Software Testing Regulatory Frameworks & Compliance 2

Question 1

Under HIPAA, which type of testing specifically verifies that electronic Protected Health Information (ePHI) is encrypted both at rest and in transit?

Accepted Answer

Security testing

Answer

Security testing under HIPAA validates that ePHI encryption safeguards are implemented and functioning correctly for both storage and transmission.

Question 2

Which compliance standard specifically governs the testing of software used in payment card processing systems?

Accepted Answer

PCI DSS

Answer

PCI DSS (Payment Card Industry Data Security Standard) sets requirements for all systems that store, process, or transmit cardholder data.

Question 3

In FDA-regulated software testing (21 CFR Part 11), what must be maintained for all test records and audit trails?

Accepted Answer

Electronic signatures and audit trails

Answer

21 CFR Part 11 requires that electronic records include audit trails and electronic signatures to ensure integrity and traceability.

Question 4

A tester discovers that a healthcare application logs patient names in plain-text error files accessible to all developers. Under HIPAA, this is a violation of which safeguard category?

Accepted Answer

Technical safeguards

Answer

Technical safeguards under HIPAA require controls that protect ePHI from unauthorized access, including proper log handling and access controls.

Question 5

What is the primary purpose of a Verification and Validation (V&V) plan in safety-critical software testing under IEC 62304?

Accepted Answer

To ensure the software meets specified requirements and its intended use

Answer

IEC 62304 V&V plans ensure medical device software is built correctly (verification) and fulfills its intended purpose (validation).

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Software Testing Practice Test

Software Testing Regulatory Frameworks & Compliance 2