STATE
OF NEVADA
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
BUSINESS
ASSOCIATE ADDENDUM
BETWEEN
The
Division of Health Care Financing and Policy
Herein
after referred to as the "Covered Entity"
and
(Enter
Business Name)
Herein
after referred to as the "Business Associate"
PURPOSE.
In order to comply with the requirements of the Health
Insurance Portability and Accountability Act (HIPAA) of 1996,
Public Law 104-191, and the Health Information Technology for
Economic and Clinical Health (HITECH) Act of 2009, Public Law 111-5
this Addendum is hereby added and made part of the Contract
between the Covered Entity and the Business Associate. This
Addendum establishes the obligations of the Business Associate
and the Covered Entity as well as the permitted uses and
disclosures by the Business Associate of protected health
information it may possess by reason of the Contract. The Covered
Entity and the Business Associate shall protect the privacy and
provide for the security of protected health information
disclosed to the Business Associate pursuant to the Contract and
in compliance with HIPAA, the HITECH Act, and regulation
promulgated there under by the U.S. Department of Health and
Human Services ("HIPAA Regulations") and other
applicable laws.
WHEREAS,
the Business Associate will provide certain services to the
Covered Entity, and, pursuant to such arrangement, the Business
Associate is considered a business associate of the Covered
Entity as defined in HIPAA Regulations; and
WHEREAS,
the Business Associate may have access to and/or create, receive,
maintain or transmit certain protected health information from or
on behalf of the Covered Entity, in fulfilling its
responsibilities under such arrangement; and
WHEREAS,
HIPAA Regulations require the Covered Entity to enter into a
Contract containing specific requirements of the Business
Associate prior to the disclosure of protected health information;
and
THEREFORE,
in consideration of the mutual obligations below and the exchange
of information pursuant to this Addendum and to protect the
interests of both Parties, the Parties agree to all provisions of
this Addendum.
I.
DEFINITIONS. The following terms in this Addendum shall have the
same meaning as those terms in the HIPAA Regulations: Breach,
Data Aggregation, Designated Record Set, Disclosure, Electronic
Health Record, Health Care Operations, Individual, Minimum
Necessary, Notice of Privacy Practices, Protected Health
Information, Required by Law, Secretary, Subcontractor, Unsecured
Protected Health Information, and Use.
1. Business Associate shall mean the
name of the organization or entity listed above and shall
have the meaning given to the term under the Privacy and
Security Rule and the HITECH Act. For full definition
refer to 45 CFR 160.103.
2. Contract shall refer to this
Addendum and that particular contract to which this
Addendum is made a part.
3. Covered Entity shall mean the name
of the Division listed above and shall have the meaning
given to such term under the Privacy Rule and the
Security Rule, including, but not limited to 45 CFR 160.103.
4.
Parties shall mean the Business Associate and the Covered
Entity.
II.
OBLIGATIONS OF THE BUSINESS ASSOCIATE
1. Access to Protected Health Information.
The Business Associate will provide, as directed by
the Covered Entity or an individual, access to inspect or
obtain a copy of protected health information about the
individual that is maintained in a designated record set
by the Business Associate or its agents or subcontractors,
in order to meet the requirements of HIPAA Regulations.
If the Business Associate maintains an electronic health
record, the Business Associate, its agents or
subcontractors shall provide such information in
electronic format to enable the Covered Entity to fulfill
its obligations under HIPAA Regulations.
2. Access to Records. The Business
Associate shall make its internal practices, books and
records relating to the use and disclosure of protected
health information available to the Covered Entity and to
the Secretary for purposes of determining Business
Associate&rsquos compliance with HIPAA Regulations.
3. Accounting of Disclosures. Upon
request, the Business Associate and its agents or
subcontractors shall make available to the Covered Entity
or the individual information required to provide an
accounting of disclosures in accordance with HIPAA
Regulations.
4. Agents and Subcontractors. The
Business Associate must ensure all agents and
subcontractors that create, receive, maintain, or
transmit protected health information on behalf of the
Business Associate agree in writing to the same
restrictions and conditions that apply to the Business
Associate with respect to such information. The Business
Associate must implement and maintain sanctions against
agents and subcontractors that violate such restrictions
and conditions and shall mitigate the effects of any such
violation as outlined under HIPAA Regulations.
5. Amendment of Protected Health
Information. The Business Associate will make
available protected health information for amendment and
incorporate any amendments in the designated record set
maintained by the Business Associate or its agents or
subcontractors, as directed by the Covered Entity or an
individual, in order to meet the requirements of HIPAA
Regulations.
6. Audits, Investigations, and
Enforcement. If the data provided or created through
the execution of the Contract becomes the subject
of an audit, compliance review, or complaint
investigation by the Office of Civil Rights or any other
federal or state oversight agency, the Business Associate
shall notify the Covered Entity immediately and provide
the Covered Entity with a copy of any protected health
information that the Business Associate provides to the
Secretary or other federal or state oversight agency
concurrently, to the extent that it is permitted to do so
by law. The Business Associate and individuals associated
with the Business Associate are solely responsible for
all civil and criminal penalties assessed as a result of
an audit, breach or violation of HIPAA Regulations.
7. Breach or Other Improper Access, Use
or Disclosure Reporting. The Business Associate must
report to the Covered Entity, in writing, any access, use
or disclosure of protected health information not
permitted by the Contract, Addendum or HIPAA Regulations
by Business Associate or its agents or subcontractors.
The Covered Entity must be notified immediately upon
discovery or the first day such breach or suspected
breach is known to the Business Associate or by
exercising reasonable diligence would have been known by
the Business Associate in accordance with HIPAA
Regulations. In the event of a breach or suspected breach
of protected health information, the report to the
Covered Entity must be in writing and include the
following: a brief description of the incident; the date
of the incident; the date the incident was discovered by
the Business Associate; a thorough description of the
unsecured protected health information that was involved
in the incident; the number of individuals whose
protected health information was involved in the incident;
and the steps the Business Associate or its agent or
subcontractor is taking to investigate the incident and
to protect against further incidents. The Covered Entity
will determine if a breach of unsecured protected health
information has occurred and will notify the Business
Associate of the determination. If a breach of unsecured
protected health information is determined, the Business
Associate must take prompt corrective action to cure any
such deficiencies and mitigate any significant harm that
may have occurred to individual(s) whose information was
disclosed inappropriately.
8. Breach Notification Requirements. If
the Covered Entity determines a breach of unsecured
protected health information by the Business Associate,
or its agents or
subcontractors has occurred, the Business
Associate will be responsible for notifying the
individuals whose unsecured protected health information
was breached in accordance with HIPAA Regulations. The
Business Associate must provide evidence to the Covered
Entity that appropriate notifications to individuals and/or
media, when necessary, as specified in HIPAA Regulations
has occurred. The Business Associate is responsible for
all costs associated with notification to individuals,
the media or others as well as costs associated with
mitigating future breaches. The Business Associate must
notify the Secretary of all breaches in accordance with
HIPAA Regulations and must provide the Covered Entity
with a copy of all notifications made to the Secretary.
9. Data Ownership. The Business
Associate acknowledges that the Business Associate or its
agents or subcontractors have no ownership rights with
respect to the protected health information it creates,
receives or maintains, or otherwise holds, transmits,
uses or discloses.
10. Litigation or Administrative
Proceedings. The Business Associate shall make itself,
any subcontractors, employees, or agents assisting the
Business Associate in the performance of its obligations
under the Contract or Addendum, available to the Covered
Entity, at no cost to the Covered Entity, to testify as
witnesses, or otherwise, in the event litigation or
administrative proceedings are commenced against the
Covered Entity, its administrators or workforce members
upon a claimed violation by Business Associate of HIPAA
Regulations or other laws relating to security and
privacy.
11. Minimum Necessary. The Business
Associate and its agents and subcontractors shall request,
use and disclose only the minimum amount of protected
health information necessary to accomplish the purpose of
the request, use or disclosure in accordance with HIPAA
Regulations.
12. Policies and Procedures. The
Business Associate must adopt written privacy and
security policies and procedures and documentation
standards to meet the requirements of HIPAA Regulations.
13. Privacy and Security Officer(s). The
Business Associate must appoint Privacy and Security
Officer(s) whose responsibilities shall include:
monitoring the Privacy and Security compliance of the
Business Associate; development and implementation of the
Business Associate&rsquos HIPAA Privacy and Security
policies and procedures; establishment of Privacy and
Security training programs; and development and
implementation of an incident risk assessment and
response plan in the event the Business Associate
sustains a breach or suspected breach of protected health
information.
14. Safeguards. The Business
Associate must implement safeguards as necessary to
protect the confidentiality, integrity and availability
of the protected health information the Business
Associate creates, receives, maintains, or otherwise
holds, transmits, uses or discloses on behalf of the
Covered Entity. Safeguards must include administrative
safeguards (e.g., risk analysis and designation of
security official), physical safeguards (e.g., facility
access controls and workstation security), and technical
safeguards (e.g., access controls and audit controls) to
the confidentiality, integrity and availability of the
protected health information, in accordance with HIPAA
Regulations. Technical safeguards must meet the standards
set forth by the guidelines of the National Institute of
Standards and Technology (NIST). The Business Associate
agrees to only use or disclose protected health
information as provided for by the Contract and Addendum
and to mitigate, to the extent practicable, any harmful
effect that is known to the Business Associate, of a use
or disclosure, in violation of the requirements of this
Addendum as outlined in HIPAA Regulations.
15. Training. The Business Associate
must train all members of its workforce on the policies
and procedures associated with safeguarding protected
health information. This includes, at a minimum, training
that covers the technical, physical and administrative
safeguards needed to prevent inappropriate uses or
disclosures of protected health information; training to
prevent any intentional or unintentional use or
disclosure that is a violation of HIPAA Regulations; and
training that emphasizes the criminal and civil penalties
related to HIPAA breaches or inappropriate uses or
disclosures of protected health information. Workforce
training of new employees must be completed within 30
days of the date of hire and all employees must be
trained at least annually. The Business Associate must
maintain written records for a period of six years. These
records must document each employee that received
training and the date the training was provided or
received.
16. Use and Disclosure of Protected
Health Information. The Business Associate must not
use or further disclose protected health information
other than as permitted or required by the Contract or as
required by law. The Business Associate must not use or
further disclose protected health information in a manner
that would violate the requirements of HIPAA Regulations.
III.
PERMITTED AND PROHIBITED USES AND DISCLOSURES BY THE BUSINESS
ASSOCIATE
The
Business Associate agrees to these general use and disclosure
provisions:
1. Permitted Uses and Disclosures:
a. Except as otherwise limited in this
Addendum, the Business Associate may use or disclose
protected health information to perform functions,
activities, or services for, or on behalf of, the Covered
Entity as specified in the Contract, provided that such
use or disclosure would not violate HIPAA Regulations, if
done by the Covered Entity.
b. Except as otherwise limited in this
Addendum, the Business Associate may use or disclose
protected health information received by the Business
Associate in its capacity as a Business Associate of the
Covered Entity, as necessary, for the proper management
and administration of the Business Associate, to carry
out the legal responsibilities of the Business Associate,
as required by law or for data aggregation purposes in
accordance with HIPAA Regulations.
c. Except as otherwise limited by this
Addendum, if the Business Associate discloses protected
health information to a third party, the Business
Associate must obtain, prior to making such disclosure,
reasonable written assurances from the third party that
such protected health information will be held
confidential pursuant to this Addendum and only disclosed
as required by law or for the purposes for which it was
disclosed to the third party. The written agreement from
the third party must include requirements to immediately
notify the Business Associate of any breaches of
confidentiality of protected health information to the
extent it has obtained knowledge of such breach.
d. The Business Associate may use or
disclose protected health information to report
violations of law to appropriate federal and state
authorities, consistent with HIPAA Regulations.
2. Prohibited Uses and Disclosures:
a. Except as otherwise limited in this
Addendum, the Business Associate shall not disclose
protected health information to a health plan for payment
or health care operations purposes if the patient has
required this special restriction and has paid out of
pocket in full for the health care item or service to
which the protected health information relates in
accordance with HIPAA Regulations.
b. The Business Associate shall not directly
or indirectly receive remuneration in exchange for any
protected health information, unless the Covered Entity
obtained a valid authorization, in accordance with HIPAA
Regulations that includes a specification that protected
health information can be exchanged for remuneration.
1. The Covered Entity will inform
the Business Associate of any limitations in the
Covered Entity&rsquos Notice of Privacy
Practices in accordance with HIPAA Regulations,
to the extent that such limitation may affect the
Business Associate&rsquos use or disclosure
of protected health information.
IV.
OBLIGATIONS OF THE COVERED ENTITY
2.
The Covered Entity will inform the Business Associate of any
changes in, or revocation of, permission by an individual to use
or disclose protected health information, to the extent that such
changes may affect the Business Associate&rsquos use or
disclosure of protected health information.
3.
The Covered Entity will inform the Business Associate of any
restriction to the use or disclosure of protected health
information that the Covered Entity has agreed to in
accordance
with HIPAA Regulations, to the extent that such restriction may
affect the Business Associate&rsquos use or disclosure of
protected health information.
4.
Except in the event of lawful data aggregation or management and
administrative activities, the Covered Entity shall not request
the Business Associate to use or disclose protected health
information in any manner that would not be permissible under
HIPAA Regulations, if done by the Covered Entity.
V.
TERM AND TERMINATION
1. Effect of Termination:
a. Except as provided in paragraph (b) of
this section, upon termination of this Addendum, for any
reason, the Business Associate will return or destroy all
protected health information received from the Covered
Entity or created, maintained, or received by the
Business Associate on behalf of the Covered Entity that
the Business Associate still maintains in any form and
the Business Associate will retain no copies of such
information.
b. If the Business Associate determines that
returning or destroying the protected health information
is not feasible, the Business Associate will provide to
the Covered Entity notification of the conditions that
make return or destruction infeasible. Upon a mutual
determination that return or destruction of protected
health information is infeasible, the Business Associate
shall extend the protections of this Addendum to such
protected health information and limit further uses and
disclosures of such protected health information to those
purposes that make return or destruction infeasible, for
so long as the Business Associate maintains such
protected health information.
c. These termination provisions will apply
to protected health information that is in the possession
of subcontractors, agents or employees of the Business
Associate.
2. Term. The Term of this Addendum
shall commence as of the effective date of this Addendum
herein and shall extend beyond the termination of the
contract and shall terminate when all the protected
health information provided by the Covered Entity to the
Business Associate, or accessed, maintained, created,
retained, modified, recorded, stored or otherwise held,
transmitted, used or disclosed by the Business Associate
on behalf of the Covered Entity, is destroyed or returned
to the Covered Entity, or if it is not feasible to return
or destroy the protected health information, protections
are extended to such information, in accordance with the
termination.
3. Termination for Breach of Contract. The
Business Associate agrees that the Covered Entity may
immediately terminate the Contract if the Covered Entity
determines that the Business Associate has violated a
material part of this Addendum.
VI.
MISCELLANEOUS
1. Amendment. The parties agree to
take such action as is necessary to amend this Addendum
from time to time for the Covered Entity to comply with
all the requirements of HIPAA Regulations.
2. Clarification. This Addendum
references the requirements of HIPAA Regulations, as well
as amendments and/or provisions that are currently in
place and any that may be forthcoming.
3. Indemnification. Each party will
indemnify and hold harmless the other party to this
Addendum from and against all claims, losses, liabilities,
costs and other expenses incurred as a result of, or
arising directly or indirectly out of or in conjunction
with:
a. Any misrepresentation, breach of
warranty or non-fulfillment of any undertaking on
the part of the party under this Addendum; and
b. Any claims, demands, awards,
judgments, actions, and proceedings made by any
person or organization arising out of or in any
way connected with the party&rsquos
performance under this Addendum.
4. Interpretation. The provisions of
this Addendum shall prevail over any provisions in the
Contract that any conflict or appear inconsistent with
any provision in this Addendum. This Addendum and the
Contract shall be interpreted as broadly as necessary to
implement and comply with HIPAA Regulations.
The parties agree that any ambiguity in this Addendum
shall be resolved to permit the Covered Entity and the
Business Associate to comply with HIPAA Regulations.
5. Regulatory Reference. A reference
in this Addendum to HIPAA Regulations means the sections
as in effect or as amended.
6. Survival. The respective rights
and obligations of Business Associate under Effect of
Termination of this Addendum shall survive the
termination of this Addendum.
IN
WITNESS WHEREOF, the Business Associate and the Covered
Entity have agreed to the terms of the above written agreement as
of the effective date set forth below.
COVERED ENTITY
|
|
BUSINESS ASSOCIATE
|
Division of Health Care
Financing and Policy
|
|
|
1100 E. William Street, Suite
101
|
|
(Business Name)
|
Carson City, NV 89701
|
|
(Business Address)
|
(775) 684-3676
|
|
(City, State and Zip Code)
__________________________________________
|
(775) 687-3735
|
|
(Business Phone Number)
|
|
|
(Business FAX Number)
|
|
|
|
(Authorized Signature)
|
|
(Authorized Signature)
|
Suzanne Bierman
|
|
|
Administrator
|
|
(Print Name)
|
|
|
(Title)
|
|
|
|
(Date)
|
|
(Date)
|
|
|