Medical Innovation Exchange

cybersecurity

Utilizing CSF to Manage Cyber Risks

Utilizing CSF to Manage Cyber Risks     In February, National Institute of Standards and Technology (NIST) released its updated Cybersecurity Framework (CSF 2.0), which included a newly added Govern function, as well as target profiles to help companies better evaluate and improve their cybersecurity strategies. We spoke with Dave Bailey, VP of Consulting Services at …

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IoT: The Next Big Thing in Precision Lab Equipment

IoT: The Next Big Thing in Precision Lab Equipment     Precision is one of the most essential equipment qualities for consistency and authenticity in experimentation. The Internet of Things (IoT) promises to enhance the accuracy of the health and pharmaceutical sectors while integrating smaller, more user-friendly devices. Thanks to its many advantages, IoT is poised …

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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations     On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity …

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NIST Releases Updated Cybersecurity Framework

NIST Releases Updated Cybersecurity Framework     The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition, which supports implementation of the National Cybersecurity Strategy, has an expanded scope that goes beyond protecting critical infrastructure, such as hospitals and power plants, to …

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FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office     As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within CDRH. Launched in 2019, the OST was designed create …

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Medcrypt Appoints Former FDA Officer to Vice President of Services

Medcrypt Appoints Former FDA Officer to Vice President of Services     Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies …

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FDA Recognizes AAMI SW96 Cybersecurity Guidance Document

FDA Recognizes AAMI SW96 Cybersecurity Guidance Document     The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device manufacturers, is an important resource for medical device sponsors, and …

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The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation

The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation     This year, revenue from the medtech market is expected to reach $571 billion, according to Statista. The largest segment—medical devices—will reach a projected market volume of $472 billion. As with most industries experiencing steady growth, the medtech market faces several challenges, including supply chain issues, …

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President Biden Issues Executive Order on Artificial Intelligence

President Biden Issues Executive Order on Artificial Intelligence     On October 30, President Biden issued an Executive Order establishing new standards for artificial intelligence (AI). The order focuses on safety and security, privacy protections, advancement of equity and civil rights, promotion of innovation and competition and advancing American leadership in AI. The Executive Order directs the …

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5 Ways to Maximize the Security of Edge Medical Devices

5 Ways to Maximize the Security of Edge Medical Devices      Cybersecurity attacks have morphed in recent years, exponentially increasing the risk of patient data exposure through lab equipment and other edge medical devices. Threat actors who once exclusively targeted the application layer have turned their attention to the physical layer targeting hardware, firmware, BMC …

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