BUSINESS ASSOCIATE AGREEMENTS UNDER HIPAA
As noted in the Task List, HIPAA requires BusinessAssociate Agreements with any entity not under your employment control towhom you release PHI for the purposes of your own operations.
ß 160.103 Definitions.
(1) Except as provided inparagraph (2) of this definition, business associate means, with respectto a covered entity, a person who:
(i) On behalf of suchcovered entity or of an organized health care arrangement (as defined in ß164.501 of this subchapter) in which the covered entity participates, but otherthan in the capacity of a member of the workforce of such covered entity orarrangement, performs, or assists in the performance of:
(A) A function or activityinvolving the use or disclosure of individually identifiable health information,including claims processing or administration, data analysis, processing oradministration, utilization review, quality assurance, billing, benefitmanagement, practice management, and repricing; or
(B) Any other function oractivity regulated by this subchapter; or (ii) Provides, other than in thecapacity of a member of the workforce of such covered
entity, legal, actuarial,accounting, consulting, data aggregation (as defined in ß 164.501 of thissubchapter), management, administrative, accreditation, or financial services toor for such covered entity, or to or for an organized health care arrangement inwhich the covered entity participates, where
the provision of the serviceinvolves the disclosure of individually identifiable health information fromsuch covered entity or arrangement, or from another business associate of suchcovered entity or arrangement, to the person.
(2) A covered entityparticipating in an organized health care arrangement that performs a functionor activity as described by paragraph (1)(i) of this definition for or on behalfof such organized health care arrangement, or that provides a service asdescribed in paragraph (1)(ii) of this definition to or for such organizedhealth care arrangement, does not, simply through the performance of suchfunction or activity or the provision of such service, become a businessassociate of other covered entities participating in such organized health carearrangement.
Thesuggested language for such an agreement presented below has been adapted fromHIPAA language which follows – oryou will find Business Associate Agreement documents for sale, or you can workwith your attorney to create your own business associate agreements.
ThisAgreement is entered into by and between professional/ practice group (hereaftercalled the Health Care Provider) and (enter name(s) of Business Associate) (hereafter called the Business Associate) to set forth the terms andconditions under which protected health information ("PHI"), asdefined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA)and Regulations enacted under that act, created or received by the BusinessAssociate on behalf of the Health Care Provider may be used or disclosed.
ThisAgreement shall begin on ________ and the obligations of this agreement shallcontinue in effect so long as the Business Associate uses, discloses, creates orotherwise possesses any PHI created or received on behalf of the Health CareProvider and until all PHI created or received by the Business Associate onbehalf of the Health Care Provider is destroyed or returned to the Health CareProvider according to Section 14 of this agreement.
1) The Health Care Provider and the Business Associate hereby agree that theBusiness Associate shall be permitted to use and/or disclose PHI created orreceived on behalf of the Health Care Provider for the following purpose(s):
[Hereyou should include a description of the purpose(s) for which the BusinessAssociate may use and disclose PHI; e.g. for your billing service:"preparing statements for clients, completing and submitting health careclaims to health plans and other third party payers”. The stated purpose(s) must reflect the nature the arrangement with theBusiness Associate. The permitted uses and disclosures must be within the scopeof, and be necessary to achieve the purposes of the Business Associate providingservices to the treating professional/s.]
2) The Business Associate may use and disclose PHI created or received bythe Business Associate on behalf of the Health Care Provider if necessary forthe proper management and administration of the Business Associate or to carryout the Business Associate's legal responsibilities, provided that
any disclosure is:
a) Required by law; or.
b) The Business Associate obtains reasonable assurances from the person towhom the PHI is disclosed that (a) the PHI will be held confidentially and usedor further disclosed only as required by law or for the purpose for which it wasdisclosed to the person; and (b) the Business Associate will be notified of anyinstances of which the person is aware in which the confidentiality of theinformation is breached.
c) The Business Associate hereby agrees to maintain the security and privacyof all PHI in a manner consistent with state and federal laws and regulations,including the Health Insurance Portability and Accountability Act of 1996("HIPAA") and Regulations pertaining to HIPAA, and all otherapplicable law.
3) The Business Associate further agrees not to use or disclose PHI exceptas expressly permitted by this Agreement, applicable law, or for the purpose ofmanaging Business Associate's own internal business processes consistent withParagraph 2 herein.
4) The Business Associate shall not disclose PHI to any member of itsworkforce unless the Business Associate has advised such person of the BusinessAssociate's privacy and security obligations under this Agreement, including theconsequences for violation of such obligations. The Business Associate shalltake appropriate disciplinary action against any member of its workforce whouses or discloses PHI in violations of this Agreement and applicable law.
5) The Business Associate shall not disclose PHI created or received by theBusiness Associate on behalf of the Health Care Provider to a person, includingany agent or subcontractor of the Business Associate but not including a memberof the Business Associate's own workforce, until such person agrees in writingto be bound by the provisions of this Agreement and applicable state
or federal law.
6) The Business Associate agrees to use appropriate safeguards to preventuse or disclosure of PHI not permitted by this Agreement or applicable law.
7) The Business Associate agrees to maintain a record of all disclosures ofPHI, including disclosures not made for the purposes of this Agreement. Suchrecord shall include the date of the disclosure, the name and, if known, theaddress of the recipient of the PHI, the name of the individual who is thesubject of the PHI, a brief description of the PHI disclosed, and the purpose ofthe disclosure. Business Associate shall make such record available to anindividual who is the subject of such information or the Health Care Providerwithin thirty (30) days
of a request and shall include disclosures made on or after the date which issix (6) years prior to the request or April 14, 2003, whichever is later.
8) The Business Associate agrees to report to the Health Care Provider anyunauthorized use or disclosure of PHI by the Business Associate or its workforceor subcontractors and the remedial action taken or proposed to be taken withrespect to such use or disclosure.
9) The Business Associate agrees to make its internal practices, books, andrecords relating to the use and disclosure of PHI received from the Health CareProvider, or created or received by the Business Associate on behalf of theHealth Care Provider, available to the Secretary of the United States Departmentof Health and Human Services, for purposes of determining the Health CareProvider’s, compliance with HIPAA.
10) Within thirty (30) days of a written request by the Health Care Provider,Business Associate shall allow a person who is the subject of PHI, such person'slegal representative, or the Health Care Provider to have access to and to copysuch person's PHI maintained by the Business Associate. The Business Associate shall provide PHI in the format requested by suchperson, legal representative, or the Health Care Provider unless it is notreadily producible in such format, in which case it shall be produced instandard hard copy format.
11) The Business Associate agrees to amend, pursuant to a request by theHealth Care Provider, PHI maintained and created or received by the BusinessAssociate on behalf of the Health Care Provider. The Business Associate furtheragrees to complete such amendment within thirty (30) days of a written requestby the Health Care Provider, and to make such amendment as directed by
the Health Care Provider.
12) In the event Business Associate fails to perform the obligations underthis Agreement, the Health Care Provider may, at its option:
a) Require Business Associate to submit to a plan of compliance, includingmonitoring by the Health Care Provider and reporting by the Business Associate,as the Health Care Provider, in its sole discretion, determines necessary tomaintain compliance with this Agreement and applicable law. Such plan shall beincorporated into this Agreement by amendment
b) Require the Business Associate to mitigate any loss occasioned by theunauthorized disclosure or use of PHI.
c) Immediately discontinueproviding PHI to the Business Associate with or without written notice to theBusiness Associate.
13) The Health Care Provider may immediately terminate this Agreement andrelated agreements if the Health Care Provider determines that the BusinessAssociate has breached a material term of this Agreement. Alternatively, theHealth Care Provider may choose to:
a) provide the BusinessAssociate with ten (10) days written notice of the existence of an allegedmaterial breach; and
b) afford the Business Associate an opportunity to cure said allegedmaterial breach to the satisfaction of the Health Care Provider within ten (10)days. The Business Associate's failure to cure shall be grounds for immediatedetermination of this Agreement. TheHealth Care Provider’s remedies under this Agreement are cumulative, and theexercise of any remedy shall not preclude the exercise of any other.
14) Upon termination of this Agreement, Business Associate shall return ordestroy all PHI received from Health Care Provider, or created or received byBusiness Associate on behalf of the Health Care Provider and that the BusinessAssociate maintains in any form, and shall retain no copies of such information.If the parties mutually agree that return or destruction of PHI is not feasible,the Business Associate shall continue to maintain the security and privacy ofsuch
PHI in a manner consistent with the obligations of this Agreement and asrequired by applicable law, and shall limit further use of the information tothose purposes that make the return or destruction of the informationinfeasible. The duties hereunder to maintain the security and privacy of PHIshall survive the discontinuance of this Agreement.
15) The Health Care Provider may amend this Agreement by providing ten (10)days prior written notice to the Business Associate in order to maintaincompliance with State or Federal law. Such amendment shall be binding upon theBusiness Associate at the end of the ten (10) day period and shall not requirethe consent of the Business Associate. The Business Associate may elect todiscontinue the Agreement within the ten (10) day period, but the BusinessAssociate's duties
hereunder to maintain the security and privacy of PHI shall survivediscontinuance of the Agreement.
16) The Health Care Provider and the Business Associate may otherwise amendthis Agreement by mutual written agreement.
17)The BusinessAssociate shall, to the fullest extent permitted by law, protect, defend,indemnify and hold harmless the Health Care Provider and his/her respectiveemployees, directors, and agents from and against any and all losses, costs,claims, penalties, fines, demands, liabilities, legal actions, judgments, andexpenses of every kind (including reasonable attorneys fees, including at trialand on appeal) asserted or imposed against the Health Care Provider and his/herrespective employees, directors, and agents arising out of the acts or omissionsof the Business Associate or any subcontractor of or consultant of the BusinessAssociate or any of the Business Associate's employees, directors, or agentsrelated to the performance or nonperformance of this Agreement.
Note: End the Business Associate Agreement withDated/Signatures of the Professional/Practice representative and BusinessAssociate or Business Associate representative, with the authority of eachsignature stipulated.
Language from HIPAA Rule pertaining to Business AssociateContracts:
FederalRegister /Vol. 67, No. 59 / Wednesday, March 27, 2002 / Proposed Rules
Appendix to thePreamble—Model Business Associate Contract Provisions
TheDepartment of Health and Human Services provides these model business associatecontract provisions in response to numerous requests for guidance. This is onlymodel language. These provisions are designed to help covered entities moreeasily comply with the business associate contract requirements of the PrivacyRule. However, use of these model provisions is not required for compliance withthe Privacy Rule. The language may be amended to more accurately reflectbusiness arrangements between the covered entity and the business associate.
Theseor similar provisions may be incorporated into an agreement for the provision ofservices between the entities or they may be incorporated into a separatebusiness associate agreement. These provisions only address concepts andrequirements set forth in the Privacy Rule and alone are not sufficient toresult in a binding contract under State law and do not include many formalitiesand substantive provisions that are required or typically included in a validcontract. Reliance on this model is not sufficient for compliance with state lawand does not replace consultation with a lawyer or negotiations between theparties to the contract.
Furthermore,a covered entity may want to include other provisions that are related to thePrivacy Rule but that are not required by the Privacy Rule. For example, acovered entity may want to add provisions in a business associate contract inorder for the covered entity to be able to rely on the business associate tohelp the covered entity meet its obligations under the Privacy Rule. Inaddition, there may be permissible uses or disclosures by a business associatethat are not specifically addressed in these model provisions. For example, thePrivacy Rule does not preclude a business associate from disclosing protectedhealth information to report unlawful conduct in accordance with 164.502(j).However, there is not a specific model provision related to this permissivedisclosure. These and other types of issues will need to be worked out betweenthe parties.
1Words orphrases contained in brackets are intended as either optional language or asinstructions to the users of these model provisions and are not intended to beincluded in the contractual provisions.
ModelBusiness Associate Contract
Catch-alldefinition: Termsused, but not otherwise defined, in this Agreement shall have the same meaningas those terms in 45 CFR 160.103 and 164.501.
Examplesof specific definitions:
(a)Business Associate. ‘‘Business Associate’’ shall mean [InsertName of Business Associate].
(b)Covered Entity. ‘‘Covered Entity’’ shall mean [Insert Name ofCovered Entity].
(c)Individual. ‘‘Individual’’ shall have the same meaning as theterm ‘‘individual’’ in 45 CFR 164.501 and shall include a person whoqualifies as a personal representative in accordance with 45 CFR 164.502(g).
(d)Privacy Rule. ‘‘Privacy Rule’’ shall mean the Standards forPrivacy of Individually Identifiable Health Information at 45 CFR part 160 andpart 164, subparts A and E.
(e)Protected Health Information. ‘‘Protected Health Information’’shall have the same meaning as the term ‘‘protected health information’’in 45 CFR 164.501, limited to the information created or received by BusinessAssociate from or on behalf of
(f)Required By Law. ‘‘Required By Law’’ shall have the same meaningas the term ‘‘required by law’’ in 45 CFR 164.501.
(g)Secretary. ‘‘Secretary’’ shall mean the Secretary of theDepartment of Health and Human Services or his designee.
Obligationsand Activities of Business Associate
(a)Business Associate agrees to not use or further disclose Protected HealthInformation other than as permitted or required by the Agreement or as RequiredBy Law.
(b)Business Associate agrees to use appropriate safeguards to prevent use ordisclosure of the Protected Health Information other than as provided for bythis Agreement.
(c)Business Associate agrees to mitigate, to the extent practicable, any harmfuleffect that is known to Business Associate of a use or disclosure of ProtectedHealth Information by Business Associate in violation of the requirements ofthis Agreement. [This provision may be included if it is appropriate for theCovered Entity to pass on its duty to mitigate damages by a Business Associate.]
(d)Business Associate agrees to report to Covered Entity any use or disclosure ofthe Protected Health Information not provided for by this Agreement.
(e)Business Associate agrees to ensure that any agent, including a subcontractor,to whom it provides Protected Health
Informationreceived from, or created or received by Business Associate on behalf of CoveredEntity agrees to the same restrictions and conditions that apply through thisAgreement to Business Associate with respect to such information.
(f)Business Associate agrees to provide access, at the request of Covered Entity,and in the time and manner designated by
CoveredEntity, to Protected Health Information in a Designated Record Set, to CoveredEntity or, as directed by Covered
Entity,to an Individual in order to meet the requirements under 45 CFR 164.524. [Notnecessary if business associate does not have protected health information in adesignated record set.]
(g)Business Associate agrees to make any amendment(s) to Protected HealthInformation in a Designated Record Set that
theCovered Entity directs or agrees to pursuant to 45 CFR 164.526 at the request ofCovered Entity or an Individual, and in the time and manner designated byCovered Entity. [Not necessary if business associate does not have protectedhealth information in a designated record set.]
(h)Business Associate agrees to make internal practices, books, and recordsrelating to the use and disclosure of Protected Health Information receivedfrom, or created or received by Business Associate on behalf of, Covered Entityavailable to the Covered Entity, or at the request of the Covered Entity to theSecretary, in a time and manner designated by the Covered Entity or theSecretary, for purposes of the Secretary determining Covered Entity’scompliance with the Privacy Rule.
(i)Business Associate agrees to document such disclosures of Protected HealthInformation and information related to such disclosures as would be required forCovered Entity to respond to a request by an Individual for an accounting ofdisclosures of Protected Health Information in accordance with 45 CFR 164.528.
(j)Business Associate agrees to provide to Covered Entity or an Individual, in timeand manner designated by Covered Entity,
informationcollected in accordance with Section [Insert Section Number in Contract WhereProvision (i) Appears] of this
Agreement,to permit Covered Entity to respond to a request by an Individual for anaccounting of disclosures of Protected Health Information in accordance with 45CFR 164.528.
PermittedUses and Disclosures by Business Associate
GeneralUse and Disclosure Provisions (alternative approaches)
Exceptas otherwise limited in this Agreement, Business Associate may use or discloseProtected Health Information on behalf of, or to provide services to, CoveredEntity for the following purposes, if such use or disclosure of Protected HealthInformation would not violate the Privacy Rule if done by Covered Entity: [ListPurposes].
Referto underlying services agreement:
Exceptas otherwise limited in this Agreement, Business Associate may use or discloseProtected Health Information to perform functions, activities, or services for,or on behalf of, Covered Entity as specified in [Insert Name of ServicesAgreement], provided that such use or disclosure would not violate the PrivacyRule if done by Covered Entity.
SpecificUse and Disclosure Provisions [only necessary if parties wish to allow BusinessAssociate to engage in such activities]
(a)Except as otherwise limited in this Agreement, Business Associate may useProtected Health Information for the proper management and administration of theBusiness Associate or to carry out the legal responsibilities of the BusinessAssociate.
(b)Except as otherwise limited in this Agreement, Business Associate may discloseProtected Health Information for the proper management and administration of theBusiness Associate, provided that disclosures are required by law, or BusinessAssociate obtains reasonable assurances from the person to whom the informationis disclosed that it will remain confidential and used or further disclosed onlyas 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 it isaware in which the confidentiality of the information has been breached.
(c)Except as otherwise limited in this Agreement, Business Associate may useProtected Health Information to provide Data
Aggregationservices to Covered Entity as permitted by 42 CFR 164.504(e)(2)(i)(B).
Obligationsof Covered Entity
Provisionsfor Covered Entity to Inform Business Associate of Privacy Practices andRestrictions [provisions dependent on business arrangement]
(a)Covered Entity shall provide Business Associate with the notice of privacypractices that Covered Entity produces in accordance with 45 CFR 164.520, aswell as any changes to such notice.
(b)Covered Entity shall provide Business Associate with any changes in, orrevocation of, permission by Individual to use or disclose Protected HealthInformation, if such changes affect Business Associate’s permitted or requireduses and disclosures.
(c)Covered Entity shall notify Business Associate of any restriction to the use ordisclosure of Protected Health Information that Covered Entity has agreed to inaccordance with 45 CFR 164.522.
CoveredEntity shall not request Business Associate to use or disclose Protected HealthInformation in any manner that would not be permissible under the Privacy Ruleif done by Covered Entity. [Include an exception if the Business Associate willuse or disclose protected health information for, and the contract includesprovisions for, data aggregation or management and administrative activities ofBusiness Associate].
(a)Term. The Term of this Agreement shall be effective as of [InsertEffective Date], and shall terminate when all of the Protected HealthInformation provided by Covered Entity to Business Associate, or created orreceived by Business Associate on behalf of Covered Entity, is destroyed orreturned to Covered Entity, or, if it is infeasible to return or destroyProtected Health Information, protections are extended to such information, inaccordance with the termination provisions in this Section.
(b)Termination for Cause. Upon Covered Entity’s knowledge of a materialbreach by Business Associate, Covered Entity shall provide an opportunity forBusiness Associate to cure the breach or end the violation and terminate thisAgreement [and the Agreement/sections of the Agreement] if Business Associatedoes not cure the breach or end the violation within the time specified byCovered Entity, or immediately terminate this Agreement [and theAgreement/sections of the Agreement] if Business Associate has breached amaterial term of this Agreement and cure is not possible. [Bracketed language inthis provision may be necessary if there is an underlying services agreement.Also, opportunity to cure is permitted, but not required by the Privacy Rule.]
(c)Effect of Termination.
(1)Except as provided in paragraph (2) of this section, upon termination of thisAgreement, for any reason, Business
Associateshall return or destroy all Protected Health Information received from CoveredEntity, or created or received by Business Associate on behalf of CoveredEntity. This provision shall apply to Protected Health Information that is inthe possession of subcontractors or agents of Business Associate. BusinessAssociate shall retain no copies of the Protected Health Information.
(2)In the event that Business Associate determines that returning or destroying theProtected Health Information is infeasible,
BusinessAssociate shall provide to Covered Entity notification of the conditions thatmake return or destruction infeasible. Upon mutual agreement of the Parties thatreturn or destruction of Protected Health Information is infeasible, BusinessAssociate shall extend the protections of this Agreement to such ProtectedHealth Information and limit further uses and disclosures of such ProtectedHealth Information to those purposes that make the return or destructioninfeasible, for so long as Business Associate maintains such Protected HealthInformation.
(a)Regulatory References. A reference in this Agreement to a section in thePrivacy Rule means the section as in effect or as amended, and for whichcompliance is required.
(b)Amendment. The Parties agree to take such action as is necessary to amendthis Agreement from time to time as is necessary for Covered Entity to complywith the requirements of the Privacy Rule and the Health Insurance Portabilityand Accountability Act, Public Law 104–191.
(c)Survival. The respective rights and obligations of Business Associateunder Section [Insert Section Number Related to
‘‘Effectof Termination’’] of this Agreement shall survive the termination of thisAgreement.
(d)Interpretation. Any ambiguity in this Agreement shall be resolved infavor of a meaning that permits Covered Entity to comply with the Privacy Rule.