Glossary Term
Business Associate Agreement (BAA)
Definition
A Business Associate Agreement (BAA) is a legally binding contract between a covered entity (e.g., healthcare providers or insurers) and a business associate (e.g., a MedTech company) under the Health Insurance Portability and Accountability Act (HIPAA). The agreement establishes the business associate's responsibilities for safeguarding protected health information (PHI) and ensuring compliance with HIPAA regulations.
Relevance to the MedTech Industry
The BAA ensures that MedTech companies handling PHI comply with HIPAA’s privacy and security rules. It defines the scope of permissible data use, establishes safeguards to protect PHI, and sets terms for breach notification, fostering trust between healthcare organizations and their technology partners.
Additional Information & Related Terms
HIPAA Compliance Ensures adherence to regulations governing PHI security and privacy.
Protected Health Information (PHI) The data covered under HIPAA and included in BAA provisions.
Cybersecurity for Medical Devices Involves implementing safeguards required by BAAs for connected devices.
Data Breach Notification A key clause in BAAs requiring timely reporting of security incidents.