Glossary Term
Data Breach Notification
Definition
Data Breach Notification refers to the process of informing affected individuals, regulatory authorities, and other stakeholders about an unauthorized access or disclosure of sensitive data. In the MedTech industry, this typically involves breaches of protected health information (PHI), personally identifiable information (PII), or proprietary medical device data, which are governed by strict regulations like HIPAA, GDPR, and others.
Relevance to the MedTech Industry
Data Breach Notification is essential for maintaining trust, ensuring transparency, and complying with legal obligations. It mitigates the impact of breaches by enabling affected parties to take protective actions while holding organizations accountable for securing sensitive information.
Additional Information & Related Terms
Cybersecurity for Medical Devices Includes measures to prevent data breaches.
HIPAA (Health Insurance Portability and Accountability Act) U.S. regulation mandating breach notifications for healthcare-related data breaches.
General Data Protection Regulation (GDPR) EU law governing breach notification for data privacy violations.
Post-Market Surveillance Involves monitoring devices for vulnerabilities that could lead to data breaches.