Latest news with #GovCloud
Yahoo
21 hours ago
- Business
- Yahoo
FDA deploys generative AI tool Elsa to transform agency operations in historic move
In a major step toward modernizing its operations, the U.S. Food and Drug Administration (FDA) on Monday launched Elsa, a generative artificial intelligence (AI) tool, designed to help agency employees, including scientific reviewers and field investigators, work smarter and faster. Elsa is the regulator's first large-scale foray into generative AI and is being dubbed as a turning point for the agency. Built in a secure GovCloud environment, the tool gives staff the ability to quickly search and summarize internal documents without compromising sensitive research and data handled by FDA staff. More than a chatbot, the tool also allows FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review the AI models do not train on information submitted by regulated industries, ensuring the confidentiality of proprietary research. 'Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,' the agency's Chief AI Officer, Jeremy Walsh, said. 'As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.' The agency said it is already using the tool to speed up clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets. FDA Commissioner Dr. Marty Makary said the launch came ahead of schedule and under budget due to strong collaboration among internal teams. 'Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,' he said. 'Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.' Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications. It is seen as the first step in a broader strategy to embed AI into FDA workflows. 'Prioritizing efficiency and responsibility, the FDA launched Elsa ahead of schedule using an all-center approach. Leaders and technologists across the agency collaborated, demonstrating the FDA's ability to transform its operations through AI,' the agency within the U.S. Department of Health and Human Services said in a release. As employees use the tool, its developers plan to expand capabilities to meet emerging needs. This includes improving usability, data processing, generative-AI functions, and tailoring outputs to center-specific needs while maintaining strict information security and compliance with FDA policy. The agency-wide rollout was coordinated by Walsh, the agency's newly-appointed Chief AI Officer, and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Mantha recently led the Office of Business Informatics in CDER.
Gizmodo
2 days ago
- Health
- Gizmodo
The FDA Launches Its Generative-AI Tool, Elsa, Ahead Of Schedule
Generative artificial intelligence has found another home in the federal government. On Tuesday, the U.S. Food and Drug Administration announced the early launch of its very own generative AI that it hopes will improve efficiency. The FDA's tool—nicknamed Elsa—is designed to assist employees with everything from scientific reviews to basic operations. Originally, the FDA planned to launch by June 30, so Elsa is well ahead of schedule and under budget, according to an FDA statement. It's not clear what exact information Elsa was trained on, but the FDA says that it didn't use any 'data submitted by regulated industry' in order to protect sensitive research and information. Currently, Elsa houses its information in GovCloud, an Amazon Web Services product specifically intended for classified information. As a language model, Elsa can help employees with reading, writing, and summarizing. In addition, the FDA said that it can summarize adverse events, generate code for nonclinical applications, and more. Per the agency, Elsa is already being used to 'accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.' In a May press release announcing the completion of the FDA's first AI-assisted scientific review, Makary said he was 'blown away' by Elsa's capabilities, which '[hold] tremendous promise in accelerating the review time for new therapies'. He added, 'We need to value our scientists' time and reduce the amount of non-productive busywork that has historically consumed much of the review process.' According to one scientist, Jinzhong Liu, the FDA's generative AI completed tasks in minutes that would otherwise take several days. In Tuesday's announcement, FDA Chief AI Officer Jeremy Walsh said, 'Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee.' Generative AI can certainly be a useful tool, but every tool has its drawbacks. With AI specifically, there has been an uptick in stories about hallucinations which are outright false or misleading claims and statements. Although commonly associated with chatbots like ChatGPT, hallucinations can still pop up in federal AI models, where they can unleash even more chaos. Per IT Veterans, AI hallucinations typically stem from factors like biases in training data or a lack of fact-checking safeguards built into the model itself. Even with those in place, though, IT Veterans cautions that human oversight is 'essential to mitigate the risks and ensure the reliability of AI-integrated federal data streams'. Ideally, the FDA has thoroughly considered and taken measures to prevent any mishaps with Elsa's use. But the expansion of technology that really needs human oversight is always concerning when federal agencies are amidst mass layoffs. At the beginning of April, the FDA laid off 3,500 employees, including scientists and inspection staff (although some layoffs were later reversed). Time will reveal how Elsa ultimately performs. But eventually, the FDA plans to expand its use throughout the agency as it matures. This includes data processing and generative-AI functions to 'further support the FDA's mission.'
Engadget
3 days ago
- Health
- Engadget
The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinformation and pushbacks against science, but why not rush things through with AI? Elsa — yes, weirdly like the snow queen from Frozen — completed a "very successful pilot program with FDA's scientific reviewers." According to the FDA, the AI tool can help with reading, writing and summarizing everything from adverse events to assessments. Elsa can also do label comparisons and generate code. It's already being used to speed up clinical protocol reviews and scientific evaluations, along with finding "high-priority inspection targets." Elsa should be a secure platform, the FDA states. It's not clear how exactly the agency trained Elsa, but the FDA claims it's not through "data submitted by regulated industry." The information exists in Amazon Web Services' GovCloud that, again, should keep all information internal. The FDA calls Elsa the first step in its AI journey. "Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee," said FDA Chief AI Officer Jeremy Walsh. "As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency." If you buy something through a link in this article, we may earn commission.
Axios
4 days ago
- Health
- Axios
FDA launches agency-wide AI tool
The Food and Drug Administration on Monday is launching an agency-wide generative AI tool aimed at helping scientific reviewers, investigators and others streamline their work, according to details shared with Axios. Why it matters: The model, dubbed "Elsa," is being rolled out weeks ahead of schedule and is designed to help with tasks such as summarizing adverse events to support drug safety profiles, and to generate code for databases. The big picture: FDA said the technology was built in Amazon Web Services' GovCloud environment, which is designed to host sensitive government data. It isn't being trained with proprietary data submitted by drug and device manufacturers, according to a summary shared ahead of the public rollout. FDA did not detail specifically what information the model is being trained on, but said it offers a "secure platform for FDA employees to access internal documents." FDA said it's using the technology to review clinical protocols and speed up scientific evaluations. It soon will be used to identify high-priority targets for inspections, though it did not specify what kind. Zoom out: Public health experts told Axios last month that using more AI within the FDA is a good idea, but questioned how secure the data will be and how quickly the technology can really be integrated into the agency's workflow.
Yahoo
4 days ago
- Business
- Yahoo
SentinelOne analysis links service disruption to software flaw
This story was originally published on Cybersecurity Dive. To receive daily news and insights, subscribe to our free daily Cybersecurity Dive newsletter. SentinelOne said on Saturday that a global service disruption a few days earlier was the result of a software flaw in the company's infrastructure control system that led to a widespread loss of network connectivity. In a root-cause analysis report, the company said Thursday's major connectivity loss — which crippled its services worldwide — was not the result of a cyberattack. Instead, critical network routes and DNS resolver rules were deleted due to a software flaw in an automated process. SentinelOne is in the process of transitioning its production system to a new cloud-based architecture built on the principles of infrastructure as code. The company said a control system that will soon be deprecated was triggered by the creation of a new account. A software flaw in that control system's configuration comparison function misidentified discrepancies and applied what it believed to be the correct configuration state, overwriting prior network settings. The Mountain View, Calif.-based company said customer endpoints continued to operate but security teams were unable to access management consoles and other related services. This loss of access 'significantly impacted their ability to manage their security operations and access important data,' the company said. SentinelOne assured enterprise customers that their endpoints were protected and that no SentinelOne security data was lost during the outage. 'A core design principle of the SentinelOne architecture is to ensure protection and prevention capabilities continue uninterrupted without constant cloud connectivity or human dependency for detection and response — even in the case of service interruptions, of any kind, including events like this one,' the company said. The incident did not impact SentinelOne's federal customers, including those using GovCloud, according to the company, which said that it nonetheless alerted federal customers for situational-awareness and transparency purposes. The company provided a detailed timeline of the outage, showing that it began at 9:37 a.m. ET and was declared resolved by 4:05 p.m. ET. Analysts said the outage raised immediate concerns about transparency on the status of their respective security environments. 'Vendors must communicate quickly and transparently with customers during outages so they can appropriately prepare, plan, and communicate with executives about it,' Allie Mellen, principal analyst for security and risk at Forrester, told Cybersecurity Dive via email. 'Further, it's crucial that vendors have some out-of-band communication methods (for example, an independent, public status page) for updates on outages like these.' The outage comes at a time when software integrity and business continuity have become ongoing concerns in the cybersecurity and broader software industry. A flawed software update from CrowdStrike, a major SentinelOne competitor, crippled more than 8.5 million Microsoft Windows computers. In a July 2024 conference call, SentinelOne boasted about how it was fielding new customer inquiries in the aftermath of the CrowdStrike outage. CEO Tomer Weingarten said the concerns raised by that outage would 'play out for years' as companies addressed the liabilities and risk issues linked to the incident.
