HIPAA Business Associate Compliance

HIPAA Business Associate Agreement Services

Every vendor that accesses, stores, or transmits Protected Health Information on behalf of your organization requires a compliant Business Associate Agreement. Petronella Technology Group, Inc. provides comprehensive BAA development, review, negotiation, and ongoing management services that protect covered entities and business associates from regulatory liability, enforcement actions, and breach exposure. Serving healthcare organizations throughout the Raleigh-Durham Research Triangle since 2002.

Founded 2002 • BBB A+ Accredited Since 2003 • 2,500+ Clients Served • HIPAA Compliance Specialists

BAA Development

Custom-drafted Business Associate Agreements that meet all HIPAA and HITECH Act requirements, tailored to the specific services each vendor provides and the PHI they access.

BAA Review & Gap Analysis

Thorough review of existing Business Associate Agreements to identify missing provisions, outdated language, and gaps that expose your organization to regulatory risk and enforcement liability.

Vendor Risk Assessment

Evaluate whether your business associates actually implement the safeguards required by their BAAs. A signed agreement means nothing if the vendor cannot demonstrate compliance.

Ongoing BAA Management

Continuous tracking of BAA expirations, vendor relationship changes, and regulatory updates. We maintain a centralized inventory so no agreement falls through the cracks.

Understanding HIPAA Business Associate Agreements

A Business Associate Agreement is a legally binding contract required by HIPAA between a covered entity — such as a healthcare provider, health plan, or healthcare clearinghouse — and any person or organization that performs functions or activities involving the use or disclosure of Protected Health Information (PHI) on the covered entity's behalf. The HITECH Act, enacted in 2009, significantly expanded the scope of BAA requirements by making business associates directly liable for HIPAA compliance and extending civil and criminal penalties to business associates that fail to safeguard PHI. Today, the failure to execute and maintain compliant BAAs is one of the most frequently cited violations in OCR enforcement actions, and it represents one of the highest-risk areas of HIPAA exposure for healthcare organizations of all sizes.

The scope of business associate relationships in modern healthcare extends far beyond what many organizations realize. Any vendor that accesses, creates, receives, maintains, or transmits PHI on your behalf is a business associate under HIPAA. This includes IT managed service providers, cloud hosting companies, electronic health record vendors, medical billing and coding services, clearinghouses, transcription services, revenue cycle management companies, patient communication platforms, answering services, document storage and shredding companies, accounting firms that receive PHI for audit purposes, consultants who access patient data, and attorneys who receive PHI in the course of providing legal services. Even subcontractors of your business associates — known as downstream business associates — must have their own BAAs in place under the HITECH Act's chain-of-trust requirements.

The consequences of operating without proper BAAs are severe and immediate. OCR has levied penalties exceeding $1 million against organizations that failed to execute BAAs with vendors who accessed PHI. In 2023, OCR's investigation of a health plan's failure to maintain BAAs resulted in a $1.3 million settlement — and the organization had no data breach. The penalty was imposed solely for the administrative failure to have compliant agreements in place. This underscores a critical point: BAA violations trigger penalties regardless of whether a breach has actually occurred. The absence of a BAA is itself a HIPAA violation that exposes the covered entity to enforcement action.

Petronella Technology Group, Inc. provides comprehensive Business Associate Agreement services for covered entities and business associates throughout the Raleigh-Durham Research Triangle and nationwide. Our approach goes beyond simply drafting template agreements. We begin with a thorough inventory of all vendor relationships that involve PHI, assess the nature and scope of each relationship, develop or review BAAs tailored to each vendor's specific role, and establish ongoing management processes to ensure agreements remain current as relationships evolve. Our team understands both the legal requirements of HIPAA BAA provisions and the technical realities of how vendors actually handle PHI — enabling us to draft agreements that are both legally compliant and operationally practical.

As a company that has provided HIPAA compliance services since 2002, we recognize that BAAs are not standalone documents but integral components of a comprehensive compliance program. A BAA establishes contractual obligations, but it does not by itself ensure that a vendor is actually protecting PHI. That is why our BAA services include vendor risk assessments that evaluate whether your business associates implement appropriate administrative, physical, and technical safeguards as required by the HIPAA Security Rule. This due diligence protects your organization from the cascading liability that occurs when a business associate experiences a breach of your patients' Protected Health Information.

Comprehensive BAA Management Services

Business Associate Identification and Inventory

The first step in BAA management is identifying every vendor relationship that involves PHI. Many organizations significantly underestimate the number of business associates they work with. We conduct a systematic review of all vendor contracts, service agreements, accounts payable records, and operational workflows to identify every entity that accesses, creates, receives, maintains, or transmits PHI on your behalf. This includes obvious relationships like EHR vendors and billing companies, as well as less obvious ones like cloud backup providers, patient satisfaction survey companies, IT consultants, scheduling software vendors, and building maintenance contractors who may access areas where PHI is stored.

We create a centralized business associate inventory that documents each vendor's name, the nature of services provided, the types of PHI accessed, the format of PHI (paper, electronic, or both), the current BAA status, the BAA execution date and renewal date, and the individual responsible for managing the relationship. This inventory becomes a critical compliance management tool and provides immediate visibility into your BAA coverage gaps.

BAA Drafting and Customization

A compliant BAA must contain specific provisions mandated by 45 CFR 164.504(e) and enhanced by the HITECH Act. Required elements include permitted and required uses and disclosures of PHI, the obligation to implement appropriate safeguards, reporting requirements for unauthorized uses, disclosures, and security incidents, the requirement to ensure subcontractors agree to the same restrictions, the obligation to make PHI available to individuals exercising their access rights, the obligation to make internal practices available to HHS for compliance determination, the requirement to return or destroy PHI upon termination, and breach notification obligations.

We draft custom BAAs that incorporate all required provisions while addressing the specific characteristics of each vendor relationship. A cloud hosting provider's BAA addresses different operational realities than a medical billing company's BAA, even though both must contain the same core HIPAA provisions. Our agreements include clear definitions of PHI scope, explicit limitations on use and disclosure, specific safeguard requirements, detailed breach notification timelines, indemnification provisions, termination procedures, and dispute resolution mechanisms.

Existing BAA Review and Gap Analysis

Many organizations have BAAs in place but those agreements contain significant gaps. Pre-HITECH BAAs often lack breach notification provisions, subcontractor flow-down requirements, and direct liability acknowledgments that became mandatory under the 2013 Omnibus Rule. We review every existing BAA against current HIPAA and HITECH requirements, identifying missing provisions, outdated language, ambiguous terms, and clauses that may not withstand regulatory scrutiny during an OCR investigation.

Our gap analysis produces a detailed report for each BAA showing the specific deficiencies identified, the regulatory provisions that require those elements, and recommended language to address each gap. We prioritize findings by risk level so you can focus immediate attention on the most critical agreements while systematically updating the remainder. For organizations with dozens or hundreds of vendor relationships, this prioritized approach ensures the highest-risk gaps are closed first.

Vendor Risk Assessment and Due Diligence

A signed BAA creates a contractual obligation, but it does not guarantee that the vendor actually protects PHI. Vendor risk assessment evaluates whether your business associates implement appropriate safeguards commensurate with the PHI they access. We develop standardized security questionnaires, review vendor SOC 2 reports and security certifications, evaluate vendor incident history, and assess the technical and administrative controls vendors have in place to protect your patients' information.

For critical vendors — those who access large volumes of PHI or provide essential services — we conduct deeper assessments that may include on-site evaluations, technical control verification, policy document review, and penetration testing of vendor-hosted systems that contain your PHI. This due diligence program enables informed decisions about vendor risk acceptance and provides documentation that demonstrates your organization's commitment to oversight of business associate compliance — a factor OCR considers during enforcement investigations.

BAA Negotiation Support

Large technology vendors, cloud providers, and enterprise software companies often present their own BAA templates as non-negotiable. These vendor-drafted agreements frequently minimize the vendor's obligations, limit liability, narrow breach notification requirements, and include broad carve-outs that may leave covered entities exposed. We review vendor-provided BAAs with the technical knowledge to identify provisions that create operational risk, and we provide negotiation guidance to strengthen protections where the vendor's template falls short.

Our negotiation support includes redline drafting, provision-by-provision analysis of vendor terms against HIPAA requirements, alternative language proposals, and strategic guidance on which provisions are essential versus negotiable. For smaller organizations that may lack leverage with large vendors, we help identify alternative vendors that offer more favorable BAA terms or escalation paths within the vendor organization.

Ongoing BAA Lifecycle Management

BAA management is not a one-time task. Vendor relationships change, new vendors are onboarded, existing vendors expand their service scope, regulations evolve, and agreements expire. We provide ongoing BAA lifecycle management that includes tracking agreement expiration and renewal dates, triggering review processes when vendor relationships change, updating agreements when regulatory requirements evolve, onboarding new vendors with compliant BAAs before PHI access begins, and managing BAA termination procedures including PHI return or destruction verification.

Our management platform maintains a centralized repository of all executed BAAs with automated alerting for upcoming renewals, expirations, and review milestones. This systematic approach ensures your organization never operates with expired or missing BAAs — a common compliance gap that OCR specifically looks for during investigations and compliance reviews.

Our BAA Management Process

01

Vendor Inventory and Assessment

We systematically identify every business associate relationship in your organization, catalog the PHI each vendor accesses, review existing BAA coverage, and identify gaps where agreements are missing, expired, or non-compliant with current HIPAA and HITECH requirements.

02

BAA Development and Remediation

We draft new BAAs for uncovered vendor relationships, update existing agreements to address identified gaps, and ensure every agreement contains all required HIPAA provisions including HITECH-mandated breach notification, subcontractor flow-down, and direct liability clauses.

03

Vendor Due Diligence

We assess each business associate's actual security posture through security questionnaires, SOC report reviews, and risk evaluations. This ensures your vendors are not merely signing agreements but actually implementing the safeguards they promise to maintain.

04

Ongoing Monitoring and Updates

We maintain your centralized BAA inventory, track renewals and expirations, onboard new vendors with compliant agreements, update BAAs when regulations change, and conduct periodic vendor reassessments to ensure continuing compliance across all business associate relationships.

Why Choose Petronella Technology Group, Inc. for BAA Management

Deep HIPAA Regulatory Knowledge

Our team understands the nuances of 45 CFR 164.504(e), HITECH Act requirements, the 2013 Omnibus Rule changes, and evolving OCR enforcement priorities. We draft BAAs that meet current regulatory standards and anticipate emerging requirements.

Technical Security Expertise

Unlike law firms that draft BAAs without understanding the technology, we combine regulatory knowledge with deep technical expertise. We know what security controls vendors should actually implement and can assess whether vendor claims match reality.

20+ Years Healthcare IT Experience

Since 2002, Petronella Technology Group, Inc. has served healthcare organizations ranging from solo dental practices to multi-location medical groups. Led by CEO Craig Petronella, an Amazon best-selling author on HIPAA compliance, our team brings unmatched depth of healthcare compliance experience.

Comprehensive Compliance Integration

BAA management integrates with our full suite of HIPAA compliance services including risk analysis, Security Rule implementation, policy development, staff training, and breach response planning — giving you a unified compliance program rather than fragmented point solutions.

Vendor Negotiation Experience

We have reviewed and negotiated BAAs with hundreds of technology vendors, cloud providers, and healthcare service companies. This experience means we know which vendor provisions create risk, which terms are negotiable, and how to strengthen agreements that protect your organization.

BBB A+ Rated Since 2003

More than two decades of BBB accreditation reflects our commitment to ethical business practices and client satisfaction. Over 2,500 organizations trust Petronella Technology Group, Inc. with their IT security and compliance needs — a track record that demonstrates reliability and accountability.

Business Associate Agreement FAQ

What is a HIPAA Business Associate Agreement?

A Business Associate Agreement is a written contract required by HIPAA between a covered entity and any person or organization that performs functions or activities involving the use or disclosure of Protected Health Information on the covered entity's behalf. The BAA establishes the permitted and required uses of PHI, requires the business associate to implement appropriate safeguards, mandates breach notification, and establishes termination provisions including PHI return or destruction. Under the HITECH Act, BAAs are also required between business associates and their subcontractors who access PHI.

Who qualifies as a business associate under HIPAA?

A business associate is any person or entity that creates, receives, maintains, or transmits PHI on behalf of a covered entity, or provides certain services to a covered entity involving PHI disclosure. Common examples include IT managed service providers, cloud hosting companies, EHR vendors, medical billing services, clearinghouses, transcription services, shredding companies, answering services, accounting firms, consultants, attorneys, and patient communication platforms. Health Information Exchanges, e-prescribing gateways, and data analytics companies that process PHI also qualify. The key determination is whether the entity accesses PHI in performing services for the covered entity.

What happens if we operate without a BAA?

Operating without a BAA for a vendor that accesses PHI is itself a HIPAA violation, regardless of whether a breach has occurred. OCR has imposed penalties exceeding $1 million for the administrative failure alone. If a breach does occur through a vendor that lacks a BAA, the covered entity faces compounded liability — penalties for both the missing BAA and the breach. Additionally, without a BAA, you have no contractual basis to require the vendor to report breaches, cooperate with investigations, or return PHI upon termination. The covered entity bears full responsibility for the vendor's handling of PHI without the legal protections a BAA provides.

What must a compliant BAA contain?

A compliant BAA must include provisions establishing the permitted and required uses and disclosures of PHI, requiring the business associate to implement appropriate safeguards per the Security Rule, requiring the business associate to report unauthorized uses or disclosures and security incidents, ensuring subcontractors agree to the same restrictions, making PHI available to individuals exercising access rights, making internal practices available for HHS compliance reviews, requiring PHI return or destruction upon termination, and establishing breach notification obligations including the required content and timeline per the Breach Notification Rule. The HITECH Act added requirements for business associate direct liability, subcontractor BAA obligations, and enhanced breach notification provisions.

Are business associates directly liable under HIPAA?

Yes. The HITECH Act made business associates directly liable for compliance with the HIPAA Security Rule's administrative, physical, and technical safeguard requirements, as well as the Privacy Rule's restrictions on use and disclosure of PHI and the Breach Notification Rule's notification requirements. This means OCR can impose penalties directly on business associates, not just on covered entities. Business associates face the same penalty tiers as covered entities — up to $50,000 per violation with annual caps of $1.5 million per violation category. Several OCR enforcement actions have resulted in settlements exceeding $1 million directly against business associates.

Do cloud service providers need BAAs?

Yes. Any cloud service provider that creates, receives, maintains, or transmits ePHI on behalf of a covered entity is a business associate and requires a BAA, even if the provider does not actually view or access the PHI content. OCR has explicitly clarified that cloud storage providers, infrastructure-as-a-service providers, and software-as-a-service platforms that host ePHI are business associates regardless of whether they have direct access to the data. AWS, Microsoft Azure, and Google Cloud all offer HIPAA-eligible services with BAAs, but you must verify that your specific configuration and services are covered by the vendor's BAA scope.

How do subcontractor BAA requirements work?

Under the HITECH Act and the 2013 Omnibus Rule, business associates must enter into BAAs with any subcontractors that create, receive, maintain, or transmit PHI on behalf of the business associate. This creates a chain-of-trust that extends HIPAA protections through the entire vendor ecosystem. For example, if your EHR vendor uses a cloud hosting provider and a database management subcontractor, both of those subcontractors need BAAs with your EHR vendor. Your primary BAA should require the business associate to flow down equivalent protections to all subcontractors and to provide you with visibility into their subcontractor relationships.

What should we do when a business associate experiences a breach?

Under the BAA and HIPAA Breach Notification Rule, the business associate must notify you of the breach without unreasonable delay and no later than 60 days after discovery. Your BAA should require the vendor to provide specific information about the breach including the nature and extent of PHI involved, the individuals affected, and the steps being taken to mitigate harm. As the covered entity, you are ultimately responsible for notifying affected individuals and HHS, though the business associate may be contractually obligated to assist with notification. You should also assess whether the breach indicates systemic security failures at the vendor that require corrective action or termination of the relationship.

Secure Your Business Associate Relationships Today

Missing or non-compliant Business Associate Agreements represent one of the highest-risk areas of HIPAA exposure. Petronella Technology Group, Inc. provides comprehensive BAA development, review, and ongoing management services that close compliance gaps and protect your organization from enforcement liability. Contact us for a free BAA assessment to identify gaps in your current vendor agreements.

Petronella Technology Group, Inc. • 5540 Centerview Dr., Suite 200, Raleigh, NC 27606 • Serving healthcare organizations in Raleigh, Durham, Chapel Hill, Cary & nationwide