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Connected Items Healthcare

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Nelson Mullins Riley & Scarborough LLP

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Stevens & Lee

Policy Considerations for Voice-Controlled Devices Used in Senior Care Facilities

Stevens & Lee on

Over the last two years, the COVID-19 pandemic created a variety of challenges to both health care systems and the individuals they serve, but dire circumstances also fostered particular health care innovations....more

Robinson+Cole Data Privacy + Security Insider

Health Care IoT Devices Pose Risk to Patient Care

As if health care entities don’t have enough to worry about  during this chaotic and difficult time in the pandemic, a new report released by Cynerio, entitled “The State of IoMT Device Security 2022,” provides a list of...more

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

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