Question

A completed Manufacturer Disclosure Statement for Medical Device Security is required if medical maintenance determines the equipment meets which criteria?

A) High Value
B) Mission-Critical
C) Cybersecurity Concerns
D) Regulatory Standards

Answer 1

A completed Manufacturer Disclosure Statement for Medical Device Security is typically required for medical devices with cybersecurity concerns. The CDRH oversees the safety and regulatory standards of these devices, making the disclosure relevant for cyber threat assessment.

Step-by-step explanation:

A completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) is typically required when medical maintenance determines that the equipment meets certain criteria related to cybersecurity concerns. This disclosure helps healthcare providers assess the cybersecurity risks and the security capabilities of medical devices. Given that such a statement relates to security concerns, it is likely needed for devices that pose potential cybersecurity threats rather than just high-value or mission-critical status; although, mission-critical devices could also have higher cybersecurity requirements. The Center for Devices and Radiological Health (CDRH) oversees the performance and safety, including cybersecurity aspects, of such devices. In this context, a Manufacturer Disclosure Statement for Medical Device Security would help satisfy regulatory standards and is usually demanded for devices that could be at risk of cyber threats, which can impact patient safety and the confidentiality, integrity, and availability of protected health information.