CONTRACTOR acknowledges and agrees that HHS is entitled to oversee and monitor
CONTRACTOR's access to and creation, receipt, maintenance, use, disclosure of the Confidential
Information to confirm that CONTRACTOR is in compliance with this DUA.
6.02 HHS Commitment and Obligations
HHS will not request CONTRACTOR to create, maintain, transmit, use or disclose PHI in
any manner that would not be permissible under applicable law if done by HHS.
6.03 HHS Right to Inspection
At any time upon reasonable notice to CONTRACTOR, or if HHS determines that
CONTRACTOR has violated this DUA, HHS, directly or through its agent, will have the right to
inspect the facilities, systems, books and records of CONTRACTOR to monitor compliance with this
DUA. For purposes of this subsection, HHS's agent(s) include, without limitation, the HHS Office of
the Inspector General or the Office of the Attorney General of Texas, outside consultants or legal
counsel or other designee.
6.04 Term; Termination of DUA; Survival
This DUA will be effective on the date on which CONTRACTOR executes the DUA, and
will terminate upon termination of the Base Contract and as set forth herein. If the Base Contract is
extended or amended, this DUA shall be extended or amended concurrent with such extension or
amendment.
(A) HHS may immediately terminate this DUA and Base Contract upon a material
violation of this DUA.
(B) Termination or Expiration of this DUA will not relieve CONTRACTOR of its
obligation to return or Destroy the Confidential Information as set forth in this DUA and to
continue to safeguard the Confidential Information until such time as determined by HHS.
(C) If HHS determines that CONTRACTOR has violated a material term of this
DUA; HHS may in its sole discretion:
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(1) Exercise any of its rights including but not limited to reports, access
and inspection under this DUA and/or the Base Contract; or
(2) Require CONTRACTOR to submit to a Corrective Action Plan,
including a plan for monitoring and plan for reporting, as HHS may determine
necessary to maintain compliance with this DUA; or
(3) Provide CONTRACTOR with a reasonable period to cure the
violation as determined by HHS; or
(4) Terminate the DUA and Base Contract immediately, and seek relief in
a court of competent jurisdiction in Texas.
Before exercising any of these options, HHS will provide written notice to
CONTRACTOR describing the violation, the requested corrective action CONTRACTOR
may take to cure the alleged violation, and the action HHS intends to take if the alleged
violated is not timely cured by CONTRACTOR.
(D) If neither termination nor cure is feasible, HHS shall report the violation to the
Secretary of the U.S. Department of Health and Human Services.
(E) The duties of CONTRACTOR or its Subcontractor under this DUA survive
the expiration or termination of this DUA until all the Confidential Information is Destro e
or returned to HHS, as required by this DUA.
6.05 Governing Law, Venue and Litigation
(A) The validity, construction and performance of this DUA and the legal relations
among the Parties to this DUA will be governed by and construed in accordance with the laws
of the State of Texas.
(B) The Parties agree that the courts of Texas, will be the exclusive venue for any
litigation, special proceeding or other proceeding as between the parties that may be brought,
or arise out of, or in connection with, or by reason of this DUA.
6.06 Injunctive Relief
(A) CONTRACTOR acknowledges and agrees that HHS may suffer irreparable
injury if CONTRACTOR or its Subcontractor fails to comply with any of the terms of this
DUA with respect to the Confidential Information or a provision of HIPAA or other laws or
regulations applicable to Confidential Information.
(B) CONTRACTOR further agrees that monetary damages may be inadequate to
compensate HHS for CONTRACTOR's or its Subcontractor's failure to comply. Accordingly,
CONTRACTOR agrees that HHS will, in addition to any other remedies available to it at law
or in equity, be entitled to seek injunctive relief without posting a bond and without the
necessity of demonstrating actual damages, to enforce the terms of this DUA.
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6.07 Responsibility.
To the extent permitted by the Texas Constitution, laws and rules, and without waiving any
immunities or defenses available to CONTRACTOR as a governmental entity, CONTRACTOR
shall be solely responsible for its own acts and omissions and the acts and omissions of its
employees, directors, officers, Subcontractors and agents. HHS shall be solely responsible for its
own acts and omissions.
6.08 Insurance
(A) As a governmental entity, and in accordance with the limits of the Texas Tort
Claims Act, Chapter 101 of the Texas Civil Practice and Remedies Code, CONTRACTOR
either maintains commercial insurance or self -insures with policy limits in an amount
sufficient to cover CONTRACTOWs liability arising under this DUA. CONTRACTOR will
request that HHS be named as an additional insured. HHSC reserves the right to consider
alternative means for CONTRACTOR to satisfy CONTRACTOWs financial responsibility
under this DUA. Nothing herein shall relieve CONTRACTOR of its financial obligations set
forth in this DUA if CONTRACTOR fails to maintain insurance.
(B) CONTRACTOR will provide HHS with written proof that required insurance
coverage is in effect, at the request of HHS.
6.08 Fees and Costs
Except as otherwise specified in this DUA or the Base Contract, if any legal action or other
proceeding is brought for the enforcement of this DUA, or because of an alleged dispute, contract
violation, Event, Breach. default, misrepresentation, or injunctive action, in connection with any of
the provisions of this DUA, each party will bear their own legal expenses and the other cost incurred
in that action or proceeding.
6.09 Entirety of the Contract
This DUA is incorporated by reference into the Base Contract as an amendment thereto
and, together with the Base Contract, constitutes the entire agreement between the parties. No
change, waiver, or discharge of obligations arising under those documents will be valid unless in
writing and executed by the party against whom such change, waiver, or discharge is sought to be
enforced. If any provision of the Base Contract, including any General Provisions or Uniform
Terms and Conditions, conflicts with this DUA, this DUA controls.
6.10 Automatic Amendment and Interpretation
If there is (i) a change in any law, regulation or rule, state or federal, applicable to HIPPA and/or
Confidential Information, or (ii) any change in the judicial or administrative interpretation of any
such law, regulation or rule„ upon the effective date of such change, this DUA shall be deemed to
have been automatically amended, interpreted and read so that the obligations imposed on HHS
and/or CONTRACTOR remain in compliance with such changes. Any ambiguity in this DUA will
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be resolved in favor of a meaning that permits HHS and CONTRACTOR to comply with HIPAA
or any other law applicable to Confidential Information.
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