BUSINESS ASSOCIATE AGREEMENT
THIS BUSINESS ASSOCIATE AGREEMENT (“Agreement”) is made by and between (ACCOUNT/PROVIDER, “covered entity”) and Total Wound, LLC (DISTRIBUTOR, “Business Associate”) on the date indicated below to be effective upon execution for purposes of complying with the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (“HIPAA”), as amended by the Health
Information Technology for Economic Clinical Health Act, Publ. L. No. 111-5 (“HITECH”), and the implementing regulations promulgated thereunder that are more specifically referred to as the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E (the “Privacy Rule”); Health Insurance Reform: Security Standards; Final Rules at 45 C.F.R Parts 160 and 164, Subparts A and C (the “Security Rule”); Breach Notification for Unsecured Protected Health Information; Interim Final Rule at 45 C.F.R. Part 164, Subpart D (the “Breach Notification Rule”); and, Administrative Simplification: Enforcement: Interim Final Rule at 45 C.F.R. Part 160 (the “Enforcement Rule”) (collectively, and as may be amended from time to time, “HIPAA”). Covered Entity and Business Associate are collectively referred to as the “Parties.”
PURPOSE
Covered Entity is a “Covered Entity” for purposes of HIPAA. Business Associate provides
services to Covered Entity which may require Business Associate to access, use or disclose PHI. The purpose of this Agreement is to satisfy the requirements of HIPAA that Business Associate provide satisfactory written assurances to Covered Entity that it will comply with the applicable requirements of HIPAA.
NOW THEREFORE, in consideration of the mutual covenants, promises and agreements contained herein, the Parties agree as follows:
1. Definitions. Unless otherwise defined in this Agreement, including the definitions stated in the Preamble and Recitals, which are incorporated into this Section 1 by reference, capitalized terms have the meanings ascribed to them under HIPAA for purpose of this Agreement:
(a) “Individual” shall have the meaning given to such term under the Privacy Rule, including, but not limited to, 45 C.F.R. Section 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. Section 164.502(g).
(b) “PHI” shall have the meaning ascribed to “protected health information” in 45 C.F.R. Section 160.103.
(c) “Secretary” shall have the meaning ascribed to this term in 45 C.F.R. § 160.103.
(d) "Security Incident" means the attempted or successful unauthorized access, use, disclosure, modification or destruction of information or interference with system operations in an information system.
(e) “Services” shall mean all functions performed by Business Associate for Covered Entity which involve creating, accessing, using, or disclosing PHI on behalf of Covered Entity and which may be outlined in one or more services agreements between the parties.
(f) “Services Agreement” shall mean any agreement(s) between the parties covering the Services. (g)“Unsecured PHI” shall have the meaning ascribed to this term in 45 C.F.R. Section 164.402.
(g).“Workforce” means employees, volunteers, trainees, and other persons or entities whose conduct, in the performance of work for the entity, is under the control of such entity, whether they are paid by the entity.
2. Obligations of Business Associate. Regarding the use and/or disclosure of PHI by the Business Associate, Business Associate agrees as follows:
(a) Limitations on Uses and Disclosures of PHI. Business Associate shall not, and shall ensure that its Workforce, subcontractors, and agents do not, use or disclose PHI in any manner that would constitute a violation of HIPAA or any other applicable State or Federal law or regulation governing the privacy of PHI. Business Associate shall use or disclose PHI only (i) to perform Services, (ii) as needed for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate, or (iii) as required by law.
(b) Safeguards to Protect PHI. Business Associate will comply with the Security Rule and will implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the PHI that it creates, receives, maintains, or transmits on behalf of Covered Entity. Business Associate will report to Covered Entity within seven (7) days any Security Incident of which it becomes aware.
(c) Breach Notification. Business Associate shall notify Covered Entity as soon as practicable, but no later than seven (7) days after it is known to Business Associate, or, by exercising reasonable diligence would have been known to Business Associate, of any event involving the access, use, or disclosure of Unsecured PHI in violation of HIPAA or this Agreement (“Breach Event”). Business Associate shall be deemed to have knowledge of a Breach Event if such Breach Event is known, or by exercising reasonable diligence would have been known, to any person, other than a person involved in the Breach Event, who is a Workforce member, subcontractor, or agent of Business Associate (determined in accordance with the federal common law of agency). Business Associate will fully cooperate with Covered Entity in its investigation of any Breach Event. Business Associate shall notify its Workforce and any agents or subcontractors with access to PHI of Business Associate’s obligation to immediately notify Covered Entity of a Breach Event. Business Associate will mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a Breach Event.
(d) Subcontractors. Business Associate will obtain and maintain an agreement with each
subcontractor or agent of Business Associate that creates, receives, maintains, transmits, or otherwise has access to PHI, which is received from, or received by, Business Associate on
behalf of Covered Entity, pursuant to which agreement such subcontractor or agent agrees to be bound by the same restrictions, terms, and conditions that apply to Business Associate pursuant to this Agreement with respect to such PHI.
(e) Access to Information. Business Associate shall make PHI maintained by Business Associate or its agents or subcontractors available to Covered Entity within ten (10) business days of a
written request by Covered Entity to enable Covered Entity to respond to a request by an
Individual for access to PHI pursuant to 45 C.F.R. Section 164.524. In the event any Individual requests access to PHI directly from Business Associate, Business Associate shall forward such request to Covered Entity within three (3) business days. Access to PHI shall be made in electronic format to the extent requested by Covered Entity or Individual in accordance with the HIPAA requirements.
(f) Availability of PHI for Amendment. Promptly upon receipt of a request from Covered Entity to amend an Individual’s PHI, Business Associate shall either provide such PHI to Covered Entity for amendment or incorporate any such amendments in the PHI as required by 45 C.F.R. Section 164.526 in the possession or under the control of Business Associate or make such amendments to said PHI that may be directed, in writing, by Covered Entity. In the event any Individual requests an amendment of PHI in accordance with 45 C.F.R. Section 164.526 directly from Business Associate, Business Associate shall forward such request to Covered Entity within three (3) business days.
(g) Availability of Internal Practices, Books and Records. Business Associate agrees to make available, at reasonable times, to Covered Entity and Secretary Business Associate’s internal practices, books and records relating to the use and disclosure of PHI received from or created or received by Business Associate on behalf of Covered Entity.
(h) Documentation and Accounting of Disclosures. Business Associate agrees to document disclosures of PHI made by Business Associate, other than disclosures of the type outlined in 45 C.F.R. Sections 164.528(a)(i) through (ix) (as amended, updated, or added to by HIPAA), which are necessary for Covered Entity to provide an accounting of such disclosures to an Individual pursuant to 45 C.F.R. Section 164.528. To the extent required by HIPAA, Business Associate shall also document disclosures of PHI made through an Electronic Health Record, as defined pursuant to HITECH, for purposes of Treatment, Payment and Health Care Operations (“TPO
Accounting”). Business Associate shall forward an accounting of such disclosures for a specific Individual within ten (10) business days of receipt of Covered Entity’s written request for such accounting.
(i) Compliance with Laws and Regulations. Business Associate understands that Covered Entity is subject to HIPAA and additional State and Federal laws governing the confidentiality of PHI.
Business Associate agrees to abide by all such laws, whether fully articulated herein.
Furthermore, if Business Associate carries out any HIPAA obligation of Covered Entity, it shall do so in accordance with HIPAA. The Parties agree to negotiate, in good faith, any amendments to this Agreement which may be necessary to comply with any applicable State or Federal law including but not limited to any future amendments to HIPAA.
3. Obligations of Covered Entity. Regarding the use and/or disclosure of PHI by the Business Associate, Covered Entity agrees as follows:
(a) Compliance with Privacy Rule. Covered Entity, its Workforce, subcontractors, and agents: (i) shall comply with the Privacy Rule in its use or disclosure of PHI; (ii) shall not use or disclose PHI in any manner that violates applicable Federal and State laws; and (iii) shall not request Business Associate to use or disclose PHI in any manner that violates applicable Federal and State laws.
(b) Notice of Privacy Practices. Covered Entity shall provide Individuals with a notice of privacy practices (the “Notice”) and shall provide Business Associate a copy of the Notice currently in use upon request.
(c) Revocation of Authorizations. Covered Entity shall promptly notify Business Associate, in writing, of any changes in or revocation of an Individual’s permission to use or disclose PHI, if such change or revocation affects Business Associate’s permitted or required uses and
disclosures.
(d) Restrictions on Uses and Disclosures. Covered Entity shall promptly notify Business
Associate in writing of any arrangements permitted or required of the Covered Entity, including, but not limited to, restrictions on use and/or disclosure of PHI agreed to by the Covered Entity pursuant to 45 C.F.R. Section 164.522, that may impact the use and/or disclosure of PHI by the Business Associate under this Agreement.
4. Term and Termination
(a) Term. This Agreement shall become effective on the Effective Date set forth above and shall terminate upon the termination or expiration of the Services Agreement (or, if earlier, when PHI is no longer needed by Business Associate to perform Services for Covered Entity) and when all PHI provided by either party to the other, or created or received by Business Associate on behalf of Covered Entity is, in accordance with subparagraph (c) of this Section 4, destroyed or returned to Covered Entity or, if it is not feasible to return or destroy PHI, protections are extended to such information, in accordance with the terms of this Agreement.
(b) Termination for Cause
(i) Where either Party has knowledge of a material breach by the other Party and cure is possible, the non-breaching Party shall provide the breaching Party with an opportunity to cure. Where said breach is not cured within ten (10) days of the breaching Party’s receipt of written notice from the non-breaching Party of said breach, the non-breaching Party may terminate this Agreement.
(ii) In the event that either Party has knowledge of a material breach of this Agreement by the other Party and cure is not possible, the non-breaching Party may terminate this Agreement. When neither cure nor termination is feasible, the non-breaching Party may report the violation to the Secretary.
(iii) Effect of Termination. Upon termination of this Agreement for any reason, the Services Agreement shall automatically terminate and if feasible, at Covered Entity’s direction, Business Associate shall return or destroy all PHI received from or created or received by Business Associate on behalf of Covered Entity that Business Associate or its Workforce, subcontractors or agents still maintain in any form, and Business Associate shall certify that it retains no copies of such PHI. If return or destruction of all PHI is not feasible, Business Associate shall extend the protections of this Agreement to such PHI at no cost to Covered Entity and limit further uses and disclosures of such PHI to those purposes that make the return or destruction of the PHI
infeasible. Once Business Associate no longer requires the PHI it shall return it to Covered Entity or destroy it.
5. Indemnification
Business Associate shall indemnify, defend and hold harmless Covered Entity and its Workforce, subcontractors, and agents from and against any and all liabilities, costs, claims, suits, actions, proceedings, demands and losses (including court costs and reasonable attorneys’ fees), expert witness fees, and costs of breach notification, investigation, credit protection, call center fees, and any civil monetary penalties or other fines imposed by HHS or any State Attorney General arising from or relating to the acts or omissions of Business Associate or any of its Workforce, subcontractors or agents in connection with the Business Associate’s violation of this Agreement.
6. Miscellaneous
(a) Amendment. If any of the regulations promulgated under HIPAA are amended or interpreted in a manner that renders this Agreement inconsistent therewith, the Parties shall, in good faith, negotiate an amendment to this Agreement to the extent necessary to comply with such amendments or interpretations. No amendments or additions to this Agreement are binding unless signed in writing by both Parties.
(b) Survival. The respective rights and obligations of the parties under this Agreement which require compliance after termination of this Agreement shall survive the termination.
(c) Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Texas.
(d) Notices. All notices, requests, approvals, demands, and other communications required or permitted to be given under this Agreement shall be in writing and delivered either personally, or by certified mail with postage prepaid and return receipt requested, or by overnight courier to the party to be notified. All communications will be deemed given when received.
(e) Severability. In the event any provision of this Agreement violates any applicable statute, regulation, or rule of law such provision shall be ineffective to the extent of such violation without invalidating any other provision of this Agreement.
(f) Waiver. A waiver with respect to one event shall not be construed as continuing or as a bar to or waiver of any right or remedy as to subsequent events.
(g) No Third-Party Beneficiaries. Nothing expressed or implied in this Agreement is intended to confer, nor shall anything herein confer, upon any person other than the parties and their respective successors or assigns, any rights, remedies, or obligations.
(h) Entire Agreement. This Agreement constitutes the entire agreement of the Parties regarding the subject matter hereof and cancels and supersedes any prior business associate agreements between the parties. It is expressly understood and agreed that no verbal representation, promise or condition, whether made before or after signing of this Agreement, shall be binding upon the Parties.
IN WITNESS WHEREOF, each of the undersigned has duly executed this Agreement on behalf of the party and on the date set forth below.