Medical Innovation Exchange

cybersecurity

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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CDRH Releases List of Proposed 2024 Guidance Documents

CDRH Releases List of Proposed 2024 Guidance Documents     Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming …

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Access Management Strategies: Best Practices and Emerging Trends for Cyber Security Teams

Access Management Strategies: Best Practices and Emerging Trends for Cyber Security Teams     Access management is an essential facet of cybersecurity and is quickly adapting to counteract the continuously shifting cyber threats. For cybersecurity professionals working in the medtech arena, staying updated on the latest trends in access management empowers them to make better choices …

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Preparing for the PATCH Act and RTA

Preparing for the PATCH Act and RTA     The Protecting and Transforming Cyber Health Care Act of 2022 (PATCH Act) comes into force on October 1, 2023. The Act strengthens cybersecurity requirements for medical device pre-market submissions and post-market surveillance. Companies must develop a product monitoring plan, cyber-anomaly response plan, coordinated messaging of cyber vulnerabilities, …

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