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PLAYBOOK TEMPLATES

HIPAA Business Associate Agreem

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.

Data Privacy & Security

Why This Matters: Data breaches can trigger regulatory penalties and loss of patient trust, so robust data safeguards and clear protocols reduce risk.

Negotiation strategy

If you're the Covered Entity:

Ensure that the contract includes specific obligations for data protection and compliance with relevant laws such as HIPAA and GDPR. Insist on clear breach notification procedures and timelines.

If you're the Business Associate:

Negotiate for reasonable efforts in data protection obligations and ensure that the responsibilities are shared. Propose flexible timelines for breach notifications.

Essential elements

1

Data Protection Obligations

Compliance with HIPAA, GDPR, etc.
2

Breach Notification

Timelines and responsible parties.
3

Technical Standards

Encryption, access controls, etc.

Action framework

ACCEPT

Propose edits if the clause lacks specific technical standards or clear breach notification timelines.

EDIT

Reject if the clause does not comply with major data protection laws like HIPAA or GDPR.

ADD

Add language if jurisdiction-specific requirements like CCPA are not addressed.

PRO TIP

Always verify that data protection clauses align with the latest legal standards and organizational policies.

Example clauses

FAVORABLE

Preferred Clause

"The parties agree to comply with all applicable data protection laws, including HIPAA and GDPR. Each party shall implement appropriate technical and organizational measures to protect personal health information. In the event of a data breach, the affected party shall notify the other party within 72 hours and cooperate in any subsequent investigation."
NEUTRAL

Fallback Clause

"The parties shall use reasonable efforts to protect personal health information and comply with applicable data protection laws. Breach notifications shall be made promptly."
UNFAVORABLE

Insufficient Data Protection

"The parties will attempt to protect data as per their capabilities without specific legal compliance obligations."

Fallbacks

High-Risk Projects

For projects involving high volumes of sensitive data, ensure additional safeguards and stricter compliance measures are in place.

Cross-Border Data Transfers

Address data transfer protocols and compliance with international data protection laws for cross-border projects.

Healthcare Sector

In healthcare, emphasize compliance with HIPAA and patient data protection to maintain trust and avoid penalties.
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