STATE OF RHODE
ISLAND AND PROVIDENCE PLANTATIONS
BUSINESS ASSOCIATE AGREEMENT
Except as otherwise provided
in this Business Associate Agreement (hereinafter referred to as
the "BAA"), INSERT VENDOR NAME, (hereinafter referred
to as "Business Associate"), may use, access or
disclose Protected Health Information to perform functions,
activities or services for or on behalf of the State of Rhode
Island, INSERT AGENCY NAME (hereinafter referred to
as the "Covered Entity"), as specified herein and the
attached Contract between the Business Associate and the Covered
Entity (hereinafter referred to as the "Contract"),
which this BAA supplements and is made part of, provided such use,
access, or disclosure does not violate the Health Insurance
Portability and Accountability Act of 1996 (hereinafter referred
to as "HIPAA"), Public Law 104-191, and the Health
Information Technology for Economic and Clinical Health Act, as
incorporated in the American Recovery and Reinvestment Act of
2009, Public Law 111-5 (hereinafter referred to as "HITECH"),
and any regulations promulgated pursuant to HIPAA and HITECH,
including, but not limited to, 45 C.F.R., Parts 160 and 164 (hereinafter
referred to as the "Omnibus Rule"), the Rhode Island
Mental Health Law, R.I. Gen. Laws § 40.1-5, and the Rhode Island
Confidentiality of Health Care Communications and Information Act,
R.I. Gen. Laws § 5-37.3 Business Associate recognizes and agrees
it is obligated by law to meet the applicable privacy, security
and confidentiality provisions of the aforementioned laws and
regulations.
Definitions.
Generally:
Terms used, but not
otherwise defined, in this BAA shall have the same
meaning as those terms in 45 C.F.R. §§ 160.103, 164.103,
164.304, 164.402, and 164.501.
The following terms
used in this BAA shall have the same meaning as those
terms in HIPAA, HITECH, and the Omnibus Rule: Breach,
Data Aggregation, Designated Record Set, Disclosure,
Health Care Operations, Individual, Minimum Necessary,
Notice of Privacy Practices, Protected Health Information,
Required By Law, Secretary, Security Incident,
Subcontractor, Unsecured Protected Health Information,
and Use.
Specific:
"BAA" means
this Business Associate Agreement.
"Contract"
means the contractual arrangement by and between the
State of Rhode Island, INSERT AGENCY NAME and Business
Associate, awarded pursuant to the State of Rhode Island&rsquos
Purchasing Law (R.I. Gen. Laws § 37-2) and the Rhode
Island Department of Administration Division of Purchases
Procurement Regulations and General Conditions of
Purchase.
"Business
Associate" generally has the same meaning as the
term "business associate" at 45 CFR 160.103,
and in reference to the party to this BAA, shall mean [Insert
Name of Business Associate].
"Covered Entity"
generally has the same meaning as the term "covered
entity" at 45 CFR 160.103, and in reference to the
party to this BAA, shall mean [Insert Name of Covered
Entity].
"Electronic
Protected Health Information" or "Electronic
PHI" or "e-PHI" means PHI that is
transmitted by or maintained in electronic media as
defined in the Omnibus Rule.
"HIPAA"
means the Health Insurance Portability and Accountability
Act of 1996, Public Law 104-191, as amended from time to
time.
"Omnibus Rule"
means the regulations promulgated under HIPAA by the
United States Department of Health and Human Services to
protect the privacy and security of Protected Health
Information and Electronic Protected Health Information
including the Privacy, Security, Breach Notification, and
Enforcement Rules at 45 CFR Parts 160 and 164.
"HITECH"
means the Health Information Technology for Economic and
Clinical Health Act, as incorporated in the American
Recovery and Reinvestment Act of 2009, Public Law 111-5,
as amended from time to time.
"Privacy Rule"
means the standards for the privacy and confidentiality
of Protected Health Information ("PHI") found
at 45 C.F.R. Part 160, and Subparts A and E of 45 C.F.R.
Part 164.
"Secured PHI"
means PHI that was rendered unusable, unreadable or
indecipherable to unauthorized individuals through the
use of technologies or methodologies specified under
HITECH § 13402 (h)(2).
"Security
Incident" means any known successful or unsuccessful
attempt by an authorized or unauthorized individual to
inappropriately use, disclose, modify, access, or destroy
any information.
"Security Rule"
means the standards for the security of Electronic
Protected Health Information found at 45 C.F.R. Part 160,
and Subparts A and C of 45 C.F.R. Part 164. The
provisions of 45 C.F.R. §§ 164.308, 164.310, 164.312,
164.314 and 164.316 shall apply to Business Associate of
Covered Entity in the same manner that such sections
apply to the Covered Entity.
"Suspected breach"
is a suspected acquisition, access, use or disclosure of
PHI in violation of the HIPAA Omnibus Rule that
compromises the security or privacy of PHI.
"Unsecured PHI"
means PHI that is not Secured PHI, as defined above,
through the use of a technology or methodology specified
by the Secretary of the U.S. Department of Health and
Human Services.
Obligations and
Activities of Business Associate.
Business
Associate agrees to not use or further disclose
PHI other than as permitted or required by this
BAA or as Required by Law, provided such use or
disclosure would also be permissible by law if
done by Covered Entity.
Business
Associate agrees to use appropriate safeguards (including
encryption as specified in the Security Rule) and
destruction, to prevent use or disclosure of PHI
other than as provided for by this BAA.
As required by
the Security Rule, Business Associate agrees to
conduct a risk assessment and implement
Administrative Safeguards, Physical Safeguards
and Technical Safeguards that reasonably and
appropriately protect the confidentiality,
integrity and availability of PHI that it creates,
receives, maintains, or transmits on behalf of
the Covered Entity.
Business
Associate agrees to use reasonable efforts to
limit PHI to the minimum necessary to accomplish
the intended purposes of the use, disclosure, or
request.
Business
Associate agrees to mitigate, to the extent
practicable, any harmful effect that is known to
Business Associate of a use or disclosure of PHI
by Business Associate in violation of the
requirements of this BAA.
Business
Associate agrees to report to Covered Entity any
use or disclosure of the PHI not provided for by
this BAA, including breaches of unsecured PHI as
required by 45 C.F.R. § 164.410, and any
Security Incident of which it becomes aware,
within five (5) days of the incident&rsquos
occurrence or Business Associate&rsquos
discovery thereof.
Business
Associate agrees to ensure that any agent,
including a subcontractor or vendor, to whom it
provides PHI received from, or created or
received by Business Associate on behalf of
Covered Entity agrees to the same restrictions
and conditions that apply through this BAA to
Business Associate with respect to such
information through a contractual arrangement
that complies with 45 C.F.R. § 164.314.
Business
Associate agrees to provide paper or electronic
access, at the request of Covered Entity and in
the time and manner designated by Covered Entity,
to PHI in a Designated Record Set to Covered
Entity or, as directed by Covered Entity, to an
Individual in order to meet the requirements
under 45 C.F.R. § 164.524. If the Individual
requests an electronic copy of the information,
Business Associate must provide Covered Entity
with the information requested in the electronic
form and format requested by the Individual and/or
Covered Entity if it is readily producible in
such form and format; or, if not, in a readable
electronic form and format as requested by
Covered Entity.
Business
Associate agrees to make any amendment(s) to PHI
in a Designated Record Set that Covered Entity
directs or agrees to pursuant to 45 C.F.R. § 164.526
at the request of Covered Entity or an Individual,
and in the time and manner designated by Covered
Entity. If Business Associate receives a request
for amendment to PHI directly from an Individual,
Business Associate shall promptly notify Covered
Entity upon receipt of such request.
Business
Associate agrees to make its internal practices,
books, and records, including policies and
procedures, relating to the use and disclosure of
PHI received from, or created or received by
Business Associate on behalf of Covered Entity
available to Covered Entity, or at the request of
Covered Entity to the Secretary, in a time and
manner designated by Covered Entity or the
Secretary, for the purposes of the Secretary
determining compliance with the Omnibus Rule.
Business
Associate agrees to document such disclosures of
PHI and information related to such disclosures
as would be required for Covered Entity to
respond to a request by an Individual for an
accounting of disclosures of PHI in accordance
with 45 C.F.R. § 164.528.
Business
Associate agrees to provide to Covered Entity or
an Individual, in a time and manner designated by
Covered Entity, information collected in
accordance with this BAA, to permit Covered
Entity to respond to a request by an Individual
for an accounting of disclosures of PHI in
accordance with 45 C.F.R. § 164.528.
If Business
Associate accesses, maintains, retains, modifies,
records, stores, destroys, or otherwise holds,
uses, or discloses Unsecured PHI (as defined in
45 C.F.R. § 164.402) for Covered Entity, it
shall, following the discovery of a Breach of
such information, notify Covered Entity of such
Breach within a period of five (5) days after
discovery of the breach. Such notice shall
include: a) the identification of each individual
whose Unsecured PHI has been, or is reasonably
believed by Business Associate to have been
accessed, acquired or disclosed during such
Breach; b) a brief description of what happened,
including the date of the Breach and discovery of
the Breach; c) a description of the type of
Unsecured PHI that was involved in the Breach; d)
a description of the investigation into the
Breach, and the steps taken by Business Associate
to mitigate harm to the affected Individuals and
protect against further Breaches; e) the results
of any and all investigation performed by
Business Associate related to the Breach; and f)
contact information of the most knowledgeable
individual for Covered Entity to contact relating
to the Breach and Business Associate&rsquos
investigation of the Breach.
To the extent
the Business Associate is carrying out an
obligation of the Covered Entity&rsquos under
the Privacy Rule, the Business Associate must
comply with the requirements of the Privacy Rule
that apply to the Covered Entity in the
performance of such obligation.
Business
Associate agrees that it will not receive
remuneration directly or indirectly in exchange
for PHI without authorization unless an exception
under 45 C.F.R. § 164.502(a)(5)(ii)(B)(2)
applies.
Business
Associate agrees that it will not receive
remuneration for certain communications that fall
within the exceptions to the definition of "Marketing"
under 45 C.F.R. § 164.501, unless permitted by
45 C.F.R. § 164.508(a)(3)(i)(A)-(B).
If applicable,
Business Associate agrees that it will not use or
disclose genetic information for "underwriting
purposes", as that term is defined in 45 C.F.R.
§ 164.502.
Business
Associate hereby agrees to comply with state laws
and rules and regulations applicable to PHI and
Individuals&rsquo personal information it
receives from Covered Entity during the term of
the Contract.
Business
Associate agrees to: (a) implement and
maintain appropriate physical, technical
and administrative security measures for
the protection of personal information as
required by any state law and rules and
regulations; including, but not limited
to: (i) encrypting all transmitted
records and files containing personal
information that will travel across
public networks, and encryption of all
data containing personal information to
be transmitted wirelessly; (ii)
prohibiting the transfer of personal
information to any portable device unless
such transfer has been approved in
advance; and (iii) encrypting any
personal information to be transferred to
a portable device; and (b) implement and
maintain a Written Information Security
Program as required by any state law as
applicable.
The
safeguards set forth in this Agreement
shall apply equally to PHI, confidential
and "personal information."
Personal information means an individual's
first name and last name or first initial
and last name in combination with any one
or more of the following data elements
that relate to such resident: (a) Social
Security number; (b) driver's license
number or state-issued identification
card number; or (c) financial account
number, or credit or debit card number,
with or without any required security
code, access code, personal
identification number or password, that
would permit access to a resident's
financial account; provided, however,
that "personal information"
shall not include information that is
lawfully obtained from publicly available
information, or from federal, state or
local government records lawfully made
available to the general public.
Permitted Uses and
Disclosures by Business Associate.
Except as
otherwise limited in this BAA, Business Associate
may use or disclose PHI to perform functions,
activities, or services for, or on behalf of,
Covered Entity as specified in the Contract,
provided that such use or disclosure would not
violate the Privacy Rule if done by Covered
Entity, or the minimum necessary policies and
procedures of Covered Entity required by 45 C.F.R.
§ 164.514(d).
Except as
otherwise limited in this Agreement, Business
Associate may use PHI for the proper management
and administration of the Business Associate or
to carry out the legal responsibilities of the
Business Associate.
Except as
otherwise limited in this Agreement, Business
Associate may disclose PHI for the proper
management and administration of the Business
Associate, or to carry out the legal
responsibilities of the Business Associate,
provided that disclosures are Required By Law, or
Business Associate obtains reasonable assurances
from the person/entity to whom the information is
disclosed that it will remain confidential and be
used or further disclosed only as Required By Law
or for the purpose for which it was disclosed to
the person/entity, and that the person/entity
will notify the Business Associate of any
instances of which it is aware in which the
confidentiality of the information has been
breached.
Except as
otherwise limited in this Agreement, Business
Associate may use PHI to provide Data Aggregation
services relating to the Health Care Operations
of the Covered Entity as permitted by 45 C.F.R.
§ 164.504 (e)(2)(i)(B).
Business
Associate may use PHI to report violations of law
to appropriate federal and state authorities,
consistent with 45 C.F.R. § 164.502(j)(1).
Obligations of
Covered Entity
Covered Entity
shall notify Business Associate of any limitation(s)
in Covered Entity&rsquos Notice of Privacy
Practices, to the extent that such limitation may
affect Business Associate&rsquos use or
disclosure of PHI.
Covered Entity
shall notify Business Associate of any changes in,
or revocation of, permission by an Individual to
use or disclose PHI to the extent that such
changes may affect Business Associate&rsquos
use or disclosure of PHI.
Covered Entity
shall notify Business Associate of any
restriction on the use or disclosure of PHI that
Covered Entity has agreed to or is required to
abide by in accordance with 45 C.F.R. § 164.522,
to the extent that such restriction may affect
Business Associate&rsquos use or disclosure
of PHI.
Covered Entity
shall provide written authorization to Business
Associate prior to requesting that Business
Associate disclose, transfer, or provide PHI to a
third party.
Permissible
Requests by Covered Entity
Covered Entity shall not request Business Associate
to use or disclose PHI in any manner that would not be
permissible under the Privacy Rule if done by Covered Entity,
provided that, to the extent permitted by the Contract, Business
Associate may use or disclose PHI for Business Associate&rsquos
Data Aggregation activities, for the Business Associate&rsquos
management and administrative activities, or to carry out the
legal responsibilities of the Business Associate.
Term and
Termination.
The term of
this Agreement shall begin as of the effective
date of the Contract and shall terminate when all
of the PHI provided by Covered Entity to Business
Associate, or created or received by Business
Associate on behalf of Covered Entity, is
destroyed or returned to Covered Entity, or, if
it is infeasible to return or destroy PHI,
protections are extended to such information, in
accordance with the termination provisions of
this Section.
Upon Covered
Entity&rsquos knowledge of a material breach
by Business Associate, Covered Entity shall
either:
Provide
an opportunity for Business Associate to
cure the breach or end the violation and
terminate this BAA and the Contract if
Business Associate does not cure the
breach or end the violation within the
time specified by Covered Entity.
Immediately
terminate this BAA and the Contract if
Business Associate has breached a
material term of this BAA and cure is not
possible.
Except as
provided in paragraph (d) of this Section, upon
any termination or expiration of this BAA,
Business Associate shall return to Covered Entity,
or destroy, all PHI received from Covered Entity,
or created or received by Business Associate on
behalf of Covered Entity, that Business Associate
still maintains in any form. This provision shall
apply to PHI that is in the possession of
subcontractors or agents of Business Associate.
Business Associate shall retain no copies of the
PHI. Business Associate shall ensure that its
subcontractors or vendors return or destroy any
of Covered Entity&rsquos PHI received from
Business Associate.
In the event that Business Associate determines that
returning or destroying the PHI is infeasible, Business Associate
shall provide to Covered Entity notification of the conditions
that make return or destruction infeasible. Upon Covered Entity&rsquos
written agreement that return or destruction of PHI is infeasible,
Business Associate shall extend the protections of this BAA to
such PHI and limit further uses and disclosures of such PHI to
those purposes that make the return or destruction infeasible,
for so long as Business Associate maintains such PHI.
The respective
rights and obligations of Business Associate
under this Section shall survive the termination
of this BAA.
Miscellaneous.
Any costs
associated with Breach notifications, including
mitigation costs, shall be the responsibility of
Business Associate.
If a term in
the Contract conflicts or is otherwise
inconsistent with a term in this BAA, the
provisions of this BAA will prevail with respect
to the subject matter hereof. This BAA and the
Contract shall be interpreted as broadly as
necessary to implement and comply with HIPAA, the
Omnibus Rule and HITECH.
A reference in
this BAA to a section in the Omnibus Rule,
Privacy Rule or Security Rule means the section
as in effect or as amended.
The parties to
this BAA agree to take such action as is
necessary to amend this BAA from time to time as
is necessary for Covered Entity to comply with
the requirements of HIPAA, the Omnibus Rule and
HITECH. If Covered Entity and Business Associate
have nevertheless not amended this BAA to address
a law or final regulation that becomes effective
after the effective date of the Contract and that
is applicable to this BAA, then upon the
effective date of such law or regulation (or any
portion thereof), this BAA shall be amended
automatically and deemed to incorporate such new
or revised provisions as are necessary for this
BAA to be consistent with such law or regulation
and for Covered Entity and Business Associate to
be and remain in compliance with all applicable
laws and regulations.
Any ambiguity
in this BAA shall be resolved to permit Covered
Entity to comply with HIPAA and HITECH.
Business
Associate confirms that it is an independent
contractor and is not acting as an agent of
Covered Entity. Business Associate is solely
responsible for all decisions made by Business
Associate regarding the safeguarding of PHI and
its obligations under this BAA.
Nothing
express or implied in this BAA is intended to
confer, nor shall anything herein confer upon any
person/entity other than Covered Entity, Business
Associate and their respective successors and
assigns, any rights, remedies, obligations or
liabilities whatsoever.
Modification
of the terms of this BAA shall not be effective
or binding upon the parties unless and until such
modification is committed to writing and executed
by the parties hereto.
This BAA shall
be binding upon the parties hereto, and their
respective subsidiaries, legal representatives,
trustees, receivers, successors and permitted
assigns; provided, however, that Business
Associate may not assign its rights or delegate
its responsibilities under this BAA.
Should any
provision of this BAA be found unenforceable, it
shall be deemed severable and the balance of the
BAA shall continue in full force and effect as if
the unenforceable provision had never been made a
part hereof.
This BAA and
the rights and obligations of the parties
hereunder shall in all respects be governed by,
and construed in accordance with, the laws of the
State of Rhode Island, including all matters of
construction, validity and performance.
All notices
and communications required or permitted to be
given hereunder shall be sent by certified or
regular mail, addressed to the other party at its
respective address as shown on the signature page,
or at such other address as such party shall from
time to time designate in writing to the other
party, and shall be effective from the date of
mailing.
This BAA,
including such portions as are incorporated by
reference herein, constitutes the entire
agreement by, between and among the parties as
required by 45 C.F.R. § 164.504(e), and such
parties acknowledge by their signature hereto
that they do not rely upon any representations or
undertakings by any person or party, past or
future, not expressly set forth in writing herein,
and that this BAA supersedes all prior agreements
and understandings, both written and oral, with
respect to the subject matter hereof.
Business
Associate shall maintain or cause to be
maintained sufficient insurance coverage as shall
be necessary to insure Business Associate and its
employees, agents, representatives or
subcontractors against any and all claims or
claims for damages arising under this BAA and
such insurance coverage shall apply to all
services provided by Business Associate or its
agents or subcontractors pursuant to this BAA.
Business Associate shall indemnify, hold harmless
and defend Covered Entity from and against any
and all claims, losses, liabilities, costs and
other expenses (including but not limited to,
reasonable attorneys&rsquo fees and costs,
administrative penalties and fines, costs
expended to notify Individuals and/or to prevent
or remedy possible identity theft, financial harm,
reputational harm, or any other claims of harm
related to a breach) incurred as a result of, or
arising directly or indirectly out of or in
connection with any acts or omissions of Business
Associate, its employees, agents, representatives
or subcontractors, under this BAA, including, but
not limited to, negligent or intentional acts or
omissions. This provision shall survive
termination of this BAA.
This BAA may
be executed in two or more counterparts, each of
which shall constitute an original but all of
which together shall constitute one and the same
instrument.
From time to
time after the effective date of the Contract,
and without any consideration, Covered Entity and
Business Associate will execute and deliver, or
arrange for execution and delivery of, such other
documents and take such other action or arrange
for such other actions as may reasonably be
requested to more fully effectuate the intent of
this BAA.
Acknowledgment.
The undersigned affirms that he/she is a duly
authorized representative of Business Associate for which he/she
is signing and has the authority to execute this BAA on behalf of
the Business Associate.
Acknowledged and agreed to by:
DIRECTOR AUTHORIZED AGENT
INSERT AGENCY NAME
TITLE
PRINTED NAME PRINTED NAME
DATE DATE
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