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Balancing Patient Engagement and Awareness with Medical Device Cybersecurity

Balancing Patient Engagement and Awareness with Medical Device Cybersecurity

Nov 20, 2019

By Amy Abernethy, MD, PhD & Suzanne B. Schwartz, MD, MBA – Medical devices are increasingly more advanced and interconnected, sharing information via Wi-Fi, the internet, our phones and across hospital networks.

Medical Devices and HIPAA Compliance: What to Know

Medical Devices and HIPAA Compliance: What to Know

Nov 13, 2019

By Kayla Matthews – Any time a medical professional works with patient information, they must carefully follow HIPAA regulations and standards, including those that protect patient data. Medical devices — which can store, analyze and transmit patient data —

Rising Vulnerabilities of Medical Devices

Rising Vulnerabilities of Medical Devices

Jun 27, 2019

By Clyde Hewitt – It is safe to assume that most hospitals still struggle to find ways to address their medical device cybersecurity risks. The primary challenge is not technical, it’s the organizational inertia that keeps getting in the way.

HITECH and the FDA’s Overhaul of Medical Device Approvals

HITECH and the FDA’s Overhaul of Medical Device Approvals

Dec 10, 2018

By Kayla Matthews – Since 1976, the U.S. Food and Drug Administration (FDA) has offered a fast-track approval process for medical device manufacturers that could prove their products were substantially similar to approved items that were already in the marketplace.

The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions

The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions

Nov 26, 2018

By Suzanne B. Schwartz – Ensuring medical devices are safeguarded from cyber intrusions is a shared responsibility across the medical device ecosystem. At the FDA, we deal with cybersecurity in the context of the total product lifecycle of a device.

CDRH FY 2019 Proposed Guidance Development and Retrospective Review

CDRH FY 2019 Proposed Guidance Development and Retrospective Review

Oct 22, 2018

By Jeff Shuren MD JD – FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff…

FDA Budget Matters: Advancing Innovation in Digital Health

FDA Budget Matters: Advancing Innovation in Digital Health

Oct 10, 2018

By Scott Gottlieb MD – When the FDA recently granted marketing authorization for two medical apps for Apple’s new Watch, it marked a significant step forward for the agency’s overall approach to the development of digital health.

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