HIPAA BUSINESS ASSOCIATE AGREEMENT
RECODE HEALTH, LLC.
and
Your Company
This HIPAA Business Associate Agreement (the “BAA”) is made and entered into by and between your company, on behalf of itself and all of its affiliates (collectively “ “Covered Entity”) and Recode Health, LLC (“Business Associate,” as defined in HIPAA, defined below) beginning as of the date of the Client Service Plan or Partner Service Plan Agreement (“Begin Date”). It supplements and is made a part of all agreements, oral or written, including any past engagement for which Business Associate retains PHI (defined in paragraph 1(d) below), any current engagement and any future engagement (collectively the “Agreement”), by and between Covered Entity and Business Associate.
RECITALS
A. Under the above Agreement, Business Associate has access to data which may include both Protected Health Information (“PHI,” defined below) and non-PHI disclosed or made available by or on behalf of Covered Entity to Business Associate.
B. Covered Entity and Business Associate are required to comply with the Health Insurance Portability and Accountability Act (“HIPAA,” defined below) and other laws which protect the privacy and security of patients’ PHI.
C. HIPAA requires the parties to enter into a contract containing specific requirements to protect the security and privacy of patients’ PHI.
In consideration of the foregoing and the mutual promises and exchange of information pursuant to this Agreement, the parties agree to amend the Agreement by incorporating all of the following into the Agreement:
1. General Provisions, Including Definitions. The recitals are incorporated by reference into this BAA. This BAA is intended to apply all services provided to Covered Entity by Business Associate, as of the Begin Date, whether or not such engagement has been reduced to writing, and supersedes any form of business associate agreement, exhibit or provision that the parties may have heretofore entered into. In this BAA, Covered Entity shall have all the rights, duties and obligations of the “Covered Entity” as defined under HIPAA (defined below), and Business Associate shall have all the rights, duties and obligations of the “Business Associate” as defined under HIPAA (defined below). All capitalized terms not defined herein shall have the meaning ascribed to them by HIPAA (defined below), including Business Associate, Covered Entity, Data Aggregation and Designated Record Set.
(a) “Breach” shall mean the unlawful or unauthorized access to, viewing, acquisition, use or disclosure of PHI that compromises the security or privacy of said PHI.
(b) “HIPAA” shall mean the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), Title XIII of the American Recovery and Reinvestment Act of 2009 (Public Law 111-005) and the rules, guidance and regulations promulgated thereunder, as amended from time to time, including 45 Code of Federal Regulations, Parts 160 and 164.
(c) “Patient” shall have the same meaning as the term “individual” under HIPAA and shall include a person who qualifies as a personal representative.
(d) “Protected Health Information” (“PHI”) shall have the meaning given to such term under HIPAA and shall include any information, whether oral or recorded in any form or medium, limited to the information created or received by Business Associate from or on behalf of Covered Entity (i) that relates to the past, present or future physical or mental health condition of the patient, the provision of health care to patient, or the past, present or future payment for the provision of health care to patient; and (ii) that identifies the patient or with respect to which there is a reasonable basis to believe the information can be used to identify the patient.
(e) “Secretary” shall mean the Secretary of the U.S. Department of Health and Human Services or her/his designee.
(f) “Security Incident” shall mean any accidental, malicious or natural act that: (i) Results in a Breach of any PHI or credit card information; or (ii) Materially adversely impacts the functionality of the Covered Entity network; or (iii) Permits unauthorized access to the Covered Entity network; or (iv) Involves the loss or loss of control of a Covered Entity owned or managed information technology resource; or (v) Involves the use of Covered Entity technology resources for illegal purposes or to launch attacks against other individuals or organizations; or (vi) Materially impacts the integrity of Covered Entity’s files or databases maintained on the Covered Entity network including, but not limited to: (1) interface failures; (2) inadequate testing or change control procedures; or (3) other failures which result in the deletion or unauthorized changes to an electronic database. A “Security Incident” shall not include any attempted access of system operations in an information system by a Packer Internet Groper (PING) program.
(g) “State” shall mean the state in which the Covered Entity is located.
(h) “Subpart E” shall mean 45 Code of Federal Regulations, Part 164, Subpart E, which consists of Sections 164.500 et seq., as amended from time to time.
- Permitted Uses and Disclosures by Business Associate
(a) For Covered Entity. Except as otherwise limited in the Agreement and this BAA, Business Associate (i) shall create, maintain, transmit, access, use or disclose PHI only for the benefit of Covered Entity and to perform functions, activities, or services as specified in the Agreement, and (ii) shall not use or disclose PHI in a manner that would violate HIPAA if done by Covered Entity. To the extent Business Associate is to carry out one or more of Covered Entity’s obligations under Subpart E of 45 CFR Part 164, Business Associate shall comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligations.
(b) Minimum Necessary. Business Associate shall use only the minimum amount of PHI necessary to perform the specified functions, activities or services, in accordance with Covered Entity’s minimum necessary policies and procedures. In the event of inadvertent access by Business Associate to more than the minimum necessary amount of Covered Entity’s PHI, Business Associate will: (i) treat all such PHI in accordance with the Agreement and this BAA; (ii) promptly notify Covered Entity, in accordance with paragraph 3(d) below, of such access; (iii) erase, delete, and/or return such PHI as quickly as possible; and (iv) take all necessary actions to prevent further unauthorized access to PHI beyond the minimum necessary amount.
(c) Management of Business Associate. Except as otherwise limited in the Agreement or this BAA, Business Associate may use or disclose PHI for its proper management and administration or to carry out its legal responsibilities, provided that (i) the disclosure is required or permitted by law, or (ii) the Business Associate obtains reasonable assurances from the person to whom the information is disclosed that such information shall remain confidential and be used or further disclosed solely as required by law or for the purpose of assisting Business Associate to meet Business Associate’s obligations under the BAA. Business Associate shall require any person to whom PHI is disclosed under this subsection to notify Business Associate of any instance of which it is aware in which the confidentiality or security of the PHI has been breached. Notwithstanding the foregoing, Business Associate may de-identify PHI in accordance with 45 C.F.R. 164.514(a)-(c).
(d) Data Aggregation. Except as otherwise permitted in the Agreement and this BAA, Business Associate may use PHI to provide Data Aggregation services.
(e) Compliance with State Laws. Business Associate may use, disclose and access PHI only as permitted by State law, unless such State law is contrary to HIPAA and is preempted by HIPAA in accordance with 45 Code of Federal Regulations Sections 160.201 et seq.
- Obligations of Business Associate
(a) Use. Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement, this BAA or as required by law.
(b) Safeguards. Business Associate shall use appropriate safeguards to prevent use or disclosure of PHI other than as provided for by the Agreement and this BAA. Business Associate shall implement administrative, physical and technical safeguards that reasonably and appropriately protect the confidentiality, security, integrity and availability of PHI that it receives, maintains, transmits or creates on behalf of Covered Entity and that comply with the requirements of HIPAA. In addition, if Business Associate conducts credit card transactions (i) such safeguards shall consist of or include the recommendations of the Payment Card Industry Data Security Standards, found at https://www.pcisecuritystandards.org and (ii) Business Associate shall not store security code (i.e. CVC) information or credit card magnetic strip information in any form.
(c) Mitigation. Business Associate shall promptly mitigate, to the extent practicable, any harmful effect of a use or disclosure of PHI by Business Associate in violation of the Agreement and this BAA.
(d) Notify Covered Entity. Business Associate shall promptly notify Covered Entity of any Security Incident or Breach in writing in the most expedient time possible, and not to exceed five business days in the event of a Breach, following Business Associate’s initial awareness of such Security Incident or Breach. Notwithstanding any notice provisions in the Agreement, such notice shall be made to the Covered Entity Chief Privacy Official or his/her designee by means of fax or by email. Business Associate shall cooperate in good faith with Covered Entity in the investigation of any Breach or Security Incident. Notwithstanding anything to the contrary in this BAA, the parties agree that this Section 3(d) satisfies notices necessary by Business Associate to Covered Entity of the ongoing existence and occurrence of attempted but Unsuccessful Security Incidents (as defined below), for which no additional notice to Covered Entity shall be required. “Unsuccessful Security Incidents” include pings, broadcast attacks on Business Associate’s firewall, port scans, unsuccessful log-on attempts, denials of service or any combination of the above, so long as no such incident results in a Breach.
(e) Breach Notification. Following notification to Covered Entity of a Breach, Business Associate shall promptly cooperate with Covered Entity in determining which entity shall provide any required Breach notification. If the parties agree that Business Associate shall provide any required Breach notification, Business Associate shall provide such notification timely and provide Covered Entity with documentation of Business Associate’s actions, including documentation of the names and addresses of those to whom the notifications were provided.
(f) Access. If Business Associate holds PHI in Designated Record Sets as determined by Covered Entity, Business Associate shall provide prompt access to the PHI to Covered Entity whenever so requested by Covered Entity, or, if directed by Covered Entity, to a Patient in order to meet the requirements of HIPAA and State Law, as applicable. If requested, such access shall be in electronic format. If Patient requests directly from Business Associate (i) to inspect or copy his or her PHI, or (ii) requests its disclosure to a third party, the Business Associate shall promptly notify Covered Entity’s facility privacy official of such request.
(g) Amendments. Business Associate shall promptly make amendment(s) to PHI requested by Covered Entity and shall do so in the time and manner requested by Covered Entity to enable it to comply with HIPAA and State Law, as applicable. If Patient requests an amendment to his or her PHI, directly from Business Associate, the Business Associate shall promptly notify Covered Entity’s facility privacy official of such request and await such official’s denial or approval of the request.
(h) Internal Records. Business Associate shall promptly make its internal practices, books, records, including its policies and procedures, relating to the use, disclosure, or security of PHI that the Business Associate received from, maintained or created for or on behalf of Covered Entity, available to the Secretary to enable the Secretary to determine compliance with HIPAA.
(i) Accountings. Business Associate shall document all disclosures of PHI and information related to such disclosures as required under HIPAA in order that it may provide an accounting of such disclosures as Covered Entity directs. Business Associate shall: (i) Provide an accounting as required under HIPAA to those Patients who direct their requests to Business Associate; or (ii) Provide the accounting information required under HIPAA to Covered Entity, if so requested by Covered Entity, in the time and manner specified by Covered Entity.
(j) Preservation. Business Associate shall cooperate with Covered Entity and its medical staff to preserve and protect the confidentiality of PHI accessed or used pursuant to the Agreement and shall not disclose or testify about such information during or after the termination of the Agreement, except as required by law.
(k) Destruction. If, during the term of the Agreement, Business Associate wishes to destroy the PHI, it shall notify Covered Entity in writing about its intent to destroy data at least ten (10) days before such date of destruction, and shall comply with the requirements for destruction of PHI found in Section 5(a) of this BAA. If Covered Entity requests the return of any PHI, Business Associate shall comply as requested.
(l) HIPAA Compliance. Business Associate shall comply with 45 Code of Federal Regulations Part 164, Subpart C with respect to electronic PHI. The written policies and procedures and documentation required to be maintained by Business Associate under the Agreement, this BAA and HIPAA shall be made available to Covered Entity, upon Covered Entity’s request.
(m) Subcontractors and International Access. Business Associate shall ensure that any agent, including a subcontractor or employee, who creates, receives, maintains, or transmits Protected Health Information (“PHI”) on behalf of the Covered Entity or the Business Associate agrees, by written contract or written employment agreement, to comply with the same restrictions, conditions, and safeguards that apply to the Business Associate with respect to such PHI.
Business Associate may permit access to, maintenance of, or transmission of PHI by employees or subcontractors located outside of the United States, including but not limited to employees located in India, provided that such access or use:
(i) Is limited to individuals who are authorized and trained to handle PHI in compliance with HIPAA and this Agreement;
(ii) Is subject to contractual obligations and privacy safeguards equivalent to those required under this Agreement and applicable law; and
(iii) Occurs only through secure, access-controlled systems that prevent unauthorized use or disclosure.
Business Associate shall remain fully responsible for any acts or omissions of its employees, agents, or subcontractors, including those located outside of the United States, that result in a use or disclosure of PHI not permitted under this Agreement.
- Effect of Breach of Obligations. If Business Associate breaches any of its obligations, Covered Entity shall have the option to do the following:
(a) Cure. Provide Business Associate an opportunity to cure the breach, to the extent curable, and end the violation within thirty (30) days written notice by Covered Entity. If Business Associate does not cure the breach or end the violation as and within the time specified by Covered Entity, or if the breach is not curable, Covered Entity may terminate this BAA; or
(b) Termination. Immediately terminate the BAA, if Covered Entity reasonably determines that Business Associate (1) has acted with gross negligence in performing its obligations; (2) is in willful violation of applicable law; (3) willfully has violated or is violating the privacy and security provisions of this BAA or HIPAA; or (4) is unable to provide, if requested, written assurances to Covered Entity of its ability to protect the confidentiality and security of the PHI. Such termination of the Agreement shall be without prejudice to other legal remedies available to Covered Entity.
- Effect of Termination
(a) Disposition of PHI. Upon termination of this BAA and subject to Section 5(b) below, Business Associate shall promptly return to Covered Entity a copy of all PHI, including derivatives thereof (which for clarity does not include de-identified information), and shall take all reasonable steps to promptly destroy all other PHI held by Business Associate by: (i) shredding; (ii) securely erasing, or (iii) otherwise modifying the information in those records to make it unreadable or undecipherable through any means. This provision shall apply to PHI in the possession of subcontractors or agents of Business Associate. At Covered Entity’s request, Business Associate shall certify in writing that it has complied with the requirements of this Section.
(b) Infeasible; Survival. If the return or destruction of PHI is infeasible, Business Associate shall promptly notify Covered Entity of the conditions that make such return or destruction infeasible. Upon mutual determination by the parties that return or destruction of PHI is infeasible, the obligations of the Business Associate under this Amendment shall survive the termination of this BAA. Business Associate shall limit the further use or disclosure of all PHI to the purposes that make its return or destruction infeasible. If Business Associate subsequently wishes to destroy PHI, Business Associate shall notify Covered Entity in writing about its intent to destroy data at least ten (10) days before such date of destruction, and shall comply with Section 5(a) above. If Covered Entity requests the return of any PHI, Business Associate shall comply as requested.
Amendment. The parties agree to promptly modify or amend this BAA to permit parties to comply with any new laws, rules or regulations that might modify the terms and conditions herein.
General. The Agreement, including this BAA and attachments hereto are intended to be construed in harmony with each other, but in the event that any provision in this BAA conflicts with the provisions of the Agreement, or its other attachments, the provisions in this BAA shall be deemed to control and such conflicting provision or part thereof shall be deemed removed and replaced with the governing provision herein to the extent necessary to reconcile the conflict, except that the insurance provisions of this BAA (if any) and the Agreement are to be read as separate, concurrent obligations such that Business Associate shall comply with each obligation and one shall not replace the other. Except as amended by this BAA, all other terms of the Agreement remain in full force and effect. This BAA supersedes and replaces all previous oral or written Business Associate agreements, amendments, or exhibits between Business Associate and Covered Entity pertaining to protection of PHI. This BAA may be signed in two or more counterparts, all of which taken together shall be deemed to be one BAA. Signatures submitted via facsimile or electronic (scanned) means shall be deemed original signatures of the parties and shall be valid and binding upon the parties hereto.
No Third Party Beneficiary. The provisions and covenants set forth in this BAA are expressly entered into only by and between Business Associate and Covered Entity, and are only for their benefit. Neither Business Associate nor Covered Entity intends to create or establish any third party beneficiary status or right (or the equivalent thereof) in any other third party and no such third party shall have any right to enforce or enjoy any benefit created or established by the provisions and covenants in this BAA.