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Manufacturer disclosure statement for medical device security

Manufacturer disclosure statement for medical device security 2025

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The document is a Manufacturer Disclosure Statement for the DirectView DR9500 medical device by CareStream Health, detailing its capabilities regarding the management and security of electronic Protected Health Information (ePHI) as per HIPAA regulations. It outlines the device's ability to transmit, maintain, and secure ePHI, including administrative, physical, and technical safeguards in place. The document also emphasizes the importance of securing networks and protecting medical information systems.

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What is a medical disclosure statement for medical device security?

The Manufacturer Disclosure Statement for Medical Device Security, generally abbreviated MDS2 (or MDS), gives healthcare providers important cybersecurity information so they can evaluate the security capabilities of their devices or compare new devices when making product selections.

What is the MDS2 information?

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 cybersecurity Labelling scheme medical devices?

The CLS(MD) seeks to improve medical device security by incentivising manufacturers to adopt a security-by-design approach while empowering healthcare providers and consumers to make informed decisions about the cybersecurity standards of the medical devices they use.

Which document type allows medical device manufacturers to disclose the security related features of their devices?

Manufacturer Disclosure Statement for Medical Device Security. Consists of the MDS2 form and instructions for completing it. Assists professionals responsible for security-risk assessment in the management of medical device security issues.

What is document control in medical device?

Document control ensures that documents are accessible to authorized personnel and that only the most current versions are available for use within the organization. Companies in the medical devices sector must adhere to requirements related to document control.

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 manufacturer disclosure statement for medical device security?

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.

Manufacturer disclosure statement for medical device security 2025

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