145 matches.
- PublicationsUnpacking Averages: Searching for Bias in Word Embeddings Trained on Food and Drug Administration Regulatory DocumentsJanuary–February 20242 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- PublicationsWhat GCs Need to Know About Algorithmic Bias3 minute read
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- PublicationsWhat the Data Says About FDA Responses to FOIA Requests2 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ Concept”2 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- PublicationsSenior Industry Leaders Need to Learn About AI3 minute read
- PublicationsQuantifying the Need for Attorney Pro Bono Services in Connection with the Social Determinants of Health2 minute read
- PublicationsData Quality for AI in Healthcare2 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 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
- PublicationsFDA's Support of AI in Telemedicine2 minute read
- PublicationsNew Developments in FDA Regulation of AI2 minute read
- PublicationsApplying Data Science Principles to FDA's PreCert Program: Some Scary Stuff3 minute read
- PublicationsCommentary: FDA's Website Has Wrong Information About the Scope of Its Software Regulation — And That's a Big Problem2 minute read
- PublicationsHow Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think2 minute read
- PublicationsDiabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting2 minute read
- PublicationsFDA's Dramatic Announcement of Apple's Clearances: Is There a Level Playing Field at FDA?2 minute read
- PublicationsCommentary: Why FDA's Software Precertification Program May Be Bad for Business2 minute read
- PublicationsCDRH’s New Post-Market Paradigm: Why the Public Should Be Worried3 minute read
- PublicationsFDA Reneged on Its Promise to Take a Risk-Based Approach to CDS Software1 minute read
- PublicationsFDA Extends Regulatory Reach to Low-Risk CDS Software2 minute read
- PublicationsFDA Guidance on Decision Support Software: Implications for Industry5 minute read
- PublicationsWhat If Digital Could Drive Revenue?2 minute read
- PublicationsFive Regulatory Myths Keeping Bio/Pharma Out of Digital Health2 minute read
- PublicationsBradley Merrill Thompson Quoted in "The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan"1 minute read
- PublicationsWhy New Guidelines Are the Best Way to Address Medium-Risk CDS Software2 minute read
- PublicationsCoalition Finalizes Guidelines for the Design of Medium Risk Clinical Decision Support Software2 minute read
- PublicationsLearning from Experience: FDA's Treatment of Machine Learning2 minute read
- PublicationsDeregulation Helps Pharma Companies Pursue Digital Health Strategies1 minute read
- PublicationsHow the FDA Could Impact Machine Learning, IoT in Healthcare2 minute read
- PublicationsHow Machine Learning Can Support Clinical Decision-Making – and Leave the Doctor in Control1 minute read
- PublicationsFDA's Next Frontier: Regulating Machine Learning in Clinical Decision Support Software2 minute read
- PublicationsThe Legal Environment for Precision Medicine1 minute read
- PublicationsBusiness Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- PublicationsMarketing Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- PublicationsStrategies for Technology Companies Entering the Health Care Internet of Things3 minute read
- PublicationsThe FDA's 5-Year Delay on Automated Medicine Must End1 minute read
- PublicationsUnderstanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities3 minute read
- PublicationsThe Social Cost of FDA's Bias Against New Technology2 minute read
- PublicationsWalking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications2 minute read
- PublicationsManaging Pharmacovigilance in Digital Health Initiatives2 minute read
- PublicationsWhy What Works for Uber May Not Work for Medical Apps2 minute read
- PublicationsPharmaceutical Apps and the US Regulatory Requirements2 minute read
- PublicationsWorking Out the Bugs: Congress Wants to Clarify FDA Software Regulation2 minute read
- PublicationsFDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease2 minute read
- PublicationsFDA Medical App Regulation and the Art of Intended Use2 minute read
- PublicationsHelp Low-Income Neighbors Fight Legal Injustice2 minute read
- PublicationsRegulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition2 minute read
- PublicationsIn-Depth: Anticipating FDA Regulation of Pharmaceutical Apps2 minute read
- PublicationsThe LDT Debate: Understanding FDA's Jurisdiction Over IVDs Made at a Clinical Lab1 minute read
- PublicationsHealthcare, Poverty, and Technology: Connecting the Dots2 minute read
- PublicationsWhat's in the Shoe Box?1 minute read
- PublicationsScarey – and True – Halloween Lawyer Story1 minute read
- PublicationsThe Evolving US mHealth Regulatory Landscape
- PublicationsDon't Leave Christian Legal Aid to the Lawyers1 minute read
- PublicationsJudging the Poor Worthy of Help1 minute read
- PublicationsMMA Roadshow: 10 Lessons for Developers1 minute read
- PublicationsInternational Guidance on Regulating Software as a Device Could Influence U.S. Oversight, in Bloomberg BNA's Health IT Law & Industry Report2 minute read
- PublicationsAnalysis: The Significance and Insignificance of the FDASIA HIT Report, in mHealthNews2 minute read
- PublicationsFDA Draft Guidances Drag Out1 minute read
- PublicationsLessons from McKesson: Insight into FDA's Stance on Clinical Decision-Support Software, in Medical Device and Diagnostic Industry2 minute read
- PublicationsEvenhanded FDA Enforcement, in Medical Device and Diagnostic Industry2 minute read
- PublicationsHow the FDA Can Improve Regulation of Mobile Health, According to FDASIA Workgroup, in MobiHealthNews1 minute read
- Publications8 Types of Medical Apps a Senate Bill Asks FDA to Stop Regulating, in Mobihealthnews2 minute read
- PublicationsE-book: FDA Regulation of Mobile Health 2013 (Second Edition) (MobiHealthNews)1 minute read
- PublicationsProtecting Mobile Health Innovations from Regulation1 minute read
- PublicationsFDA (Finally) Returns Industry's Calls for Mobile Medical Apps Guidance, in Medical Device and Diagnostic Industry2 minute read
- PublicationsPart 2: Set FDA's Mobile Medical App Guidance Free, on MobihealthNews.com2 minute read
- PublicationsShould the FDA Regulate Mobile Medical Apps?1 minute read
- PublicationsSet the FDA Mobile Medical App Guidance Free, on MobihealthNews.com2 minute read
- PublicationsThree Reasons FDA's Enforcement Helps Mobile Health, inMobihealthnews.com1 minute read
- PublicationsAmerican Telemedicine Association Annual Meeting Connects At-Risk Patients to Specialists and Home Aging, in Medical Device and Diagnostic Industry1 minute read
- PublicationsManaging Your Business Risk in Mobile Health: Part 2, in Mobihealthnews.com1 minute read
- PublicationsCounting Our Blessings with the Office of Combination Products, in Medical Device and Diagnostic Industry1 minute read
- PublicationsManaging Business Risk in Mobile Health: Part 1, in Mobihealthnews1 minute read
- PublicationsInternational Regulators Focus on Medical Software, Including Apps, in Mobihealthnews2 minute read
- PublicationsAfter FDA's Mobile Medical Apps Final Guidance, What's Next? in Mobihealthnews.com1 minute read
- PublicationsFDA App Enforcement, in Medical Device and Diagnostic Industry2 minute read
- PublicationsFood and Drug Administration Regulation of Diabetes-Related mHealth Technologies2 minute read
- PublicationsHow the FDA Regulates Pharmaceutical Apps, in MobiHealthNews2 minute read
- PublicationsComparing EU and US Approaches to Regulating Clinical Decision Support Software2 minute read
- PublicationsFDA's Approach to Clinical Decision Support Software: A Brief Summary, as appeared in FierceHealthIT1 minute read
- PublicationsMobile Medical Apps Guidance: What's Good for the US Is Good for the EU, as appeared on ScripRegulatoryAffairs.com1 minute read
- PublicationsIs FDA's EHR Exemption Becoming Extinct? in MobiHealthNews1 minute read
- PublicationsChapter 5, "In Vitro Diagnostic Devices," in Medical Devices Law and Regulation Answer Book 2011-12 (PLI)1 minute read
- PublicationsThe Future Regulation of Mobile Healthcare, as appeared in Regulatory Affairs Medtech1 minute read
- PublicationsFDA Regulatory Update: Top 10 Policy Development Issues for 2011 & What May Stand in the Way of Advancing Them, as appeared in Drug Development & Delivery1 minute read
- PublicationsUnderstanding FDA's New MDDS Rule1 minute read
- PublicationsThree Key Questions for FDA mHealth Regulation, in Mobihealthnews1 minute read
- PublicationsFDA Regulation on Mobile Health: MobiHealthNews 2010 Report1 minute read
- PublicationsFDA Regulation of Mobile Health1 minute read
- PublicationsWill the FDA Regulate mHealth Care Providers?1 minute read
- PublicationsIn Vitro Diagnostics: The Complete Regulatory Guide1 minute read
- PublicationsNewly Proposed Good Manufacturing Practices, as appeared in Drug Delivery Technology Magazine11 minute read
- PublicationsWashington Signals Possible FDA Regulation of mHealth, as appeared in MobiHealthNews8 minute read
- PublicationsTop Ten Connected Health Challenges in 20108 minute read
- PublicationsShould mHealth Companies Want FDA Regulation?, as appeared in MobiHealthNews1 minute read
- PublicationsHow to Get FDA to Clear a Mobile Health App, as appeared in MobiHealthNews17 minute read
- PublicationsTop Ten Key Issues Concerning "Biosimilars"13 minute read
- PublicationsTop Ten Considerations for Industry Support of Investigator-Initiated Research7 minute read
- PublicationsNew Regulatory Developments in the Combination Product Area2 minute read
- PublicationsFDA's New Draft Guidance on Technical Considerations for Pen, Jet & Related Injectors Intended for Use With Drups and Biological Products: Comments and Concerns, as appeared in Combination Update1 minute read
- PublicationsTop Ten Best Practices in Complying with Current Good Manufacturing Practice for Combination Products7 minute read
- PublicationsStep-by-Step: FDA Wireless Health Regulation1 minute read
- PublicationsTop Ten Tips to Follow When Entering Into Financial Relationships With Health Care Professionals7 minute read
- PublicationsFDA May Regulate Certain Mobile Phones, Accessories9 minute read
- PublicationsNew FDA Draft Guidance on Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products5 minute read
- PublicationsTop Ten Best Practices for Effective Communication with FDA on Product Development Issues7 minute read
- PublicationsTop Ten Issues for Reimbursement of Remote Monitoring Devices In a Changing Health Care Environment8 minute read
- PublicationsTop Ten Tips For Operating An Effective Corporate Compliance Program6 minute read
- PublicationsTop Ten Ways Health Care Reform Benefits Packages Will Affect Innovation in the Life Sciences Sector6 minute read
- PublicationsTop Ten Ways For Sponsors To Manage Risk Better With CROs6 minute read
- PublicationsOff-Label Communications: A Guide to Sales and Marketing Compliance
- PublicationsRegulating the Human Tissue Trade, as appeared in Health Lawyers Weekly1 minute read
- PublicationsAn Uncertain Path: A New Survey Indicates Industry's Desire for More Detailed Guidance for Developing and Commercialing Combination Products, in MX Magazine
- PublicationsImpact on Patient Care Must Be Factor When Assessing "Gainsharing" Arrangement, as appeared in Legal Backgrounder1 minute read
- PublicationsMeasuring Compliance
- PublicationsThe IVAT Solution, IVD Technology
- PublicationsThe FDA Approval and Medicare Coverage Processes, Part 2: Striving Toward Harmonization
- PublicationsThe FDA Approval and Medicare Coverage Processes, Part 1: Current Interconnections1 minute read
- PublicationsBook: Guide to Medicare Coverage Decision-Making and Appeals1 minute read
- PublicationsHealth Care Industry Working Group Develops Draft PE Guidance, FDA Advertising and Promotion Manual 4
- PublicationsCLIA Reform: Present and Future, IVD Technology
- PublicationsMedical Devices in China, 6 The Regulatory Affairs Journal 25
- PublicationsThe Product Development Protocol, Vol. 2, No. 11, RA Focus
- PublicationsThe Demise of Rule Making and the Rise of Guidances, 18 Medical Device & Diagnostic Industry 99
- PublicationsBook: FDA Regulation of Medical Devices(Interpharm Press)
- Publications510(k)s for Sale, 16 Medical Device & Diagnostic Industry 34
- PublicationsKeeping Track of Medical Devices, 11 Food, Drug, Cosmetic and Medical Device Law Digest 24
- PublicationsFDA's Expanding Definition of Diagnostic Devices, 15 Medical Device & Diagnostic Industry58
- PublicationsCompanies Should Police Themselves, Indiana Business Magazine 91
- PublicationsFDA's New and Improved Approach to Device Tracking, 14 Medical Device & Diagnostic Industry 66
- PublicationsFDA's New Rules for Investigational and Research IVDs, 4 Regulatory Affairs 305
- PublicationsResurrecting the Product Development Protocol for Medical Devices, 46 Food Drug Cosmetic Law Journal
- PublicationsTax Savings for Small Exporters, Vol. 11, No. 20, Indianapolis Business Journal
- PublicationsLifting the Burden of IDE Regulations Off Device Feasibility Studies, Medical Device & Diagnostic Industry
- PublicationsSome Tips for Protecting the Confidentiality of an Environmental Audit, Vol. 10, No. 22, Indianapolis Business Journal
- PublicationsCompanies Must Weigh Competing Interests in Planning for FDA Inspection, Vol. 8, No. 52, Indianapolis Business Journal
- PublicationsFDA's Candid Camera, 43 Food Drug Cosmetic Law Journal 335
- PublicationsResearch and Development Strategies: Competitive Implications for American Firms, Outstanding Papers