BUSINESS ASSOCIATE AGREEMENT.pdf

BUSINESS ASSOCIATE AGREEMENT

BETWEEN

SOUTH CAROLINA DEPARTMENT OF PUBLIC HEALTH

CONTRACTOR

II. DEFINITIONS Tern1s used, but not otherwise defined, in this Agreement shall have the same meanings as set forth in HIPAA and HITECH. A change to HIPAA or HITECH which modifies any defined term, or which alters the regulatory citation for the definition, shall be deemed incorporated into this Agreement.

a. Breach. "Breach" shall have the meaning given under HITECH Section 13400, 42 U.S.C § 17921, and 45 CFR §164.402.

b. Data Aggregation. "Data Aggregation" shall have the meaning given under the Privacy Rule, including, but not limited to, 45 CFR §164.501.

c. Designated Record Set. "Designated Record Set" shall have the same meaning as the te1111 "designated record set" in 45

CFR §164.501.

d. Disclose" and "Disclosure" shall have the meaning given in 45 CFR §160.103.

e. Electronic Protected Health Information. "Electronic Protected Health Information" (referred to below as EPHI) shall have the same meaning as the term "electronic protected health info1mation" in 45 CFR § 160.103.

f. HIPAA. "HIPAA" shall mean the Health Insurance Portability and Accountability Act of 1996, Public Law 104-91, as amended, and related HIPAA regulations ( 45 CFR Parts 160-164.)

g. HITECH. "HITECH" shall mean the Health Information Technology for Economic and Clinical Health Act, found in

Title XIII of the American Recovery and Reinvestment Act of 2009, Public Law 111-005.

Individual. "Individual" shall have the same meaning as the term "individual" in 45 CFR § 160. l 03 and shall include a person who qualifies as a personal representative in accordance with 45 CFR § l 64.502(g).

1. Privacy Rule. "Privacy Rule" shall mean the Standards for Privacy of individually Identifiable Health Information codified at 45 CFR Part 160 and Part 164, Subparts A and E and any other applicable provisions of HIPAA, or amendments thereto, including HITECH.

J. Protected Health Information. "Protected Health Information" (referred to below as PHI) shall have the same definition contained in 45 CFR §160.103. For purposes of this Agreement, PHI is limited to the information created or received by Business Associate from or on behalf of Covered Entity. "Protected Health Information" includes, without limitation, "Electronic Protected Health Infonnation," as defined below.

k. Required By Law. "Required By Law" shall have the meaning given to the term under the Privacy Rule, including but not limited to, 45 CFR §164.103, and any additional requirements created under HITECH.

I. Secretary. "Secretary" shall mean the Secretary of the U. S. Department of Health and Human Services or his/her designee.

m. Security Incident. "Security Incident" shall have the meaning given in 45 CFR §164.304.

n. Security Standards. "Security Standards" shall mean the Standards for the Protection of Electronic Protected Health

Information that are codified at 45 CFR Part 160 and Part 164, Subparts A and C, and any other applicable provision of

HIPAA, or amendments thereto, including HITECH.

o. Unsecured PHI. 'Unsecured PHI" shall mean PHI that is not secured through the use of a technology or methodology specified by the Secretary in guidance or as otherwise defined in Section 13402 of HITECH.

p. "Use" or "Uses" shall have the meaning given in 45 CFR §160.103.

DPH 0854 (Revised 3/06/13)

III. USE OR DISCLOSURE OF PHI BY BUSINESS ASSOCIATE

a. Except as otherwise limited in this Agreement, Business Associate may use or disclose PHI to perform functions, activities, or services for, or on behalf of, Covered Entity as specified in Contract or as otherwise provided by law, if such use or disclosure would not violate the Privacy Rule or the Security Standards if done by Covered Entity.

b. 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, and may disclose PHI for those purposes provided that as to any such disclosure: I) the disclosure is required by law; or 2) Business

Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and will be used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which the person is aware in which the confidentiality of the information has been breached.

c. Business Associate will notify the Covered Entity of any breach of confidentiality or security by a person to whom the

Business Associate has disclosed PHI pursuant to this Section and will mitigate and/or assist the person and the Covered

Entity in mitigating any harmful effects resulting from the breach of info1mation.

d. Except as otherwise limited in this Agreement, Business Associate may use PHI to provide Data Aggregation services to

Covered Entity as permitted by 42 CFR § 164.504(e)(2)(i)(B).

e. Business Associate may use PHI to report violations of law to appropriate Federal and State authorities, consistent with §

164.502(j)(l).

f. Business Associate may disclose PHI to any of its subcontractors for use in filling the obligations of this Agreement as long as the subcontractor agrees in writing to the restrictions and conditions in this Agreement with respect to PHI.

g. Business Associate may disclose PHI to another entity as authorized by the Covered Entity in a separate written agreement or amendment to this agreement, if such disclosure of PHI would not violate the Privacy Rule or HITECH if done by

Covered Entity itself.

h. Business Associate, upon entering into an agreement using PHI for any of its functions and activities on behalf of the

Covered Entity or in its general operations, will make available that agreement to the Covered Entity upon request.

IV. DUTIES OF BUSINESS ASSOCIATE RELATIVE TO PHI

a. Business Associate shall comply with the Confidentiality provision contained in Contract and any Confidentiality

Agreement signed by the Business Associate pursuant to that Contract for so long as this BA Agreement remains in effect.

b. Business Associate shall not use or disclose PHI other than as permitted or required by this Agreement or as required by law. Business Associate will not use PHI in any manner that would constitute a violation of the P1ivacy Rule, Security Standards, HIPAA, or HITECH if so used by Covered Entity.

c. Business Associate shall develop, implement, maintain, and use appropriate safeguards to prevent any use or disclosure of

PHI or EPHI other than as provided by this Agreement, and shall implement administrative, physical, and technical safeguards to comply with the Security Standards as required by 45 CFR Sections 164.308, 164.310, 164.312 and 164.316 in order to protect the confidentiality, integrity, and availability of EPHI or PHI that Business Associate creates, receives, maintains, or transmits, to the same extent as if Business Associate were a Covered Entity, pursuant to HlTECH Section

13401, 42 U.S.C. § 17931. These safeguards are required regardless of the mechanism used to transmit the information.

d. Business Associate shall adopt the effective and appropriate technical safeguards and technology and methodology standards provided in any guidance issued by the Secretary pursuant to HITECH Sections 13401-13402, 42 U.S.C. §§

17931-17932.

e. 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 Agreement or of a Breach of

Unsecured PHI, pursuant to 45 CFR § 164.530(t) and HITECH § 13402.

f. Business Associate shall notify Covered Entity by the most expedient manner within one business day of any use or disclosure of PHI or EPHI not authorized by this Agreement or in violation of any applicable federal or state laws or regulations of which Business Associate becomes aware, or of any suspected or actual Security Incident or Breach, unless delayed in accordance with 45 CFR §164.412. Business Associate shall notify Covered Entity immediately upon the law enforcement delay being lifted.

g. In addition to the notification required by IV.f, Business Associate will provide written notification of a Breach of

Unsecured PHI to Covered Entity without unreasonable delay and in no event later than 5 calendar days after discovery of the Breach. A Breach of Unsecured PHI shall be treated as discovered by the Business Associate as of the first day on which such breach is known to Business Associate or, by exercising reasonable diligence, would have been known to the

Business Associate. Notification of a Breach of Unsecured PHI required by this paragraph shall comply with HITECH

Section 13402, 42 U.S.C. § 17932, and 45 CFR § 164.410. The Breach notice shall include, to the extent possible, the identification of each individual whose Unsecured PHI has been or is reasonably believed by the Business Associate to have been, accessed, acquired, or disclosed during the Breach. Business Associate shall provide Covered Entity with the following information at the time of the Breach notification or promptly thereafter as soon as information becomes available:

I. A brief description of what happened, including the date of the Breach and the date of the discovery of the Breach, if known, and the nature of the non-permitted use or disclosure;

2. A description of the unsecured PHI that was involved in the Breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved);

3. Who made the non-permitted use or disclosure;

4. Who received the non-permitted use or disclosure;

5. Any steps individuals should take to protect themselves from potential harm resulting from the Breach; and

6. What Business Associate is doing to investigate the Breach, to mitigate harm to individuals, and to protect against any further breaches.

h. Business Associate shall ensure that any agent or subcontractor to whom it provides PHI received from Covered Entity, or that creates, receives, maintains, or transmits PHI on behalf of Business Associate, agrees to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such information, including this paragraph, and agrees to implement reasonable and appropriate safeguards to protect such PHI, including the safeguards required by paragraph IV.c and IV.ct above with respect to PHT. Business Associate shall implement and maintain sanctions against agents and subcontractors that violate such restrictions and conditions and shall mitigate the effects of such violation.

1. Business Associate shall provide 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 fulfill the requirements of 45 CFR § 164.524 if the Business Associate has PHI in a designated record set. If Business

Associate receives a request directly from an Individual, Business Associate will direct the Individual to the Covered Entity.

J. Business Associate shall make any amendment(s) to PHI in a Designated Record Set that the Covered Entity directs or agrees to pursuant to 45 CFR § 164.526 at the request of Covered Entity or an Individual, and in the time and maimer designated by Covered Entity, if Business Associate has PHI in a Designated Record St. Business Associate shall not amend PHI received from the Covered Entity or created and/or provided to the Business Associate on behalf of the Covered

Entity unless the amendment is directed by or consented to by the Covered Entity. If an Individual requests an amendment of PHI directly from Business Associate or any of its agents or subcontractors, Business Associate will direct Individual to

Covered Entity. The Business Associate shall provide a copy of the amended PHI to the Covered Entity.

k. 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 CFR § 164.528. Business Associate agrees to collect and maintain disclosure information as it relates to PHI including: (i) the date of disclosure; (ii) the name of the entity or person who received the PHI and, if known, the address of the entity or person: (iii) a brief description of the PHI disclosed; and (iv) a brief statement of purpose of the disclosure that reasonably informs the Individual of the basis for the disclosure, or a copy of the written request for disclosure under

45 CFR § l 64.502(a)(2)(ii) or I 64.512, if any. Business Associate will maintain records related to disclosures of PHI for at least six (6) years after the date of the disclosure. The provisions of this subparagraph shall survive tem1ination of this

Agreement.

I. Business Associate will provide to Covered Entity or an Individual, in the time and manner designated by Covered Entity, information collected in accordance with Section IV.k of this Agreement, to pern1it Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR § 164.528. In addition, Business Associate agrees to make PHI available for purposes of accounting of disclosures as required by Section 164.528 of the Privacy Rule and

Section 13405(c)(3) of HITECH, 42 U.S.C. § 17935(c)(3). If the request for an accounting is delivered directly to Business

Associate or its agents or subcontractors, Business Associate shall within five (5) days of a request forward it to Covered Entity in writing.

m. Business Associate shall comply with any requests for restrictions on certain disclosures of PHI pursuant to Section

164.522 of the Privacy Rule to which Covered Entity has agreed and of which Business Associate is notified by Covered Entity

n. Business Associate shall comply, pursuant to HITECH and its implementing regulations, with all additional requirements of the Privacy Rule, including those contained in 45 CFR 164.502( e) and 164.504(e)( I )(ii) at such time as the requirements are applicable to Business Associate, pursuant to HITECH Section 13404, 42 U.S.C. § 17934.

o. If applicable, and if requested by Covered Entity, Business Associate will provide a copy of Covered Entity's Notice of

Privacy Practices to the client at the time of first contact and maintain documentation of the client's receipt of the Notice.

p. Business Associate shall make its internal practices, books, and records, including policies and procedures and PHI, relating to the use and disclosure of PHI received from, or created or received by Business Associate on behalf of, Covered Entity available to the Secretary for purposes of the Secretary determining compliance with the Privacy Rule. Business Associate shall comply and cooperate with any request for documents or other information from the Secretary directed to Covered Entity that seeks documents or other info1mation held by Business Associate. Business Associate shall provide to Covered Entity a copy of any PHI that Business Associate provides to the Secretary concurrently with providing such PHI to the Secretary.

q. Business Associate and its agents and subcontractors may only request, use, or disclose the minimum amount of PHI necessary to accomplish the purpose of the request, use, or disclosure pursuant to this agreement and consistent with Covered

Entity's minimum necessary policies and procedures. Except as otherwise pe1mitted by HIPAA standards, until the effective date on which the Secretary issues guidance on what constitutes "minimum necessary," when using or disclosing PHI or responding to a request for PHI, Business Associate and its agents or subcontractors must limit such PHI, to the extent practicable, to a Limited Data Set, or if more info1mation than a Limited Data Set is required, to the minimum necessary to accomplish the intended purpose of such use, disclosure or request. After the effective date on which the Secretary issues guidance on what constitutes "minimum necessary," Business Associate and its agents or subcontractors shall only request, use, and disclose the minimum amount of PHI necessary to accomplish the purpose of the request, use or disclosure, and shall comply with the Secretary's guidance on what constitutes "minimum necessary." See HITECH Section 13405, 42 U.S.C. §

17935.

r. Business Associate shall provide Covered Entity reasonable access to its premises for review and demonstration of its internal practices and procedures for safeguarding PHI of Covered Entity for purposes of determining that Business

Associate has complied with this Agreement and HITECH; provided that 1) the Parties mutually agree in advance upon the scope, location and timing of such access, and 2) Covered Entity shall protect confidential and proprietary information of Business Associate to which Covered Entity has access.

s. Business Associate acknowledges that Business Associate has no ownership rights with respect to the PHI.

t. If Business Associate knows of a pattern of activity or practice of Covered Entity that constitutes a material breach or violation of Covered Entity's obligations under the Agreement or other management, Business Associate must take reasonable steps to cure the breach or end the violation. If the steps are unsuccessful, Business Associate must terminate the Agreement or other management if feasible, or, if termination is not feasible, report the problem to the Secretary.

Business Associate shall provide written notice to Covered Entity of any pattern of activity or practice of the Covered

Entity that Business Associate believes constitutes a material breach or violation of the Covered Entity's obligations under the Agreement within five (5) days of discovery and shall meet with Covered Entity to discuss and attempt to resolve the problem as one of the reasonable steps to cure the breach or end the violation.

LI. Business Associate acknowledges that if it violates any of the requirements provided under this Business Associate

Agreement, Business Associate will be subject to the same civil and criminal penalties that a Covered Entity would be subject to if such Covered Entity violated the same requirement.

v. The additional requirements of HITECH that relate to privacy and security and that are made applicable with respect to covered entities shall also be applicable to Business Associate and shall be and by this reference are incorporated into this

Agreement.

w. Business Associate will contact the Covered Entity's Privacy Officer at (803) 898-3318 at any time clarification or guidance is needed regarding compliance with the terms of this Agreement.

x. Business Associate shall not use or disclose PHI for fundraising or marketing purposes.

y. Business Associate may not enter into any agreements with its agents or subcontractors pertaining to its obligations under this Agreement without the express written consent of Covered Entity.

V. DUTIES OF COVERED ENTITY

a. If applicable, Covered Entity shall provide the Business Associate with a copy of its policies and procedures implementing the Privacy Rule, including the Notice of Privacy Practices.

b. Covered Entity shall notify Business Associate of any limitation(s) in Covered Entity's Notice of Privacy Practices in accordance with 45 CFR § 164.520, to the extent that such limitation may affect Business Associate's use or disclosure of PHI.

c. 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's use or disclosure of PHI, within a reasonable period of time after Covered Entity becomes aware of such changes to or revocation of permission.

cl. Covered Entity shall notify Business Associate of any restriction to the use or disclosure of PHI that Covered Entity has agreed to or must comply with in accordance with 45 CFR § 164.522 and HITECH § 13405{a), 42 USC§ 17935(a), to the extent that such restriction may affect Business Associate's use or disclosure of PHI.

e. Covered Entity will not request Business Associate to use or disclose PHI in any manner that would not be pe1111issible under the Privacy Rule if done by Covered Entity.

VI. TERM AND TERMINATION

a. Term. The Tem1 of this Agreement shall be effective when the Contract is signed by all parties and a purchase order has been issued 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 tern1ination provisions in this Section.

b. Termination for Cause. Upon Covered Entity's knowledge of a material breach of this Agreement by Business Associate, Covered Entity shall do any of the following:

I. Provide an opportunity for Business Associate to cure the breach or end the violation, and terminate this Agreement and Contract if Business Associate does not cure the breach or end the violation within the time specified by Covered

Entity;

2. Immediately terminate this Agreement and Contract if Business Associate has breached a material te1111 of this

Agreement and cure is not feasible;

3. If neither termination nor cure is feasible, Covered Entity shall report the violation to the Secretary;

4. Immediately stop all further disclosures of PHI to Business Associate pursuant to each agreement between Covered

Entity and Business Associate that is the subject of such breach, until the breach is cured.

c. Effect of Termination.

1. Except as provided in paragraph (2) of this section, upon te1111ination of this Agreement for any reason or upon written demand from Covered Entity, Business Associate shall return or destroy all PHI received from Covered Entity or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to PHI that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies, including backups, of the PHI. If the return or destruction of PHI held by the Business Associate is not pe1111issible pursuant to

South Carolina law, the Business Associate will extend the protections of this Agreement to the PHI and limit further uses and disclosures to those purposes that make the return or destruction of the PHI infeasible.

2. 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 muh1al agreement of the parties that reh1rn, or destruction of PHI is infeasible, Business Associate shall extend the protections of this Agreement to such Pm 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.

d. Continuing Privacy Obligation. Business Associate's obligation to protect the privacy of PHI is continuous and survives any termination, cancellation, expiration, or other conclusion of this Agreement or any other agreement between Business

Associate and Covered Entity.

VII. INDEMNIFICATION (the following does not apply to other government agencies or political subdivisions)

Business Associate agrees to indemnify and hold harn1less Covered Entity from any claims, demand, suit, loss, liability, or administrative penalties that the Covered Entity may sustain as a result of the Business Associate's breach of this Agreement, including any breach of confidentiality by a person to whom the Business Associate has disclosed information pursuant to this

Agreement; provided, however, that the Business Associate shall not hold the Covered Entity harmless from any claims, demands or causes of action arising or resulting directly or indirectly from negligence of the Covered Entity, its officers, agents, representatives or employees, or any person or entity not subject to the Business Associate's supervision or control. This indemnification shall include reasonable expenses, including attorney fees incurred by defending such claims and damages incurred by reason of the Business Associate's failure to comply with applicable laws and regulations or for damages caused by the Business Associate, its employees and/or agents, including subcontractors. As a condition precedent to asserting a right of indemnity, the Covered Entity shall provide timely written notice to the Business Associate of the asse1tion of the claim to which the right of indemnification is claimed to exist.

VIII. MISCELLANEOUS

a. Regulato1y References. A reference in this Agreement to a section in the Privacy Rule or the Security Standards means the section as in effect or as amended.

b. Amendment. The Parties agree to take such action as is necessary to amend this Agreement to comply with the requirements of the Privacy Rule, the Security Standards, HIPAA, HITECH, or any other state or federal law affecting this

Agreement. If a Party believes in good faith that any provision of this Agreement fails to comply with the then- current requirements of HITECH or its regulations, such Party shall notify the other Party in writing. For a period of thirty days, the Parties shall address such concern in good faith and amend the terms of the Agreement if necessary to bring it into compliance. If, after such thirty-day period, the Agreement fails to comply with HIPAA, the Privacy Rule, the Security

Standards or HTTECH, then either Party has the right to terminate upon written notice to the other Party.

c. Survival. The respective rights and obligations of Business Associate under Section VI.c and VI.d of this Agreement shall survive termination of this Agreement.

d. Interpretation. Any ambiguity in this Agreement shall be resolved to pem1it Covered Entity to comply with the Privacy

Rule and the Security Standards.

e. All notices pursuant to this Agreement must be given in writing and shall be effective when received if hand-delivered or upon dispatch if sent by reputable overnight delive1y service, facsimile, or U.S. Mail to the appropriate address or facsimile number. Notification of any unauthorized use or disclosure of PHI or of a Breach of Unsecured PHI under paragraphs

IV.f and IY.g shall be made to the DPH Privacy Officer at 2600 Bull Street, Columbia, SC 2920 I, 803-898-0707 (phone), 803-898-0476 (fax).

f. Business Associate and Covered Entity agree that Individuals who are the subject of PHI are not third-party beneficiaries of this Agreement.

g. The parties acknowledge that state and federal laws relating to electronic data security and privacy are evolving and that amendment of this Agreement 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 HIPAA and HlTECH and other applicable laws relating to the security or confidentiality of PHI. The parties understand and agree that Covered Entity must receive satisfactory written assurance from Business Associate that Business Associate will adequately safeguard all PHI that it receives or creates pursuant to this Agreement. Upon Covered Entity's request, Business

Associate agrees to promptly enter into negotiations with Covered Entity concerning the terms of any amendment to the

Agreement embodying written assurances consistent with the standards and requirements of HIPAA and HlTECH or other applicable laws. Covered Entity may terminate this Agreement and Contract upon thirty (30) days written notice if (i)

Business Associate does not promptly enter into negotiations to amend this Agreement when requested by Covered Entity

h. pursuant to this Section, or (ii) Business Associate does not enter into an amendment to this Agreement providing assurances regarding the safeguarding of PHI that Covered Entity, in its sole discretion, deems sufficient to satisfy the standards and requirements of HIPAA and HlTECH.

i. If any provision of this Agreement violates any applicable statute, ordinance, or rule of law in any jurisdiction that governs this Agreement, such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement.

1. This Agreement may not be amended, altered, or modified except by written agreement signed by Business Associate and

Covered Entity.

j. No provision of this Agreement may be waived except by an agreement in writing signed by the waiving party. A waiver of any term or provision shall not be construed as a waiver of any other tern1 or provision.

k. The persons signing below have the right and authority to execute this Agreement for their respective entities and no further approvals are necessary to create a binding Agreement.

l. Neither Covered Entity nor Business Associate shall use the names or trademarks of the other party or of any of the respective party's affiliated entities in any advertising, publicity, endorsement, or promotion unless prior written consent has been obtained for the particular use contemplated.

m. All references to specific statutes, codes, or regulations shall be deemed to be references to those statutes, codes or regulations as they may be amended from time to time.

n. Neither party is an employee, agent, partner, or joint venturer of the other. Neither party has the right or authority to control or direct the activities of the other or the right or authority to bind the other to any agreement with a third party or to incur any obligation or liability on behalf of the other party, unless expressly authorized in this or another agreement between the parties.

AS TO THE CONTRACTING PARTY

BY:________________________________

Contractor signature

DATE: ___________________________________

VENDOR NO. __

MAILING ADDRESS: (PLEASE PRINT)