A HIPAA Business Associate Agreement establishes privacy and security obligations for handling protected health information. This playbook reviews compliance controls, breach notification, and indemnification provisions.
Why This Matters: Audit rights ensure compliance with quality, regulatory, and financial provisions, reducing hidden risks.
Negotiation strategy
If you're the Covered Entity:
Ensure the audit clause covers all necessary compliance areas, including financial and operational records. Negotiate for reasonable notice periods and confidentiality protections.
If you're the Business Associate:
Limit the scope of audit rights to essential areas, such as financial records, and negotiate shorter notice periods to minimize disruption.
Essential elements
1
Audit Scope
Defines areas subject to audit.
2
Notice Period
Timeframe for audit notification.
3
Confidentiality
Protections for reviewed materials.
Action framework
ACCEPT
Propose edits to ensure comprehensive audit rights covering all relevant compliance areas.
EDIT
Reject if the clause lacks essential compliance coverage or imposes unreasonable burdens.
ADD
Add language to specify audit scope, frequency, and confidentiality protections.
PRO TIP
Always align audit rights with industry standards and regulatory requirements to avoid compliance issues.
Example clauses
FAVORABLE
Comprehensive Audit Clause
"The party shall have the right to audit and inspect all records and procedures related to compliance with this agreement, with a minimum of 30 days' notice, ensuring confidentiality of all reviewed materials."
NEUTRAL
Limited Audit Clause
"Audit rights are limited to financial records, with 15 days' notice and standard confidentiality protections."
UNFAVORABLE
Restrictive Audit Clause
"Audit rights are restricted to annual financial statements only, with 60 days' notice required."
Fallbacks
High-Risk Projects
In high-risk projects, expand audit rights to include operational and safety compliance checks to mitigate potential liabilities.
International Contracts
For international contracts, ensure audit rights comply with local laws and consider cultural differences in audit practices.
Technology Agreements
In technology agreements, include rights to audit cybersecurity measures and data protection compliance.
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