73 matches.
- PublicationsWhat GCs Need to Know About Algorithmic Bias3 minute read
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- Media CoverageEpstein Becker Green Forms Collaboration with Data, Social Scientists for AI Consulting5 minute read
- AnnouncementsEBG Advisors and Epstein Becker Green Expand AI Advisory Capabilities Backed by Nearly 1,000 Projects Across Hundreds of Clients5 minute read
- BlogsUnpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents18 minute read
- EventsAchieving Legal Compliance in AI: Minimizing Bias in Algorithms3 minute read
- PublicationsWhat the Data Says About FDA Responses to FOIA Requests2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request23 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New Submissions”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance for AI Change Control Shifts Workload to Initial Premarket Filing”1 minute read
- EventsLegal Framework of AI in the United States1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down Without a Fight”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
Unpacking FDA's Final Clinical Decision Support Guidance- Media CoverageBradley Merrill Thompson Quoted in “NIST Releases New AI Risk Management Framework for ‘Trustworthy’ AI”3 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- BlogsUnpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment15 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”October 24, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device, Says FDA”October 11, 20224 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”October 3, 20226 minute read
- BlogsUnpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRsOctober 3, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “A ‘Disaster,’ or a ‘Clear Path’ Forward?: New FDA Guidance on AI in Medicine Sparks Strong Reactions”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”September 27, 20222 minute read
- BlogsUnpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on ImportsSeptember 6, 202212 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Draft for Digital Tech in Clinical Trials Languishes Despite Agency’s Digital Push”September 1, 20221 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”August 3, 20222 minute read
- BlogsUnpacking Averages: Common Root Causes Driving Medical Device RecallsJuly 5, 20229 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”June 14, 20222 minute read
- EventsFDLI: Legal and Regulatory Opportunities to Address Bias and Transparency in Artificial Intelligence/Machine Learning in Medical DevicesJune 14, 20221 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”June 13, 20223 minute read
- EventsExplainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the "Black Box" ProblemJune 9, 20222 minute read
- BlogsUnpacking Averages: Violations Found in Medical Device Warning LettersJune 1, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help”May 31, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”March 29, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”February 2, 20224 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Combo Products Guidance Offers More Flexibility for Cross-Labeling”January 31, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Use This App and Call Me in the Morning: The Promise of Prescription Digital Therapeutics”January 8, 20222 minute read
- BlogsUnpacking Averages: Likelihood of FDA Medical Device InspectionsJanuary 4, 20226 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Top Med-Tech Trends of 2021: Regulatory Torpor Adding Drag to Advances in Artificial Intelligence, Machine Learning”6 minute read
- EventsTransparency in AIDecember 9, 20211 minute read
- PublicationsSenior Industry Leaders Need to Learn About AI3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “After the Buzz, AI Finding Its Place in Health Care”2 minute read
- BlogsUnpacking Averages: FDA Review Time for 510(k)s5 minute read
- EventsEU-US Webinar: Shaping the Future of Artificial Intelligence (AI) Within Life SciencesSeptember 30, 20212 minute read
- EventsArtificial Intelligence: Bias and Explainability in Algorithms2 minute read
- EventsNIST’s Proposal on Bias in Artificial Intelligence Roundtable3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Regulation of AI Complicated by Hospital’s Use of In-House Algorithms”4 minute read
- EventsBias in Artificial Intelligence: Legal Risks and Solutions3 minute read
- PublicationsData Quality for AI in Healthcare2 minute read
- BlogsExploring Intentional Bias in the Marketing of Consumer Products4 minute read
- BlogsBias in Healthcare Algorithms5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Promises a Draft Guidance for Change Control for Artificial Intelligence in 2021”2 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 minute read
- EventsVirtual Engineering Week: FDA & Medical Artificial Intelligence - What You Need to Know1 minute read
- EventsRAPS Convergence 2020: Software as Medical Device - Has AI Learned Too Much?2 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part III — FDA Should Not Expand Its Oversight of Commercialized AI3 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part II — What Industry Should Do in Commercializing Medical AI2 minute read
- PublicationsPost-Market Responsibilities for Medical AI: Part I – FDA's Plan to Increase Its Oversight3 minute read
- EventsFDA Registration for Digital Health – AI2 minute read
- PublicationsFDA's Support of AI in Telemedicine2 minute read
- PublicationsNew Developments in FDA Regulation of AI2 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
- PublicationsFDA Guidance on Decision Support Software: Implications for Industry5 minute read
- AnnouncementsEBG Advisor, Bradley Merrill Thompson, Comments on FDA Regulation of Mobile Medical Apps in Healthcare Finance News1 minute read
