626 matches.
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived7 minute read
- Media CoverageKate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct”1 minute read
- Media CoverageCSHA Members Join Epstein Becker Green1 minute read
- Media CoverageRaja Sékaran, John Puente, Melissa Borrelli Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Media CoverageEpstein Becker Green Grows Health Care & Life Sciences Practice2 minute read
- Media CoverageEpstein Becker Green Adds 6-Atty Healthcare Team in San Francisco2 minute read
- Media CoverageEpstein Becker Green’s Bay Area Healthcare Attorney Additions Featured in the San Francisco Business Times1 minute read
- Firm AnnouncementsEpstein Becker Green Fuels West Coast Momentum with Six-Attorney Health Care Team6 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- Media CoverageWes Scott Featured in "In Charge 2024: Finance"1 minute read
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants9 minute read
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- EventsAHLA: Advising Providers – Legal Strategies for AMCs, Physicians, and HospitalsFebruary 5–7, 20242 minute read
- PublicationsHealth Care M&A Insights: Q4 2023 & Outlook for 2024 Deal Activity4 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 CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Media CoverageAlaap Shah Quoted in “Don’t Worry, You (Probably) Won’t Have to Deal with ONC: Algorithm Transparency Rule May Have Surprise Effects on Medtech Firms”2 minute read
- Media CoverageWes Scott Featured in “People on the Move”1 minute read
- Media CoverageWes Scott Featured in “Legal Notes: New Partners”2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- Media CoverageWes Scott Featured in “Epstein Becker Adds M&A Specialist to Health Care Practice in Nashville”4 minute read
- Firm AnnouncementsEpstein Becker Green Expands Capabilities in Nashville with M&A Attorney Wes Scott3 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance14 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct7 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- PublicationsState Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of Oklahoma PBM Law25 minute read
- EventsWhat Should Executives Know About Artificial Intelligence?2 minute read
- Media CoverageEpstein Becker Green Update Cited in “Physicians Could Be in Financial Danger with This Stark Law Change”2 minute read
- Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year26 minute read
- PublicationsEuropean Commission Adopts an Adequacy Decision for a New EU-U.S. Data Privacy Framework6 minute read
- Media CoverageRachel Snyder Good Featured in “The Top Mid-Law People Moves of 2023 So Far”2 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- Firm AnnouncementsElizabeth Scarola Named to the 2023 Florida Rising Stars List6 minute read
- Media CoverageHemant Gupta, Jeff McGoff, and Adelee Traylor Featured in “Epstein Becker Grows Health Care Practice in Dallas, Memphis”3 minute read
- Media CoverageHemant Gupta, W. Jeff McGoff, and Adelee Traylor Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Firm AnnouncementsEpstein Becker Green Adds Health Care Transactional, Technology & IP Attorneys in Memphis and Dallas Amid Ongoing Expansion4 minute read
- Media CoverageAlaap Shah Quoted in "New Health App Rule Would Better Protect Users – and So Can You"2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Managing Trade Secrets and Restrictive Covenants in Health Care M&A Deals
- Direct Access Laboratory Testing: Physician Orders and Specimen Collection
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New Submissions”5 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
- Firm AnnouncementsEpstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare2 minute read
- PublicationsDOJ’s Antitrust Division Continues Its Pursuit of Overlapping Directorates2 minute read
- Media CoverageRachel Snyder Good Featured in Law360 Pulse2 minute read
- Firm AnnouncementsRachel Snyder Good, Health Care Attorney, Former Advisor to U.S. House of Representatives Majority Leader Steny H. Hoyer, Joins Epstein Becker Green3 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry”3 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
- Direct Access Laboratory Testing: Reimbursement & Compliance
- 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
- Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- 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
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs14 minute read
- PublicationsRecap: Top 10 Antitrust Issues in 20222 minute read
- 2023 Health Policy Outlook
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- Leslie Norwalk Featured in Her Story Podcast: “Continue to Be Curious”
- EventsTrade Secrets, Restrictive Covenants, and No-Poach Agreements in Health Care2 minute read
- Media CoverageElizabeth Scarola Featured in “People on the Move”1 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Health Care's Past, Present, and Future
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”2 minute read
- EventsZeroTo510: ComplianceOctober 12, 20221 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
- PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- Media CoverageRichard Hughes Featured in Washington Lawyer’s “On the Move”1 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
- PublicationsThe Inflation Reduction Act Will Help the U.S. Achieve Maximum Vaccine Access and Uptake, but Access Gaps Remain3 minute read
- EventsNational Vaccine Law Conference 2022September 15-16, 20222 minute read
- EventsASPL Roundtable: The Impact of Roe v. Wade's Reversal on Pharmacies and PharmacistsSeptember 9, 20222 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- Media CoverageErik Weibust Featured in “Class Notes: 2005”2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
- Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act
- PublicationsSecond Quarter Sees Slight Slowdown in Health-Care Deals3 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- PublicationsOn First Anniversary of Executive Order on Competition, DOJ Celebrates Interagency Efforts to Promote Competitive MarketsJune 28, 20222 minute read
- EventsNWABR Hybrid IRB Conference: Privacy Pile-Up—Making Sense of Multiple Frameworks for Research Participant Privacy and Data ProtectionJuly 28, 20221 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
- Firm AnnouncementsLynn Shapiro Snyder Serves on the Nashville Health Care Council’s Board of Directors2 minute read
- Media CoverageLynn Shapiro Snyder Continues Service on Nashville Health Care Council’s Board of Directors2 minute read
- Media CoverageGary Herschman, Anjana Patel, Tim McHale Quoted in “Health-Care Dealmaking Slows as US Inflation Hits Record High”3 minute read
- Media CoverageRichard Hughes Featured in “Class Notes”2 minute read
- Firm AnnouncementsElizabeth Scarola Named to the 2022 Florida Rising Stars List6 minute read
- The Opportunities and Challenges Ahead for Biopharma and Public Health – Richard Hughes
- Media CoverageRichard Hughes Featured in “Industry Moves”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 minute read
- Media CoverageRichard Hughes Featured in “Laterals, Moves, In-House”1 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 CoverageRichard Hughes Featured in “Ex-Moderna Public Policy VP Rejoins Epstein Becker”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”3 minute read
- Firm AnnouncementsAttorney and Biopharma Strategist Richard Hughes Returns to Epstein Becker Green in Washington, DC4 minute read
- PublicationsConstitutionality of FTC’s Structure and Procedures Under SCOTUS Review2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 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
- PublicationsFinal Listening Forum on Firsthand Effects of Mergers and Acquisitions to Be Held on May 12, 20222 minute read
- Firm AnnouncementsEpstein Becker Green’s Theodora McCormick Recognized as a Trailblazing Change-Maker by the Executive Women of New Jersey4 minute read
- Firm AnnouncementsEpstein Becker Green Again Recognized as One of the Largest Health Care Law Firms2 minute read
- Firm AnnouncementsEpstein Becker Green’s Managing Director James P. Flynn Named a “Leader in Law”4 minute read
- Career Pathways: Attorney Brad Thompson – Commitment to Lifelong Learning
- PublicationsWhat Happens When Parties Abandon a Transaction Challenged by the FTC?April 21, 20222 minute read
- EventsABA: FemTech Revolution—Technology Innovation to Address Gaps in Women's HealthApril 28, 20221 minute read
- Entrepreneurship in Biotech: Growing Your Business
- Media CoverageErik Weibust Featured in “Hub Hires”2 minute read
- Media CoverageErik Weibust Featured in “IP Hires”2 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- Media CoverageErik Weibust Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Media CoverageErik Weibust Featured in “Epstein Becker Hires Trade Secret Litigator in Boston”3 minute read
- Firm AnnouncementsEpstein Becker Green Welcomes Seasoned Trade Secret Litigator Erik Weibust in Boston4 minute read
- PublicationsFTC and DOJ to Hold Listening Forums on Merger Experience2 minute read
- Record-Shattering Year for FCA Recoveries in Health Care
- PublicationsFDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure18 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
- Media CoverageGary Herschman, Anjana Patel, Timothy McHale Quoted in “Health-Care Deals Stay Strong Amid Fears Over War in Ukraine”3 minute read
- PublicationsRecord Number of Health-Care Deals Close 2021 with a Bang4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”4 minute read
- PublicationsFTC and DOJ Seek Public Comments on Merger Guidelines2 minute read
- PublicationsRecap: Top 10 Antitrust Issues in 20212 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
- 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
- Media CoverageEpstein Becker Green Article Featured in “The Top 10 Healthcare M&A Deals of 2021”2 minute read
- Media CoverageTheodora McCormick Quoted in “The Top Product Liability Cases of 2021”2 minute read
- PublicationsThe $2 Trillion Build Back Better Act Passes the House, Bringing the Potential for a Significant Health Care Expansion4 minute read
- Media CoverageGary Herschman, Anjana Patel, Zachary Taylor Quoted in “Health-Care Deals on Record Pace to Hit 3,000 by Year’s End”3 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 CoverageEpstein Becker Green Article Cited in “Volume of Healthcare Deals in 2021 Has Surpassed 2020 Levels”2 minute read
- PublicationsVolume of Health-Care Deals Remains at Record Pace for 20212 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageEpstein Becker Green Insight on CMS Proposal to Repeal Medicare Coverage of Breakthrough Devices Featured in Orthopedics This Week3 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
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”2 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
- PublicationsMedical Device Manufacturers, Beware: FTC Ramps Up Enforcement Against Repair RestrictionsAugust 26, 20212 minute read
- PublicationsRevisions to the PhRMA Code on Interactions with Health Care Professionals9 minute read
- EventsMachine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy, and Security Risks2 minute read
- PublicationsHealth IT, Software Deals Lead Industry Moves So Far in 20212 minute read
- Media CoverageJames Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”3 minute read
- Firm AnnouncementsElizabeth Scarola Named to 2021 Florida Rising Stars List6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Google Launches a New Medical App—Outside the US”5 minute read
- Media CoverageLynn Shapiro Snyder Joins Nashville Health Care Council’s Board of Directors2 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
- PublicationsRansomware: A Guide to Practical, Regulatory, and Reputational Risk Management16 minute read
- EventsExpert Webcast: U.S. Healthcare Consolidation - M&A Trends and Opportunities1 minute read
- PublicationsHealth-Care M&A Deals in Q1 Set Record Pace as Economy Recovers2 minute read
- PublicationsDistinguishable Products and Tying Claims in Health Care Markets3 minute read
- Firm AnnouncementsModern Healthcare Ranks Epstein Becker Green as One of the Nation’s Largest Health Care Law Firms2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Regulation of AI Complicated by Hospital’s Use of In-House Algorithms”4 minute read
- PublicationsFTC Annual Review Shows Focus on Health Care2 minute read
- President Biden’s Use of the Defense Production Act
- EventsBias in Artificial Intelligence: Legal Risks and Solutions3 minute read
- EventsOppenheimer 31st Annual Healthcare Conference1 minute read
- Media CoverageLynn Shapiro Snyder Discusses 10 Best Practices for Advancing Women in Business on Inspiring Women5 minute read
- PublicationsData Quality for AI in Healthcare2 minute read
- Media CoverageBob Hearn Featured in Law360 Pulse Article on Recent Health Care Litigator Hires in Florida2 minute read
- Media CoverageBob Hearn Featured in “Epstein Becker Adds Health Care Atty from Phelps Dunbar”3 minute read
- Firm AnnouncementsHealth Care Attorney & Commercial Litigator Robert R. Hearn Joins Epstein Becker Green3 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- PublicationsRobust Health-Care M&A Volume Ends 2020, Will Continue in 20212 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 Finalizes Speedier Medical Device Pathway Alternative to Breakthrough Status”3 minute read
- Media CoverageGary Herschman, Anjana Patel Quoted in "Covid-19 Surges, Vaccines Drive Pharma, Device Deal Growth"2 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 minute read
- EventsFDLI Enforcement, Litigation, and Compliance Conference: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities1 minute read
- Events2020 Advancing Ethical Research Conference: Complex Conflict of Interest - Understanding the COI Landscape2 minute read
- PublicationsUSA: HIPAA and Wearable Technology – Does It Provide a Loophole?2 minute read
- Privacy Concerns When Contact Tracing in the Health Care Workplace
- EventsVirtual Engineering Week: FDA & Medical Artificial Intelligence - What You Need to Know1 minute read
- EventsGCMI Virtual Experiential Learning Program: Reimbursement Pathways1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Prescription Pulse: Experts Split on HHS Sunset Rule”2 minute read
- PublicationsHealth-Care M&A Deals in Q3 Impacted by Covid-19; Election Could Shape Q43 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AdvaMed Seeks Regulatory Clarity on FDA’s New Digital Health Center”2 minute read
- Firm AnnouncementsDavid S. Poppick, Peter M. Stein Named to 2020 Connecticut Super Lawyers List, Marylana Saadeh Helou Named to 2020 Massachusetts Rising Stars List7 minute read
- Key Considerations for Reshoring U.S. Drug Manufacturing
- EventsHealthcare Compliance Training: An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers1 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 CoverageEpstein Becker Green’s Latest Health Hires in Boston Featured in Law3602 minute read
- Product Launching in the Era of COVID-19
- 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
- PublicationsEpstein Becker Green’s Boston Health Care and Life Sciences Practice Featured in “Hire Up: This Week’s Lateral Market”2 minute read
- Firm AnnouncementsEpstein Becker Green Adds Group of Health Care & Life Sciences Attorneys in Boston6 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
- PublicationsCMS Proposes to Expand the Scope of Medicare Coverage Determinations9 minute read
- Firm AnnouncementsEpstein Becker Green's Paul Gilbert Becomes General Counsel and Corporate Secretary at Rite Aid4 minute read
- EventsZeroTo510: Reimbursement – Medical Device Accelerator1 minute read
- PublicationsU.S. Department of Justice’s Pandemic-Related Enforcement Priorities Warrant Caution by Businesses16 minute read
- Firm AnnouncementsEpstein Becker Green Ranks Highly as One of the Largest Health Care Law Firms by Modern Healthcare2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans"3 minute read
- Media CoverageGary Herschman, Anjana Patel, Zachary Taylor Quoted in "Health-Care Deals in May Relatively Strong Despite Pandemic"4 minute read
- Media CoverageDelia Deschaine Featured in Law360's "Health Hires"2 minute read
- Firm AnnouncementsElizabeth Scarola Named to 2020 Florida Rising Stars List5 minute read
- Firm AnnouncementsEpstein Becker Green Adds FDA Attorney Delia A. Deschaine to Health Care and Life Sciences Practice4 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
- PublicationsINSIGHT: Health-Care Transactions Will Pick Back Up After Virus3 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
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- PublicationsINSIGHT: Fake Cures and Test Kits—Scammers Target Health Care4 minute read
- PublicationsNew Developments in FDA Regulation of AI2 minute read
- PublicationsThe CARES Act: Key Provisions for Health Care Providers7 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 CoverageGary Herschman, Anjana Patel Quoted in "Health-Care Deals Drop in February, Uncertainty Ahead Amid Crisis"3 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
- PublicationsAntitrust Law Compliance During Public Health Emergencies2 minute read
- Media CoverageConor Murphy Featured in "New Partners Yearbook 2020"2 minute read
- PublicationsFDA and FTC Join Forces to Promote Biosimilars3 minute read
- Media CoverageGary Herschman Featured in "Hot Healthcare Sectors for Investment, Growth & Consolidation in 2020"2 minute read
- Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
- Media CoverageEpstein Becker Green Analysis Featured in "Healthcare Predictions for 2020: Health Systems Will Get Bigger, Demand for Physicians Will Grow"3 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
- 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
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How Apple, Fitbit, Samsung and More Are Helping to Modernize the FDA"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Product Reporting Rule Set for 2020 Enforcement"2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "Legal Briefs – EBG Adds to Nashville Healthcare Practice"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer Applauds Combo Products Guide but Says Some Details Missing"4 minute read
- Media CoverageJulie Watson Lampley Featured in "Laterals, Moves"1 minute read
- Media CoverageJulie Watson Lampley Featured in Law360's Roundup of Health Hires2 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 CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "Prominent Law Firm Loses Nashville Chief"2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "National Firm Adds to Tennessee Health Care Team"2 minute read
- Firm AnnouncementsEpstein Becker Green Grows Tennessee Presence with Experienced Health Care Hires4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pear Files Insomnia and Depression Software as Pre-Cert Pilot 510(k)"3 minute read
- Media CoverageAlaap Shah Quoted in "Can Pacemakers (and Other Medical Devices) Really Be Hacked?"2 minute read
- Firm AnnouncementsModern Healthcare Recognizes Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Trends in Cybersecurity of Medical Devices: Thought Leaders in Health Law Video Series
- 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
- 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
- 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 Quoted in "Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews"2 minute read
- EventsRetail and Specialty Pharmacy: Strategic and Regulatory Considerations for Expanding Hospital Pharmacy Options1 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 CoverageRobert Wanerman Quoted in "CMS Floats New Add-On Payment Route for Breakthrough Devices"2 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
- 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 Unveils Framework for AI-Based Medical Devices"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsOppenheimer Healthcare Investor Conference: 2019 Healthcare Outlook – Key Legal, Legislative, and Regulatory Issues and Trends1 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
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- PublicationsFDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices1 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 "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 "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
- Media CoverageAlaap Shah Quoted in "After a Busy Month in Cyber, HHS Rebrands Its Cybersecurity Center"3 minute read
- Media CoverageAlaap Shah Quoted in "FDA Cyber Guide Provides Key Testing, Documentation Updates"3 minute read
- EventsFDA Medical Device Recalls: Now and Then4 minute read
- Media CoverageStuart Gerson Quoted in "Drug, Device Lobbies Weigh In on Utah Device Liability Case"1 minute read
- EventsFood and Drug Law Institute: Developments in FDA Software Regulation1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan"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 CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 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
- PublicationsCDRH’s New Post-Market Paradigm: Why the Public Should Be Worried3 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 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 CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Regulating CDS and AI: Which Way Forward?"2 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Releases Draft Patient-Experience Data Guidance"2 minute read
- EventsSeton Hall Law: U.S. Healthcare Compliance Certification Program - An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers1 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
- Media CoverageBradley Merrill Thompson Quoted in "FDA Permits Marketing of AI Software That Autonomously Detects Diabetic Retinopathy"2 minute read
- EventsFDLI: Introduction to US Medical Device Law and Regulation - Overview of Medical Device Law and Regulation Organizational Structures1 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 CoverageJames Boiani Quoted in "Nicotine Replacement Trials and the App Effect"3 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
- PublicationsDurable Medical Equipment1 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
- Trends in TRICARE: Thought Leaders in Health Law Video Series
- Firm AnnouncementsEpstein Becker Green Named a 2017 "Health Practice Group of the Year" by Law3602 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
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Device Experts Criticize FDA's Clinical Decision Support Draft Guide"2 minute read
- Trends in Precision Medicine: Thought Leaders in Health Law Video Series
- 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
- PublicationsThe "New" NDC: Are You Aware of FDA's Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Gives Advice on Getting Innovative Devices to Market Faster"2 minute read
- EventsSigns You May Have a Problem: White-Collar Crash Course Webinar Series2 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
- EventsThe Criminalization of Health Care: White-Collar Crash Course Webinar Series3 minute read
- Media CoverageJames Boiani Quoted in "FDA Final Guidance on Drug/Device Classifications Misses the Mark, Attorneys Say"2 minute read
- EventsWhat Are the Risks? Business Types Facing Increased Scrutiny: White-Collar Crash Course Webinar Series2 minute read
- Events"To Be a Legal Opinion or Not to Be a Legal Opinion?" That Is the In-House Communication Question: White-Collar Crash Course Webinar Series2 minute read
- EventsAMDM 2017 Focus Meeting: CLIA Waiver Updates1 minute read
- EventsThe Current Enforcement Environment: White-Collar Crash Course Webinar Series3 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
- EventsFDLI Advertising and Promotion Conference: Risk Information in Direct-to-Consumer Broadcast Advertisements for Prescription Drugs1 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
- EventsMedical Device Usability and Human Factors Engineering Conference: FDA Oversight of Human Factors Engineering for Combination Products1 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 "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 "FDA Appears to Answer AdvaMed Concerns Over Device Tool Program"3 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 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 CoverageJames Boiani Quoted in "Combo Product Appeals Low in Number, but Lengthy in Decision Time"2 minute read
- Events2017 BIO International Convention: Medical Device Regulations1 minute read
- Events2017 BIO International Convention: Coverage and Reimbursement Strategies for Biotech Products1 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 "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
- EventsCombination Products Regulation, Policy & Best Practices: Combination Products - Perspective of the Combination Products Coalition1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Reject Off-Label Drug, Device Promotion Bills, Groups Tell Lawmakers"2 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 CoverageJames Boiani Quoted in "FDA Takes Steps Toward Creating Lab Accreditation System for Evaluating Medical Devices"2 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
- 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 CoverageEpstein Becker Green’s 50-State Survey of Telemental/Telebehavioral Health (2016)Cited in "ATA's Practice Guidelines Target Telestroke, Telemental Health"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 "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 "New York Attorney General Settles with Three Mobile Health Apps"2 minute read
- Media CoverageJames Boiani Quoted in "Combo Products Won't Get Special Review Pathway at US FDA Anytime Soon"1 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 "Will Remote Software Updates Become the Norm for Medical Devices?"2 minute read
- Media CoverageJames Boiani Discusses Petitioning FDA on Combo Drug Appeals Within 60 Days2 minute read
- Media CoverageJames Boiani Quoted in "Law Firm Challenges FDA on Combination Product Appeals"2 minute read
- Media CoverageJames Boiani Quoted in "Combination Product Designations at US FDA Need Faster Appeals, Petition Says"2 minute read
- Events17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology: Regulatory and Legal Considerations When Using Social Media to Promote Drugs and Medical Devices1 minute read
- Events17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology: Not So Safe - Exploring the Boundaries of the Discount Safe Harbor in Light of Recent Court Decisions1 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Named to Law360 Editorial Advisory Boards2 minute read
- Media CoverageAmy Dow Featured in "Law360Life Sciences Editorial Advisory Board"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
- 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 "FDA Clarifies Rule on Tobacco Products in Medical Realm"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 "Drug/Device Combo Makers Get Clarity on Manufacturing Requirements"2 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 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 CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"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
- Trends in Digital Health: Thought Leaders in Health Law Video Series
- Media CoverageRobert Wanerman Quoted in "Doctors Argue Leadless Pacemakers Deserve Broader Medicare Coverage"1 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 CoverageJames Boiani Quoted in "What's Next for LDTs? FDA May Be Eyeing a New Game Plan"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What Will a Trump Presidency Mean for Digital Health?"1 minute read
- Media CoverageJames Boiani Quoted in "Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX"1 minute read
- EventsTCT 2016 (Transcatheter Cardiovascular Therapeutics)1 minute read
- Media CoverageEpstein Becker Green's 50-State Survey of Telemental/Telebehavioral Health (2016)Featured in "How Teletherapy Addresses Mental Health Needs"2 minute read
- EventsACI's 2nd National Advanced Forum on Medical Liability Claims, Coverage & Risk Management: Fighting the Latest Cyber Threats to the Healthcare Industry2 minute read
- Media CoverageRobert Wanerman Quoted in "Program to Speed Medical Device Coverage Now Permanent"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Interview: Putting the Pieces Together for Combo Products Oversight"3 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
- EventsHarvard T.H. Chan School of Public Health: Health Care and the Elections1 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
- Events2016 SupplySide West Conference: Developing and Substantiating Product Claims1 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 CoverageJames Boiani Quoted in "FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide"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 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, 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
- 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 CoverageEpstein Becker Green's Telemental/Telebehavioral Health Survey Mentioned in "Telehealth: How Companies Are Managing Employees' Mental Health"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Outlines When New Clearances Are Needed for Existing Devices"2 minute read
- Media CoverageJames Boiani Quoted in "FDA's New Combo Products Pilot Distinct from Planning Office Proposals"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 Discusses FDA's Final Guidance on Low Risk Devices, in Multiple Publications2 minute read
- Media CoverageJames Boiani Quoted in "FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Google's App a Medical Device?"1 minute read
- PublicationsNext-Generation Sequencing: FDA Issues New Guidance for Genetic Tests15 minute read
- Media CoverageEpstein Becker Green Survey Featured in "Telemental Health Is Trending Upward"2 minute read
- EventsCorrecting Misinformation in Social Media: When, Where, Why and How to Do It1 minute read
- Media CoverageEpstein Becker Green 50-State Survey of Telemental/Telebehavioral Health (2016) Mentioned in Fierce Healthcare1 minute read
- Firm AnnouncementsModern Healthcare Again Ranks Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- EventsPrivacy and Wearables - Wearables Crash Course Webinar Series2 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Offers Guidance in Support of Sharing Device Data with Patients"1 minute read
- PublicationsThe State of Telemental Health Care2 minute read
- PublicationsPatricia Wagner Quoted in "FDA Issues Draft Guidance on Sharing Medical Device Data with Patients"1 minute read
- EventsSeton Hall Law U.S. Healthcare Compliance Certification Program: An Overview of Federal Health Care Programs for Drug and Device Manufacturers1 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney"2 minute read
- Firm AnnouncementsEpstein Becker Green Assists in Launch of Mental Health App2 minute read
- EventsFDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices - Wearables Crash Course Webinar Series2 minute read
- Media CoverageEpstein Becker Green Survey Featured in "Telemental Health Services on Rise, but Barriers Remain"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer Urges FDA to Release Combo Product Final Rule"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "5 Factors Influencing Telemental Health"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "Telehealth Increasingly Used for Mental Health Care"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 CoverageEpstein Becker Green's Telehealth Practice Featured in "Telemental Health Services Bridge Gaps in Care, but Regulatory Issues a Barrier"2 minute read
- Firm AnnouncementsEpstein Becker Green Releases Comprehensive 50-State Survey on Telemental Health Laws in the United States6 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "Analyzing Telemental Health: 50 States, 50 Policies"2 minute read
- Media CoverageAmy Dow Quoted in "FDA Seeks Comments on Draft 3-D Device Printing Guidance"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
- EventsHCCA's 20th Annual Compliance Institute1 minute read
- EventsHealth Insights Spring 2016 Conference: Are Innovative Payment Models the Solution to High Quality, More Affordable, Patient Centered Health Care?1 minute read
- EventsDesign of Medical Devices Conference: Federal Cybersecurity Initiatives & Smart IT Devices1 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
- Firm AnnouncementsEpstein Becker Green's Amy Dow Named to Law360 Life Sciences Editorial Advisory Board1 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 CoverageJames Boiani Quoted in “Troubled Health Start-Up Theranos Faces Washington Reckoning”1 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
- PublicationsCMS Issues Final Rule on Covered Outpatient Drugs38 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
- EventsProtecting Portable PHI: Tips for Providers, Physicians, and Allied Healthcare Professionals2 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