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FDA’s New Digital Health Report To update health care providers, patients, and developers about some of the risks and benefits surrounding software products, the FDA released a report based on impact to patient safety, health benefits and risks, and best practices. |
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FDA Updates Cybersecurity Recommendations for Medical Devices Because of the rapidly evolving nature of cybersecurity threats and risks, the U.S. Food and Drug Administration recently released a draft of updated premarket cybersecurity recommendations on how device manufacturers can better protect their products and proactively address security. |
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FDA Reviewing Guidelines for AI and Health Care Artificial intelligence is projected to revolutionize health care and make high-quality medical treatment more accessible and affordable. While 3D-printed donor organs may still be on the horizon, AI tools to detect strokes, diagnose diabetic retinopathy, and help identify wrist fractures are already here. |
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FDA Pilots Program to Pre-Certify Digital Health Software As healthcare undergoes a digital transformation, how can the traditional regulatory process keep pace? The FDA recently announced the initial participants in a pilot program that will pre-certify digital health tech companies that meet quality standards for software design, validation, and maintenance. |
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FDA Won’t Regulate “Low Risk” Medical Devices It’s expected that a product such as a left ventricular assist device that helps maintain the pumping ability of a heart comes under the scrutiny of the FDA. But should wearables for healthcare that simply record heart rates and sleep cycles be regulated as medical devices? |
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Heart-to-Heart Security Proposed for Implanted Medical Devices Like any wireless device that can be accessed remotely, implanted medical devices are vulnerable to hacking. The FDA acknowledged that embedded medical devices are a potential target for cyber security breaches and issued a warning to device manufacturers. Pamela Rentz looks at a proposed solution. |
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FDA Urges Medical Device Makers and Hospitals to Increase Security Cybersecurity incidents reported involving some medical devices have prompted the U.S. Food and Drug Administration to issue stern warnings to medical device manufacturers and health care facilities to ramp up safeguards. Pamela Rentz highlights the latest FDA recommendations. |
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Is the FDA Ready to Regulate Mobile Medical Apps? With the growing adoption of mobile technologies for health care delivery, the FDA has proposed regulating mobile medical applications. Even though the FDA issued preliminary guidance in 2001, final guidance has not yet been delivered. |
