Medical Software Development & Integration Flashcards

Which IEC 62304 software safety class requires the most rigorous development and maintenance processes?

Answer: Class C

IEC 62304 Class C applies to software where a failure could result in death or serious injury, requiring the highest level of rigor.

In HL7 FHIR, what is the primary purpose of a 'Bundle' resource?

Answer: Group multiple resources into a single transaction or message

A FHIR Bundle groups multiple resources together, enabling batch operations, transactions, and document assembly.

What is 'software of unknown provenance' (SOUP) in the context of IEC 62304?

Answer: Pre-existing software not developed under a quality system for the current device

SOUP refers to software items used in medical device software that were not developed under a quality system specifically for the device being developed.

Which cryptographic standard is recommended for protecting ePHI in transit under HIPAA Security Rule guidance?

Answer: TLS 1.2 or higher

TLS 1.2 or higher is the current recommended standard for encrypting ePHI in transit, as older protocols are considered insecure.

In a risk-based testing approach for medical software, what determines the depth of testing for a given module?

Answer: The software's safety classification and associated risk

Risk-based testing prioritizes test depth based on the software's safety class and the severity of potential failures.

When integrating a medical device with an EHR via an HL7 v2 ADT message, what does the 'A01' event code signify?

Answer: Patient admit

ADT^A01 is the HL7 v2 event code for a patient admit or visit notification.

Which software development lifecycle model is most commonly required by FDA for high-risk medical device software?

Answer: A documented, risk-managed lifecycle with design controls

FDA requires a documented software lifecycle with design controls per 21 CFR Part 820, regardless of whether the team uses agile or waterfall.