Mike has over 15 years of experience in healthcare, including extensive experience designing and developing medical devices. MedCrypt, Inc.
On October 1, 2024, the Food and Drug Administration (FDA) marked a major milestone in medical device cybersecurity enforcement. This marks one year since the retracted Refuse to Accept (RTA) policy and the full implementation of the Protecting and Transforming Cyber Healthcare (PATCH) Act amendment to the Food, Drug & Cosmetic Act (FD&C). The FDA’s new requirements represent a fundamental shift in the regulatory landscape for medical device manufacturers (MDMs), as cybersecurity is now a non-negotiable element of device development and compliance.
The timing is not coincidental. In 2023, the FDA issued its final guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This outlined the detailed cybersecurity requirements and considerations that MDMs must address in their submissions, highlighting the security measures in place to gain regulatory approval. With these requirements, the FDA is taking a hard stance: Cybersecurity is a core consideration, with compliance being systematically enforced.
Imagine sitting down with an AI model for a spoken two-hour interview. A friendly voice guides you through a conversation that ranges from your childhood, your formative memories, and your career to your thoughts on immigration policy. Not long after, a virtual replica of you is able to embody your values and preferences with stunning accuracy.
That’s now possible, according to a new paper from a team including researchers from Stanford and Google DeepMind, which has been published on arXiv and has not yet been peer-reviewed.
🚀 Q: How might Trump’s administration impact AI development in the US? A: Trump aims to make America “first in AI” by dismantling Biden’s policy framework and reducing government regulation, potentially leading to skyrocketing growth in AI, cryptocurrencies, blockchain, Web3, and augmented reality.
🔓 Q: What’s J.D. Vance’s stance on AI development? A: Trump’s potential VP J.D. Vance supports open source AI and decentralized power, aiming to prevent large tech companies from steering regulation and allowing smaller innovators to compete.
Ionut Constantinescu, Tiago Pimentel, Ryan Cotterell, Alex Warstadt ETH Zurich 2024 https://arxiv.org/abs/2407.
Children are better at learning a…
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Dimon was speaking at the Georgetown Psaros Center for Financial Markets and Policy’s annual Financial Markets Quality Conference when he was asked whether he had any advice for the students there.
“For most of you guys, turn off TikTok, Facebook. A total stupid waste of time,” Dimon said.
Reading widely and consuming history books, Dimon said, would be a far better use of their time.
The Salton Sea, California’s largest lake by surface area, is experiencing an increasing rate of shoreline retreat following a policy change that shifted more water from the Colorado River to San Diego, according to a newly published study. The resulting dried lakebed is creating more polluted dust from dried agricultural runoff that affects nearby communities, researchers said.
A two-line comment about “various compliance requirements” spurred questions about sanctions policy and procedure on the Linux kernel mailing list.
