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Tag Archives: FDA

Scott Gottlieb: FDA Eyes Regulatory Framework for AI-Based Medical Devices

Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices. “We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained,” Gottlieb said in a statement published Tuesday

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DHS Helping FDA Cyber Secure Medical Devices

The Department of Homeland Security is working with the U.S. Food and Drug Administration to protect connected medical devices from emerging cyber threats, Federal News Network reported Thursday. In October, DHS began using the medical device security playbook the FDA issued to guide the government and industry in protecting such technologies.

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FDA Issues Draft Guidance for Medical Device Cyber Management

The Food and Drug Administration has released a draft guidance to provide recommendations that seek to help companies address cyber risks in medical devices prior to the submission of premarket applications for their products. FDA said Thursday the recommendations in the guidance document aim to facilitate the review process for premarket submissions and reduce the risk of patient harm associated with devices with cyber vulnerabilities.

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Researchers Call Out HHS for Lack of Standardized Data Sharing Protocols

Researchers from the Department of Health and Human Services' Office of the Chief Technology Officer have learned that HHS constituent agencies do not have a standardized mechanism for sharing restricted and nonpublic data. The researchers said in a September 2018 report that there is no uniform documentary requirement among HHS agencies for data requests, and, in many agencies, there is a lack of a "data governance group" that tracks requests and their outcomes. Such deficiencies result in procedural inefficiencies and the siloing of information.

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DARPA Program Seeks Gene Modulators to Boost Human Body’s Defenses Against Biological, Chemical Threats

The Defense Advanced Research Projects Agency has launched a four-year program that aims to develop transient and programmable gene modulators designed to temporarily boost the body’s defenses against chemical, biological and radiological threats. The PReemptive Expression of Protective Alleles and Response Elements program “will study how to support [the human …

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FDA Unveils Health Data Science Projects Under Incubator Program

Scott Gottlieb, commissioner of the Food and Drug Administration, has introduced information technology initiatives under the agency’s data science incubator program during  the Health Datapalooza conference in Washington, D.C., MedCityNews reported Thursday. Gottlieb highlighted the FDA’s Information Exchange and Data Transformation program that seeks to standardize methods to examine potential applications of artificial …

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