The Arizona
Department of Economic Security (DES) of on behalf of a DES
Division or Program ("DES Covered Component"), and
undersigned Business Associate hereby enter into this Business
Associate Agreement ("BAA" or "Agreement").
Arizona Department
of Economic Security
Health Insurance
Portability & Accountability Act of 1996 -HIPAA and Health
Information Technology for Economic and Clinical Health Act of
2009 -HITECH
Business Associate
Agreement
This BAA has the
same effective date as the Contract, Intergovernmental Agreement,
Memorandum of Understanding or lnteragency Service Agreement to
which it is appended ("Related Contract" or "Contract"),
or the date of the last signature, whichever is later. If there
is no Related Contract, the effective date of this BAA is the
date of the last signature to this Agreement. This Agreement
supplements any Contract between a DES Covered Component and the
Business Associate which involves the disclosure of Protected
Health Information ("PHI") as defined in HIPAA. In the
event of conflicting terms or conditions, this Agreement's terms
shall supersede the provisions of the Related Contract to which
it is appended.
The DES Covered
Component and the Business Associate agree to comply with
applicable Privacy and Security Standards of HIPAA and HITECH,
and with other applicable federal and state laws, in order to
protect the privacy of PHI in any form and to safeguard the
confidentiality, integrity, and availability of any Electronic
PHI ("ePHI') related to this Agreement.
1.0.
DEFINITIONS. Capitalized terms not otherwise defined in this
Agreement shall have the same meanings as those terms in the
Privacy Rule and HITECH.
1.1
Breach shall have the meaning given to
such term under the HITECH Act (42 U.S.C. §
17921).
1.2
Business Associate shall have the meaning
given to such term under the Privacy Rule, the
Security Rule, and the HITECH Act (45 C.F.R. §
160.103 and 42 U.S.C.
§17938).
1.3
Covered Component shall have the meaning
given to such term under the Privacy Rule and the
Security Rule (45 C.F.R §160.103).
1.4
Data Aggregation shall have the meaning
given to such term under the Privacy Rule (45 C.F.R.
§164.501).
1.5
Designated Record Set shall have the
meaning given to such term under the Privacy Rule
(45 C.F.R. §164.501).
1.6
Electronic Health Record shall have the
meaning given to such term in the HITECH Act (42
C.F.R. § 17921).
1.7
Electronic Protected Health Information shall
have the meaning given to such term under the
Privacy Rule (45 CFR §134.501and §106.103)
1.8
Health Care Operations shall have the
meaning given to such term under the Privacy Rule
(45 C.F.R. §164.501).
1.9
Individual shall have the meaning given to
such term under the Privacy Rule (45 C.F.R.
§160.103) and
shall include a person who qualifies as a personal representative
(45 C.F.R. §164.502(g)).
1.10
Privacy Rule shall mean the Standards for
Privacy of Individually Identifiable Health ·
Information codified at 45 C.F.R. Parts 160 and
164, Subparts A and E.
1.11
Protected Health Information shall have
the meaning given to such term under the Privacy
Rule (45 C.F.R. §164.501). Protected Health
Information includes Electronic Protected Health
Information (C.F.R. §160.103 and §164.501).
1.12
Protected Information shall have the
meaning given to such term under the Privacy Rule
(45 C.F.R. §164.501). Protected Information
includes Electronic Protected Information (C.F.R.
§160.103 and §164.501).
1.13
Required By Law shall have the meaning
given to such term under the Privacy Rule (45 C.F.R.
§164.512).
1.14
Secretary shall mean the Secretary of the
U.S. Department of Health and Human Services or
his designee.
1.15
Security Rule shall mean the HIPAA
Regulation that is codified at 45 C.F.R. Parts
160 and 164, Subparts A and C.
1.16
Unsecured PHI shall have the meaning given
to such term under the HITECH Act and any
guidance issued pursuant to such Act ( 42 U.S.C.
§17932(h)).
2.0
PERMITTED USES AND DISCLOSURES OF PHI. The
Business Associate will use and disclose PHI only
for those purposes necessary to perform functions,
activities, or services for, or on behalf of, the
DES Covered Component as specified in the
underlying Contract, this BAA , or as Required By
Law. Any use or disclosure by the Business
Associate shall not violate applicable Privacy
Rule provisions, the terms of this BAA, or the
DES Covered Component policies and procedures for
using or disclosing only the Minimum Necessary
PHI.
2.1
Prohibited Use and Disclosures. The Business
Associate shall not use or disclose Protected
Information for fundraising or marketing purposes.
The Business Associate shall not disclose
Protected Information to a health plan for
payment or health care operations purposes if the
patient has requested a restriction and has paid
out of pocket in full for health care items or
services to which the PHI solely related as
described in 42
U.S.C. §17935(a).
The Business Associate shall not directly or indirectly receive
remuneration in exchange for Protected Information, except with
the prior written consent of the Covered Component and as
permitted by the HITECH Act, 42 U.S.C.
§17935(d)(2);
however, this prohibition shall not affect payment by the Covered
Component to the Business Associate for services provided
pursuant to the Contract. Disclosure for research is prohibited
without the Covered Component's permission prior to such
disclosure.
2.2
Business Activities of Business Associate. The
Business Associate may use PHI for the necessary
management and administration of the Business
Associate, or to carry out the legal
responsibilities of the Business Associate if:
1. The disclosure is Required Sy
Law; or
2. The Business Associate
obtains reasonable written assurances
from a third party receiving the PHI that
the third party will:
i.
Maintain the confidentiality of
the PHI;
ii. Use
or disclose the PHI only as
Required By Law or for the
purpose for which the PHI was
disclosed to the person;
iii.
Notify the Business Associate
within 1 business day of any
discovered breach of
confidentiality of the Protected
Information (42 U.S.C. §17932;
45 C.F.R.
§164.504(e)(2)(ii)(D))
and comply in writing with paragraphs 3.1, 3.2, 3.3, 3.4, 3.5
and 3.6; and
iv.
Ensure that any third party to
whom it provides Protected
Information receives from, or
created or received by the
Business Associate on behalf of
the Covered Component, agrees to
the same restrictions and
conditions that apply to the
Business Associate with respect
to such information (45 C.F.R. §164.504
(e)(2)(ii)(D)).
2.3. Aggregation
of PHI. The Business Associate shall provide data aggregation
services with regard to PHI created or received from or on behalf
of the DES Covered Component, if requested to do so by the DES
Covered Component. (45 C.F.R.
§164.504(e)(2)(i)(B)).
2.4
De-Identification of PHI. Under 45 C.F.R.
§164.502(d) (2), de-identified information does
not constitute PHI and is not subject to the
terms of this Agreement. The Business Associate
may de-identify any and all PHI, provided
1. The de-identification
conforms to the requirements of 45 C.F.R.
§164.514(b),
2. The Business Associate
maintains the documentation required by
45 C.F.R.
§164.514(b), and
3. The Business Associate gives
written assurance to the DES Covered
Component that the Business Associate
appropriately maintains the documentation
required by 45 C.F.R. §164.514(b).
3.0.
OBLIGATIONS AND ACTIVITIES OF BUSINESS ASSOCIATE.
3.1.
Safeguards. The Business Associate shall
implement appropriate safeguards as are necessary
to prevent the use or disclosure of Protected
information otherwise that as permitted by the
Contract and the Business Associate Agreement,
including, but not limited to, administrative,
physical, and technical safeguards that
reasonably and appropriately protect the
confidentiality, integrity and availability of
the Protected Information, in accordance with 45
C.F.R §164.308, §164.310, and §164.312. The
Business Associate shall comply with the policies,
procedures, and documentation requirements of the
HIPAA Security Rule, including but not limited to
42 U.S.C. §17931 and 45 C.F.R. §164.316.
3.2
Reporting Impermissible Use or Disclosure and
Security Incidents. The Business Associate
agrees to report to the DES Covered Component in
writing of any access, use or disclosure of
Protected Information not permitted by the
contract or the Business Associate Agreement, and
any breach of Unsecured PHI of which it becomes
aware of as described in 42 U.S.C. §17921 and 45
C.F.R. §134.308(b) and §164.504(e)(2)(ii)(C),
within 1 business day after discovery. The
Business Associate shall:
1. Promptly take corrective
action to secure any such deficiencies;
and
2. Grant prompt and immediate
access to DES Covered Component and other
individuals from DES or the State of
Arizona authorized by DES to participate
in the incident investigation, mitigation,
resolution, or breach notification; and
3. Contact the DES Chief Privacy
Officer if DES Covered Component cannot
be notified within 1 business day after
discovery of incident; and
4. Secure and preserve all
records pertinent to the incident; and
5. Promptly require within 1
business day of incident discovery
applicable subcontractors and agents to
secure and preserve all records pertinent
to the incident; and
6. Any action pertaining to such
unauthorized disclosure required by
applicable federal and state statutes and
regulations.
3.3. Mitigation.
The Business Associate agrees to mitigate, to the extent
practicable, any harmful effects that are known to the Business
Associate of a use or disclosure of PHI by the Business Associate
or its agents or subcontractors in violation of the requirements
of this Agreement ( 45 C.F.R §164.530(f)).
3.4
Agents and Subcontractors. The Business
Associate agrees to the following:
1. Ensure that any agent,
including a subcontractor, to whom it
provides PHI received from, or created or
received by the Business Associate on
behalf of the DES Covered Component,
agrees in writing to the same
restrictions and conditions that apply to
the Business Associate through this
Agreement with respect to such PHI and
implementing the safeguards required by
paragraph 2.1 above with respect to
Protected Information (45 C.F.R. §164.308(b)
and §164.504(e)(2)(ii)(D)).
2. It shall implement and
maintain sanctions against agents and
subcontractors that violate such
restrictions and conditions and shall
mitigate the effects of any such
violations as described in 45 C.F.R. §164.530(e)(I)
and 164.530(f).
3.5
Personnel. The Business Associate shall
appropriately inform all of its employees, agents,
representatives, and members of its workforce
("Personnel"), whose services may be
used to satisfy the Business Associate's
obligations under this Agreement and the Related
Contract, of the terms of this Agreement. The
Business Associate represents and warrants that
the Personnel are under sufficient legal
obligations to the Business Associate for the
Business Associate to fully comply with the
provisions of this Agreement. The Business
Associate agrees to train its workforce on the
HIPAA Rule and keep appropriate records of the
training as prescribed in 45 C.F.R.
§164.530(b)(1)(2).
3.6. Access to
Protected Information. The Business Associate shall make
Protected Information maintained by the Business Associate or its
agents or subcontractors in Designated Record Sets available to
the DES Covered Component for inspection and copying within 10.
business days of a request by the DES Covered Component to enable
the DES Covered Component to fulfill its obligations under the
Privacy Rule, including, but not limited to, 45 C.F.R. §164.524.
If the Business Associate maintains an Electronic Health Record,
the Business Associate shall provide such information in
electronic format to enable the DES Covered Component to fulfill
its obligations under the HITECH Act, including, but not limited
to, 42 U.S.C. §17935(e).
3.7 Individual
Access to PHI. If an Individual requests direct access to PHI
in possession of the Business Associate which is maintained under
its contract with DES, prior to disclosure of any PHI the
Business Associate shall first consult in writing with the DES
Covered Component's Privacy Officer or the DES Chief Privacy
Officer. The Business Associate shall grant or deny access
pursuant to written instructions from the DES Covered Component
which are consistent with 45 C.F.R. §164.524 or other applicable
law. Within 5 business days, the Business Associate shall notify
the DES Covered Component's Privacy Officer or the DES Chief
Privacy Officer in writing of the actions it has taken pursuant
to the request for access and DES Covered Component's
authorization.
3.8. Amendment
of PHI. The Business Associate agrees to make any amendment(s)
to PHI in a Designated Record Set within 5 business days after
the Business Associate receives from the DES Covered Component
instructions to amend PHI. Such instructions generally follow an
Individual's request to the DES Covered Component to amend the
Individual's PHI held by the DES Covered Component or its
Business Associates in a Designated Record Set. If the DES
Covered Component declines an Individual's request to amend that
Individual's PHI, the DES Covered Component shall provide to its
Business Associate, who shall promptly incorporate into the
Individual's Designated Record Set, any statements of
disagreement and/or rebuttals supplied by the Individual, as
required by 45 C.F.R. § 164.526.
3.9
Individual Amendment of PHI. If an
individual requests an amendment of PHI directly
from the Business Associate or its agents or
subcontractors on behalf of the DES Covered
Component, the Business Associate must notify the
DES Covered Component in writing within 5
business days of the request. Any approval or
denial of amendment to Protected Information
maintained by the Business Associate or its
agents or subcontractors shall be the
responsibility of the DES Covered Component,
which shall notify the Business Associate of its
decision in writing.
3.10
Documentation of Disclosure. The Business
Associate agrees to document all disclosures of
PHI made by the Business Associate and
information related to such disclosures as would
be required by the DES Covered Component to
respond to a request by an Individual for an
accounting of disclosures of PHI c;1ccording to
45 C.F.R.
§164.528. At a
minimum, the documentation related to the Business Associate's
disclosure of PHI shall include:
1. The date of disclosure;
2. The name of the PHI recipient
and, if known, the address of the PHI
recipient;
3. A brief description of the
PHI disclosed; and
4. A brief statement of the
purpose of the disclosure that reasonably
informs the Individual of the basis for
the disclosure, or instead of such
statement, a copy of the written request
for disclosure by the Secretary or under
45 C.F.R. §164.512.
3.11. Accounting
of Disclosures. Within 10 business days after receipt of
notice from the DES Covered Component to the Business Associate
that the DES Covered Component has received a request for an
accounting of disclosures of an Individual's PHI, the Business
Associate agrees to provide the DES Covered Component with the
disclosure information requested by the Individual and as
required in paragraph 3.10 above. If an individual requests an
accounting of disclosures directly from the Business Associate,
the Business Associate shall, within sixty (60) business days,
provide or deny an accounting according to 45 C.F.R §164.528.
Unless otherwise directed by the DES Covered Component, the
Business Associate shall notify the DES Covered Component of the
action it has taken and shall do so in writing within five (5)
business days after the action. The accounting of disclosure
shall include all PHI disclosures for the time period the
Individual requested, but not for a date earlier than six years
prior to the date of creation or last entry, which ever occurred
last. If the Business Associate is unable to provide the
accounting of disclosure within the allowed time frame, the
Business Associate shall provide the DES Covered Component with a
written statement of the reason for delay and the date the
Business Associate will provide the accounting.
3.12
Government Access to Records. For the
purpose of determining the DES Covered Component
compliance with the Privacy Rule, as well as the
Business Associate's compliance with this BAA,
the Business Associate agrees to make available
to the DES Covered Component or its authorized
agent, or to the Secretary, in the time and
manner designated:
1. The Business Associate's
internal practices, books, and records,
including policies and procedures,
relating to the use and disclosure of PHI
received from, or created or received by
the Business Associate on behalf of the
DES Covered Component; and
2. All PHI received by the
Business Associate from the DES Covered
Component or created or received by the
Business Associate on behalf of the DES
Covered Component.
3.13
Minimum Necessary. The Business Associate
and its agents and subcontractors shall request,
use, and disclose only the minimum amount of
Protected Information necessary to accomplish the
purpose of the request, use or disclosure as
described in 42 U.S,C. § 17935(b); 45 C. F. R.
§ 164.502(b)(1) and 164.514(d).
3.14
Data Ownership. The Business Associate
acknowledges that the Business Associate has no
ownership rights with respect to the Protected
Information.
3.15
Transaction Standards Regulation. If the
Business Associate conducts in whole or part
Standard Transactions for or on behalf of the DES
Covered Component, the Business Associate agrees
to comply with the Electronic Data Transaction
Standards and Code Sets, 45 C.F.R. Part 162 (I -
R). The Business Associate agrees to require any
subcontractor or agent involved in conducting
Standard Transactions for or on behalf of the DES
Covered Component, to comply with the Transaction
Standards and Code Sets. The Business Associate
and its subcontractors or agents shall not engage
in any practice or enter into any agreement
related to conducting in whole or in part
Standard Transactions for or on behalf of the DES
Covered Component that:
1. Changes the definition, Data
Condition, or use of a Data Element or
Segment in a Standard Transaction;
2. Adds a Data Element or
Segments to the maximum defined Data Set;
3. Uses any code or Data Element
that is marked "not used" in
the Standard Transaction's implementation
specification or that is not in the
Standard Transaction's implementation
specification; or
4. Changes the meaning or intent
of the Standard transaction
implementation specification.
3.16
Retention of Records. All records
containing PHI created or received by the
Business Associate from or on behalf of the DES
Covered Component will be retained for six years
from the date of creation (e.g., PHI) or the date
when it last was in effect (e.g., a policy or
form), whichever is later.
3.17
Violations of Law. The Business Associate
may use PHI to report violations of law to
appropriate Federal and State authorities,
consistent with 45 C.F.R. §164.5020).
3.18 Audits,
Inspection and Enforcement.
1. Within 10 business days of a
written request by the DES Covered
Component, the Business Associate and its
agents or subcontractors shall allow the
DES Covered C.omponent to conduct a
reasonable inspection of the facilities,
systems, books, records, agreements, and
policies and procedures relating to the
use, acquisition, or disclosure of
Protected Information pursuant to this
Agreement for the purpose of determining
whether the Business Associate has
complied with this Agreement; provided,
however that:
1. The Business
Associate and the DES Covered Component shall mutually agree in
advance upon the scope, timing and location of such inspection.
If an agreement can not be concluded, then DES will decide; and
11. To the extent
allowed by law, the DES Covered Component shall safeguard all
trade secret information of the Business Associate to which the
DES Covered Component has access during the course of such
inspection; and
2. The fact that the DES Covered
Component inspects, fails to inspect, or
has the right to inspect the Business
Associate's facilities, systems, books,
records, agreements, and polices and
procedures does not relieve the Business
Associate of its responsibilities to
comply with this Agreement. The following
acts by the DES Covered Component do not
constitute acceptance of such practices
or waive the DES Covered Entity's
enforcement rights under the contract or
Agreement.
i.
Failure to detect; or
ii.
Detection, but failure to notify
the Business Associate; or
iii.
Requiring the Business Associate
to correct any unsatisfactory
practices.
3. The Business Associate shall
notify the DES Covered Component in
writing within 1 business day of learning
that the Business Associate has become
the subject of an audit, compliance
review, or complaint investigation by the
Office for Civil Rights.
4. Notwithstanding paragraph 3.18.1,
pursuant to paragraphs 3.1 through 3.4
and in compliance with 42 U.S.C. §17921
and 45 C.F.R. §164.308(b) and
§164.504(e)(2)(ii)(C),
Business Associate, its subcontractors and agents shall permit
prompt and immediate access to the Covered Component to all
physical locations and business records, including electronic
records and all relevant data files, under the control or
maintained by the Business Associate, its subcontractors and
agents on behalf of Covered Component, for the purpose of
mitigating a data breach, conducting a risk analysis and
obtaining information which will identify individuals affected.
4.0
OBLIGATIONS OF DES COVERED COMPONENT
4.1. Notice of
Privacy Practices The DES Covered Component shall notify the
Business Associate of any changes or limitation(s) in the DES
Covered Component's Notice of Privacy Practices according to 45 C.F.R.
§164.520, to the extent that such changes or limitation(s) may
effect the Business Associate's use or disclosure of PHI.
4.2
Changes in Permission by Individual. The
DES Covered Component shall notify the Business
Associate of any changes in, or revocation of, an
Individual's permission to use or disclose PHI,
to the extent that such changes may affect the
Business Associate's use or disclosure of PHI.
4.3
Restriction on PHI. The DES Covered
Component shall notify the Business Associate of
any restriction on PHI uses and disclosures that
the DES Covered Component has agreed to in
accordance with 45 C.F.R. §164.522, to the
extent that such restriction may affect the
Business Associate's use or disclosure of PHI.
4.4
Permissible Requests by DES Covered Component.
The DES Covered Component shall not request the
Business Associate to use or disclose PHI in any
manner that would not be permissible under the
Privacy Rule if done by the DES Covered Component.
5.0 TERM AND
TERMINATION
5.1
Term. The term of this Agreement is specified
on page one (1) of this Agreement or in the
Contract to which it is appended and shall
terminate when all PHI provided by the DES
Covered Component to the Business Associate, or
created or received by the Business Associate on
behalf of the DES Covered Component, is destroyed
or returned to the DES Covered Component. If it
is not feasible for the Business Associate to
return to the DES Covered Component or destroy
all PHI when this Agreement terminates under the
Contract or is terminated early, protections
agreed to by the Business Associate are extended
to such information, whether PHI is held or
controlled by the Business Associate or its
agents or subcontractors.
5.2 Effect of
Termination.
1. Except as provided in
subparagraph 3 of this paragraph, upon
termination of this Agreement for any
reason, the Business Associate shall
return or destroy all PHI received from
the DES Covered Component, or created or
received by the Business Associate on
behalf of the DES Covered Component. No
copies or data repositories can be
retained as to this information.
2. This provision shall apply to
PHI in the possession or under the
control of subcontractors or agents of
the Business Associate. The Business
Associate and its subcontractors and
agents shall retain no copies or data
repositories of any type of returned or
destroyed PHI unless ordered to do so by
a court of law.
3. If the Business Associate
determines that returning or destroying
PHI is not feasible, the Business
Associate shall provide to the DES
Covered Component notification of the
conditions making the return or
destruction not feasible. The Business
Associate shall extend the protections of
this Agreement to the PHI and shall limit
further uses and disclosures of the PHI
to the purpose that make the return or
destruction not feasible, for so long as
the Business Associate maintains the PHI.
If it is not feasible for the Business
Associate to recover from a subcontractor
or agent any PHI, the Business Associate
shall provide a written explanation to
the DES Covered Component. The Business
Associate shall require the subcontractor
or agent to agree:
i. To
extend the protections of this
Agreement to the PHI in the
possession of the subcontractor
or agent; and
ii. To
limit further uses or disclosures
of the PHI to the purpose that
makes the return or destruction
not feasible, for so long as the
subcontractor or agent maintains
the PHI.
5.3
Termination for Cause.
1. Breach. Upon the DES Covered
Component's knowledge of a material
breach by the Business Associate of the
terms of this Agreement, the DES Covered
Component shall take one or more of the
following actions:
i.
Provide an opportunity for the
Business Associate to cure the
breach within a specified
timeframe;
ii.
Terminate this Agreement and the
underlying Contract if the
Business Associate does not cure
the breach or end the violation
within the time specified by the
DES Covered Component, or if a
cure of the breach is not
possible;
iii.
Immediately terminate this
Agreement and the underlying
contract; or
iv.
Report the violation to the
Secretary, if neither termination
nor cure is feasible.
2. Judicial or Administrative
Proceedings. The DES Covered Component
may terminate the Agreement if;
i. The
Business Associate is named as a
defendant in a criminal
proceeding for a violation of
HIPAA, the HITECH Act, the HIPAA
Regulations or other security or
privacy laws; or
ii.
There is a governmental agency or
tribunal finding or stipulation
that the Business Associate has
violated any standard or
requirement of HIPAA, the HITECH
Act, the HIPAA regulations or
other security or privacy laws.
6.0
MISCELLANEOUS
6.1
HIPAA Reference. A reference in this
Agreement to HIPAA or the Privacy Rule means the
regulation including the HITECH Act of 2009, as
in effect on the effective date or as
subsequently amended, and for which compliance is
required. (45 C.F.R. § 160, §162, and §164 and
42 U.S.C. §17938).
6.2. Amendment.
The parties agree to take the action necessary to amend this
Agreement from time to time so that the DES Covered Component may
comply with the requirements of HIPAA, HITECH, court decisions
and any regulatory changes.
6.3 Interpretation.
Any ambiguity in this Agreement shall be resolved to permit
the DES Covered Component to comply with the HIPAA and HITECH
Rules.
Contractor
hereby acknowledges receipt and |
The above
referenced HIPAA Business Associate Agreement is hereby executed this day of
201_ by the Department of Economic Security.
DES Chief Privacy
Officer
Printed Name
|
acceptance
of this HIPAA Business |
|
Associate
Agreement and that a signed copy |
|
must be
filed with the DES Procurement |
|
Office. |
|
Signature
Date |
|
Printed
Name |
|
Title |
|
Name of
Contractor |
|
|
|