HomeMy WebLinkAboutC14-290 HIPAA Business Associate Addendum •
HIPAA BUSINESS ASSOCIATE ADDENDUM
This Business Associate Addendum("Addendum") is a part of the Contract dated
October 1, 2013 between the Colorado Department of Human Services and the Eagle County
Department of Social Services, contract number RX IID DBHM1400041 (the "Contract"). For
purposes of this Addendum, the State is referred to as "Covered Entity"or"CE" and the
Contractor is referred to as "Associate". Unless the context clearly requires a distinction
between the Contract document and this Addendum, all references herein to "the Contract" or
"this Contract"include this Addendum.
RECITALS
A. CE wishes to disclose certain information to Associate pursuant to the terms of the
Contract, some of which may constitute Protected Health Information("PHP') (defined
below).
B. CE and Associate intend to protect the privacy and provide for the security of PHI
disclosed to Associate pursuant to this Contract in compliance with the Health Insurance
Portability and Accountability Act of 1996, 42 U.S.C. § 1320d— 1320d-8 ("HIPAA") as
amended by the American Recovery and Reinvestment Act of 2009 ("ARRA")/HITECH
Act (P.L. 111-005), and its implementing regulations promulgated by the U.S.
Department of Health and Human Services, 45 C.F.R. Parts 160, 162 and 164 (the
"HIPAA Rules") and other applicable laws, as amended.
C. As part of the HIPAA Rules, the CE is required to enter into a written contract containing
specific requirements with Associate prior to the disclosure of PHI, as set forth in,but not
limited to, Title 45, Sections 160.103, 164.502(e) and 164.504(e) of the Code of Federal
Regulations ("C.F.R.") and contained in this Addendum.
The parties agree as follows:
1. Definitions.
a. Except as otherwise defined herein, capitalized terms in this Addendum shall have
the definitions set forth in the HIPAA Rules at 45 C.F.R. Parts 160, 162 and 164, as amended.
In the event of any conflict between the mandatory provisions of the HIPAA Rules and the
provisions of this Contract,the HIPAA Rules shall control. Where the provisions of this
Contract differ from those mandated by the HIPAA Rules,but are nonetheless permitted by the
HIPAA Rules, the provisions of this Contract shall control.
b. "Protected Health Information" or"PHP'means any information, whether oral or
recorded in any form or medium: (i) that relates to the past, present or future physical or mental
condition of an individual; the provision of health care to an individual; or the past, present or
future payment for the provision of health care to an individual; and (ii)that identifies the
individual or with respect to which there is a reasonable basis to believe the information can be
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used to identify the individual, and shall have the meaning given to such term under the HIPAA
Rules, including, but not limited to, 45 C.F.R. Section 164.501.
c. "Protected Information" shall mean PHI provided by CE to Associate or created
received, maintained or transmitted by Associate on CE's behalf To the extent Associate is a
covered entity under HIPAA and creates or obtains its own PHI for treatment, payment and
health care operations, Protected Information under this Contract does not include any PHI
created or obtained by Associate as a covered entity and Associate shall follow its own policies
and procedures for accounting, access and amendment of Associate's PHI.
d. "Subcontractor" shall mean a third party to whom Associate delegates a function,
activity, or service that involves CE's Protected Information, in order to carry out the
responsibilities of this Agreement.
2. Obligations of Associate.
a. Permitted Uses. Associate shall not use Protected Information except for the
purpose of performing Associate's obligations under this Contract and as permitted under this
Addendum. Further, Associate shall not use Protected Information in any manner that would
constitute a violation of the HIPAA Rules if so used by CE, except that Associate may use
Protected Information: (i) for the proper management and administration of Associate; (ii) to
carry out the legal responsibilities of Associate; or(iii) for Data Aggregation purposes for the
Health Care Operations of CE. Additional provisions, if any, governing permitted uses of
Protected Information are set forth in Attachment A to this Addendum. Associate accepts full
responsibility for any penalties incurred as a result of Associate's breach of the HIPAA Rules.
b. Permitted Disclosures. Associate shall not disclose Protected Information in any
manner that would constitute a violation of the HIPAA Rules if disclosed by CE, except that
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Associate may disclose Protected Information: (i) in a manner permitted pursuant to this
Contract; (ii) for the proper management and administration of Associate; (iii) as required by
law; (iv) for Data Aggregation purposes for the Health Care Operations of CE; or(v)to report
violations of law to appropriate federal or state authorities, consistent with 45 C.F.R. Section
164.502(j)(1). To the extent that Associate discloses Protected Information to a third party
Subcontractor, Associate must obtain, prior to making any such disclosure: (i) reasonable
assurances through execution of a written agreement with such third party that such Protected
Information will be held confidential as provided pursuant to this Addendum and only disclosed
as required by law or for the purposes for which it was disclosed to such third party; and that
such third party will notify Associate within two (5)business days of any breaches of
confidentiality of the Protected Information, to the extent it has obtained knowledge of such
breach. Additional provisions, if any, governing permitted disclosures of Protected Information
are set forth in Attachment A.
c. Appropriate Safeguards. Associate shall implement appropriate safeguards as are
necessary to prevent the use or disclosure of Protected Information other than as permitted by
this Contract. Associate shall comply with the requirements of the HIPAA Security Rule at 45
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C.F.R. Sections 164.308, 164.310, 164.312, and 164.316. Associate shall maintain a
comprehensive written information privacy and security program that includes administrative,
technical and physical safeguards appropriate to the size and complexity of the Associate's
operations and the nature and scope of its activities. Associate shall review, modify, and update
documentation of, its safeguards as needed to ensure continued provision of reasonable and
appropriate protection of Protected Information.
d. Reporting of Improper Use or Disclosure. Associate shall report to CE in writing
any use or disclosure of Protected Information other than as provided for by this Contract within
five(5)business days of becoming aware of such use or disclosure.
e. Associate's Agents. If Associate uses one or more Subcontractors or agents to
provide services under the Contract, and such Subcontractors or agents receive or have access to
Protected Information, each Subcontractor or agent shall sign an agreement with Associate
containing the same provisions as this Addendum and further identifying CE as a third party
beneficiary with rights of enforcement and indemnification from such Subcontractors or agents
in the event of any violation of such Subcontractor or agent agreement. The Agreement between
the Associate and Subcontractor or agent shall ensure that the Subcontractor or agent agrees to at
least the same restrictions and conditions that apply to Associate with respect to such Protected
Information. Associate shall implement and maintain sanctions against agents and
Subcontractors that violate such restrictions and conditions and shall mitigate the effects of any
such violation.
f. Access to Protected Information. If Associate maintains Protected Information
contained within CE's Designated Record Set, Associate shall make Protected Information
maintained by Associate or its agents or Subcontractors in such Designated Record Sets
available to CE for inspection and copying within ten(10)business days of a request by CE to
enable CE to fulfill its obligations to permit individual access to PHI under the HIPAA Rules,
including,but not limited to, 45 C.F.R. Section 164.524. If such Protected Information is
maintained by Associate in an electronic form or format, Associate must make such Protected
Information available to CE in a mutually agreed upon electronic form or format.
g. Amendment of PHI. If Associate maintains Protected Information contained
within CE's Designated Record Set, Associate or its agents or Subcontractors shall make such
Protected Information available to CE for amendment within ten(10)business days of receipt of
a request from CE for an amendment of Protected Information or a record about an individual
contained in a Designated Record Set, and shall incorporate any such amendment to enable CE
to fulfill its obligations with respect to requests by individuals to amend their PHI under the
HIPAA Rules, including,but not limited to, 45 C.F.R. Section 164.526. If any individual
requests an amendment of Protected Information directly from Associate or its agents or
Subcontractors, Associate must notify CE in writing within five(5)business days of receipt of
the request. Any denial of amendment of Protected Information maintained by Associate or its
agents or Subcontractors shall be the responsibility of CE.
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h. Accounting Rights. If Associate maintains Protected Information contained
within CE's Designated Record Set, Associate and its agents or Subcontractors shall make
available to CE within ten(10)business days of notice by CE, the information required to
provide an accounting of disclosures to enable CE to fulfill its obligations under the HIPAA
Rules, including,but not limited to, 45 C.F.R. Section 164.528. In the event that the request for
an accounting is delivered directly to Associate or its agents or Subcontractors, Associate shall
within five (5)business days of the receipt of the request forward it to CE in writing. It shall be
CE's responsibility to prepare and deliver any such accounting requested. Associate shall not
disclose any Protected Information except as set forth in Section 2(b) of this Addendum.
i. Governmental Access to Records. Associate shall keep records and make its
internal practices,books and records relating to the use and disclosure of Protected Information
available to the Secretary of the U.S. Department of Health and Human Services (the
"Secretary"), in a time and manner designated by the Secretary, for purposes of determining
CE's or Associate's compliance with the HIPAA Rules. Associate shall provide to CE a copy of
any Protected Information that Associate provides to the Secretary concurrently with providing
such Protected Information to the Secretary when the Secretary is investigating CE. Associate
shall cooperate with the Secretary if the Secretary undertakes an investigation or compliance
review of Associate's policies, procedures or practices to determine whether Associate is
complying with the HIPAA Rules, and permit access by the Secretary during normal business
hours to its facilities,books, records, accounts, and other sources of information, including
Protected Information, that are pertinent to ascertaining compliance.
j. Minimum Necessary. Associate(and its agents or subcontractors) shall only
request, use and disclose the minimum amount of Protected Information necessary to accomplish
the purpose of the request, use or disclosure, in accordance with the Minimum Necessary
requirements of the HIPAA Rules including,but not limited to 45 C.F.R. Sections 164.502(b)
and 164.514(d).
k. Data Ownership. Associate acknowledges that Associate has no ownership rights
with respect to the Protected Information.
1. Retention of Protected Information. Except upon termination of the Contract as
provided in Section 4(d) of this Addendum, Associate and its Subcontractors or agents shall
retain all Protected Information throughout the term of this Contract and shall continue to
maintain the information required under Section 2(h) of this Addendum for a period of six (6)
years.
m. Associate's Insurance. Associate shall maintain insurance to cover loss of PHI
data and claims based upon alleged violations of privacy rights through improper use or
disclosure of PHI. All such policies shall meet or exceed the minimum insurance requirements
of the Contract (e.g., occurrence basis, combined single dollar limits, annual aggregate dollar
limits, additional insured status and notice of cancellation).
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n. Notice of Privacy Practices. Associate shall be responsible for reviewing CE's
Notice of Privacy Practices, available on CE's external website, to determine any requirements
applicable to Associate per this Contract.
o. Notification of Breach. During the term of this Contract, Associate shall notify
CE within two (5)business days of any suspected or actual breach of security, intrusion or
unauthorized use or disclosure of PHI and/or any actual or suspected use or disclosure of data in
violation of any applicable federal or state laws or regulations. Associate shall not initiate
notification to affected individuals per the HIPAA Rules without prior notification and approval
of CE. Information provided to CE shall include the identification of each individual whose
unsecured PHI has been, or is reasonably believed to have been accessed, acquired or disclosed
during the breach. Associate shall take(i)prompt corrective action to cure any such deficiencies
and (ii) any action pertaining to such unauthorized disclosure required by applicable federal and
state laws and regulations.
p. Audits, Inspection and Enforcement. Within ten (10)business days of a written
request by CE, Associate and its agents or subcontractors shall allow CE to conduct a reasonable
inspection of the facilities, systems,books, records, agreements, policies and procedures relating
to the use or disclosure of Protected Information pursuant to this Addendum for the purpose of
determining whether Associate has complied with this Addendum; provided, however, that: (i)
Associate and CE shall mutually agree in advance upon the scope, timing and location of such an
inspection; and (ii) CE shall protect the confidentiality of all confidential and proprietary
information of Associate to which CE has access during the course of such inspection. The fact
that CE inspects, or fails to inspect, or has the right to inspect, Associate's facilities, systems,
books, records, agreements, policies and procedures does not relieve Associate of its
responsibility to comply with this Addendum, nor does CE's (i) failure to detect or(ii) detection,
but failure to notify Associate or require Associate's remediation of any unsatisfactory practices,
constitute acceptance of such practice or a waiver of CE's enforcement rights under the Contract.
q. Safeguards During Transmission. Associate shall be responsible for using
appropriate safeguards, including encryption of PHI, to maintain and ensure the confidentiality,
integrity and security of Protected Information transmitted pursuant to the Contract, in
accordance with the standards and requirements of the HIPAA Rules.
r. Restrictions and Confidential Communications. Within ten (10) business days of
notice by CE of a restriction upon uses or disclosures or request for confidential communications
pursuant to 45 C.F.R. Section 164.522, Associate will restrict the use or disclosure of an
individual's Protected Information. Associate will not respond directly to an individual's
requests to restrict the use or disclosure of Protected Information or to send all communication of
Protect Information to an alternate address. Associate will refer such requests to the CE so that
the CE can coordinate and prepare a timely response to the requesting individual and provide
direction to Associate.
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3. Obligations of CE.
a. Safeguards During Transmission. CE shall be responsible for using appropriate
safeguards, including encryption of PHI, to maintain and ensure the confidentiality, integrity and
security of Protected Information transmitted pursuant to the Contract, in accordance with the
standards and requirements of the HIPAA Rules.
b. Notice of Changes. CE maintains a copy of its Notice of Privacy Practices on its
website. CE shall provide Associate with any changes in, or revocation of, permission to use or
disclose Protected Information, to the extent that it may affect Associate's permitted or required
uses or disclosures. To the extent that it may affect Associate's permitted use or disclosure of
PHI, CE shall notify Associate of any restriction on the use or disclosure of Protected
Information that CE has agreed to in accordance with 45 C.F.R. Section 164.522.
4. Termination.
a. Material Breach. In addition to any other provisions in the Contract regarding
breach, a breach by Associate of any provision of this Addendum, as determined by CE, shall
constitute a material breach of this Contract and shall provide grounds for immediate termination
of this Contract by CE pursuant to the provisions of the Contract covering termination for cause,
if any. If the Contract contains no express provisions regarding termination for cause, the
following terms and conditions shall apply:
(1) Default. If Associate refuses or fails to timely perform any of the
provisions of this Contract, CE may notify Associate in writing of the non-performance, and if
not promptly corrected within the time specified, CE may terminate this Contract. Associate
shall continue performance of this Contract to the extent it is not terminated and shall be liable
for excess costs incurred in procuring similar goods or services elsewhere.
(2) Associate's Duties. Notwithstanding termination of this Contract, and
subject to any directions from CE, Associate shall take timely,reasonable and necessary action
to protect and preserve property in the possession of Associate in which CE has an interest.
(3) Compensation. Payment for completed supplies delivered and accepted
by CE shall be at the Contract price. In the event of a material breach under paragraph 4a, CE
may withhold amounts due Associate as CE deems necessary to protect CE against loss from
third party claims of improper use or disclosure and to reimburse CE for the excess costs
incurred in procuring similar goods and services elsewhere.
(4) Erroneous Termination for Default. If after such termination it is
determined, for any reason, that Associate was not in default, or that Associate's action/inaction
was excusable, such termination shall be treated as a termination for convenience, and the rights
and obligations of the parties shall be the same as if this Contract had been terminated for
convenience, as described in this Contract.
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b. Reasonable Steps to Cure Breach. If CE knows of a pattern of activity or practice
of Associate that constitutes a material breach or violation of the Associate's obligations under
the provisions of this Addendum or another arrangement and does not terminate this Contract
pursuant to Section 4(a), then CE shall take reasonable steps to cure such breach or end such
violation.. If CE's efforts to cure such breach or end such violation are unsuccessful, CE shall
either(i)terminate the Contract, if feasible or(ii) if termination of this Contract is not feasible,
CE shall report Associate's breach or violation to the Secretary of the Department of Health and
Human Services. If Associate knows of a pattern of activity or practice of a Subcontractor or
agent that constitutes a material breach or violation of the Subcontractor's or agent's obligations
under the written agreement between Associate and the Subcontractor or agent, Associate shall
take reasonable steps to cure such breach or end such violation, if feasible.
c. Judicial or Administrative Proceedings. Either party may terminate the
Contract, effective immediately, if(i) the other party is named as a defendant in a criminal
proceeding for a violation of the HIPAA Rules or other security or privacy laws or(ii) a finding
or stipulation that the other party has violated any standard or requirement of the HIPAA Rules
or other security or privacy laws is made in any administrative or civil proceeding in which the
party has been joined.
d. Effect of Termination.
(1) Except as provided in paragraph(2) of this subsection, upon termination
of this Contract, for any reason, Associate shall return or destroy all Protected Information that
Associate or its agents or Subcontractors still maintain in any form, and shall retain no copies of
such Protected Information. If Associate elects to destroy the PHI, Associate shall certify in
writing to CE that such PHI has been destroyed.
(2) If Associate believes that returning or destroying the Protected
Information is not feasible, Associate shall promptly provide CE notice of the conditions making
return or destruction infeasible. Associate shall continue to extend the p rotections of Sections
2(a), 2(b), 2(c), 2(d) and 2(e) of this Addendum to such Protected Information, and shall limit
further use of such PHI to those purposes that make the return or destruction of such PHI
infeasible.
5. Injunctive Relief. CE shall have the right to injunctive and other equitable and legal
relief against Associate or any of its Subcontractors or agents in the event of any use or
disclosure of Protected Information in violation of this Contract or applicable law.
6. No Waiver of Immunity. No term or condition of this Contract shall be construed or
interpreted as a waiver, express or implied, of any of the immunities, rights, benefits,protection,
or other provisions of the Colorado Governmental Immunity Act, CRS 24-10-101 et seq. or the
Federal Tort Claims Act, 28 U.S.C. 2671 et seq. as applicable, as now in effect or hereafter
amended.
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7. Limitation of Liability. Any limitation of Associate's liability in the Contract shall be
inapplicable to the terms and conditions of this Addendum.
8. Disclaimer. CE makes no warranty or representation that compliance by Associate with
this Contractor the HIPAA Rules will be adequate or satisfactory for Associate's own purposes.
Associate is solely responsible for all decisions made by Associate regarding the safeguarding of
PHI.
9. Certification. To the extent that CE determines an examination is necessary in order to
comply with CE's legal obligations pursuant to the HIPAA Rules relating to certification of its
security practices, CE or its authorized agents or contractors, may, at CE's expense, examine
Associate's facilities, systems, procedures and records as may be necessary for such agents or
contractors to certify to CE the extent to which Associate's security safeguards comply with the
HIPAA Rules or this Addendum.
10. Amendment.
a. Amendment to Comply with Law. The parties acknowledge that state and federal
laws relating to data security and privacy are rapidly evolving and that amendment of this
Addendum may be required to provide for procedures to ensure compliance with such
developments. The parties specifically agree to take such action as is necessary to implement the
standards and requirements of the HIPAA Rules and other applicable laws relating to the
confidentiality, integrity, availability and security of PHI. The parties understand and agree that
CE must receive satisfactory written assurance from Associate that Associate will adequately
safeguard all Protected Information and that it is Associate's responsibility to receive satisfactory
written assurances from Associate's Subcontractors and agents. Upon the request of either party,
the other party agrees to promptly enter into negotiations concerning the terms of an amendment
to this Addendum embodying written assurances consistent with the standards and requirements
of the HIPAA Rules or other applicable laws. CE may terminate this Contract upon thirty(30)
days written notice in the event(i)Associate does not promptly enter into negotiations to amend
this Contract when requested by CE pursuant to this Section, or(ii) Associate does not enter into
an amendment to this Contract providing assurances regarding the safeguarding of PHI that CE,
in its sole discretion, deems sufficient to satisfy the standards and requirements of the HIPAA
Rules.
b. Amendment of Attachment A. Attachment A may be modified or amended by
mutual agreement of the parties in writing from time to time without formal amendment of this
Addendum.
11. Assistance in Litigation or Administrative Proceedings. Associate shall make itself, and
any Subcontractors, employees or agents assisting Associate in the performance of its obligations
under the Contract, available to CE, at no cost to CE up to a maximum of 30 hours, to testify as
witnesses, or otherwise, in the event of litigation or administrative proceedings being
commenced against CE, its directors, officers or employees based upon a claimed violation of
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the HIPAA Rules or other laws relating to security and privacy or PHI, except where Associate
or its Subcontractor, employee or agent is a named adverse party.
12. No Third Party Beneficiaries. Nothing express or implied in this Contract is intended to
confer, nor shall anything herein confer, upon any person other than CE, Associate and their
respective successors or assigns, any rights, remedies, obligations or liabilities whatsoever.
13. Interpretation and Order of Precedence. The provisions of this Addendum shall prevail
over any provisions in the Contract that may conflict or appear inconsistent with any provision in
this Addendum. Together, the Contract and this Addendum shall be interpreted as broadly as
necessary to implement and comply with the HIPAA Rules. The parties agree that any
ambiguity in this Contract shall be resolved in favor of a meaning that complies and is consistent
with the HIPAA Rules. This Contract supercedes and replaces any previous separately executed
HIPAA addendum between the parties.
14. Survival of Certain Contract Terms. Notwithstanding anything herein to the contrary,
Associate's obligations under Section 4(d) ("Effect of Termination") and Section 12 ("No Third
Party Beneficiaries") shall survive termination of this Contract and shall be enforceable by CE as
provided herein in the event of such failure to perform or comply by the Associate. This
Addendum shall remain in effect during the term of the Contract including any extensions.
15. Representatives and Notice.
a. Representatives. For the purpose of the Contract, the individuals identified
elsewhere in this Contract shall be the representatives of the respective parties. If no
representatives are identified in the Contract, the individuals listed below are hereby designated
as the parties' respective representatives for purposes of this Contract. Either party may from
time to time designate in writing new or substitute representatives.
b. Notices. All required notices shall be in writing and shall be hand delivered or
given by certified or registered mail to the representatives at the addresses set forth below.
State/Covered Entity Representative:
Name: Claudia Zundel
Title: Director, Child, Adolescent and Family Services
Department and Division: Office of Behavioral Health
Address: 3824 West Princeton Circle
Denver, CO 80236
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Contractor/Business Associate Representative:
Name: Toni M. Rozanski
Title: Children, Family and Adult Services Director
County of Eagle, State of Colorado
Department of Health and Human Services
Address: PO Box 660
Eagle, CO 81631
Contractor/Associate State/Covered Entity
Eagle County, Department . S cial STATE OF COLORADO
Services,b .n. t► .ugh ' s 'oard of John W. Hickenlooper, GOVERNOR
County . .n-
By: L, L/ By:
Print Name: Jillian H. Ryan, Chairman For the Executive Director
Department of Human Services
at ATT T: ' �, ,�j �
Teak Simont.nO
Clerk to the Board
Ig ..•►�!^���� 04 41 n i�
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ATTACHMENT A
This Attachment sets forth additional terms to the HIPAA Business Associate
Addendum, which is part of the Contract dated October 1, 2013, between the Colorado
Department of Human Services and the Eagle County Department of Social Services, contract
number DBHM1400041 ("Contract") and is effective as of (the
"Attachment Effective Date").
This Attachment may be amended from time to time as provided in Section 10(b) of the
Addendum.
1. Additional Permitted Uses. In addition to those purposes set forth in Section 2(a) of the
Addendum, Associate may use Protected Information as follows:
2. Additional Permitted Disclosures. In addition to those purposes set forth in Section 2(b)
of the Addendum, Associate may disclose Protected Information as follows:
3. Subcontractor(s). The parties acknowledge that the following subcontractors or agents of
Associate shall receive Protected Information in the course of assisting Associate in the
performance of its obligations under this Contract:
4. Receipt. Associate's receipt of Protected Information pursuant to this Contract shall be
deemed to occur as follows, and Associate's obligations under the Addendum shall commence
with respect to such PHI upon such receipt:
5. Additional Restrictions on Use of Data. CE is a Business Associate of certain other
Covered Entities and, pursuant to such obligations of CE, Associate shall comply with the
following restrictions on the use and disclosure of Protected Information:
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6. Additional Terms. [This section may include specifications for disclosure format,
method of transmission, use of an intermediary, use of digital signatures or PKI, authentication,
additional security of privacy specifications, de-identification or re-identification of data and
other additional terms.]
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