CompTIA SecurityX (CAS-005)Governance, Risk and ComplianceEasy
An organization is developing a new medical device that processes highly sensitive patient health information. Due to the critical nature of the data and the potential impact on patient safety, the organization wants to ensure the highest level of data privacy and security throughout the device's lifecycle. Which of the following regulatory frameworks is MOST relevant and impactful for guiding the development and deployment of this medical device in the United States?
- APayment Card Industry Data Security Standard (PCI DSS)
- BHealth Insurance Portability and Accountability Act (HIPAA)
- CSarbanes-Oxley Act (SOX)
- DGeneral Data Protection Regulation (GDPR)
Show answer & explanationAnswer & explanation
Correct answer: B. Health Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) is the primary U.S. federal law governing the privacy and security of protected health information (PHI). For a medical device processing sensitive patient health information in the United States, HIPAA compliance is paramount and the most directly relevant regulatory framework.
Why the other options are wrong
- A. PCI DSS applies to organizations that handle credit card information, which is unrelated to patient health data.
- C. SOX primarily focuses on financial reporting and corporate governance, not patient health information.
- D. GDPR is a European Union regulation for data protection and privacy, while relevant for global operations, HIPAA is the primary U.S. framework for health data.
HIPAA
The Health Insurance Portability and Accountability Act of 1996 is a U.S. federal law that sets standards for the protection of sensitive patient health information (PHI).
- Protects Protected Health Information (PHI).
- Applies to healthcare providers, plans, and clearinghouses.
- Mandates security and privacy rules for PHI.
Memory trick: HIPAA protects health, PCI protects cards.