1244 matches.
- Media CoverageBradley Merrill Thompson Quoted in “FDA's Device Center Vigorously Stirred the Regulatory Pot in 2024”2 minute read
- BlogsUnpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA14 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Final PCCP Guidance Clarifies Expectations for AI Submissions”2 minute read
- BlogsUnpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software6 minute read
- Media CoverageBradley Merrill Thompson Featured in AHLA’s Speaking of Health Law Podcast, “AI in Health Care: Managing Algorithmic Bias and Fairness”2 minute read
- BlogsUnpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 52211 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Convergence: Experts Offer Advice on Leveraging AI in Regulatory”3 minute read
- EventsRAPS Convergence: Cross-Industry Insights - Leveraging AI to Elevate NextGen Regulatory1 minute read
- BlogsUnpacking Averages: How Old Are Medical Devices on the US Market?5 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202514 minute read
- BlogsUnpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?13 minute read
- EventsAHLA: Managing Algorithmic Bias and Fairness in AI for Health Care1 minute read
- BlogsUnpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials8 minute read
- EventsUnpacking the Legal Challenges in Sourcing AI in Health Care and Life Sciences in the US and the EUJune 17 and 21, 202410 minute read
- Media CoverageBradley Merrill Thompson Cited in “AI Regulation: Global Picture Balances Innovation and Insight”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Experts Advise Against Prescriptive FDA Policies for Regulating AI”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Medical Board Group Keeps AI Liability Focus on Doctors”2 minute read
- BlogsUnpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials12 minute read
- EventsNew Final Regulation Prohibiting Algorithmic Discrimination by Health Care Providers and Payers2 minute read
- EventsAHLA: The Complexities of AI in Health Care1 minute read
- BlogsUnpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program11 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Fighting the Bots Is the New Attorney Niche”4 minute read
- BlogsHHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms16 minute read
- Firm AnnouncementsFourteen Epstein Becker Green Attorneys Named to the 2024 Washington, DC, Super Lawyers and Rising Stars Lists7 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Protests FDA Plan to Clear Guidance Backlog by Skipping Comments”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read
- BlogsUnpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents14 minute read
Firm AnnouncementsThree Epstein Becker Green Attorneys Cited for Noteworthy Thought Leadership in JD Supra 2024 Readers’ Choice Awards4 minute read- BlogsUnpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities10 minute read
- Media CoverageBradley Merrill Thompson Discusses “Problematic Guidance Patterns Remain at FDA”2 minute read
- EventsCurrent Developments in Digital Health Technology and Regulation: More Than Medical Devices - Development and Use of Companion Apps for Pharmaceutical Products and Beyond1 minute read
- EventsFundamentals of Digital Health Regulation: What Advertising and Promotion Requirements Apply?1 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- BlogsUnpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship10 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsUnpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance13 minute read
- PublicationsUnpacking Averages: Searching for Bias in Word Embeddings Trained on Food and Drug Administration Regulatory DocumentsJanuary–February 20242 minute read
- BlogsWhite House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries6 minute read
- EventsACI National Conference on AI Law, Ethics, and Compliance: Preventing and Detecting BIAS in Algorithms, Testing, and AI Outputs2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI vs. the Health Bureaucracy”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI Has Arrived in Your Doctor’s Office. Washington Doesn’t Know What to Do About It.”4 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- PublicationsWhat GCs Need to Know About Algorithmic Bias3 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- EventsACC NYC: Data Rights, Privacy, and Cybersecurity Issues in Contracts with AI Vendors1 minute read
- EventsACC NYC Webinar: Data Rights, Privacy and Cybersecurity Issues in Contracts with AI Vendors1 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?13 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession12 minute read
- Media CoverageBradley Merrill Thompson Quoted in “More FDA Guidance Needed to Untangle Combination Product Regulations”2 minute read
- 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
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
Firm AnnouncementsEpstein Becker Green and Affiliate Consultancy EBG Advisors 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 Documents17 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI: US and EU Policymakers Move to Regulate After Industry Rings Alarm Bells”2 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 “FDA, Industry Coalition Still at Odds Over September 2022 CDS Final Guidance”2 minute read
- BlogsUnpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study29 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- BlogsUnpacking Averages: Success Rates for FDA FOIAs by Topic and Requester8 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- Firm AnnouncementsThirteen Epstein Becker Green Attorneys Named to the 2023 Washington, DC, Super Lawyers and Rising Stars Lists4 minute read
- BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request17 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
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ Concept”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 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
- EventsMachine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy, and Security Risks1 minute read
- BlogsUnpacking Averages: Exploring New Data on FDA Responses to FOIA Requests14 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 Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
Unpacking FDA's Final Clinical Decision Support Guidance- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- BlogsUnpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development18 minute read
- 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 Environment9 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- BlogsUnpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database9 minute read
- Media CoverageBradley Merrill Thompson Discusses “The Impact of Clinical Decision Support Software on the Healthcare Industry”2 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device, Says FDA”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency Requirement”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- BlogsUnpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRs9 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lays Out CDS Stance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated”2 minute read
- Media CoverageBradley Merrill Thompson Featured in BioWorld: Discussion of FDA Guidance for CDS Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Guidance Hikes Oversight of Clinical Decision Support Software”3 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”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority”2 minute read
- Media CoverageBradley Merrill Thompson Featured in Medtech Monthly Podcast: Breakthrough Device Analysis7 minute read
- BlogsUnpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports9 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Draft for Digital Tech in Clinical Trials Languishes Despite Agency’s Digital Push”1 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession11 minute read- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- BlogsUnpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful10 minute read
- Media CoverageBradley Merrill Thompson Featured in “Meet the Top 8 Lawyers Helping Startups Patent Artificial Intelligence and Comply with Rules on Privacy and Safety”2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “MDMA Blasts FDA Cybersecurity Draft for Mention of Health Care Facility Networks”1 minute read
- BlogsUnpacking Averages: Common Root Causes Driving Medical Device Recalls7 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 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”3 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 Letters13 minute read
- Media CoverageBradley Merrill Thompson Featured in “Epstein Becker Partner on Getting a Master's at 60”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help”2 minute read
- BlogsUnpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters19 minute read
- Firm AnnouncementsThirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
Career Pathways: Attorney Brad Thompson – Commitment to Lifelong Learning-
Career Pathways: Attorney Brad Thompson – Commitment to Our Industry Focus
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Career Pathways: Attorney Brad Thompson – Tips for Continued Learning
- BlogsUnpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA13 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”2 minute read
- EventsAmerican University Business Law Review Spring Symposium: Developing Safeguards for AI Caused Gender Bias in Business1 minute read
- BlogsUnpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals9 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”4 minute read
- BlogsUnpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects7 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Combo Products Guidance Offers More Flexibility for Cross-Labeling”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Use This App and Call Me in the Morning: The Promise of Prescription Digital Therapeutics”2 minute read
- BlogsUnpacking Averages: Likelihood of FDA Medical Device Inspections6 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
- BlogsUnpacking Averages: Popular Ways to Combine Device Functionality3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Biden Nominates Robert Califf to Return as FDA Head”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old Policy”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- BlogsUnpacking Averages: Analyzing Descriptions from Cardiovascular Device Adverse Events5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future”4 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
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”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
- Media CoverageBradley Merrill Thompson Quoted in “UK Seeks Overhaul of AI, Software as a Medical Device Regs”3 minute read
- EventsArtificial Intelligence: Bias and Explainability in Algorithms2 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20227 minute read
- EventsNIST’s Proposal on Bias in Artificial Intelligence Roundtable3 minute read
- EventsFDLI: Machine Learning for Regulatory Attorneys and English Majors1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Google Launches a New Medical App—Outside the US”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Need Mental Health Help? There Are Apps for That, but Picking the Right One Is Tough”6 minute read
- EventsRAPS: US Regulation of Advertising, Promotion, and Labeling for Medical Devices2 minute read
- EventsFDLI Annual Conference: Machine Learning for Regulatory Attorneys and English Majors1 minute read
- Firm AnnouncementsTen Epstein Becker Green Attorneys Named to 2021 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- PublicationsQuantifying the Need for Attorney Pro Bono Services in Connection with the Social Determinants of Health2 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
- BlogsAI-Based Compensation Management and Bias: Can AI Close the Pay Gap?5 minute read
- PublicationsData Quality for AI in Healthcare2 minute read
- BlogsExploring Intentional Bias in the Marketing of Consumer Products3 minute read
- BlogsBias in Healthcare Algorithms4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Action Plan Puts Focus on AI-Enabled Software as Medical Device”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Promises a Draft Guidance for Change Control for Artificial Intelligence in 2021”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Speedier Medical Device Pathway Alternative to Breakthrough Status”3 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
- Media CoverageBradley Merrill Thompson Quoted in “Prescription Pulse: Experts Split on HHS Sunset Rule”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AdvaMed Seeks Regulatory Clarity on FDA’s New Digital Health Center”2 minute read
- Media CoverageBradley Merrill Thompson Featured in MobiHealthNews HIMSSCast: “Is the FDA Taking Digital Health Regulation in the Right Direction?”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Establishes Digital Health Center of Excellence”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Device Experts Say FDA Is Too Heavily Invested in Pre-Cert Program”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Touts Lessons from Pre-Cert, Though Next Steps Murky”3 minute read
- EventsRAPS Convergence 2020: Software as Medical Device - Has AI Learned Too Much?2 minute read
- Firm AnnouncementsFifty-Five Epstein Becker Green Attorneys Recognized for Professional Excellence–Two Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20217 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
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans"3 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
- Media CoverageBradley Merrill Thompson Quoted in "FDA Offers Psychiatric Device Flexibility, Expands 'Wellness' Definition"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How FDA Is Backing the Use of Artificial Intelligence in Telemedicine"2 minute read
- PublicationsFDA's Support of AI in Telemedicine2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Akili's Digital Therapeutic Launches Early for Housebound Children with ADHD"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Eases Guidelines for New mHealth, Telemental Health Treatments"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA: Devs Can Release Digital Products for Psychiatric Disorders Without 510(k) Submission During COVID-19 Crisis"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2020 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- PublicationsNew Developments in FDA Regulation of AI2 minute read
- EventsFDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Gives Guidance on 'Coronavirus’ Thermal Fever Detection Systems"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Digital Health Advice from FDA Amid Coronavirus Leaves More Questions Than Answers"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Still Trying to Fine-Tune Pre-Cert as Pilot Enters 2020"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Steps on Gas for Digital Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Expands Use of Vital Sign Monitors to Enable Remote Care, Modifications During COVID-19 Emergency"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Greenlights Expanded Remote Patient Monitoring to Keep Patients Out of Coronavirus-Slammed Hospitals"3 minute read
- Media CoverageEpstein Becker Green Analysis Featured in "Healthcare Predictions for 2020: Health Systems Will Get Bigger, Demand for Physicians Will Grow"3 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Latest FDA Clinical Decision Support Software Draft a Step Forward, Industry Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Stakeholders See More Holes in FDA's Revised CDS Draft Guidance"3 minute read
- Media CoverageBradley Merrill Thompson Cited in "A Closer Look at the FDA's Moves, Clearances in the Second Half of 2019"3 minute read
- Media CoverageBradley Merrill Thompson Featured in "Faces of UMSI" – a Michigan Law Grad Who Decided to Go Blue Again, Three Decades Later4 minute read
- EventsPATH Summit 2019: New Public Policy Developments Affecting PATH Members1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dexcom App Outage Highlights Communication Pitfalls for Device Makers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dexcom Talks More About Alerts Outage"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Special Treatment of Big Tech Faces Mounting Scrutiny"3 minute read
- PublicationsApplying Data Science Principles to FDA's PreCert Program: Some Scary Stuff3 minute read
- Events2019 Wharton Health Care Conference on Artificial Intelligence: The Future of Software as a Medical Device (SaMD) – Early Government Investment and Federal Oversight1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "There's a Lot on FDA’s 2020 Guidance Priorities Lists – but the Software Pre-Cert Program Isn't One of Them"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Expert Says FDA's CDS Guide Revision Could Raise Legal Issues"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Puts Out New Decision Support Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Revises Clinical Decision Support Software Draft After Industry Blowback"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Releases Revised Draft Guidance on CDS Software, Final Guidelines on 'Device' Definitions for Software Such as Wellness Apps"3 minute read
- EventsXavier Health Combination Products Summit
- Media CoverageBradley Merrill Thompson Quoted in "How Apple, Fitbit, Samsung and More Are Helping to Modernize the FDA"1 minute read
- EventsXavier Health AI Summit
- Firm AnnouncementsForty-Seven Epstein Becker Green Attorneys Named by The Best Lawyers in America 2020, One Attorney Distinguished as "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Product Reporting Rule Set for 2020 Enforcement"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer Applauds Combo Products Guide but Says Some Details Missing"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Lawyer: FDA's Pre-Cert Update Seems Promotional, Lacks Answers"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "One Small Step for US FDA, but Maybe a Giant Leap for SaMDs"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pear Files Insomnia and Depression Software as Pre-Cert Pilot 510(k)"3 minute read
- EventsStartup Roadshow Encore Webinar: AI in Healthcare3 minute read
- EventsUS Regulation of Advertising, Promotion, and Labeling for Medical Devices: Intended Use & Off-Label Promotion1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Roche, J&J Regulatory Leads Weigh In on Pre-Cert's Progress, Challenges of Regulating Digital Health"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FitBit, Verily Make Inroads at FDA as It Weighs Software Rules"2 minute read
- Events2019 BIO International Convention: Current and Future Regulatory Environment for Digital Health1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Expert Worries FDA Might Not Get Takers for Pre-Cert Test Plan"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Moving on Pre-Cert Test Plan Despite Questions About Authority"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Software Developer Test Cases for Precertification Program"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Call for Volunteers"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Testing the Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Wants New Companies to Help Test Its Pre-Cert Program"2 minute read
- Events2019 BrightInsight Ecosystem Event: How to Thrive in Today’s Complex Digital Health Regulatory Environment1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "An Illini Lineage: The Thompson Family's Relationship with Illinois Goes Back Almost a Century"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Extends Postmarket Reporting Deadline for Combo Products"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Seek Alignment of Standards Recognition Across FDA's CDER, CBER, CDRH"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys in Washington, DC, Named to 2019 Super Lawyers and Rising Stars Lists6 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsCenter for Artificial Intelligence Driven Health Data Systems
- Media CoverageBradley Merrill Thompson Quoted in “FDA Unveils Framework for AI-Based Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New AI White Paper"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Takes First Steps Toward New Guidance for Adaptive Medical AI"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA: Device Center’s Total-Life-Cycle Reorganization to Begin March 18"3 minute read
- PublicationsCommentary: FDA's Website Has Wrong Information About the Scope of Its Software Regulation — And That's a Big Problem2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What Does Gottlieb's Resignation Mean for Medtech?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb, Whose FDA Made Major Strides in Digital Health, Resigns as Commissioner"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Officials: Too Soon to Answer Device Industry Pre-Cert Questions"3 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsPropel Medical Device Executive Webinar Series: Are Your Products Ready for the FDA’s New Digital Health Pre-Cert Program?1 minute read
- PublicationsHow Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Combo Products Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "510(k) Modernization: FDA Floats Need to Pursue New Authority"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageBradley Merrill Thompson Featured in "Quoted," on the FDA’s Digital Health Pre-Certification Program1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Regulatory Uncertainty Persists Around Medical Software"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pre-Cert Program Will Start Off Slow with De Novo Framing, but Big Questions Remain"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Disagree Over Whether FDA Has Authority for PreCert"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Looks to De Novo Pathway Model as it Unveils Updates to Pre-Cert Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will Telehealth and mHealth Fulfill Their Potential in 2019?"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyers: FDA Proposed De Novo Rule Might Discourage Developers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA Medical Software Report Rests Concerns of Increased Regulation"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple Now Says Its Smartwatch Tech to Detect Atrial Fibrillation Is Not for Those with Atrial Fibrillation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's De Novo Pathway Is About to Get a Makeover"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Lawyer: 510(k) Plan Violates Statute, FDA 'Too Big for Britches'"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Looks to Restrict Older Predicate Devices, Introduce New Regulatory Pathway"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Considering Imposing 10-Year Limit When Manufacturers Choose Older Predicates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks $46M to Fund National Evaluation System for Health Technology"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Rolls Out New Rx-Use-App Paper"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Roundup: 12 Healthcare Algorithms Cleared by the FDA"2 minute read
- EventsDiabetes Technology Meeting: The FDA Pre-Certification Program for Software as a Medical Device1 minute read
- PublicationsDiabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting2 minute read
- EventsFDA Medical Device Recalls: Now and Then4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Top Democrats Question FDA Pre-Cert Program Safety, Statutory Authority"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert"2 minute read
- EventsPATH Summit: Legal and Policy Issues Surrounding the Use of Advanced Technologies to Provide Healthcare Services1 minute read
- EventsPATH Summit: Partnership for Artificial Intelligence and Automation in Healthcare1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Approval of Apple Watch ECG Monitoring Capability6 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
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer Says FDA-Proposed Device Accessory List Too Short"2 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Selected for The Best Lawyers in America 2019 and Four Attorneys Named "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA's Software Pre-Cert Program: Is the Authority on the Books?"3 minute read
- PublicationsCDRH’s New Post-Market Paradigm: Why the Public Should Be Worried3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Balks at FDA's Cybersecurity Plans"2 minute read
- EventsDigital Health Tools: What YOU Need to Know - Prepare Now for the FDA's Transformative Project1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer: Pre-Cert Program Exceeds Statute, Issues Unresolved"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Second Draft Pre-Cert Released but Real Rule-Making Needed"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design"2 minute read
- Media CoverageBradley Merrill Thompson Comments on the FDA's Pre-Certification Program Working Model2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Heads Call for Flexible Regulatory Framework for Medical Software"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Regulating CDS and AI: Which Way Forward?"2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Pre-Certification Update in Multiple Publications4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Releases Draft Patient-Experience Data Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Attorney: FDA Draft Re-Do of Part 3 Eases Agency's Legal Burden"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Changes to Classification Rules for Combo Products"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Unveils Working Model for Software Precertification Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lays Out Next Steps for Pre Cert Pilot"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Readies Digital Health Pre-Cert Program for Lift Off"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Attorney Says FDA's New Device Plan Oversteps Authority"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb Unveils Digital Health Tools for Drug Development, Pre-Cert Model"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "As FDA's Pre-Cert Plan Takes Shape, Worries Emerge About Overreach"2 minute read
- Firm AnnouncementsSeventeen Epstein Becker Green Attorneys Named to 2018 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The Fourth Wave: Digital Health Newsletter for Apr 13"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Permits Marketing of AI Software That Autonomously Detects Diabetic Retinopathy"2 minute read
- PublicationsFDA Reneged on Its Promise to Take a Risk-Based Approach to CDS Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Digital Health Program Not Broad Enough, Industry Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why the FDA's Recent Glucose Monitoring System Approval Matters for Interoperability"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CMS Under Pressure to Cover mHealth Tools for Diabetes Management"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves Interoperable Continuous Glucose Monitoring System"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Products: US FDA Extends Safety-Reporting Deadline"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Delays Combination Product Safety Reporting Requirements"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Streamlines Safety Reporting for Drug-Device Combos"3 minute read
- EventsCHPA 2018 Annual Executive Conference: The Changing Consumer Health IT Regulatory Environment1 minute read
- PublicationsFDA Extends Regulatory Reach to Low-Risk CDS Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves AI Stroke Application, Signaling a Shift in Triage Software Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Viz.ai's Stroke-Detecting CDS App Receives FDA Nod"2 minute read
- Media CoverageBradley Merrill Thompson and CDS Coalition Discuss the FDA’s Draft Guidance on Clinical Decision Support4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's First Pre-Cert Workshops Give Industry and Agency a Chance to Talk"3 minute read
- EventsDigitalHealth.il: Panel Discussion - Predictions on the Future of Digital Healthcare1 minute read
- EventsDigitalHealth.il: FDA's Approach to AI in Healthcare - New Wine in an Old Wineskin1 minute read
- Media Coverage"FDA Guidance on Decision Support Software: Implications for Industry" Featured in POLITICO Morning eHealth2 minute read
- PublicationsFDA Guidance on Decision Support Software: Implications for Industry5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Outlook 2018: Pharma/Life Sciences Law and Policy"2 minute read
- PublicationsWhat If Digital Could Drive Revenue?2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Device Experts Criticize FDA's Clinical Decision Support Draft Guide"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Aims to Ease Medical Device Approval Burdens"2 minute read
- Media CoverageBradley Merrill Thompson Discusses the FDA's Long Anticipated New Guidance on Digital Health Devices and Clinical Decision Support Guidelines5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Who Is Liable for Faulty Artificial Intelligence in Health Care?"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks to Speed Approvals of Generic Drug-Device Combos"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves First Drug with Digital Ingestion Tracking System"2 minute read
- EventsCTeL Executive Telehealth Fall Summit 20171 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health-Care Cybersecurity Takes Center Stage"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Grading Gottlieb: How Attys View FDA Chief's First 6 Months"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Privacy Official's Departure Unlikely to Rock the Boat"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Announces New Market Pathway for Genetic Health Risk Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Some Genetic Tests Will Get Quicker FDA Path to Market"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Gives Advice on Getting Innovative Devices to Market Faster"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Get FDA Guidance on Premarket Clearances"3 minute read
- PublicationsFive Regulatory Myths Keeping Bio/Pharma Out of Digital Health2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clarifies When to Submit 510(K) for a Software Change"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes Guidance on Software Modifications"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes New Guidance to Support Medical Device Innovation and Ease Burden of Software Updates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New FDA Guidances Aim to Increase Clarity on When Developers Need to Resubmit 510(K)s"3 minute read
- PublicationsBradley Merrill Thompson Quoted in "The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple Watch: Fast-Tracking Medical Tech with Its Heart Rate Monitor"2 minute read
- PublicationsWhy New Guidelines Are the Best Way to Address Medium-Risk CDS Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "We Now Know That Apple, Alphabet and Samsung Are Making Long-Term Bets on Health Care"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on How to Review Certain Device, Drug Combos"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple and Fitbit Among the 9 Companies Selected for FDA's Coveted Digital Health Pilot"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Analysis: 2 Barriers to Apple's Smartwatch, Arrhythmia Detection Project"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Don't Wait for the Apple Watch to Dole Out Medical Advice Anytime Soon"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why the Apple Watch Won't Replace Your Doctor Anytime Soon"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Federal Agency Guidance: An Institutional Perspective"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Drug/Device Combo Makers: Wait for Reporting Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple Watch to Act as Heart Monitor"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Ignores Advamed Requests in Final RWE Device Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition Issues Final Guidelines on CDS Software Design"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Hire Entrepreneurs-in-Residence to Help Develop PreCert Software Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "September Eyes Turn to CHIP Funding"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Software Industry Issues Guidance to Keep FDA at Bay"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Government Urged to Avoid Burdening Health-Data Exchange Users"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Coalition Finalizes Clinical Decision Support Guidelines Aimed at Self-Regulation"2 minute read
- Media CoverageBradley Merrill Thompson, Kim Tyrrell-Knott Featured in "CDS Coalition Drops Voluntary Guidelines for Unregulated Clinical Decision Support Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Releases Guidelines in Self-Regulatory Effort"2 minute read
- PublicationsCoalition Finalizes Guidelines for the Design of Medium Risk Clinical Decision Support Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Watchers: Gottlieb May Fly Under Trump Deregulatory Radar with Product-Specific Moves"2 minute read
- PublicationsLearning from Experience: FDA's Treatment of Machine Learning2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb Issues Fewer Guidances and Delays Some Key Rules, But Hasn't Chopped Any Yet"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Stakeholders Praise Gottlieb for Keeping the Agency on Track"2 minute read
- Firm Announcements38 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2018, One Honored as "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Appears to Answer AdvaMed Concerns Over Device Tool Program"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Federal Advisers Likely to Push for Better Health Data Exchange"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "9 Companies Will Play a Huge Role in Shaping the FDA's Novel Approach to Digital Health"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Defeat for Obamacare Repeal in the Senate"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Announcement of Digital Health Innovation Action Plan and Launch of Pre-Cert Pilot Program4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Rx, Device Groups Tell FDA to Scrap Latest Off-Label Rule"2 minute read
- EventsWebinar on What Investors and Startups Need to Know About Using Machine Learning in Clinical Decision Support Software and the Scope of FDA Regulation2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Innovation Initiative to Modernize the FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pharma Raises Stakes in Digital Health"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Says It Will Clarify Digital Health Regulations"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Bayer Gets FDA Nod for App-Connected Injector for MS Patients"2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Commissioner's New Plan for Mobile App Regulation4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA's New Game Plan for Digital Health"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will a New FDA User Fee Discourage Medical Device Innovation?"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cyber on Stage"1 minute read
- PublicationsDeregulation Helps Pharma Companies Pursue Digital Health Strategies1 minute read
- EventsCombination Products Regulation, Policy & Best Practices: Combination Products - Perspective of the Combination Products Coalition1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Questions Ahead for VA-Cerner Marriage"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Reject Off-Label Drug, Device Promotion Bills, Groups Tell Lawmakers"2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2017 Edition of Chambers USA3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How Should Digital Health Vendors Interpret New York’s Move to Flex Its Regulatory Muscle?"1 minute read
- PublicationsHow the FDA Could Impact Machine Learning, IoT in Healthcare2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate User Fee Bill Sets Up New Path to Reclassify Device Accessories"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Create Centralized Digital Health Unit"2 minute read
- Media CoverageStuart Gerson, Bradley Merrill Thompson Quoted in "Bipartisan House Bills Take Aim at Unsafe Medical Devices"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Floats Guidelines for Mobile Health App Design"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New Clinical Decision Support Software Guidelines Highlight Keys to Self-Regulation"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug, Device Industries Seek Fewer Limits on Off-Label Communications"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Legislation Would Streamline Risk-Classification for Device Accessories"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Bipartisan House Bill Would Ease Device-Accessory Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Congress Chugging Along"2 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2017 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Tools Fall Short in Meeting Physicians' Needs in Care Delivery"2 minute read
- PublicationsHow Machine Learning Can Support Clinical Decision-Making – and Leave the Doctor in Control1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Survey: Uncertainty About ACA Future Prevalent in Healthcare Industry"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Loosens Controls on Some Low-Risk Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "NY AG Puts Mobile Health App Makers on Notice That FDA, FTC Not Only Enforcers of Health Claims"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New HHS Technology Office Leader Has Health-Care Industry Experience"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Wellness Apps Evade the FDA, Only to Land in Court"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Arizona Law Puts Pressure on FDA to Change Off-Label Policies"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "NY Attorney General Takes on Mobile Health App Makers"2 minute read
- Media CoverageBradley Merrill Thompson Discusses States' Mobile Health App Regulations2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New York Taps Away Misleading Health Info for Smartphone Users"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Tech Oversight Up in the Air in Wake of New HHS Position"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New York Attorney General Settles with Three Mobile Health Apps"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Trump's Proposal to Increase FDA User Fees Could Impact Small Digital Health Innovators"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices"2 minute read
- PublicationsFDA's Next Frontier: Regulating Machine Learning in Clinical Decision Support Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "3 Ways Trump's FDA Nominee Could Reshape Digital Health"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Wants HHS Scrutiny of Health Information Technology Office"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Seeking Feedback on New Office of Patient Affairs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will Remote Software Updates Become the Norm for Medical Devices?"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Forty Under 40 Anniversary Profile"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Citizens Petition Challenges FDA's Off-Label Rule"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senators Want to Fix FDA's Inspection Process for Device Companies"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Big Pharma Objects to New Hurdles for Off-Label Drug, Device Promotion"1 minute read
- PublicationsThe Legal Environment for Precision Medicine1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Delays Rule Affecting Off-Label Drug, Device Promotion"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Lame Duck Document Dump Prompts Congressional Scrutiny, Industry Sources Mixed"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The FDA's Proposed Rule on E-Labeling Raises Serious Concerns"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Hiring Freeze May Hurt FDA User Fee Programs, Democrats Say"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health IT Fallout from Latest Trump Order"1 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in "Trump's Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say"2 minute read
- PublicationsBusiness Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "FDA Wins Kudos from Industry in Combo Product GMP Final"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Wins Kudos from Industry in Combo Product Good Manufacturing Practice Final"2 minute read
- PublicationsMarketing Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "A Look Ahead at Digital Health and Health Policy Under President Trump"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lab Test Oversight Plan Scaled Back Under Revised FDA Proposal"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clarifies Rule on Tobacco Products in Medical Realm"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Floats New Oversight Plan on Lab Tests"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug/Device Combo Makers Have Chance to Weigh in on FDA Policies"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lays Out Possible Risk-Based Approach to LDT Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug/Device Combo Makers Get Clarity on Manufacturing Requirements"2 minute read
- PublicationsStrategies for Technology Companies Entering the Health Care Internet of Things3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Passes the Buck on LDTs, but Floats Ideas"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Provides Accessories Guidance, but May Be 'Missed' Opportunity"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Potential Cures Hiccup Spotted"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Offers Tech Companies Scant Help in Device Guidance"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What the FDA Did in Digital Health in 2016"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH's Guidance Goals for 2017"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Device Decision Guidance Revised in Response to Criticism"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Praises Combo Product Rule But Still Seeks New Postmarket System"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Clinical Decision Support Software Guidance Kicked Off FDA's Priority List"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pharma/Device Firms Get Clarity on Safety Reports for Combo Products"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combo Product Sponsors Convince US FDA to Change Postmarket Reporting Rule"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Act Adds Tough Penalties for Electronic Information Blocking"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “What a Trump Administration May Mean for Digital Health”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Congress Sends Cures Legislation to President"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combo Product Safety: US FDA Rule on Post-Market Reporting Nears Finalization"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "21st Century Cures Act Clarifies FDA Regulation of Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "'Cures' Bill Circumvents FDA on Medical Software Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Bill Could Lift FDA Regulation of Physician Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "As Cures Bill Heads Towards Vote, Here's What It Could Mean for Digital Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Scoop: Emails Show FDA Asked Apple to Advise on Software as a Medical Device"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cybersecurity Asks: More on FDA"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What Will a Trump Presidency Mean for Digital Health?"1 minute read
- EventsTCT 2016 (Transcatheter Cardiovascular Therapeutics)1 minute read
- Media CoverageBradley Merrill Thompson Featured in "Interview: Putting the Pieces Together for Combo Products Oversight"3 minute read
- Firm AnnouncementsFive Epstein Becker Green Attorneys in Boston and Stamford Named to 2016 Super Lawyers and Rising Stars Lists8 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on Clinical Evaluation of Software as a Medical Device"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Floats New Draft Guidance, Created by International Group, on Software as a Medical Device"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on Software-As-A-Med Device Regulation"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Next Step in Global Convergence: FDA Looks to Make IMDRF Software Guidance Its Own"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "House Rules Chair Seeks to Limit Agency Use of Guidance Documents"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "International Guidance on Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Global Group Offers Guidance on Medical Software"2 minute read
- PublicationsThe FDA's 5-Year Delay on Automated Medicine Must End1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Updates Food Categories in Rare Guidance with 'Binding Effect' "1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Eyes Plan to Lessen Review Burden for Software Updates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Device Priorities Include Streamlining Clinical Trials"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dispatch from FDA/CTA Digital Health Tech Expo"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks to Prevent Opioid Overdoses Through Its First-Ever Mobile App Challenge"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Group Urges Advisory Opinions for Clinical-Decision Support Products"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Special Report: Obama Policy Wind-Up Could Affect Drugmakers, Device Companies"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Petitions FDA for Guidance on Drug Treatment Software"1 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Apple Guidelines Could Help Boost Health App Quality"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Include Risk Tolerance Info in Device Approval Requests: FDA”1 minute read
- Media CoverageBradley Merrill Thompson Featured in “Brad Thompson: FDA Software Guidance Provides Much-Needed Clarity”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software Coalition to FDA: Revamp Guidance Approach by Using Advisory Opinions”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Medical Software Group Presses FDA for Regulatory Clarity”2 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "Attorneys Question Usefulness of New Combo Products Pre-RFD Process"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Says It Won't Regulate Fitbit, Many Other Fitness Wearables"1 minute read
- Firm Announcements35 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2017, One Honored as "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Confirms Agency Won't Actively Regulate Low Risk General Wellness Products"1 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
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Regulates Device, Software Changes"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Could Improve Cybersecurity"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Outlines When New Clearances Are Needed for Existing Devices"2 minute read
- Media CoverageBradley Merrill Thompson Discusses How the FDA's Final Guidance on Low-Risk Devices Will Affect Wearables, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What It Will Take for Theranos to Make a Comeback"2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA's Final Guidance on Low Risk Devices, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Google's App a Medical Device?"1 minute read
- EventsCorrecting Misinformation in Social Media: When, Where, Why and How to Do It1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Attorneys Want FDA to Improve Postmarket Compliance Guidance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Will Allow Device Makers to Use Symbols in Labels"1 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2016 Edition of Chambers USA3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer Urges FDA to Release Combo Product Final Rule"2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Republican Senators Press FDA on Use of Draft Guidances"2 minute read
- Events2016 FDLI Annual Conference: Current Trends in Medical Device Law: Wearables and MMAs1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Drug, Device Divisions Not on Same Page?"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Concerns: Drugs and Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Ban on Certain Electrical Stimulation Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Apps: Unlimited Promise or 'Like Having a Really Bad Doctor'"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Guidance Tells Health App Makers What Laws Apply"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FTC's Stance on Mobile Health App Regulation, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition Survey Highlights CDS Uncertainty"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Software Industry Again Calls for Better Regulations"2 minute read
- Media CoverageBradley Merrill Thompson Discusses the Senate HELP Committee's Passage of the MEDTECH Act, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Imposes Limits on FDA Regulation of Apps, Software"2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Senate Tweaks Bill to Let FDA Step in If Health Software Poses Serious Risk"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Unveils Updated Combination Products Effort"1 minute read
- Media CoverageBradley Merrill Thompson Featured in "FDA May Change Refurbished Device Oversight, Attorney Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Hypertense About Blood Pressure App"1 minute read
- Media CoverageBradley Merrill Thompson Discusses Software Developers' Need for MEDTECH Act, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Action Risks Stifling Innovation, Health App Inventor Says"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Feedback on Plan for Medical Device Interoperability"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Software Companies Push FDA for Guidance on Decision Support Tools"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Surely You Must Be Postal”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Meets With Clinical Decision Support Firms to Address Challenging Cases”2 minute read
- Media CoverageBradley Merrill Thompson Featured in Podcast Q&A, "Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Combination Products Design Draft Guidance"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Feds: Theranos's Deficiencies Put Patient Safety in 'Immediate Jeopardy'"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA's Draft Guidance on Medical Device Interoperability with Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Class Action Filed Against Fitbit in the US Over Accuracy Claims”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Due to This Obscure Loophole, Some Medical Tests Avoid Oversight”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “OUTLOOK 2016: Lab Tests, Cybersecurity, Off-Label Use Among Top Device Issues”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Fiscal 2016 Device Guidance List”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Theranos's Alleged Tampering with Data Is Almost Unheard of in Biotech, Say Experts"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "5 Bold Predictions for Medtech in 2016"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Targets More Firms Marketing Genetic Tests"1 minute read
- Media CoverageBradley Merrill Thompson's Combination Products Q&A Featured as MEDFlix Top Video of 20152 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Mobile Health App Developers Seek Guidance on Federal Regulations"2 minute read
- Media CoverageBradley Merrill Thompson's Articles and Comments on Legislation and Regulatory Guidance For Mobile Health Apps Cited in Maryland Law Review2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Theranos Scrutiny Shows FDA's Murky Oversight of Lab Tests"1 minute read
- EventsXavier Health Combination Products Summit 20151 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Theranos – The Mess Gets Bloodier Still”2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "FDA's 'Ossification Tango' Side 2: What's the Social Cost?"2 minute read
- Firm Announcements58 Epstein Becker Green Attorneys Named to 2015 Super Lawyers and Rising Stars Lists7 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues Regulatory Science Priorities"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Combo Products Report Good First Step, Lawyers Say"1 minute read
- Media CoverageBradley Merrill Thompson Featured in “FDA’s Combo Products Report Good First Step, Lawyers Say”2 minute read
- PublicationsThe Social Cost of FDA's Bias Against New Technology2 minute read
- EventsFDLI's Advertising & Promotion Conference: Mobile Medical Applications - FDA & FTC Issues1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "UC Riverside Professor Slams Feds, Stands by His Health App"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Fitbit Wellness Platform Now HIPAA Compliant"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Clinical Trials, Combo Products Among FDA Commish Nominee Califf's Priorities"1 minute read
- Media CoverageHow the FDA Process Is Biased Against New Technology2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Avoiding the FDA Health IT-Medical Device Regulatory Trap for General IT Companies"2 minute read
- PublicationsWalking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications2 minute read
- Firm Announcements32 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 20165 minute read
- PublicationsManaging Pharmacovigilance in Digital Health Initiatives2 minute read
- Media CoverageBradley Merrill Thompson Grades the Government’s Work in “FDA Report Card 2015”1 minute read
- PublicationsWhy What Works for Uber May Not Work for Medical Apps2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Navigating FDA Regulations of Medical Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Aims to Streamline FDA Approval of Combination Products"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Group Calls for Classification Clarity Before Clinical-Decision Support Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition to FDA: Craft Plan to Classify New Health Information Tech"1 minute read
- EventsmPharma Summit: Explore the Regulation of Pharmaceutical Apps, Medical Device Software, and Clinical Decision Support (CDS) Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Industry May Seek Product Review Changes"1 minute read
- Media CoverageBradley Merrill Thompson Featured in "Progress of FDA's Office of Combination Products" Video Q&A1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Describes Plans to Exempt Multiple Types of Devices from 510(k)"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Center Leader Asks If FDA Should Develop User Fee Goals for Combo Products"2 minute read
- EventsSocial Media Regulatory Affairs Summit: Correcting Misinformation - Should You Do It and How1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The FDA Doesn't Want to Regulate Wearables, and Device Makers Want to Keep It That Way"1 minute read
- EventsThe Medical Device Summit: Aligning Pharmaceutical CGMP and the Medical Device QSR1 minute read
- EventsBio International Convention: Light in the Tunnel - Successful Navigation of the Regulatory Landscape1 minute read
- EventsContinuing Growth in Combination Products: More Products, More Questions - Perspectives from FDA and Industry1 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "House Committee Draft Bill Would Change Regulation of Diagnostic Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Regulatory Agenda Includes Updates on Combo Products, Labeling Rules"2 minute read
- PublicationsPharmaceutical Apps and the US Regulatory Requirements2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Burgess Is Reworking His Interoperability Bill - Privacy Advocates Speak Out - Docs Attack 21st Century Bill"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Bill Retains FDA Oversight of Software Used in Blood Transfusions"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Updated SOFTWARE Act: Still Too Ambiguous for Industry?"2 minute read
- Media CoverageBradley Merrill Thompson Provides Additional Commentary Regarding the 21st Century Cures Act2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2015 Edition of Chambers USA3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Sen. Alexander Begins Investigation Into Agencies' Use of Regulatory Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "2nd Cures Draft Pegs Low-Risk Software Exempt from FDA, but Gives Agency Some Latitude"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Manufacturers Seek More Clarity On GMP Obligations for Combo Products"1 minute read
- PublicationsWorking Out the Bugs: Congress Wants to Clarify FDA Software Regulation2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Multiple Publications Regarding the 21st Century Cures Act2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Multiple Publications Regarding the MEDTECH Act3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Apps Tricky for Pharma"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Supportive of FDA Move on Device Accessories, Wellness Products"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Expresses Desire to Work with Industry on CGMPs for Combination Products"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Expresses Desire to Work with Industry on CGMPs for Combo Products"1 minute read
- PublicationsFDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease2 minute read
- EventsDIA EuroMeeting 2015: Development, Innovation, Access and Patient Safety1 minute read
- PublicationsFDA Medical App Regulation and the Art of Intended Use2 minute read
- EventsWhat's Next for Mobile Medical Apps?1 minute read
- PublicationsHelp Low-Income Neighbors Fight Legal Injustice2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Proposes Its FDA Guidance Priorities, Reforms"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Do the FDA's Regulations Governing Medical Devices Need to Be Overhauled?" - The Wall Street Journal2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Stakeholders Float Ways to Speed FDA Development of Final Guidance"2 minute read
- PublicationsRegulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition2 minute read
- EventsHealth Technology Forum: Spring Success Stories in Health Technology1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Accompanying Apple Watch, a Medical Surprise"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Scope Blamed for Superbug Infections Not FDA Cleared"1 minute read
- PublicationsIn-Depth: Anticipating FDA Regulation of Pharmaceutical Apps2 minute read
- Media CoverageBradley Merrill Thompson Quoted Regarding the FTC's Actions on Mobile Apps Marketing Claims - Media Coverage Roundup2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clears Path for Some Genetic Tests to Skip 510(k) Process"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Signals Easier Rule on Genetic Tests" - The Wall Street Journal1 minute read
- Media CoverageBradley Merrill Thompson Comments on the FDA's Permission to Market Genetic Test for Bloom Syndrome to Consumers – Media Coverage Roundup2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Despite FDA Moves, Push Continues for Congress to Act on Mobile Health"1 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "FDA Final Guidance on mHealth Eases Regulation of MDDS, mHealth (Updated)"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues New Guidance; Won't Regulate Low-Risk Device Data Systems”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Officially Halts Oversight of Passive Device Data Systems"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lightens Regulations on Medical Device Data Systems, Mobile Apps”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes Plans to Deregulate MDDS Health Software"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Makes Official Its Hands-Off Approach to Regulating Health Apps and Medical Software"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes Guidance on Medical Device Data Systems"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Takes Lighter Touch with New Health IT Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA: MDDS Software Will Be Exempted from Class I Regulatory Controls"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Won't Regulate Medical Device Data Systems"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry: New SOFTWARE Act Provides Certainty"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Draft Bill Shows Congress' Struggle to Define FDA's Role in Medical Software"2 minute read
- EventsOSMA Annual Conference: Perspective – FDASIA Work Group1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "SOFTWARE Act Would Exempt EHRs, Other Health IT from FDA Regulation"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clarifies Rules for Drug Containers, Delivery Systems in Draft Guide"2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "‘21st Century Cures' Bill Seeks Regulatory Certainty for Health IT"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues First Approval for Remote Continuous-Glucose-Monitoring App"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Asks for Input on Draft Guidance for Combination Product Manufacturing"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combo Products Guidance Fills in Gaps on Drug-Delivery Device Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why 2015 Could Be a Watershed Year for mHealth Regulatory Decisions"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Wellness Draft Guidance Does Its Jobs, Industry Group Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted "FDA Approves DexCom Share Update, Downclassifies CGM Accessory"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Accessorize at Your Own Risk: Draft Guidance Clarifies Regs for Device Add-Ons"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves Dexcom’s CGM Accessory App Days After Relevant Draft Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted Regarding FTC Charges Against Medical App Developer’s Advertising Claims2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Move on LDTs Is a Power Grab"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Bill Eases Limits on 'Customer Service' for Research-Only Medical Tests"2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Groundhog Day: FDA and Proposed Oversight of LDTs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Stays Tough on Health Software, Even as FDA Eases Up"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Eased Oversight Is Good Omen for Health IT"1 minute read
- Media CoverageBradley Merrill Thompson Comments on FTC Charges Against Medical App Developer's Advertising Claims - Media Coverage Roundup2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Tax Repeal, FDA's Actions Affecting Industry Remain Top Issues"2 minute read
- Media CoverageBradley Merrill Thompson Quoted Regarding FDA Draft Guidance on Medical Device Accessories - Media Coverage Roundup3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Attorney Points to Compounding Regs to Guide FDA in LDT Oversight"2 minute read
- PublicationsThe LDT Debate: Understanding FDA's Jurisdiction Over IVDs Made at a Clinical Lab1 minute read
- BlogsThe LDT Debate: Understanding FDA's Jurisdiction Over IVDs Made at a Clinical Lab26 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lab Directors Look for Ways to Adjust to Proposed LDT Framework"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Digital Health Dilemma: Regulators Struggle to Keep Pace with Health-Care Technology Innovation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS a Priority As The Center for Device and Radiological Health Releases 2015 Guidance Plans"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “CDRH Looks Ahead, and Behind, on Guidance Development”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Puts Interoperability Guidance on Back Burner”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senators Order GAO Review of ONC-Funded HIEs - Why Wearables Alone Can't Make Us Healthy - FDA Puts Out Year's List of Guidance Priorities"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH Sets Performance Goals to Reduce Draft Guidance Ambiguity"2 minute read
- EventsFDA Workshop – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lab-Testing Regulation in the Crossfire"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Consulting Services at a Discount for mHealth Firms Targeting the Underserved”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How FDA Approved Hysterectomy Tools It Now Disfavors" - The Wall Street Journal1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "In-Depth: News, Novel Quotes, and Notable Trends from the mHealth Summit 2014"2 minute read
- Media CoverageBradley Merrill Thompson Provides Commentary in "ONC Outlines Plan to Expand Telehealth, Mobile Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Tech Attorney: MEDTECH Act Won't Offer Oversight Clarity or Promote Innovation"1 minute read
- EventsmHealth Summit 2014: US Business Landscape; Practical Impact of Recent and Future FDA Regulation1 minute read
- Media CoverageBradley Merrill Thompson Comments on the MEDTECH Act - Media Coverage Roundup3 minute read
- PublicationsHealthcare, Poverty, and Technology: Connecting the Dots2 minute read
- Media CoverageBradley Merrill Thompson Launches Aventor to Advise Mobile Health Entrepreneurs on Aiding the Poor – Media Coverage Roundup2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Assessing the Good and the Bad in the LDT Guidances"2 minute read
- PublicationsWhat's in the Shoe Box?1 minute read
- Media CoverageBradley Merrill Thompson, James A. Boiani Quoted in "GOP Senate Will Press FDA to Ease Up"2 minute read
- PublicationsScarey – and True – Halloween Lawyer Story1 minute read
- EventsWireless Health 20141 minute read
- Firm Announcements54 Epstein Becker Green Attorneys Named to 2014 Super Lawyers and Rising Stars Lists6 minute read
- PublicationsThe Evolving US mHealth Regulatory Landscape
- Media CoverageBradley Merrill Thompson Quoted in "6 Secrets of Highly Paid Partners" - Law3601 minute read
- PublicationsDon't Leave Christian Legal Aid to the Lawyers1 minute read
- Media CoverageEpstein Becker Green's Bradley Merrill Thompson and Kim Tyrrell-Knott Represent Becton Dickinson in $12 Billion Acquisition - Media Coverage Roundup1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "IBM, Oracle Prod Congress to Clarify FDA's Health IT Powers" – Law3601 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health IT Oversight Requires Legislative Action, Groups Argue" - FierceHealthIT2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Groups Asking Congress to Outline FDA Oversight of Health IT" - Bloomberg BNA2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "58 Tech Companies Ask Congress to Codify Health IT Laws So Innovators Know What the Rules Are" - Venture Beat2 minute read
- Media CoverageBradley Merrill Thompson Quoted by FDA Week in "FDA Should Define Company 'Influence' On Social Media Platforms"1 minute read
- Media CoverageBradley Merrill Thompson and Robert Hudock Quoted by Modern Healthcare in "FDA Seeks Cybersecurity Assessments from Medical-Device Makers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "An Active Fall Anticipated for mHealth Regulatory Policymaking" - The Gray Sheet2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pressure Builds on FDA to Overhaul Guidance Process" - Law3602 minute read
- Media CoverageBradley Merrill Thompson Quoted by Health Data Managementin “Quinn Leaves FCC Health Unit After Short Stint”2 minute read
- Media CoverageBradley Merrill Thompson Quoted by Bloomberg BNA in "Lawmakers Ask HHS to Clarify HIPAA Privacy Requirements for App Developers"1 minute read
- PublicationsJudging the Poor Worthy of Help1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Court Again Vacates FDA Combination Product Classification for Prevor Skin Wash"1 minute read
- Media CoverageBradley Merrill Thompson Comments on Apple Watch and Health Apps2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Defends Lab Test Oversight Before Critical Lawmakers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “As Apple Moves into Health Apps, What Happens to Privacy?”2 minute read
- EventsCCA Annual Convention: The Skyrocketing Growth in Digital Health for Consumers1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Amazon, FDA Meeting a Harbinger for Potential Healthcare Move"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple, Google Are Jumping Into Health Care. Is Amazon Next?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Amazon Meets with FDA, Healthcare is Likely the Topic"3 minute read
- Firm Announcements24 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 20154 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Med Management Market to Pass $1.6 Billion by 2019"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lenient Regulations for Digital Medical Devices"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Benefits of New Premarket Device Exemptions Not Clear, Attorneys Say"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will FDA Regulate Your Mobile Medical App?"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Asserts Regulatory Authority Over Laboratory Developed Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Stakes Out Exemptions to Medical Device Premarket Requirements"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Suggested Deregulation Affects Smart Scales, Fertility Thermometers, and More"2 minute read
- Media CoverageBradley Merrill Thompson and James A. Boiani Mentioned in "Breaking Down the Regulation of LDTs: Moving Forward"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "23andMe to Open Database to External Researchers After Securing NIH Grant"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Deregulation of Several Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Draft Guidance Would Exempt Some Devices from Premarket Notification Requirement"2 minute read
- PublicationsMMA Roadshow: 10 Lessons for Developers1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks to Regulate Lab-Developed Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes to Exempt Dozens of Devices from 510(k) Requirements"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Top FDA Device Official Skeptical Of Breakthrough Path For Companion Dx"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "ACLA Rebukes Idea of Congress Handling Confusion Over LDTs as It Did HIT"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lab Test Oversight Will Touch Off Industry Tug-Of-War"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Targets 'High-Risk' LDTs In Notice Outlining Regulatory Framework"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "23andMe Gets a $1.4M NIH Grant, Still Awaits FDA Approval"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The LDT Letter Battle"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Biggest New Policies of 2014: Midyear Report"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "ONC Tells Lawmakers Health IT Safety Center Won't Be a Regulatory Body"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CMS: Don't Over-Rely on EHR Decision Support Alerts"2 minute read
- Media CoverageBradley Merrill Thompson and James Boiani Mentioned in "Breaking Down the Regulation of LDTs: Access to Innovative IVDs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Could Health Apps Save Your Life? That Depends on the FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "mHealth Coalition Blasts Agencies for Ignoring HIT Framework Proposals"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Industry Groups Largely Support Proposed Framework for Health IT Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Critics Worry Health IT Regulatory Plan Is Already Outdated"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Trackers Put Health Data at Hand"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA: New Guidance Underscores Flexible Oversight of Low-Risk Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Can Data from Your Fitbit Transform Medicine?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Draft Proposes No Regulation of Medical Device Data Systems"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Genetics Startup 23andMe Takes Step on Path to FDA Approval"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues Guidance on Medical Device Data System"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New FDA Mobile Apps Guidance Wins Praise"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Loosens Grip in Latest Win for Digital Health Firm"2 minute read
- EventsDigital Health Summer Summit: Get Smart – Strategies in Sound Decision Making1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Are Smartphones the Best Medicine?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition Uses FDA Device Guidance Meeting to Raise Bigger Process Issues"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Wanted: A Watchdog for the Mobile Medical App Explosion"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH Looks for Input on Guidance-Development Practices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Apps Boom While Regs Lag"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawmakers Question ONC Authority To Take on New Health IT Activities"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "ONC Queried on Power to Regulate IT"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition: OMB Caved to Pressure by Shielding Lab-Made Tests from FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "ONC Announces Realignment"2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2014 Edition of Chambers USA4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Product Group Calls For New FDA Policy on Two Kinds of Tests"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Healthcare IT Discussion Stresses Local Implementation, Legislation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDASIA Hearing Spurs Debate Over Role of Congress in Health IT Legislation Health Care Technology"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Clinical Decision Support Remains Regulatory Gray Area"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Software Regulation Is A Sticking Point At Tri-Agency HIT Meeting"2 minute read
- Events9th Annual WLSA Convergence Summit: Payment and Coverage Reform – Taking Stock of Major Policy Initiatives1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Decision Support Dangers: Who's Responsible?"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Critics Attack FDA for Overly Modest Health IT Regulatory Framework"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Definition of 'Function' Differs Among Health IT Stakeholders"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Role of FDA in Regulating Clinical Decision Support Tools Debated at Meeting"2 minute read
- EventsMMA Roadshow: A Workshop on Managing mHealth App Development Under FDA Regulation3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "UPDate 1-Gene Startup 23andme Casts Eyes Abroad After U.S. Regulatory Hurdle"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Overcoming Regulatory Challenges in Companion Diagnostics."3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Time May Be Ripe for FDA Focus on Apps, Expert Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Expedited Access Program for High-Risk Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Sebelius Departure from HHS will have Negligible Effect on HIT"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Proposed Oversight Strategy for Health IT Contains Few Surprises, Details, Sources Say"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Global Regulators, Stakeholders Draft 'Software as a Medical Device' Framework"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Fed HIT Report Provides Few Details on Clinical Decision Support Software."1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "International Regulators Coalition Weighs in on Medical Software Regulation"3 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
- Media CoverageBradley Merrill Thompson Quoted in "EU Appears Open to Suggestions on Mobile Health Oversight"2 minute read
- EventsAMDM Annual Conference: The Future of FDA Regulation of HIT, Including mHealth1 minute read
- PublicationsAnalysis: The Significance and Insignificance of the FDASIA HIT Report, in mHealthNews2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Initial mHealth Framework Proposal: A Mixed Bag"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "mHealth Experts Analyze FDASIA Report"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Goes for 'Light Touch' on Health IT"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Not Much New in FDASIA Report, Congress Still Champing at the Bit"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Feds Release FDASIA Workgroup Report on Health IT Governance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Tri-Agency Health IT Report Emphasizes Risk-Based Scheme, But Lacks Some Detail, Observers Say"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Tri-Agency HIT Report Pushes 'Light Touch' Oversight, Sets Up New Center"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Stays Hands-Off in Long-Awaited Health IT Report"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Int'l Approach Floated for Medical App Regulation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "6 Takeaways from New FDASIA Report"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "International Forum Issues Guidance Framework on Regulating Device Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposal Aims to Streamline Device Classification According to Risk"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Simplify Mobile Device Classification"2 minute read
- Media CoverageBradley Merrill Thompson Featured in Video Segment Discusses the Combination Products Regulatory Landscape1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Draft Guidances Drag Out"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation"2 minute read
- PublicationsFDA Draft Guidances Drag Out1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Update to mHealth Rule"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "UK's Mobile Medical Apps Guidance Parallels FDA's"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposal Aims to Streamline Device Classification According to Risk Medical Symbol"2 minute read
- PublicationsLessons from McKesson: Insight into FDA's Stance on Clinical Decision-Support Software, in Medical Device and Diagnostic Industry2 minute read
- EventsMMA Roadshow: A Workshop on Managing mHealth App Development Under FDA Regulation3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues Recall Notice on McKesson Clinical Decision Support Software Product Food and Drug Administration Logo"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "McKesson Tagged with Rare Class I Recall for Clinical Decision Support Software"3 minute read
- PublicationsEvenhanded FDA Enforcement, in Medical Device and Diagnostic Industry2 minute read
- EventsLaw and Information Society Symposium: Connected Health Care1 minute read
- Media CoverageBradley Merrill Thompson Discusses Recent Regulations Passed by FDA on Medical Mobile Apps1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "PROTECT Act Under Fire"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "PROTECT Act Riposte"1 minute read
- PublicationsHow the FDA Can Improve Regulation of Mobile Health, According to FDASIA Workgroup, in MobiHealthNews1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Debate on Mobile App Regulatory Oversight Heats Up"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Congress Wants to Kick the FDA Out of Digital Health with This New Bill"2 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Selected as Members of Law360's 2014 Editorial Advisory Boards2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Debate Over FDA Oversight of Apps Continues"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Opponents Say PROTECT Act Could Destroy mHealth, Endanger Patients"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Takes Aim at Potential for FDA Overreach in IT Regulation."2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Shifts Oversight of Clinical Support Software from FDA to NIST"3 minute read
- Publications8 Types of Medical Apps a Senate Bill Asks FDA to Stop Regulating, in Mobihealthnews2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Undermines FDA Regulatory Role"2 minute read
- EventsMD&M West Conference 2014: Ways to Modernize FDA Regulation to Support mHealth Innovation1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Health IT Deregulation Bill Coming to the Senate"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Attorneys, FDA Hit the Road to Instruct on Mobile Health Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA, Industry Groups Launch mHealth Educational Outreach Tour"2 minute read
- EventsMMA Roadshow: A Workshop on Managing mHealth App Development Under FDA Regulation3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "MMA Roadshow Explains the Ins and Outs of FDA App Regulation"2 minute read
- Media CoverageBradley Merrill Thompson and Bethany Hills Quoted in "FDA's Performance, Medicare Coverage, Pressure from Excise Tax on 2014 Agenda"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Nationwide 'Roadshow' to Educate mHealth App Developers About FDA Regulations"2 minute read
- EventsMMA Roadshow: A Workshop on Managing mHealth App Development Under FDA Regulation3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "mHealth Regulatory Coalition Proposes HIT Paradigm, Counters House Bill"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Mobile Health Group Urges Lawmakers to Be Cautious on Regulating New Health IT"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Increase Your Chances of Survival in the Obamacare Apocalypse"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "mHealth Coalition Counters Blackburn Push Against Health IT Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "MRC to Congress: Don't Pass Legislation, Wait for FDASIA Report"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "IMS Health Launches Mobile Prescribing Platform, Health App Development Tool"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Digital Health Regulation Debate Continues at mHealth Summit"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "HIT Study to Assert FDA Regulates Clinical Software, Guidance Will Follow"2 minute read
- Events2013 mHealth Summit: HiMSS Conference MRC Special Session1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "EU Health IT Sector on Alert After Parliament Adds 'Prediction' to Medical Device Definition"2 minute read
- Events2013 mHealth Summit: An Industry Perspective - Impacts of FDA Oversight1 minute read
- EventsMD&DI Wireless Connectivity West 20131 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Comes Down Hard on 23andMe, Putting Consumer-Directed Genetic Testing on Notice"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Groups, Lawmakers Push Changes to Blackburn HIT Bill"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Knowledge Is Not Enough for Enforcement in FDA's Final Research-Use DX Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA's Revised IVD Guide Focuses on 'Totality of the Circumstances'"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Scrutiny Looms for Unapproved Research Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Representatives Grill Shuren, Advance SOFTWARE Act"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Congress Must Wait for FDASIA Report"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Targets DTC Gene Test Company, Possibly Signaling Broader Enforcement"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Let the SOFTWARE Act Die in Committee"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Tells 23andMe to Stop, Get Clearance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Removes Firms' Responsibility to 'Know' in Research-Use Only Final Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Tells 23andMe to Pull Personal Genome Service"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "IT Developers Differ Over How Federal Government Should Oversee Health Software"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "DA Lays Down Health Risk Claim Law in 23andMe Warning Letter"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "IMS Health Suggests All Mobile Medical Apps Be Subject to Clinical Trials"3 minute read
- EventsFDA Mobile Medical App Guidance: Implications for the Industry - a Bloomberg BNA Webinar2 minute read
- PublicationsE-book: FDA Regulation of Mobile Health 2013 (Second Edition) (MobiHealthNews)1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Mobile Health Apps: Blackburn's SOFTWARE Act Would Limit FDA's Power, Ensure Regulatory Restraint"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Mobile Health Apps: Blackburn's SOFTWARE Act Would Limit FDA's Power, Ensure Regulatory Restraint"2 minute read
- EventsDIA Meeting on Combination Products: Use of Mobile Medical Applications as Companions2 minute read
- EventsWireless Health 20131 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Bill Risks Confusion to Curb FDA's Already-Lax App Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Bill Provides Guidance on FDA Mobile Medical Apps Regulation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Navigating FDA's Final Mobile App Guidelines: The Good, The Bad, The Unanswered"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Bipartisan House Bill Introduced to Curb FDA Health IT Oversight"3 minute read
- EventsMD&M Minneapolis Conference 2013: Clarifying Plans for the Mobile Health App Regulation1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Bipartisan House Bill Attempts to Limit FDA's HIT Oversight"3 minute read
- EventsCEA Industry Forum: Health and Fitness Working Group Meeting1 minute read
- EventsMedical Mobile Apps: What Does the FDA Consider a Regulated App? Understanding the FDA's Final Guidance, Enforcement Discretion and Definition of Accessories1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA's Mobile Medical Apps Guidance: Our Advisors Weigh In"2 minute read
- PublicationsProtecting Mobile Health Innovations from Regulation1 minute read
- Media CoverageBradley Merrill Thompson Featured in Article, "FDA Issues Final Guidance on Mobile Medical Apps"2 minute read
- Events2013 RAPS: Advertising, Promotion, and Labeling1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Plans to Use Enforcement Discretion on Low-Risk Mobile Apps"2 minute read
- Media CoverageBradley Merrill Thompson Featured in Article, "mHealth Industry Groups Plan to Monitor FDA Enforcement, Software Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Final FDA Guidance Provides Clarification and Confusion"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Developers, IT Groups React to FDA's Mobile Health App Guidance"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "7 Takeaways from FDA's Mobile Medical Apps Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "With FDA Releasing Final Guidance for Mobile Health Apps, Innovators Have Clarity on Regulatory Policy"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Experts Praise FDA's 'Expansive' Mobile App Regulations"3 minute read
- PublicationsFDA (Finally) Returns Industry's Calls for Mobile Medical Apps Guidance, in Medical Device and Diagnostic Industry2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Readers Weigh In: The FDA Should Regulate Mobile Medical Apps"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Final Mobile Medical App Guidance Mirrors 2011 Draft"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Updates Guidance on Mobile-Software Apps"2 minute read
- Media CoverageBradley Merrill Thompson Featured in Article, "FDA Emphasizes 'Deregulatory' Efforts in Mobile Medical Apps Final Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Featured in Article, "FDA Emphasizes 'Deregulatory' Efforts in Mobile Medical Apps Final Guidance"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Releases Final Mobile App Guidance, Reserves Oversight for High-Risk Products"3 minute read
- EventsRadcliffe Exploratory Seminar: Mobile Health1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Lack of FDA Social Media Guidance Isn't Only Problem Facing Regulated Industry"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Will FDA Finally Make the Call on Mobile Medical Apps?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Industry Advocates Call for FDA to Update, Clarify Health IT Regulations"3 minute read
- EventsFDLI's Annual Advertising & Promotion Conference: How Technology Is Driving Communication - Social Media Vehicles1 minute read
- Media CoverageBradley Merrill Thompson Featured in Article, "Why Regulation of Mobile Medical Apps Isn't a Bad Thing"2 minute read
- PublicationsPart 2: Set FDA's Mobile Medical App Guidance Free, on MobihealthNews.com2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "HIT Stakeholders Propose Modernizing, Limiting FDA Role in Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Role, Safety Oversight Addressed in Health IT Framework Comments"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Urged to Modernize for Sake of mHealth Innovation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "HIT Stakeholders Propose Modernizing, Limiting FDA Role In Oversight"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Advocates Urge FDA to Modernize to Keep Pace with Innovation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Industry Advocates Call for FDA To Update, Clarify Health IT Regulations"3 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
- Media CoverageBradley Merrill Thompson Quoted in Article "Industry Groups Continue Fight over FDA Final Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Pending Mobile Medical Apps Guidance Provokes Heated Controversy"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "More Health Apps Out There, But Regulation Lagging"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Groups Divided Over Whether FDA Should Delay Final Mobile Medical Apps Guidance"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Coalition Proposes FDA Regulatory Framework for Clinical-Decision Support"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Oversight Suggestions Nearing End of the Beginning"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Stakeholders Divided on House Draft Clarifying FDA's mHealth Authority"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "New Regulatory Environment Needed for Mobile Apps"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Who Should Oversee mHealth Regs?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Draft Bill Aims to Clarify FDA Regulation of Mobile Medical Apps"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Who Should Regulate mHealth?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Regs Spark Debate"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Rep. Honda Reintroduces Bill to Create FDA Office of Wireless Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Mobile Health Groups Say the FDA's Final Guidance Will 'Unlock Investment'"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "'Voice of Mobile Health' Predicts FDA's Final Guidance Will Not Mean More Rules"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Group Urges FDA to Publish Final Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "mHealth Regulatory Coalition Urges FDA to Release Final Apps Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDASIA Workgroup Narrows Focus to Avoid Overregulation, Duplication Food and Drug Administration Logo"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Can't Hold Back Stream of Mobile Health Apps"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Letter on Mobile App May Bring Welcome Clarity to Field"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA's Mobile App Letter Doesn't Spell Out Broader Policy"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "UChek's Response to an FDA Letter: An Unfolding Saga"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Telemedicine: Mobile App Maker Biosense Receives FDA 'It Has Come to Our Attention' Letter"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Warns Mobile Health Apps Makers"1 minute read
- PublicationsThree Reasons FDA's Enforcement Helps Mobile Health, inMobihealthnews.com1 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2013 Edition of Chambers USA4 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Busy Week for FDA and Mobile Health, But No Final Guidelines Yet"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "FDA Shows Deft Touch with 1st Mobile App Enforcement"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "99 Cent Urinalysis App Raises Questions About mHealth Standards"3 minute read
- Firm AnnouncementsSuper Lawyers 2013 Recognizes Epstein Becker Green Attorneys3 minute read
- PublicationsAmerican Telemedicine Association Annual Meeting Connects At-Risk Patients to Specialists and Home Aging, in Medical Device and Diagnostic Industry1 minute read
- EventsAmerican Telemedicine Association 20131 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Health IT Stakeholders Call for New FDA Regulatory Framework, Enforcement"3 minute read
- PublicationsManaging Your Business Risk in Mobile Health: Part 2, in Mobihealthnews.com1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "iPads, iPhones, Androids, and Smartphones: FDA Regulation of Mobile Phone Applications as Medical Devices"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Expert: Don't Be Too Hands-Off with Medical Apps"1 minute read
- EventsLegal and Business Guide to mHealth and Wireless Medical Technology: Bridging the Digital Innovation and Regulatory Divide: Bringing Mobile Apps to Market in a Compliant and Timely Manner2 minute read
- EventsPOLITICO's Tech Intersection: Health Care of the Future1 minute read
- PublicationsCounting Our Blessings with the Office of Combination Products, in Medical Device and Diagnostic Industry1 minute read
- EventsRAPS Webcast - Advertising, Promotion, and Labeling: Using Social Media to Discuss Biologics, Drugs, and Devices1 minute read
- PublicationsManaging Business Risk in Mobile Health: Part 1, in Mobihealthnews1 minute read
- EventsAMDM Annual Meeting: The Future of LDTs and Their Impact on the IVD Industry1 minute read
- PublicationsInternational Regulators Focus on Medical Software, Including Apps, in Mobihealthnews2 minute read
- Media CoverageBradley Merrill Thompson Featured in Blog Segment "More Mobile Health App Guidance from FDA for Pharma to Worry About"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA's Light Touch with Medical Apps May Let Industry Bloom"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Telemedicine: FDA Will Not Regulate Consumers' Mobile Devices, Official Tells Panel"3 minute read
- Media CoverageBradley Merrill Thompson Featured in Podcast About FDA's Final Guidance on the Regulation of Mobile Medical Apps1 minute read
- Media CoverageBradley Merrill Thompson Featured in Podcast About the Regulation of Mobile Medical Apps1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Congress Explores Potential Regulation of Mobile Health Apps"2 minute read
- PublicationsAfter FDA's Mobile Medical Apps Final Guidance, What's Next? in Mobihealthnews.com1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Reiterates Intention to Regulate Only a Small Portion of Mobile Medical Apps"2 minute read
- Media CoverageBradley Merrill Thompson Featured in Blog Segment "FDA Urged to Take 'Small Steps' in Developing Final Guidelines for Mobile Medical Apps. Good Advice for Social Media Guidelines As Well"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Several Articles Regarding His Testimony on Behalf of the mHealth Regulatory Coalition at House Energy and Commerce Hearing on March 19, 20133 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "FDA Device Official Defends mHealth Oversight Amid Lawmakers' Concerns"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "House Subcommittee Chairman Fears Medical Device Tax on Mobile Health Apps"3 minute read
- EventsHealth Information Technologies: Harnessing Wireless Innovation, Before the House Energy and Commerce Committee, Subcommittee on Communications and Technology1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "European Regulation Looms Over Mobile Health"2 minute read
- PublicationsFDA App Enforcement, in Medical Device and Diagnostic Industry2 minute read
- Media CoverageAt HIMSS, Interoperability Calls Shotgun, in Medical Device and Diagnostic Industry2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Public vs. Private Oversight of Mobile Health"2 minute read
- PublicationsFood and Drug Administration Regulation of Diabetes-Related mHealth Technologies2 minute read
- EventsCGMPs for Combination Products - Final Rule and Implementation2 minute read
- EventsInstitute of Medicine – Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Regulatory and Legal Oversight1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Industry Seeks More Clarity Following Combo Product GMP Final Rule"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Modification Guide Could Up-Classify Devices in Combo Products, Lawyer Says"2 minute read
- EventsMedical Devices and the FDA - Tips for Researchers: Medical Device Apps1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Combination Products: FDA Issues Final Rule on cGMP Requirements for Combination Products, Draft Guidance"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Off-Label Promotion, Enforcement, 510(k) Revisions Are Key Issues for Industry in 2013"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "FDA Issues Long-Awaited Combo Product GMPs, Industry Seeks Further Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article "Combo Products May See Double ACA Tax Under IRS Rule, But Kits Exempt"2 minute read
- EventsDiabetes Technology Meeting: Overcoming Regulatory Hurdles to Make Wireless Diabetes Real1 minute read
- EventsDIA Workshop: Regulatory Considerations for Drug/Device Combinations and Companion Diagnostics2 minute read
- Events2012 RAPS Annual Conference: Combination Product Regulation for the US Market1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Attorney: Proposed mHealth Bill Will Do Little Without More FDA Funding"3 minute read
- Events2012 CEA Industry Forum: Health and Fitness Tech - the Consumer, the Product, and Regulation1 minute read
- EventsMed Tech Webcast Series: Calculating the Medical Device Tax3 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Social Media Use Presents Challenges for Drug Manufacturers, Experts Say"2 minute read
- EventsFDLI's Advertising and Promotion Conference: Social Media in Medical Product Companies: Using Emerging Technology to Communicate About Products1 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Federal Task Force Recommends Stepped up Role for FCC in mHealth Policy"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, " Panel Discusses How New User Fee Law Changes Interactions Between FDA, Industry"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in Article, "Challenges Abound in Creating Regulatory Framework for Mobile Medical Apps, Health IT"3 minute read
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