MDS2 form HN 1-2013-2025

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The document is a Manufacturer Disclosure Statement for Medical Device Security (MDS2) for the FUJIFILM SonoSite Edge ultrasound device. It outlines the device's capabilities regarding data privacy, security features, and management of private data, including its ability to display, transmit, and maintain electronic Protected Health Information (ePHI). The document details various security mechanisms such as user authentication, audit controls, and configuration options for managing private data. It also addresses the device's limitations in terms of remote access and malware protection.

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What is the MDS2 standard?

The MDS2 form was introduced in 2004 to capture medical device security standards which provides healthcare delivery organizations (HDOs) with important information about risk management and medical device security controls to harden the devices against unauthorized access and cyberattacks.

Is the MDS2 mandatory?

Although the MDS2 was not required by law, it was recommended by various regulatory bodies and industry organizations such as the FDA, the International Electrotechnical Commission (IEC), and the Association for the Advancement of Medical Instrumentation (AAMI).

What is the MDS2 form?

The MDS2 form is the medical device manufacturers response to its clinical users on the security and privacy controls of the devices. Without this visibility, they cant set up effective risk management strategies.

What is the MDS2 guideline?

The MDS2 form provides information about the security controls, which are implemented in a medical device in order to protect the PROTECTED HEALTH INFORMATION (PHI) transmitted or stored by the medical device. Healthcare providers may use the MDS2 form during the risk analysis of their organization.

What is the FDA guidance on MDR?

Manufacturers must submit an MDR report to the FDA no later than 30 days after learning their device has caused or contributed to the death or serious injury or has malfunctioned and a similar device is likely to cause an adverse event (death or serious injury) if it malfunctions.

What is the manufacturer disclosure statement for medical device security MDS?

What is a Manufacturer Disclosure Statement (MDS)? A Manufacturer Disclosure Statement (MDS) is a document that provides information about the security features and capabilities of a medical device. It is typically created by the device manufacturer and contains technical details related to the devices security.

MDS2 form HN 1-2013-2025

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