Center for Devices and Radiological Health (CDRH)

See the following -

Apple Watch Leaves Patients Connected with Nowhere To Go

The highly anticipated unveiling of the Apple Watch Series 4 caused a news and social media sensation. Apple coined the iconic timepiece as the "guardian of your health", with health tracking functionalities such as the ability to detect atrial fibrillation (AFib) by a self-performed electrocardiogram (ECG). But from patients' and carepartners' perspectives, there is a long road to a universally accessible, seamlessly implemented, mass-adoption, and meaningful use for this wearable technology...Unfortunately, the vast majority of concerns in the public domain haven't emphasized the risks to health due to poor implementation, integration, and adoption strategies of digital tools and wearables.

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FDA Partners with Sensato-ISAO and H-ISAC to Create Open Source Cybersecurity Intelligence Network and Resource

Press Release | Sensato, Food and Drug Administration (FDA), Health Information Sharing and Analysis Center (H-ISAC) | October 9, 2018

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has officially executed a tri-lateral agreement between the FDA, the Health Information Sharing and Analysis Center (H-ISAC) and the Sensato-Information Sharing and Analysis Organization (Sensato-ISAO), Sensato announced today. The goal of the agreement is "to ensure that essential medical device or healthcare cybersecurity vulnerability information can be shared with all stakeholders within the HPH Sector, including those who are not members of H-ISAC and Sensato-ISAO," according to a statement from the FDA. "This collaboration will help inform a common understanding of that risk threshold upon which exploit of a vulnerability might impact on patient safety and/or public health."

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U.S. Government Probes Medical Devices For Possible Cyber Flaws

Jim Finkle | Reuters | October 22, 2014

The U.S. Department of Homeland Security is investigating about two dozen cases of suspected cybersecurity flaws in medical devices and hospital equipment that officials fear could be exploited by hackers, a senior official at the agency told Reuters...

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