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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.

Warranties & Representations

Why This Matters: Accurate warranties ensure accountability and provide remedies for breaches, reducing the likelihood of disputes over performance.

Negotiation strategy

If you're the Covered Entity:

Ensure that warranties are specific to the healthcare standards and regulatory requirements. Negotiate for clear remedies in case of breaches.

If you're the Business Associate:

Limit the scope of warranties to what is commercially reasonable and ensure that warranty periods are clearly defined to manage liability.

Essential elements

1

Authority Assurance

Party's right to enter agreement.
2

Regulatory Compliance

Adherence to healthcare regulations.
3

Quality Standards

Deliverables meet agreed standards.

Action framework

ACCEPT

Propose edits if warranties are too broad or lack specificity.

EDIT

Reject if warranties impose unreasonable liability or are non-compliant with regulations.

ADD

Add language if warranties are missing or insufficiently detailed.

PRO TIP

Always align warranties with the latest industry standards and regulatory requirements to avoid compliance issues.

Real-world examples

FAVORABLE

Preferred Warranty Language

"The party warrants that all deliverables will meet the specified quality standards and comply with applicable healthcare regulations."
NEUTRAL

Fallback Warranty Language

"The party represents that it will use commercially reasonable efforts to ensure deliverables meet quality standards."
UNFAVORABLE

Overly Broad Warranty

"The party guarantees all deliverables will be perfect and free from any defects."

Alternative scenarios & positions

High-Risk Projects

In high-risk projects, warranties should be more stringent, with detailed compliance checks and quality assurance processes.

Cross-Border Transactions

Consider additional warranties for compliance with international regulations and standards.

New Product Launches

Warranties should cover extensive testing and validation to ensure product safety and efficacy.

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