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HIPAA Compliance Agreement

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HIPAA Privacy Compliance Agreement for Business Associates

Complying with the HITECH Privacy Provisions

Agreement made on the (date), between

, a professional corporation organized and existing under the laws of the state of , with its principal office located at , referred to herein as Covered Entity, and , a corporation organized and existing under the laws of the state of , with its principal office located at , referred to herein as Business Associate.

Covered Entity and Business Associate shall collectively be known herein as the Parties.

Whereas, Covered Entity is a health care provider whose activities are generally described as:

Whereas, Business Associate is in the business of providing services to the health care industry and its activities are generally described as:

Whereas, Covered Entity wishes to continue an existing business relationship with Business Associate that has been memorialized in a separate services agreement which is still in effect; and

Whereas, the nature of the existing contractual relationship between Covered Entity and Business Associate may involve the exchange of Protected Health Information (PHI) as that term is defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as amended by Health Information Technology for Economic and Clinical Health Act of 2009 (the HITECH Act), including all pertinent regulations issued by the Department of Health and Human Services (HHS);

I. Definitions

A. Breach. Breach has the same meaning as this term has in §13400 of Health Information Technology for Economic and Clinical Health Act of 2009 (the HITECH Act).

B. Business Associate. Business Associate shall mean .

C. Covered Entity. Covered Entity shall mean .

D. Designated Record Set. Designated Record Set has the same meaning as this term has in 45 CFR §164.501.

E. Individual. Individual has the same meaning as this term has in 45 CFR §164.501.

F. Privacy Rule. Privacy Rule shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR Part 160 and Part 164, Subparts A and E, as amended by the HITECH Act.

G. Protected Health Information. Protected Health Information (or PHI) has the same meaning as this term has in 45 CFR §160.103 (as amended by the HITECH Act), limited to the information created or received by Business Associate from or on behalf of Covered Entity.

H. Required By Law. Required By Law has the same meaning as this term has in 45 CFR §164.501.

I. Security Standards. Security Standards means the security standards for protection of PHI promulgated by the Secretary in Title 45 C.F.R.

J. Unsecured Protected Health Information. Unsecured Protected Health Information shall mean Protected Health Information (PHI) that is not secured through the use of a technology or methodology specified by the Secretary in regulations or as otherwise defined in the §13402(h) of the HITECH Act.

K. Any prospective amendment to the laws referenced in this definitional section prospectively amend this agreement to incorporate said changes by Congressional act or by regulation of the Secretary of HHS.

II. Obligations and Activities of Business Associate.

A. Business Associate agrees to not use or disclose Protected Health Information other than as permitted or required by the Agreement or as Required By Law.

B. Business Associate agrees to employ administrative, physical, and technical safeguards meeting required Security Standards for business associates as Required By Law to prevent disclosure or use of PHI other than as allow by this Agreement.

C. 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 held by Business Associate in violation of the requirements of this Agreement.

D. Business Associate agrees to report to Covered Entity any use or disclosure of the Protected Health Information not provided for by this Agreement of which it becomes aware.

E. If a breach of unsecured protected health information occurs at or by Business Associate, the Business Associate must notify Covered Entity following the discovery of the breach without unreasonable delay and, in all cases, no later than 60 days from the discovery of the breach. To the extent possible, the Business Associate should provide the Covered Entity with the identification of each individual affected by the breach as well as any information required to be provided by the Covered Entity in its notification to affected individuals. Business Associates shall comply with all regulations issued by HHS and applicable state agencies regarding breach notification to Covered Entity.

F. Business Associate agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity agrees to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to PHI.

G. Business Associate agrees, at the request of Covered Entity, to provide Covered Entity (or a designate of Covered Entity) access to Protected Health Information in a Designated Record Set in prompt commercially reasonable manner in order to meet the requirements under 45 CFR §164.524.

H. Business Associate agrees to make any amendment(s) to Protected Health Information 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, in a prompt and commercially reasonable manner.

I. Business Associate agrees to make internal practices, books, and records, including policies and procedures and Protected Health Information, relating to the use and disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of, Covered Entity available to the Covered Entity, or to the Secretary (including official representatives of the Secretary), in a prompt commercially reasonable manner for purposes of determining Covered Entity's compliance with the Privacy Rule.

J. Business Associate agrees to document such disclosures of Protected Health Information 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 Protected Health Information in accordance with 45 CFR §164.528.

K. Business Associate agrees to provide to Covered Entity or an Individual, in a prompt commercially reasonable manner, information collected in accordance with this Agreement, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR §164.528.

III. Permitted Uses and Disclosures by Business Associate.

Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information, as follows:

A. On behalf of, Covered Entity, provided that such use or disclosure would not violate the Privacy Rule if done by Covered Entity.

B. Except as otherwise limited in this Agreement, Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that disclosures are required by law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and 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 it is aware in which the confidentiality of the information has been breached.

IV. Obligations of Covered Entity

Covered Entity shall notify Business Associate of any limitation(s) in its notice of privacy practices of Covered Entity in accordance with 45 CFR §164.520, to the extent that such limitation may affect Business Associate's use or disclosure of Protected Health Information.

A. Covered Entity shall notify Business Associate of any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, to the extent that such changes may affect Business Associate's use or disclosure of Protected Health Information.

B. Covered Entity shall notify Business Associate of any restriction to the use or disclosure of Protected Health Information that Covered Entity has agreed to in accordance with 45 CFR §164.522, to the extent that such restriction may affect Business Associate's use or disclosure of Protected Health Information.

C. Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under the Privacy Rule if done by Covered Entity. Nothing in this paragraph shall restrict the ability of Business Associate to use or disclose PHI as set forth in Paragraph III.A herein.

V. Remedies in Event of Breach.

Business Associate hereby recognizes that irreparable harm will result to Covered Entity, and to the business of Covered Entity, in the event of breach by Business Associate of any of the covenants and assurances contained in Paragraphs II or III of this Agreement. As such, in the event of breach of any of the covenants and assurances contained in Paragraphs II or III above, Covered Entity shall be entitled to enjoin and restrain Business Associate from any continued violation of Paragraphs II or III. Furthermore, in the event of breach of Paragraphs II or III by Business Associate, Covered Entity shall be entitled to reimbursement and indemnification from Business Associate for the Covered Entity's reasonable attorney’s fees and expenses and costs that were reasonably incurred as a proximate result of the Business Associate's breach. The remedies contained in this Paragraph V shall be in addition to (and not supersede) any action for damages and/or any other remedy Covered Entity may have for breach of any part of this Agreement.

VI. Term and Termination.

A. Term of Agreement.

The Term of this Agreement shall be effective as of the date given at the top of Page 1 herein, and shall terminate when all of the Protected Health Information 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 Protected Health Information, protections are extended to such information, in accordance with the termination provisions in this Section.

B. Termination for Cause.

Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall either:

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

2. Immediately terminate this Agreement if Business Associate has breached a material term of this Agreement and cure is not possible; or

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

C. Effect of Termination.

1. Except as provided in Paragraph VI.C.2 of this Section, upon termination of this Agreement, for any reason, Business Associate shall return or destroy all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies of the Protected Health Information.

2. In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon notification to Covered Entity that return or destruction of Protected Health Information is infeasible, Business Associate shall extend the protections of this Agreement to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such Protected Health Information.

VII. Miscellaneous Terms.

A. State Law. If state law applicable to the relationship between Business Associate and Covered Entity contains additional or more stringent requirements than federal law for Business Associates regarding any aspect of PHI privacy, then Business Associate agrees to comply with the higher standard contained in applicable state law.

B. Consideration. Business Associate recognizes that the promises it has made in this Agreement shall, henceforth, be detrimentally relied upon by Covered Entity in choosing to continue or commence a business relationship with Business Associate.

C. Modification. This Agreement may only be modified through a writing signed by the Parties and, thus, no oral modification hereof shall be permitted. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for Covered Entity to comply with the requirements of the Privacy Rule and the Health Insurance Portability and Accountability Act of 1996, as amended.

D. Notice to Covered Entity.

1. Any notice to Covered Entity provided for or concerning this Agreement shall be in writing and shall be deemed sufficiently given when sent by certified or registered mail if sent to the respective address of Covered Entity as set forth at the beginning of this Agreement.

2. Any notice to Business Associate provided for or concerning this Agreement shall be in writing and shall be deemed sufficiently given when sent by certified or registered mail if sent to the respective address of Business Associate as set forth at the beginning of this Agreement.

WITNESS our signatures as of the day and date first above stated.

By:

By:

Enter text✕

What a HIPAA Compliance Agreement Covers

A HIPAA Compliance Agreement is a written contract that defines how a business associate or vendor will handle protected health information (PHI) on behalf of a covered entity. The agreement documents permitted uses and disclosures, required safeguards, breach notification procedures, and reporting obligations. It typically includes obligations to implement administrative, physical, and technical safeguards consistent with the HIPAA Security Rule and to permit audits or access necessary to verify compliance. The agreement supports the covered entity's statutory duties under HIPAA and demonstrates contractual controls over third-party PHI handling.

Why a Clear Agreement Matters for PHI Protection

A precise HIPAA Compliance Agreement allocates responsibility for PHI safeguards, reduces legal exposure, and documents breach response responsibilities. It also establishes operational expectations and supports regulatory compliance for both covered entities and business associates.

Why a Clear Agreement Matters for PHI Protection

Typical parties who prepare and sign this agreement

Covered entities and business associates, including hospitals, clinics, billing companies, IT vendors, and cloud providers, use HIPAA Compliance Agreements to set PHI handling rules.

  • Healthcare providers and clinics that share PHI with vendors for billing, analytics, or patient communications.
  • Health plans and payers when outsourcing claims processing or data analysis.
  • Technology and cloud vendors that store, process, or transmit PHI on behalf of a covered entity.

The agreement framework scales for vendors of all sizes; organizations should match obligations to the sensitivity of the PHI and the services performed.

Common signatories and their roles

Privacy Officer

Chief privacy or compliance officers typically review and approve HIPAA Compliance Agreements, ensuring contractual language meets regulatory requirements, documents administrative controls, and aligns with internal policies and incident response plans.

Vendor Executive

An authorized vendor representative or general counsel signs on behalf of the business associate and confirms operational controls, employee training commitments, and the vendor's ability to meet breach notification and mitigation obligations.

Essential clauses to include in the agreement

A professional HIPAA Compliance Agreement explicitly assigns responsibilities, limits data uses, and sets security and reporting standards so both parties understand obligations and remedies.

Permitted Uses

Specifies exactly which PHI uses and disclosures the business associate may perform and prohibits uses outside those purposes.

Safeguards

Requires implementation of administrative, physical, and technical safeguards consistent with HIPAA Security Rule standards.

Breach Notification

Defines timing and process for notifying the covered entity of unauthorized PHI access or disclosure.

Subcontractors

Requires the business associate to flow down equivalent obligations to subcontractors or agents handling PHI.

Term and Termination

Describes the agreement term, termination rights for material breaches, and return or destruction of PHI on termination.

Audit and Inspection

Grants rights to inspect, audit, or require evidence of compliance, including documentation and access to policies.

Technical and compliance assurances often included

Encryption: TLS 1.2/1.3 transit; AES-256 at rest
Certifications: SOC 2 Type II; ISO 27001 available
HIPAA BAA: Business associate agreement required
Audit Trail: Timestamps, IP, action logs retained
Access Controls: Role-based access and least privilege
Authentication: Multi-factor options for sensitive actions

Step-by-step: completing a HIPAA Compliance Agreement

Follow these steps to draft, review, and finalize a HIPAA Compliance Agreement so responsibilities are clear and the contract supports compliance obligations.

  • 01
    Identify Parties: Record full legal names and addresses.
  • 02
    Define Scope: Specify PHI categories and permitted uses.
  • 03
    Set Safeguards: Detail administrative, physical, technical controls.
  • 04
    Review and Sign: Obtain authorized signatures and dates.

Configuring an online signing workflow

Set up an eSignature workflow that enforces signer order, authentication, and audit trail capture for HIPAA agreements.

Field Configuration
Signer Order Sequential or parallel as required
Authentication Email link, SMS code, or stronger
Audit Options Capture IP, timestamp, and event log
Document Retention Automate archival and secure access

Typical eSubmission flow for the agreement

A standard online signing flow ensures the document is delivered, authenticated, signed, and stored with an auditable record of events.

  • Upload Document: Sender uploads final agreement PDF or DOCX.
  • Place Fields: Add signature, date, and initial fields.
  • Set Authentication: Choose email, SMS, or MFA methods.
  • Sign and Archive: Signers complete signatures and the platform stores audit trail.

What to require from an eSignature platform

Ensure the chosen eSignature provider supports HIPAA controls, audit trails, and a BAA before using it for PHI agreements.

  • Security Certifications: SOC 2 Type II, ISO 27001, PCI if payments involved
  • Technical Controls: AES-256 at rest, TLS 1.2/1.3 in transit
  • Integrations: Connectors for EHRs, cloud storage, and SSO

Document these platform requirements in procurement records and include them in the agreement to align operational and contractual controls.

Timing and deadlines to track during execution

Monitor key dates such as effective date, periodic reviews, termination notice windows, and incident reporting timeframes to maintain compliance.

Effective Date:

Date obligations begin; enter as MM/DD/YYYY

Breach Notice Window:

Notify covered entity promptly; internal SLA typically 72 hours

Review Cadence:

Annual security and policy reviews recommended

Termination Notice:

Follow contract-specified cure and notice periods

Record Retention Start:

Retention calculated from creation or last effective date

Common mistakes to avoid when preparing the agreement

  • Leaving permitted uses too broad, which can allow PHI handling beyond intended services and increase regulatory risk.
  • Failing to require a written subcontractor flow-down clause so downstream vendors are not contractually bound to safeguard PHI.
  • Omitting precise breach notification timelines and contact points, delaying incident response and regulatory reporting obligations.
  • Relying on verbal assurances about security controls instead of documenting technical and administrative safeguards in the agreement.

Regulatory and contractual risks from inadequate agreements

HIPAA Fines: Civil monetary penalties and corrective actions
Breach Costs: Notification, remediation, and forensic expenses
Contract Termination: Loss of business or vendor replacement costs
State Fines: Additional penalties under state privacy laws
Reputational Harm: Patient trust damage and brand impact
Liability Claims: Potential private suits and indemnity exposure

Practical provisions that strengthen compliance

Include clear, measurable obligations and testable controls so compliance is demonstrable during audits or investigations.

Specify Controls
List encryption, logging, access review, and data disposal requirements with measurable thresholds and review frequency.
Define Subprocessors
Require prior notice or approval for new subprocessors and ensure flow-down of obligations to maintain PHI protections.
Detail Breach Response
Include investigative steps, timelines for notification, and responsibilities for remediation and communication to affected individuals.
Require Evidence
Allow periodic audits, attestations, and access to security reports to verify ongoing compliance.

How a HIPAA Compliance Agreement differs from similar contracts

Compare this agreement to related documents to ensure you choose the right instrument for PHI protections and operational needs.

Document HIPAA Agreement Data Processing Agreement
Primary Purpose phi protection general personal data processing
Regulatory Basis hipaa rules gdpr/state privacy laws
Required Clauses baa, breach notice dpa, data subject rights
Typical Industries healthcare tech, marketing, cloud

Vendor pricing and capability snapshot for eSignature and HIPAA workflows

A vendor comparison helps assess cost and compliance capabilities for executing HIPAA Compliance Agreements; signNow is listed first per table convention.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial Varies by plan Varies by plan Varies by plan Varies by plan
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies

Frequently asked questions about HIPAA Compliance Agreements

These answers address common execution, retention, and eSignature concerns when using a HIPAA Compliance Agreement.


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