In the News
January 8, 2019 – In the News
Bradley Merrill Thompson Quoted in “FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert”
Medtech Dive
December 31, 2018 – In the News
Bradley Merrill Thompson Quoted in “Will Telehealth and mHealth Fulfill Their Potential in 2019?”
mHealthIntelligence
December 19, 2018 – In the News
Bradley Merrill Thompson Quoted in “Lawyers: FDA Proposed De Novo Rule Might Discourage Developers”
InsideHealthPolicy
December 18, 2018 – In the News
Bradley Merrill Thompson Quoted in “Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips”
Inside Health Policy
December 17, 2018 – In the News
Bradley Merrill Thompson Quoted in “US FDA Medical Software Report Rests Concerns of Increased Regulation”
MedTech Insight Pharma Intelligence
December 12, 2018 – In the News
Bradley Merrill Thompson Quoted in “An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain”
MedTech Insight Pharma Intelligence
December 3, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA’s De Novo Pathway Is About to Get a Makeover”
MedTech Dive
November 29, 2018 – In the News
Bradley Merrill Thompson Quoted in “Device Lawyer: 510(k) Plan Violates Statute, FDA ‘Too Big for Britches'”
Inside Health Policy
November 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Looks to Restrict Older Predicate Devices, Introduce New Regulatory Pathway”
MobiHealthNews
November 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway”
Regulatory Affairs Professionals Society (RAPS)
November 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks $46M to Fund National Evaluation System for Health Technology”
HealthData Management
November 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Considering Imposing 10-Year Limit When Manufacturers Choose Older Predicates”
MedCity News
November 20, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Rolls Out New Rx-Use-App Paper”
POLITICO Morning eHealth
November 15, 2018 – In the News
Bradley Merrill Thompson Quoted in “Roundup: 12 Healthcare Algorithms Cleared by the FDA”
MobiHealthNews
October 11, 2018 – In the News
Bradley Merrill Thompson Quoted in “Top Democrats Question FDA Pre-Cert Program Safety, Statutory Authority”
MedTech Dive
October 10, 2018 – In the News
Bradley Merrill Thompson Quoted in “Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert”
MobiHealthNews
October 10, 2018 – In the News
Bradley Merrill Thompson Quoted in “Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan”
Inside Health Policy Daily News
September 14, 2018 – In the News
Bradley Merrill Thompson Discusses FDA Approval of Apple Watch ECG Monitoring Capability
Multiple Publications
August 16, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Lawyer Says FDA-Proposed Device Accessory List Too Short”
Inside Health Policy
August 13, 2018 – In the News
Bradley Merrill Thompson Quoted in “US FDA’s Software Pre-Cert Program: Is the Authority on the Books?”
Medtech Insight
July 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Lawyer: Pre-Cert Program Exceeds Statute, Issues Unresolved”
FDA Week
July 25, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Second Draft Pre-Cert Released But Real Rule-Making Needed”
Healthcare IT News
July 24, 2018 – In the News
Bradley Merrill Thompson Quoted in “CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design”
Regulatory Affairs Professionals Society (RAPS)
July 18, 2018 – In the News
Bradley Merrill Thompson Comments on the FDA’s Pre-Certification Program Working Model
POLITICO Morning eHealth
July 5, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations”
MobiHealthNews
July 5, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Heads Call for Flexible Regulatory Framework for Medical Software”
FDA Week
June 2018 – In the News
Bradley Merrill Thompson Featured in “Regulating CDS and AI: Which Way Forward?”
Insights: HIMSS Europe
June 20, 2018 – In the News
Bradley Merrill Thompson Discusses FDA Pre-Certification Update in Multiple Publications
Multiple Publications
June 13, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Releases Draft Patient-Experience Data Guidance”
Politico Morning eHealth
May 17, 2018 – In the News
Bradley Merrill Thompson Quoted in “Attorney: FDA Draft Re-Do of Part 3 Eases Agency’s Legal Burden”
BioWorld
May 14, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Changes to Classification Rules for Combo Products”
Regulatory Affairs Professionals Society (RAPS)
April 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Lays Out Next Steps for Pre Cert Pilot”
Healthcare Dive
April 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Unveils Working Model for Software Precertification Program”
Health Data Management
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “As FDA’s Pre-Cert Plan Takes Shape, Worries Emerge About Overreach”
MobiHealthNews
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “Gottlieb Unveils Digital Health Tools for Drug Development, Pre-Cert Model”
InsideHealthPolicy
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Attorney Says FDA’s New Device Plan Oversteps Authority”
InsideHealthPolicy
April 17, 2018 – In the News
Bradley Merrill Thompson Quoted in “The Fourth Wave: Digital Health Newsletter for Apr 13”
Story of Digital Health
April 12, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Permits Marketing of AI Software That Autonomously Detects Diabetic Retinopathy”
MobiHealthNews
April 3, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Digital Health Program Not Broad Enough, Industry Says”
Bloomberg BNA Big Law Business
March 30, 2018 – In the News
Bradley Merrill Thompson Quoted in “Why the FDA’s Recent Glucose Monitoring System Approval Matters for Interoperability”
Becker's Hospital Review
March 28, 2018 – In the News
Bradley Merrill Thompson Quoted in “CMS Under Pressure to Cover mHealth Tools for Diabetes Management”
mHealth Intelligence
March 28, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Approves Interoperable Continuous Glucose Monitoring System”
POLITICO Morning eHealth
March 22, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Streamlines Safety Reporting for Drug-Device Combos”
Bloomberg BNA Medical Devices & Industry Report
March 22, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Delays Combination Product Safety Reporting Requirements”
FDA Week
February 14, 2018 – In the News
Bradley Merrill Thompson Quoted in “Viz.ai’s Stroke-Detecting CDS App Receives FDA Nod”
MobiHealth News
February 14, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Approves AI Stroke Application, Signaling a Shift in Triage Software Oversight”
FierceHealthcare
February 7, 2018 – In the News
Bradley Merrill Thompson and CDS Coalition Discuss the FDA’s Draft Guidance on Clinical Decision Support
Multiple Publications
February 1, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA’s First Pre-Cert Workshops Give Industry and Agency a Chance to Talk”
MobiHealthNews
January 4, 2018 – In the News
“FDA Guidance on Decision Support Software: Implications for Industry” Featured in POLITICO Morning eHealth
POLITICO Morning eHealth
January 2, 2018 – In the News
Bradley Merrill Thompson Quoted in “Outlook 2018: Pharma/Life Sciences Law and Policy”
Bloomberg BNA Health Care Daily Report
December 21, 2017 – In the News
Bradley Merrill Thompson Quoted in “Medical Device Experts Criticize FDA’s Clinical Decision Support Draft Guide”
FDA Week
December 15, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Aims to Ease Medical Device Approval Burdens”
Bloomberg BNA Medical Devices Law & Industry Report
December 7, 2017 – In the News
Bradley Merrill Thompson Discusses the FDA’s Long Anticipated New Guidance on Digital Health Devices and Clinical Decision Support Guidelines
Multiple Publications
December 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “Who Is Liable for Faulty Artificial Intelligence in Health Care?”
Bloomberg BNA Medical Devices Law & Industry Report
December 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks to Speed Approvals of Generic Drug-Device Combos”
Bloomberg BNA Medical Devices Law & Industry Report
December 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Approves First Drug with Digital Ingestion Tracking System”
Digital Health Legal
November 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways”
Regulatory Affairs Professionals Society
November 9, 2017 – In the News
Bradley Merrill Thompson Quoted in “Grading Gottlieb: How Attys View FDA Chief’s First 6 Months”
Law360
November 9, 2017 – In the News
Bradley Merrill Thompson Quoted in “Health-Care Cybersecurity Takes Center Stage”
Bloomberg BNA
November 8, 2017 – In the News
Bradley Merrill Thompson Quoted in “Health Privacy Official’s Departure Unlikely to Rock the Boat”
Bloomberg BNA
November 7, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Announces New Market Pathway for Genetic Health Risk Tests”
MobiHealthNews
November 7, 2017 – In the News
Bradley Merrill Thompson Quoted in “Some Genetic Tests Will Get Quicker FDA Path to Market”
Bloomberg BNA Medical Devices Law & Industry Report
October 31, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Gives Advice on Getting Innovative Devices to Market Faster”
Bloomberg BNA Medical Devices Law & Industry Report
October 30, 2017 – In the News
Bradley Merrill Thompson Quoted in “Device Makers Get FDA Guidance on Premarket Clearances”
Bloomberg BNA Medical Devices Law & Industry Report
October 26, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Clarifies When to Submit 510(K) for a Software Change”
Healthcare Dive
October 25, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Finalizes New Guidance to Support Medical Device Innovation and Ease Burden of Software Updates”
FierceHealthcare
October 25, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Finalizes Guidance on Software Modifications”
POLITICO Morning eHealth
October 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “New FDA Guidances Aim to Increase Clarity on When Developers Need to Resubmit 510(K)s”
MobiHealthNews
October 17, 2017 – Book
Bradley Merrill Thompson Quoted in “The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan”
The New Mobile Age, by Joseph C. Kvedar
September 28, 2017 – In the News
Bradley Merrill Thompson Quoted in “Apple Watch: Fast-Tracking Medical Tech with Its Heart Rate Monitor”
MIMS Today
September 27, 2017 – In the News
Bradley Merrill Thompson Quoted in “We Now Know That Apple, Alphabet and Samsung Are Making Long-Term Bets on Health Care”
CNBC
September 26, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks Input on How to Review Certain Device, Drug Combos”
Bloomberg BNA Medical Devices Law & Industry Report
September 26, 2017 – In the News
Bradley Merrill Thompson Quoted in “Apple and Fitbit Among the 9 Companies Selected for FDA’s Coveted Digital Health Pilot”
FierceHealthcare
September 25, 2017 – In the News
Bradley Merrill Thompson Quoted in “Analysis: 2 Barriers to Apple’s Smartwatch, Arrhythmia Detection Project”
Becker’s Health IT & CIO Review
September 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “Don’t Wait for the Apple Watch to Dole Out Medical Advice Anytime Soon”
TechCrunch
September 20, 2017 – In the News
Bradley Merrill Thompson Quoted in “Why the Apple Watch Won’t Replace Your Doctor Anytime Soon”
CNBC
September 18, 2017 – In the News
Bradley Merrill Thompson Quoted in “Federal Agency Guidance: An Institutional Perspective”
Administrative Conference of the United States
September 14, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA to Drug/Device Combo Makers: Wait for Reporting Guidance”
Bloomberg BNA Medical Devices Law & Industry Report
September 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “Apple Watch to Act as Heart Monitor”
POLITICO Morning eHealth
September 8, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Ignores Advamed Requests in Final RWE Device Guidance”
FDA Week
September 7, 2017 – In the News
Bradley Merrill Thompson Quoted in “Coalition Issues Final Guidelines on CDS Software Design”
Healthcare Dive
September 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA to Hire Entrepreneurs-In-Residence to Help Develop PreCert Software Program”
Inside Health Policy
September 5, 2017 – In the News
Bradley Merrill Thompson Quoted in “September Eyes Turn to CHIP Funding”
POLITICO Morning eHealth
September 5, 2017 – In the News
Bradley Merrill Thompson Quoted in “Medical Software Industry Issues Guidance to Keep FDA at Bay”
Bloomberg BNA Medical Devices Law & Industry Report
September 5, 2017 – In the News
Bradley Merrill Thompson Quoted in “Government Urged to Avoid Burdening Health-Data Exchange Users”
Bloomberg BNA Health Care Daily Report
September 1, 2017 – In the News
Bradley Merrill Thompson Quoted in “Industry Coalition Finalizes Clinical Decision Support Guidelines Aimed at Self-Regulation”
Fierce Healthcare
September 1, 2017 – In the News
Bradley Merrill Thompson, Kim Tyrrell-Knott Featured in “CDS Coalition Drops Voluntary Guidelines for Unregulated Clinical Decision Support Software”
Mobi Health News
August 31, 2017 – In the News
Bradley Merrill Thompson Quoted in “CDS Coalition Releases Guidelines in Self-Regulatory Effort”
FDA Week
August 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Watchers: Gottlieb May Fly Under Trump Deregulatory Radar with Product-Specific Moves”
Inside Health Policy
August 22, 2017 – In the News
Bradley Merrill Thompson Quoted in “Gottlieb Issues Fewer Guidances and Delays Some Key Rules, But Hasn’t Chopped Any Yet”
Inside Health Policy
August 18, 2017 – In the News
Bradley Merrill Thompson Quoted in “Stakeholders Praise Gottlieb for Keeping the Agency on Track”
Inside Health Policy
August 11, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Appears to Answer AdvaMed Concerns Over Device Tool Program”
FDA Week
August 9, 2017 – In the News
Bradley Merrill Thompson Quoted in “Federal Advisers Likely to Push for Better Health Data Exchange”
Bloomberg BNA Health Care Daily Report
August 2, 2017 – In the News
Bradley Merrill Thompson Quoted in “9 Companies Will Play a Huge Role in Shaping the FDA’s Novel Approach to Digital Health”
FierceHealthcare
July 28, 2017 – In the News
Bradley Merrill Thompson Quoted in “Defeat for Obamacare Repeal in the Senate”
POLITICO Morning eHealth
July 27, 2017 – In the News
Bradley Merrill Thompson Discusses FDA Announcement of Digital Health Innovation Action Plan and Launch of Pre-Cert Pilot Program
Multiple Publications
July 26, 2017 – In the News
Bradley Merrill Thompson Quoted in “Rx, Device Groups Tell FDA to Scrap Latest Off-Label Rule”
Bloomberg BNA Medical Devices Law & Industry Report
July 17, 2017 – In the News
Bradley Merrill Thompson Quoted in “Innovation Initiative to Modernize the FDA”
CWWeekly (A CenterWatch Publication)
July 7, 2017 – In the News
Bradley Merrill Thompson Quoted in “Pharma Raises Stakes in Digital Health”
PharmExec
June 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “Bayer Gets FDA Nod for App-Connected Injector for MS Patients”
MobiHealthNews
June 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Says It Will Clarify Digital Health Regulations”
Bloomberg BNA Medical Devices Law & Industry Report
June 16, 2017 – In the News
Bradley Merrill Thompson Discusses FDA Commissioner’s New Plan for Mobile App Regulation
Multiple Publications
June 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications”
FDA News
June 12, 2017 – In the News
Bradley Merrill Thompson Quoted in “Will a New FDA User Fee Discourage Medical Device Innovation?”
Bloomberg BNA Medical Devices Law & Industry Report
June 8, 2017 – In the News
Bradley Merrill Thompson Quoted in “Cyber on Stage”
POLITICO Morning eHealth
June 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “Questions Ahead for VA-Cerner Marriage”
POLITICO Morning eHealth
June 5, 2017 – In the News
Bradley Merrill Thompson Quoted in “Reject Off-Label Drug, Device Promotion Bills, Groups Tell Lawmakers”
Bloomberg BNA Medical Devices Law & Industry Report
May 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “How Should Digital Health Vendors Interpret New York’s Move to Flex Its Regulatory Muscle?”
MedCityNews
May 8, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA to Create Centralized Digital Health Unit”
Health Data Management
May 8, 2017 – In the News
Bradley Merrill Thompson Quoted in “Senate User Fee Bill Sets Up New Path to Reclassify Device Accessories”
Inside Health Policy
May 5, 2017 – In the News
Stuart Gerson, Bradley Merrill Thompson Quoted in “Bipartisan House Bills Take Aim at Unsafe Medical Devices”
Bloomberg BNA Medical Devices Law & Industry Report
May 2, 2017 – In the News
Bradley Merrill Thompson Quoted in “CDS Coalition Floats Guidelines for Mobile Health App Design”
mHealth Intelligence
May 2, 2017 – In the News
Bradley Merrill Thompson Quoted in “New Clinical Decision Support Software Guidelines Highlight Keys to Self-Regulation”
FierceHealthcare
May 1, 2017 – In the News
Bradley Merrill Thompson Quoted in “Drug, Device Industries Seek Fewer Limits on Off-Label Communications”
Bloomberg BNA Medical Devices Law & Industry Report
April 27, 2017 – In the News
Bradley Merrill Thompson Quoted in “Legislation Would Streamline Risk-Classification for Device Accessories”
Medtech Insight
April 27, 2017 – In the News
Bradley Merrill Thompson Quoted in “Congress Chugging Along”
POLITICO Morning eHealth
April 27, 2017 – In the News
Bradley Merrill Thompson Quoted in “Bipartisan House Bill Would Ease Device-Accessory Reviews”
Bloomberg BNA Medical Devices Law & Industry Report
April 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “CDS Tools Fall Short in Meeting Physicians’ Needs in Care Delivery”
Health Data Management
April 17, 2017 – In the News
Bradley Merrill Thompson Quoted in “Survey: Uncertainty About ACA Future Prevalent in Healthcare Industry”
Healthcare Dive
April 12, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Loosens Controls on Some Low-Risk Devices”
Bloomberg BNA Medical Devices Law & Industry Report
April 10, 2017 – In the News
Bradley Merrill Thompson Quoted in “NY AG Puts Mobile Health App Makers on Notice That FDA, FTC Not Only Enforcers of Health Claims”
Inside Health Policy
April 4, 2017 – In the News
Bradley Merrill Thompson Quoted in “New HHS Technology Office Leader Has Health-Care Industry Experience”
Bloomberg BNA Health Care Daily Report
April 3, 2017 – In the News
Bradley Merrill Thompson Quoted in “Arizona Law Puts Pressure on FDA to Change Off-Label Policies”
Bloomberg BNA Health Care Daily Report
April 3, 2017 – In the News
Bradley Merrill Thompson Quoted in “Wellness Apps Evade the FDA, Only to Land in Court”
Wired
March 31, 2017 – In the News
Bradley Merrill Thompson Quoted in “NY Attorney General Takes on Mobile Health App Makers”
FDA Week
March 27, 2017 – In the News
Bradley Merrill Thompson Discusses States’ Mobile Health App Regulations
Multiple Publications
March 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “Health Tech Oversight Up in the Air in Wake of New HHS Position”
Bloomberg BNA Health Care Daily Report
March 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “New York Taps Away Misleading Health Info for Smartphone Users”
Bloomberg BNA
March 23, 2017 – In the News
Bradley Merrill Thompson Quoted in “New York Attorney General Settles with Three Mobile Health Apps”
MobiHealthNews
March 22, 2017 – In the News
Bradley Merrill Thompson Quoted in “Trump’s Proposal to Increase FDA User Fees Could Impact Small Digital Health Innovators”
FierceHealthcare
March 20, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices”
Bloomberg BNA Medical Devices Law & Industry Report
March 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “3 Ways Trump’s FDA Nominee Could Reshape Digital Health”
FierceHealthcare
March 16, 2017 – In the News
Bradley Merrill Thompson Quoted in “Industry Wants HHS Scrutiny of Health Information Technology Office”
Bloomberg BNA Health Care Daily Report
March 15, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeking Feedback on New Office of Patient Affairs”
MobiHealthNews
March 14, 2017 – In the News
Bradley Merrill Thompson Quoted in “Will Remote Software Updates Become the Norm for Medical Devices?”
Medical Device and Diagnostic Industry (MD+DI)
February 27, 2017 – In the News
Bradley Merrill Thompson Featured in “Forty Under 40 Anniversary Profile”
Indianapolis Business Journal
February 22, 2017 – In the News
Bradley Merrill Thompson Quoted in “Citizens Petition Challenges FDA’s Off-Label Rule”
Policy and Medicine
February 21, 2017 – In the News
Bradley Merrill Thompson Quoted in “Senators Want to Fix FDA’s Inspection Process for Device Companies”
Bloomberg BNA Medical Devices Law & Industry Report
February 15, 2017 – In the News
Bradley Merrill Thompson Quoted in “Big Pharma Objects to New Hurdles for Off-Label Drug, Device Promotion”
Bloomberg BNA Health Care Daily Report
February 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Delays Rule Affecting Off-Label Drug, Device Promotion”
Bloomberg BNA Medical Devices Law & Industry Report
February 3, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Lame Duck Document Dump Prompts Congressional Scrutiny, Industry Sources Mixed”
Inside Health Policy
February 2017 – In the News
Bradley Merrill Thompson Quoted in “The FDA’s Proposed Rule on E-Labeling Raises Serious Concerns”
Digital Health Legal
February 1, 2017 – In the News
Bradley Merrill Thompson Quoted in “Hiring Freeze May Hurt FDA User Fee Programs, Democrats Say”
Bloomberg BNA Health Care Daily Report
January 31, 2017 – In the News
Bradley Merrill Thompson Quoted in “Health IT Fallout from Latest Trump Order”
POLITICO Morning eHealth
January 30, 2017 – In the News
James Boiani, Bradley Merrill Thompson Quoted in “Trump’s Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say”
Medtech Insight
January 25, 2017 – In the News
Bradley Merrill Thompson Mentioned in “FDA Wins Kudos from Industry in Combo Product GMP Final”
BioWorld
January 24, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Wins Kudos from Industry in Combo Product Good Manufacturing Practice Final”
Medical Device Daily
January 20, 2017 – In the News
Bradley Merrill Thompson Quoted in “A Look Ahead at Digital Health and Health Policy Under President Trump”
MobiHealthNews
January 17, 2017 – In the News
Bradley Merrill Thompson Quoted in “Lab Test Oversight Plan Scaled Back Under Revised FDA Proposal”
Bloomberg BNA Health Care Daily Report
January 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Lays Out Possible Risk-Based Approach to LDT Oversight”
Inside Health Policy
January 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “Drug/Device Combo Makers Have Chance to Weigh in on FDA Policies”
Bloomberg BNA Medical Devices Law & Industry Report
January 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Floats New Oversight Plan on Lab Tests”
Law360
January 13, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Clarifies Rule on Tobacco Products in Medical Realm”
Bloomberg BNA Health Care Blog
January 11, 2017 – In the News
Bradley Merrill Thompson Quoted in “Drug/Device Combo Makers Get Clarity on Manufacturing Requirements”
Bloomberg BNA Medical Devices Law & Industry Report
January 6, 2017 – In the News
Bradley Merrill Thompson Quoted in “Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices”
Bloomberg BNA Medical Devices Law & Industry Report
January 4, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Provides Accessories Guidance, but May Be ‘Missed’ Opportunity”
Medtech Insight
January 4, 2017 – In the News
Bradley Merrill Thompson Quoted in “Potential Cures Hiccup Spotted”
POLITICO Moring eHealth
January 4, 2017 – In the News
Bradley Merrill Thompson Quoted in “FDA Provides Accessories Guidance, but May Be ‘Missed’ Opportunity”
Medtech Insight
December 30, 2016 – In the News
Bradley Merrill Thompson Quoted in “What the FDA Did in Digital Health in 2016”
MobiHealthNews
December 30, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Offers Tech Companies Scant Help in Device Guidance”
Bloomberg BNA Medical Devices Law & Industry Report
December 29, 2016 – In the News
Bradley Merrill Thompson Quoted in “CDRH’s Guidance Goals for 2017”
Medical Device and Diagnostic Industry (MD+DI)
December 29, 2016 – In the News
Bradley Merrill Thompson Quoted in “Medical Device Decision Guidance Revised in Response to Criticism”
Bloomberg BNA Medical Devices Law & Industry Report
December 27, 2016 – In the News
Bradley Merrill Thompson Quoted in “Industry Praises Combo Product Rule But Still Seeks New Postmarket System”
Inside Health Policy
December 23, 2016 – In the News
Bradley Merrill Thompson Quoted in “Clinical Decision Support Software Guidance Kicked Off FDA’s Priority List”
Bloomberg BNA Medical Devices Law & Industry Report
December 20, 2016 – In the News
Bradley Merrill Thompson Quoted in “Pharma/Device Firms Get Clarity on Safety Reports for Combo Products”
Bloomberg BNA Health Care Daily Report
December 19, 2016 – In the News
Bradley Merrill Thompson Quoted in “Combo Product Sponsors Convince US FDA to Change Postmarket Reporting Rule”
Pharma & MedTech Business Intelligence’s The Pink Sheet Daily
December 15, 2016 – In the News
Bradley Merrill Thompson Quoted in “Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say”
FDA Week
December 8, 2016 – In the News
Bradley Merrill Thompson Quoted in “What a Trump Administration May Mean for Digital Health”
Healthcare Dive
December 7, 2016 – In the News
Bradley Merrill Thompson Quoted in “Congress Sends Cures Legislation to President”
Bloomberg BNA Health Care Daily Report
December 5, 2016 – In the News
Bradley Merrill Thompson Quoted in “21st Century Cures Act Clarifies FDA Regulation of Software”
Health Data Management
December 5, 2016 – In the News
Bradley Merrill Thompson Quoted in “Combo Product Safety: US FDA Rule on Post-Market Reporting Nears Finalization”
Medtech Insight
November 30, 2016 – In the News
Bradley Merrill Thompson Quoted in “‘Cures’ Bill Circumvents FDA on Medical Software Regs”
Medtech Insight
November 29, 2016 – In the News
Bradley Merrill Thompson Quoted in “Cures Bill Could Lift FDA Regulation of Physician Software”
Bloomberg BNA Health Care Daily Report
November 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “As Cures Bill Heads Towards Vote, Here’s What It Could Mean for Digital Health”
MobiHealthNews
November 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “Scoop: Emails Show FDA Asked Apple to Advise on Software as a Medical Device”
MobiHealthNews
November 17, 2016 – In the News
Bradley Merrill Thompson Quoted in “Cybersecurity Asks: More on FDA”
POLITICO Morning eHealth
November 11, 2016 – In the News
Bradley Merrill Thompson Quoted in “What Will a Trump Presidency Mean for Digital Health?”
MobiHealthNews
October 20, 2016 – In the News
Bradley Merrill Thompson Featured in “Interview: Putting the Pieces Together for Combo Products Oversight”
Medtech Insight
October 17, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks Input on Clinical Evaluation of Software as a Medical Device”
Health Data Management
October 17, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Floats New Draft Guidance, Created by International Group, on Software as a Medical Device”
MobiHealthNews
October 14, 2016 – In the News
Bradley Merrill Thompson Quoted in “House Rules Chair Seeks to Limit Agency Use of Guidance Documents”
FDA Week
October 14, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks Input on Software-As-A-Med Device Regulation”
FierceHealthcare
October 14, 2016 – In the News
Bradley Merrill Thompson Quoted in “Next Step in Global Convergence: FDA Looks to Make IMDRF Software Guidance Its Own”
Medtech Insight
October 14, 2016 – In the News
Bradley Merrill Thompson Quoted in “International Guidance on Software”
Politico Morning eHealth
October 13, 2016 – In the News
Bradley Merrill Thompson Quoted in “Global Group Offers Guidance on Medical Software”
Bloomberg BNA Health Care Daily Report
October 6, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Updates Food Categories in Rare Guidance with ‘Binding Effect'”
FDA Week
September 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Eyes Plan to Lessen Review Burden for Software Updates”
Health Data Management
September 27, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Device Priorities Include Streamlining Clinical Trials”
Bloomberg BNA Medical Devices Law & Industry Report
September 27, 2016 – In the News
Bradley Merrill Thompson Quoted in “Dispatch from FDA/CTA Digital Health Tech Expo”
POLITICO Morning eHealth
September 19, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks to Prevent Opioid Overdoses Through Its First-Ever Mobile App Challenge”
Inside Health Policy, FDA Week, Inside Health Reform, Health Policy Newsstand
September 16, 2016 – In the News
Bradley Merrill Thompson Quoted in “Group Urges Advisory Opinions for Clinical-Decision Support Products”
MedTech Insights
September 7, 2016 – In the News
Bradley Merrill Thompson Quoted in “Special Report: Obama Policy Wind-Up Could Affect Drugmakers, Device Companies”
Bloomberg BNA Health Care Daily Report
September 6, 2016 – In the News
Bradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA for Guidance on Drug Treatment Software”
CTel Center for Telehealth & e-Health Law
September 5, 2016 – In the News
Bradley Merrill Thompson Mentioned in “Apple Guidelines Could Help Boost Health App Quality”
Fierce Healthcare
August 23, 2016 – In the News
Bradley Merrill Thompson Quoted in “Include Risk Tolerance Info in Device Approval Requests: FDA”
Bloomberg BNA Medical Devices Law & Industry Report
August 23, 2016 – In the News
Bradley Merrill Thompson Featured in “Brad Thompson: FDA Software Guidance Provides Much-Needed Clarity”
Fierce Healthcare
August 22, 2016 – In the News
Bradley Merrill Thompson Quoted in “Software Coalition to FDA: Revamp Guidance Approach by Using Advisory Opinions”
Inside Health Policy, Inside Health Reform, FDA Week
August 22, 2016 – In the News
Bradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA”
POLITICO Morning eHealth
August 19, 2016 – In the News
Bradley Merrill Thompson Quoted in “Medical Software Group Presses FDA for Regulatory Clarity”
Bloomberg BNA Medical Devices Law & Industry Report
August 18, 2016 – In the News
Bradley Merrill Thompson, James Boiani Quoted in “Attorneys Question Usefulness of New Combo Products Pre-RFD Process”
FDA Week
August 18, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Says It Won’t Regulate Fitbit, Many Other Fitness Wearables”
The Advisory Board’s The Daily Briefing
August 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Guidance Confirms Agency Won’t Actively Regulate Low Risk General Wellness Products”
eHealth Law & Policy Journal
August 10, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Guidance Regulates Device, Software Changes”
Health Data Management
August 8, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Guidance Could Improve Cybersecurity”
POLITICO Morning eHealth
August 5, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Outlines When New Clearances Are Needed for Existing Devices”
Bloomberg BNA Medical Devices Law & Industry Report
August 2, 2016 – In the News
Bradley Merrill Thompson Discusses How the FDA’s Final Guidance on Low-Risk Devices Will Affect Wearables, in Multiple Publications
Multiple Publications
August 1, 2016 – In the News
Bradley Merrill Thompson Quoted in “What It Will Take for Theranos to Make a Comeback”
Fast Company
July 29, 2016 – In the News
Bradley Merrill Thompson Discusses FDA’s Final Guidance on Low Risk Devices, in Multiple Publications
Multiple Publications
July 21, 2016 – In the News
Bradley Merrill Thompson Quoted in “Google’s App a Medical Device?”
POLITICO Morning eHealth
June 24, 2016 – In the News
Bradley Merrill Thompson Quoted in “Attorneys Want FDA to Improve Postmarket Compliance Guidance”
Bloomberg BNA Medical Devices Law & Industry Report
June 14, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Will Allow Device Makers to Use Symbols in Labels”
Bloomberg BNA Medical Devices Law & Industry Report
May/June 2016 – In the News
Bradley Merrill Thompson Mentioned in “Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down”
FDLI Update Magazine
May 25, 2016 – In the News
Bradley Merrill Thompson Quoted in “Industry Lawyer Urges FDA to Release Combo Product Final Rule”
Bloomberg BNA Medical Devices Law & Industry Report
May 9, 2016 – In the News
Bradley Merrill Thompson Quoted in “Republican Senators Press FDA on Use of Draft Guidances”
Bloomberg BNA Pharmaceutical Law & Industry Report
May 2, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Drug, Device Divisions Not on Same Page?”
POLITICO Prescription Pulse
April 29, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Concerns: Drugs and Devices”
POLITICO Morning eHealth
April 25, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Ban on Certain Electrical Stimulation Devices”
Bloomberg BNA Medical Devices Law & Industry Report
April 12, 2016 – In the News
Bradley Merrill Thompson Quoted in “Health Apps: Unlimited Promise or ‘Like Having a Really Bad Doctor'”
Los Angeles Times
April 5, 2016 – In the News
Bradley Merrill Thompson Quoted in “FTC Guidance Tells Health App Makers What Laws Apply”
Bloomberg BNA Medical Devices Law & Industry Report
March 23, 2016 – In the News
Bradley Merrill Thompson Discusses FTC’s Stance on Mobile Health App Regulation, in Multiple Publications
Health Data Management
March 2016 – In the News
Bradley Merrill Thompson Quoted in “Coalition Survey Highlights CDS Uncertainty”
eHealth Law & Policy Journal
March 10, 2016 – In the News
Bradley Merrill Thompson Quoted in “Medical Software Industry Again Calls for Better Regulations”
Bloomberg BNA Medical Devices Law & Industry Report
March 10, 2016 – In the News
Bradley Merrill Thompson Discusses the Senate HELP Committee’s Passage of the MEDTECH Act, in Multiple Publications
Multiple Publications
March 10, 2016 – In the News
Bradley Merrill Thompson Quoted in “Senate Bill Imposes Limits on FDA Regulation of Apps, Software”
Health Data Management
March 9, 2016 – In the News
Bradley Merrill Thompson Mentioned in “Senate Tweaks Bill to Let FDA Step in If Health Software Poses Serious Risk”
Inside Health Policy
March 7, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Unveils Updated Combination Products Effort”
Bloomberg BNA Medical Devices Law & Industry Report
March 4, 2016 – In the News
Bradley Merrill Thompson Featured in “FDA May Change Refurbished Device Oversight, Attorney Says”
Bloomberg BNA Medical Devices Law & Industry Report
March 3, 2016 – In the News
Bradley Merrill Thompson Quoted in “Hypertense About Blood Pressure App”
POLITICO Morning eHealth
February 26, 2016 – In the News
Bradley Merrill Thompson Discusses Software Developers’ Need for MEDTECH Act, in Multiple Publications
Multiple Publications
February 24, 2016 – In the News
Bradley Merrill Thompson Quoted in “FTC Action Risks Stifling Innovation, Health App Inventor Says”
Bloomberg BNA Medical Devices Law & Industry Report
February 22, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks Feedback on Plan for Medical Device Interoperability”
Health Data Management
February 19, 2016 – In the News
Bradley Merrill Thompson Quoted in “Software Companies Push FDA for Guidance on Decision Support Tools”
Bloomberg BNA Health IT Law & Industry Report, Bloomberg BNA Health Care Blog
February 18, 2016 – In the News
Bradley Merrill Thompson Quoted in “Surely You Must Be Postal”
POLITICO Morning eHealth
February 11, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Meets With Clinical Decision Support Firms to Address Challenging Cases”
The Gray Sheet
February 9, 2016 – In the News
Bradley Merrill Thompson Featured in Podcast Q&A, “Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort”
The Gray Sheet
February 8, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Combination Products Design Draft Guidance”
Bloomberg BNA Medical Device Today
January 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “Feds: Theranos’s Deficiencies Put Patient Safety in ‘Immediate Jeopardy'”
Fast Company
January 28, 2016 – In the News
Bradley Merrill Thompson Quoted in “FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives”
FDA Week
January 26, 2016 – In the News
Bradley Merrill Thompson Discusses FDA’s Draft Guidance on Medical Device Interoperability with Multiple Publications
Multiple Publications
January 15, 2016 – In the News
Bradley Merrill Thompson Quoted in “Class Action Filed Against Fitbit in the US Over Accuracy Claims”
eHealth Law & Policy
January 13, 2016 – In the News
Bradley Merrill Thompson Quoted in “Due to This Obscure Loophole, Some Medical Tests Avoid Oversight”
Fast Company
January 11, 2016 – In the News
Bradley Merrill Thompson Quoted in “OUTLOOK 2016: Lab Tests, Cybersecurity, Off-Label Use Among Top Device Issues”
Bloomberg BNA Medical Devices Law & Industry Report
December 29, 2015 – In the News
Bradley Merrill Thompson Quoted in “Fiscal 2016 Device Guidance List”
Bloomberg BNA Medical Devices Law & Industry Report
December 28, 2015 – In the News
Bradley Merrill Thompson Quoted in “Theranos’s Alleged Tampering With Data is Almost Unheard of in Biotech, Say Experts”
Fast Company
December 15, 2015 – In the News
Bradley Merrill Thompson Quoted in “5 Bold Predictions for Medtech in 2016”
Medical Device and Diagnostic Industry (MD+DI)
December 10, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Targets More Firms Marketing Genetic Tests”
Bloomberg BNA
December 4, 2015 – In the News
Bradley Merrill Thompson’s Combination Products Q&A Featured as MEDFlix Top Video of 2015
MedTech Intelligence
November 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “Mobile Health App Developers Seek Guidance on Federal Regulations”
American Association for the Advancement of Science (AAAS)
Fall 2015 – In the News
Bradley Merrill Thompson’s Articles and Comments on Legislation and Regulatory Guidance For Mobile Health Apps Cited in Maryland Law Review
Maryland Law Review
October 30, 2015 – In the News
Bradley Merrill Thompson Quoted in “Theranos Scrutiny Shows FDA’s Murky Oversight of Lab Tests”
Law360
October 28, 2015 – In the News
Bradley Merrill Thompson Quoted in “Theranos – The Mess Gets Bloodier Still”
POLITICO Morning eHealth
October 23, 2015 – In the News
Bradley Merrill Thompson Mentioned in “FDA’s ‘Ossification Tango’ Side 2: What’s the Social Cost?”
Telehealth & Telecare Aware
October 21, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Issues Regulatory Science Priorities”
POLITICO Morning eHealth
October 19, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Combo Products Report Good First Step, Lawyers Say”
Bloomberg BNA’s Health Care Blog
October 16, 2015 – In the News
Bradley Merrill Thompson Featured in “FDA’s Combo Products Report Good First Step, Lawyers Say”
Bloomberg BNA Pharmaceutical Law & Industry Report
September 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “UC Riverside Professor Slams Feds, Stands by His Health App”
KQED Public Television
September 17, 2015 – In the News
Bradley Merrill Thompson Quoted in “Fitbit Wellness Platform Now HIPAA Compliant”
HealthData Management
September 15, 2015 – In the News
Bradley Merrill Thompson Quoted in “Clinical Trials, Combo Products Among FDA Commish Nominee Califf’s Priorities”
The Gray Sheet
September 10, 2015 – In the News
How the FDA Process Is Biased Against New Technology
Mobi Health News
September 1, 2015 – In the News
Bradley Merrill Thompson Mentioned in “Avoiding the FDA Health IT-Medical Device Regulatory Trap for General IT Companies”
Telehealth & Telecare Aware
August 10, 2015 – In the News
Bradley Merrill Thompson Grades the Government’s Work in “FDA Report Card 2015”
Medical Device and Diagnostic Industry (MD+DI)
July 26, 2015 – In the News
Bradley Merrill Thompson Featured in “Navigating FDA Regulations of Medical Software”
Clinical Innovation & Technology
July 24, 2015 – In the News
Bradley Merrill Thompson Quoted in “Senate Bill Aims to Streamline FDA Approval of Combination Products”
Pharmaceutical Law & Industry Report
July 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “CDS Coalition to FDA: Craft Plan to Classify New Health Information Tech”
FDA Week
July 23, 2015 – In the News
Bradley Merrill Thompson Featured in “Group Calls for Classification Clarity Before Clinical-Decision Support Guidance”
The Gray Sheet
July 13, 2015 – In the News
Bradley Merrill Thompson Quoted in “Device Industry May Seek Product Review Changes”
Health Care Report Daily
July 7, 2015 – In the News
Bradley Merrill Thompson Featured in “Progress of FDA’s Office of Combination Products” Video Q&A
MedTech Intelligence
July 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Guidance Describes Plans to Exempt Multiple Types of Devices from 510(k)”
Bloomberg BNA
June 25, 2015 – In the News
Bradley Merrill Thompson Quoted in “Device Center Leader Asks If FDA Should Develop User Fee Goals for Combo Products”
Pharmaceutical Law & Industry Report
June 24, 2015 – In the News
Bradley Merrill Thompson Quoted in “The FDA Doesn’t Want to Regulate Wearables, and Device Makers Want to Keep It That Way”
The Verge
June 12, 2015 – In the News
Bradley Merrill Thompson, James Boiani Quoted in “House Committee Draft Bill Would Change Regulation of Diagnostic Tests”
Medical Devices Law & Industry Report
June 8, 2015 – In the News
Bradley Merrill Thompson Quoted in “Regulatory Agenda Includes Updates on Combo Products, Labeling Rules”
Medical Device Reporter
June 4, 2015 – In the News
Bradley Merrill Thompson Quoted in “Burgess Is Reworking His Interoperability Bill – Privacy Advocates Speak Out – Docs Attack 21st Century Bill”
Politico
May 28, 2015 – In the News
Bradley Merrill Thompson Quoted in “Cures Bill Retains FDA Oversight of Software Used in Blood Transfusions”
Inside CMS
May 26, 2015 – In the News
Bradley Merrill Thompson Quoted in “Updated SOFTWARE Act: Still Too Ambiguous for Industry?”
The Gray Sheet
May 20, 2015 – In the News
Bradley Merrill Thompson Provides Additional Commentary Regarding the 21st Century Cures Act
Multiple Publications
May 13, 2015 – In the News
Bradley Merrill Thompson Quoted in “Sen. Alexander Begins Investigation Into Agencies’ Use of Regulatory Guidance”
Health Care Daily Report
May 12, 2015 – In the News
Bradley Merrill Thompson Quoted in “2nd Cures Draft Pegs Low-Risk Software Exempt from FDA, but Gives Agency Some Latitude”
FDA Week
May 11, 2015 – In the News
Bradley Merrill Thompson Quoted in “Manufacturers Seek More Clarity On GMP Obligations for Combo Products”
The Gray Sheet
April 30, 2015 – In the News
Bradley Merrill Thompson Quoted in Multiple Publications Regarding the 21st Century Cures Act
Multiple Publications
April 28, 2015 – In the News
Bradley Merrill Thompson Quoted in Multiple Publications Regarding the MEDTECH Act
Multiple Publications
April 27, 2015 – In the News
Bradley Merrill Thompson Quoted in “Medical Apps Tricky for Pharma”
PharmExec.com
April 27, 2015 – In the News
Bradley Merrill Thompson Quoted in “Industry Supportive of FDA Move on Device Accessories, Wellness Products”
Bloomberg BNA's Health Care Daily Report
April 24, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Expresses Desire to Work with Industry on CGMPs for Combination Products”
Healthcare Packaging
April 15, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Expresses Desire to Work with Industry on CGMPs for Combo Products”
Regulatory Affairs Professionals Society
March 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “Industry Proposes Its FDA Guidance Priorities, Reforms”
The Gray Sheet
March 22, 2015 – In the News
Bradley Merrill Thompson Quoted in “Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?”
The Wall Street Journal
March 19, 2015 – In the News
Bradley Merrill Thompson Quoted in “Stakeholders Float Ways to Speed FDA Development of Final Guidance”
FDA Week
March 10, 2015 – In the News
Bradley Merrill Thompson Quoted in “Accompanying Apple Watch, a Medical Surprise”
Politico
March 5, 2015 – In the News
Bradley Merrill Thompson Quoted in “Scope Blamed for Superbug Infections Not FDA Cleared”
Medical Device and Diagnostic Industry
February 25, 2015 – In the News
Bradley Merrill Thompson Quoted Regarding the FTC’s Actions on Mobile Apps Marketing Claims – Media Coverage Roundup
Multiple Publications
February 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Clears Path for Some Genetic Tests to Skip 510(k) Process”
FDA Week
February 20, 2015 – In the News
Bradley Merrill Thompson Comments on the FDA’s Permission to Market Genetic Test for Bloom Syndrome to Consumers – Media Coverage Roundup
Multiple Publications
February 20, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Signals Easier Rule on Genetic Tests” – The Wall Street Journal
The Wall Street Journal
February 11, 2015 – In the News
Bradley Merrill Thompson Quoted in “Despite FDA Moves, Push Continues for Congress to Act on Mobile Health”
Politico Pro
February 10, 2015 – In the News
Bradley Merrill Thompson Mentioned in “FDA Final Guidance on mHealth Eases Regulation of MDDS, mHealth (Updated)”
Telehealth & Telecare Aware
February 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Finalizes Plans to Deregulate MDDS Health Software”
MobiHealthNews
February 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Lightens Regulations on Medical Device Data Systems, Mobile Apps”
Health Data Management
February 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Officially Halts Oversight of Passive Device Data Systems”
Pharma & MedTech Business Intelligence's The Gray Sheet
February 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Issues New Guidance; Won’t Regulate Low-Risk Device Data Systems”
BNA Snapshot
February 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Makes Official Its Hands-Off Approach to Regulating Health Apps and Medical Software”
Venture Beat
February 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Finalizes Guidance on Medical Device Data Systems”
FierceHealthIT
February 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Takes Lighter Touch with New Health IT Guidance”
Modern Healthcare
February 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA: MDDS Software Will Be Exempted from Class I Regulatory Controls”
FDA Week
February 6, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Won’t Regulate Medical Device Data Systems”
Bloomberg BNA's Medical Devices Law & Industry Report
February 5, 2015 – In the News
Bradley Merrill Thompson Quoted in “Industry: New SOFTWARE Act Provides Certainty”
Pharma & MedTech Business Intelligence's The Gray Sheet
January 30, 2015 – In the News
Bradley Merrill Thompson Quoted in “Draft Bill Shows Congress’ Struggle to Define FDA’s Role in Medical Software”
FDA Week
January 29, 2015 – In the News
Bradley Merrill Thompson Mentioned in “‘21st Century Cures’ Bill Seeks Regulatory Certainty for Health IT”
Health Data Management
January 29, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Clarifies Rules for Drug Containers, Delivery Systems in Draft Guide”
FDA Week
January 29, 2015 – In the News
Bradley Merrill Thompson Quoted in “SOFTWARE Act Would Exempt EHRs, Other Health IT from FDA Regulation”
BNA Snapshot
January 28, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Issues First Approval for Remote Continuous-Glucose-Monitoring App”
Modern Healthcare
January 27, 2015 – In the News
Bradley Merrill Thompson Quoted in “Combo Products Guidance Fills in Gaps on Drug-Delivery Device Regs”
The Gray Sheet
January 27, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Asks for Input on Draft Guidance for Combination Product Manufacturing”
BNA Snapshot
January 26, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Approves Dexcom’s CGM Accessory App Days After Relevant Draft Guidance”
MobiHealthNews
January 26, 2015 – In the News
Bradley Merrill Thompson Quoted in “Accessorize at Your Own Risk: Draft Guidance Clarifies Regs for Device Add-Ons”
The Gray Sheet
January 26, 2015 – In the News
Bradley Merrill Thompson Quoted “FDA Approves DexCom Share Update, Downclassifies CGM Accessory”
The Gray Sheet
January 26, 2015 – In the News
Bradley Merrill Thompson Quoted in “Wellness Draft Guidance Does Its Jobs, Industry Group Says”
The Gray Sheet
January 26, 2015 – In the News
Bradley Merrill Thompson Quoted in “Why 2015 Could Be a Watershed Year for mHealth Regulatory Decisions”
FierceMobileHealthcare
January 25, 2015 – In the News
Bradley Merrill Thompson Quoted Regarding FTC Charges Against Medical App Developer’s Advertising Claims
Multiple Publications
January 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “Bill Eases Limits on ‘Customer Service’ for Research-Only Medical Tests”
FDA Week
January 23, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Move on LDTs Is a Power Grab”
Medical Device and Diagnostic Industry
January 22, 2015 – In the News
Bradley Merrill Thompson Quoted in “FTC Stays Tough on Health Software, Even as FDA Eases Up”
Law360
January 22, 2015 – In the News
Bradley Merrill Thompson Mentioned in “Groundhog Day: FDA and Proposed Oversight of LDTs”
Genomics Law Report
January 21, 2015 – In the News
Bradley Merrill Thompson Comments on FTC Charges Against Medical App Developer’s Advertising Claims – Media Coverage Roundup
Multiple Publications
January 21, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Eased Oversight Is Good Omen for Health IT”
Law360
January 20, 2015 – In the News
Bradley Merrill Thompson Quoted Regarding FDA Draft Guidance on Medical Device Accessories – Media Coverage Roundup
Multiple Publications
January 20, 2015 – In the News
Bradley Merrill Thompson Quoted in “Device Tax Repeal, FDA’s Actions Affecting Industry Remain Top Issues”
Bloomberg BNA's Health Care Daily Report
January 16, 2015 – In the News
Bradley Merrill Thompson Quoted in “Attorney Points to Compounding Regs to Guide FDA in LDT Oversight”
FDA Week
January 14, 2015 – In the News
Bradley Merrill Thompson Quoted in “Lab Directors Look for Ways to Adjust to Proposed LDT Framework”
The Gray Sheet
January 13, 2015 – In the News
Bradley Merrill Thompson Quoted in “CDS a Priority As The Center for Device and Radiological Health Releases 2015 Guidance Plans”
Radiology Business
January 13, 2015 – In the News
Bradley Merrill Thompson Quoted in “Digital Health Dilemma: Regulators Struggle to Keep Pace with Health-Care Technology Innovation”
Government Technology
January 9, 2015 – In the News
Bradley 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”
Politico
January 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Puts Interoperability Guidance on Back Burner”
Modern Healthcare
January 9, 2015 – In the News
Bradley Merrill Thompson Quoted in “CDRH Looks Ahead, and Behind, on Guidance Development”
The Gray Sheet
January 8, 2015 – In the News
Bradley Merrill Thompson Quoted in “CDRH Sets Performance Goals to Reduce Draft Guidance Ambiguity”
The Gray Sheet
January 5, 2015 – In the News
Bradley Merrill Thompson Quoted in “FDA Lab- Testing Regulation in the Crossfire”
POLITICO Pro
December 30, 2014 – In the News
itemprop="url">Bradley Merrill Thompson Quoted in “Consulting Services at a Discount for mHealth Firms Targeting the Underserved”
The Gray Sheet
December 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “How FDA Approved Hysterectomy Tools It Now Disfavors” – The Wall Street Journal
The Wall Street Journal
December 12, 2014 – In the News
Bradley Merrill Thompson Provides Commentary in “ONC Outlines Plan to Expand Telehealth, Mobile Health”
The Gray Sheet
December 12, 2014 – In the News
Bradley Merrill Thompson Quoted in “In-Depth: News, Novel Quotes, and Notable Trends from the mHealth Summit 2014″
MobiHealthNews
December 10, 2014 – In the News
Bradley Merrill Thompson Quoted in “Health Tech Attorney: MEDTECH Act Won’t Offer Oversight Clarity or Promote Innovation”
Bloomberg BNA
December 5, 2014 – In the News
Bradley Merrill Thompson Comments on the MEDTECH Act – Media Coverage Roundup
Multiple Publications
December 3, 2014 – In the News
itemprop="url">Bradley Merrill Thompson Launches Aventor to Advise Mobile Health Entrepreneurs on Aiding the Poor – Media Coverage Roundup
Multiple Publications
November 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “Assessing the Good and the Bad in the LDT Guidances”
Medical Design Technology
November 5, 2014 – In the News
Bradley Merrill Thompson, James A. Boiani Quoted in “GOP Senate Will Press FDA to Ease Up”
Law360
October 10, 2014 – In the News
Bradley Merrill Thompson Quoted in “6 Secrets of Highly Paid Partners” – Law360
Law360
October 9, 2014 – In the News
itemprop="url">Epstein Becker Green’s Bradley Merrill Thompson and Kim Tyrrell-Knott Represent Becton Dickinson in $12 Billion Acquisition – Media Coverage Roundup
Multiple Publications
October 8, 2014 – In the News
Bradley Merrill Thompson Quoted in “Health IT Oversight Requires Legislative Action, Groups Argue” – FierceHealthIT
FierceHealthIT
October 8, 2014 – In the News
Bradley Merrill Thompson Quoted in “IBM, Oracle Prod Congress to Clarify FDA’s Health IT Powers” – Law360
Law360
October 7, 2014 – In the News
October 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “Industry Groups Asking Congress to Outline FDA Oversight of Health IT” – Bloomberg BNA
Bloomberg BNA
October 3, 2014 – In the News
Bradley Merrill Thompson Quoted by FDA Week in “FDA Should Define Company ‘Influence’ On Social Media Platforms”
FDA Week
October 2, 2014 – In the News
itemprop="url">Bradley Merrill Thompson and Robert Hudock Quoted by Modern Healthcare in “FDA Seeks Cybersecurity Assessments from Medical-Device Makers”
Modern Healthcare
October 1, 2014 – In the News
Bradley Merrill Thompson Quoted in “An Active Fall Anticipated for mHealth Regulatory Policymaking” – The Gray Sheet
The Gray Sheet
September 29, 2014 – In the News
Bradley Merrill Thompson Quoted by Health Data Management in “Quinn Leaves FCC Health Unit After Short Stint”
Health Data Management
September 29, 2014 – In the News
Bradley Merrill Thompson Quoted in “Pressure Builds on FDA to Overhaul Guidance Process” – Law360
Law360
September 22, 2014 – In the News
September 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “Court Again Vacates FDA Combination Product Classification for Prevor Skin Wash”
Bloomberg BNA
September 12, 2014 – In the News
Bradley Merrill Thompson Comments on Apple Watch and Health Apps
Multiple Publications
September 9, 2014 – In the News
Bradley Merrill Thompson Quoted in “As Apple Moves into Health Apps, What Happens to Privacy?”
Wall Street Journal
September 9, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Defends Lab Test Oversight Before Critical Lawmakers”
Law360
August 27, 2014 – In the News
Bradley Merrill Thompson Quoted in “Amazon, FDA Meeting a Harbinger for Potential Healthcare Move”
Fiercehealthit.com
August 22, 2014 – In the News
Bradley Merrill Thompson Quoted in “Apple, Google Are Jumping Into Health Care. Is Amazon Next?”
Forbes.com
August 21, 2014 – In the News
Bradley Merrill Thompson Quoted in “Amazon Meets with FDA, Healthcare is Likely the Topic”
ModernHealthcare.com
August 11, 2014 – In the News
Bradley Merrill Thompson Quoted in “Med Management Market to Pass $1.6 Billion by 2019″
FierceHealthIT
August 9, 2014 – In the News
Bradley Merrill Thompson Quoted in “Lenient Regulations for Digital Medical Devices”
BioSpectrum India
August 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “Benefits of New Premarket Device Exemptions Not Clear, Attorneys Say”
FDA Week
August 6, 2014 – In the News
Bradley Merrill Thompson Quoted in “Will FDA Regulate Your Mobile Medical App?”
Medical Device and Diagnostic Industry
August 5, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Stakes Out Exemptions to Medical Device Premarket Requirements”
Medical Practice Insider
August 5, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Asserts Regulatory Authority Over Laboratory Developed Tests”
BNA Medical Device Reporter
August 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “23andMe to Open Database to External Researchers After Securing NIH Grant”
FierceBiotechIT
August 4, 2014 – In the News
Bradley Merrill Thompson and James A. Boiani Mentioned in “Breaking Down the Regulation of LDTs: Moving Forward”
Medical Design Technology
August 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Suggested Deregulation Affects Smart Scales, Fertility Thermometers, and More”
MobiHealthNews
August 1, 2014 – In the News
Bradley Merrill Thompson Quoted in “Draft Guidance Would Exempt Some Devices from Premarket Notification Requirement”
BNA
August 1, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Deregulation of Several Medical Devices”
FierceMobileHealthcare
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Targets ‘High-Risk’ LDTs In Notice Outlining Regulatory Framework”
FDA Week
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Lab Test Oversight Will Touch Off Industry Tug-Of-War”
Law360
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “ACLA Rebukes Idea of Congress Handling Confusion Over LDTs as It Did HIT”
FDA Week
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “Top FDA Device Official Skeptical Of Breakthrough Path For Companion Dx”
FDA Week
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes to Exempt Dozens of Devices from 510(k) Requirements”
The Gray Sheet
July 31, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Seeks to Regulate Lab-Developed Tests”
The Wall Street Journal
July 30, 2014 – In the News
Bradley Merrill Thompson Quoted in “23andMe Gets a $1.4M NIH Grant, Still Awaits FDA Approval”
VentureBeat
July 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Biggest New Policies of 2014: Midyear Report”
Law360
July 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “The LDT Letter Battle”
Medical Design Technology
July 25, 2014 – In the News
Bradley Merrill Thompson Quoted in “ONC Tells Lawmakers Health IT Safety Center Won’t Be a Regulatory Body”
FDA Week
July 22, 2014 – In the News
Bradley Merrill Thompson Quoted in “CMS: Don’t Over- Rely on EHR Decision Support Alerts”
Health Data Management
July 21, 2014 – In the News
Bradley Merrill Thompson and James Boiani Mentioned in “Breaking Down the Regulation of LDTs: Access to Innovative IVDs”
Medical Design Technology
July 18, 2014 – In the News
Bradley Merrill Thompson Quoted in “mHealth Coalition Blasts Agencies for Ignoring HIT Framework Proposals”
FDA Week
July 18, 2014 – In the News
Bradley Merrill Thompson Quoted in “Could Health Apps Save Your Life? That Depends on the FDA”
Venturebeat.com
July 10, 2014 – In the News
Bradley Merrill Thompson Quoted in “Health Industry Groups Largely Support Proposed Framework for Health IT Oversight”
BNA Medical Device Law
July 8, 2014 – In the News
Bradley Merrill Thompson Quoted in “Critics Worry Health IT Regulatory Plan Is Already Outdated”
Modern Healthcare
June 24, 2014 – In the News
Bradley Merrill Thompson Quoted in “Trackers Put Health Data at Hand”
The Wall Street Journal
June 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Issues Guidance on Medical Device Data System”
HealthData Management
June 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “Genetics Startup 23andMe Takes Step on Path to FDA Approval”
Reuters
June 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Draft Proposes No Regulation of Medical Device Data Systems”
BNA
June 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “Can Data from Your Fitbit Transform Medicine?”
The Wall Street Journal
June 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA: New Guidance Underscores Flexible Oversight of Low-Risk Devices”
Inside FDA
June 20, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Loosens Grip in Latest Win for Digital Health Firm”
Law360
June 20, 2014 – In the News
Bradley Merrill Thompson Quoted in “Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement”
The Gray Sheet
June 20, 2014 – In the News
Bradley Merrill Thompson Quoted in “New FDA Mobile Apps Guidance Wins Praise”
Politico Pro
June 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “Are Smartphones the Best Medicine?”
The Hill
June 6, 2014 – In the News
Bradley Merrill Thompson Quoted in “Coalition Uses FDA Device Guidance Meeting to Raise Bigger Process Issues”
FDA Week
June 5, 2014 – In the News
Bradley Merrill Thompson Quoted in “Wanted: A Watchdog for the Mobile Medical App Explosion”
Reuters
June 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “CDRH Looks for Input on Guidance-Development Practices”
The Gray Sheet
June 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Lawmakers Question ONC Authority To Take on New Health IT Activities”
FDA Week
June 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Health Apps Boom While Regs Lag”
Politico
June 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “ONC Queried on Power to Regulate IT”
Modern Healthcare
May 30, 2014 – In the News
Bradley Merrill Thompson Quoted in “ONC Announces Realignment”
Modern Healthcare
May 30, 2014 – In the News
Bradley Merrill Thompson Quoted in “Coalition: OMB Caved to Pressure by Shielding Lab-Made Tests from FDA”
FDA Week
May 22, 2014 – In the News
Bradley Merrill Thompson Quoted in “Combination Product Group Calls For New FDA Policy on Two Kinds of Tests”
Bloomberg BNA's Medical Devices Law & Industry Report
May 19, 2014 – In the News
Bradley Merrill Thompson Quoted in “Healthcare IT Discussion Stresses Local Implementation, Legislation”
The Gray Sheet
May 16, 2014 – In the News
Bradley Merrill Thompson Quoted in “CDS Software Regulation Is A Sticking Point At Tri-Agency HIT Meeting”
FDA WEEK
May 16, 2014 – In the News
Bradley Merrill Thompson Quoted in “Clinical Decision Support Remains Regulatory Gray Area”
Health Data Management
May 16, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDASIA Hearing Spurs Debate Over Role of Congress in Health IT Legislation Health Care Technology”
Bloomberg BNA's Medical Devices Law & Industry Report
May 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “Decision Support Dangers: Who’s Responsible?”
FierceHealthIT
May 14, 2014 – In the News
Bradley Merrill Thompson Quoted in “Role of FDA in Regulating Clinical Decision Support Tools Debated at Meeting”
Bloomberg BNA's Medical Devices Law & Industry Report
May 14, 2014 – In the News
Bradley Merrill Thompson Quoted in “Definition of ‘Function’ Differs Among Health IT Stakeholders”
FierceHealthIT
May 14, 2014 – In the News
Bradley Merrill Thompson Quoted in “Critics Attack FDA for Overly Modest Health IT Regulatory Framework”
Politico
May 6, 2014 – In the News
Bradley Merrill Thompson Quoted in “UPDate 1-Gene Startup 23andme Casts Eyes Abroad After U.S. Regulatory Hurdle”
Reuters
April 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “Overcoming Regulatory Challenges in Companion Diagnostics.”
Medical Design Technology
April 25, 2014 – In the News
Bradley Merrill Thompson Quoted in “Time May Be Ripe for FDA Focus on Apps, Expert Says”
FDA News
April 23, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Expedited Access Program for High-Risk Medical Devices”
Health Data Management
April 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “Global Regulators, Stakeholders Draft ‘Software as a Medical Device’ Framework”
Health Data Management
April 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “Fed HIT Report Provides Few Details on Clinical Decision Support Software.”
Health Data Management
April 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “Sebelius Departure from HHS will have Negligible Effect on HIT”
Health Data Management
April 15, 2014 – In the News
Bradley Merrill Thompson Quoted in “Proposed Oversight Strategy for Health IT Contains Few Surprises, Details, Sources Say”
Bloomberg BNA's Medical Devices Law & Industry Report
April 14, 2014 – In the News
Bradley Merrill Thompson Quoted in “International Regulators Coalition Weighs in on Medical Software Regulation”
Inside Health Policy
April 11, 2014 – In the News
Bradley Merrill Thompson Quoted in “EU Appears Open to Suggestions on Mobile Health Oversight”
The Gray Sheet
April 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “Initial mHealth Framework Proposal: A Mixed Bag”
FierceMobileHealthcare
April 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “Not Much New in FDASIA Report, Congress Still Champing at the Bit”
Mobihealthnews
April 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “mHealth Experts Analyze FDASIA Report”
mHealthNews
April 4, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Goes for ‘Light Touch’ on Health IT”
Healthcare IT News
April 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Tri-Agency Health IT Report Emphasizes Risk-Based Scheme, But Lacks Some Detail, Observers Say”
The Gray Sheet
April 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Tri-Agency HIT Report Pushes ‘Light Touch’ Oversight, Sets Up New Center”
FDA Week
April 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Stays Hands-Off in Long-Awaited Health IT Report”
Law360
April 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Int’l Approach Floated for Medical App Regulation”
Law360
April 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “Feds Release FDASIA Workgroup Report on Health IT Governance”
Government Health IT
April 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “Simplify Mobile Device Classification”
Health IT Outcomes
April 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposal Aims to Streamline Device Classification According to Risk”
Bloomberg BNA's Medical Devices Law & Industry Report
April 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “6 Takeaways from New FDASIA Report”
Government Health IT
April 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “International Forum Issues Guidance Framework on Regulating Device Software”
Bloomberg BNA's Medical Devices Law & Industry Report
April 1, 2014 – In the News
Bradley Merrill Thompson Featured in Video Segment Discusses the Combination Products Regulatory Landscape
Bloomberg BNA's Health Law Resource Center
March 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation”
FDA Week
March 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Draft Guidances Drag Out”
Medical Device and Diagnostic Industry
March 27, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Update to mHealth Rule”
Government Health IT
March 21, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposal Aims to Streamline Device Classification According to Risk Medical Symbol”
Bloomberg BNA's Medical Devices Law & Industry Report
March 21, 2014 – In the News
Bradley Merrill Thompson Quoted in “UK’s Mobile Medical Apps Guidance Parallels FDA’s”
Law360
March 19, 2014 – In the News
March 18, 2014 – In the News
Bradley Merrill Thompson Quoted in “McKesson Tagged with Rare Class I Recall for Clinical Decision Support Software”
The Gray Sheet
March 10, 2014 – In the News
Bradley Merrill Thompson Discusses Recent Regulations Passed by FDA on Medical Mobile Apps
Conversations on Health Care Radio Show
March 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “PROTECT Act Riposte”
The Gray Sheet
March 3, 2014 – In the News
Bradley Merrill Thompson Quoted in “PROTECT Act Under Fire”
Clinical Innovation & Technology
February 28, 2014 – In the News
Bradley Merrill Thompson Quoted in “Debate on Mobile App Regulatory Oversight Heats Up”
FierceMobileHealthcare
February 26, 2014 – In the News
Bradley Merrill Thompson Quoted in “Congress Wants to Kick the FDA Out of Digital Health with This New Bill”
VentureBeat
February 18, 2014 – In the News
Bradley Merrill Thompson Quoted in “Debate Over FDA Oversight of Apps Continues”
Government Health IT
February 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “Senate Bill Takes Aim at Potential for FDA Overreach in IT Regulation.”
FDA News
February 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “Opponents Say PROTECT Act Could Destroy mHealth, Endanger Patients”
mHealthNews
February 13, 2014 – In the News
Bradley Merrill Thompson Quoted in “Senate Bill Shifts Oversight of Clinical Support Software from FDA to NIST”
FDA Week
February 10, 2014 – In the News
Bradley Merrill Thompson Quoted in “Senate Bill Undermines FDA Regulatory Role”
FierceMobileHealthcare
February 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA Health IT Deregulation Bill Coming to the Senate”
The Gray Sheet
January 27, 2014 – In the News
Bradley Merrill Thompson Quoted in “Attorneys, FDA Hit the Road to Instruct on Mobile Health Regs”
The Gray Sheet
January 24, 2014 – In the News
Bradley Merrill Thompson Quoted in “FDA, Industry Groups Launch mHealth Educational Outreach Tour”
FDA WEEK
January 17, 2014 – In the News
Bradley Merrill Thompson Quoted in “MMA Roadshow Explains the Ins and Outs of FDA App Regulation”
mHealthNews
January 16, 2014 – In the News
itemprop="url">Bradley Merrill Thompson and Bethany Hills Quoted in “FDA’s Performance, Medicare Coverage, Pressure from Excise Tax on 2014 Agenda”
Bloomberg BNA's Medical Devices Law & Industry Report
January 16, 2014 – In the News
Bradley Merrill Thompson Quoted in “Nationwide ‘Roadshow’ to Educate mHealth App Developers About FDA Regulations”
FierceMobileHealth
January 10, 2014 – In the News
Bradley Merrill Thompson Quoted in “mHealth Regulatory Coalition Proposes HIT Paradigm, Counters House Bill”
FDA Week
January 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “Increase Your Chances of Survival in the Obamacare Apocalypse”
Medical Device and Diagnostic Industry
January 7, 2014 – In the News
Bradley Merrill Thompson Quoted in “Mobile Health Group Urges Lawmakers to Be Cautious on Regulating New Health IT”
Bloomberg BNA's Medical Devices Law & Industry Report
January 6, 2014 – In the News
Bradley Merrill Thompson Quoted in “mHealth Coalition Counters Blackburn Push Against Health IT Regs”
The Gray Sheet
January 2, 2014 – In the News
Bradley Merrill Thompson Quoted in “MRC to Congress: Don’t Pass Legislation, Wait for FDASIA Report”
FierceMobileHealth
December 17, 2013 – In the News
Bradley Merrill Thompson Quoted in “IMS Health Launches Mobile Prescribing Platform, Health App Development Tool”
Bloomberg BNA's Medical Devices Law & Industry Report
December 16, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Digital Health Regulation Debate Continues at mHealth Summit”
The Gray Sheet
December 12, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “HIT Study to Assert FDA Regulates Clinical Software, Guidance Will Follow”
FDA Week
December 9, 2013 – In the News
Bradley Merrill Thompson Quoted in “EU Health IT Sector on Alert After Parliament Adds ‘Prediction’ to Medical Device Definition”
The Gray Sheet
December 2, 2013 – In the News
Bradley Merrill Thompson Quoted in “Industry Groups, Lawmakers Push Changes to Blackburn HIT Bill”
Inside Health Policy
December 2, 2013 – In the News
Bradley Merrill Thompson Quoted in “Knowledge Is Not Enough for Enforcement in FDA’s Final Research-Use DX Guidance”
The Gray Sheet
December 2, 2013 – In the News
Bradley Merrill Thompson Quoted in “FDA Comes Down Hard on 23andMe, Putting Consumer-Directed Genetic Testing on Notice”
The Gray Sheet
November 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA’s Revised IVD Guide Focuses on ‘Totality of the Circumstances'”
FDA Week
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Removes Firms’ Responsibility to ‘Know’ in Research-Use Only Final Guidance”
The Gray Sheet
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Tells 23andMe to Pull Personal Genome Service”
Bloomberg BNA's Medical Devices Law & Industry Report
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Let the SOFTWARE Act Die in Committee”
FierceMobileHealthcare
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Tells 23andMe to Stop, Get Clearance”
MobiHealthNews
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Congress Must Wait for FDASIA Report”
FierceMobileHealthcare
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Targets DTC Gene Test Company, Possibly Signaling Broader Enforcement”
Inside Health Policy
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Scrutiny Looms for Unapproved Research Tests”
Law360
November 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Representatives Grill Shuren, Advance SOFTWARE Act”
The Gray Sheet
November 22, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “IT Developers Differ Over How Federal Government Should Oversee Health Software”
Bloomberg BNA's Medical Devices Law & Industry Report
November 15, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “DA Lays Down Health Risk Claim Law in 23andMe Warning Letter”
The Gray Sheet
November 14, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “IMS Health Suggests All Mobile Medical Apps Be Subject to Clinical Trials”
Inside FDA
November 9, 2013 – In the News
November 9, 2013 – In the News
Bradley Merrill Thompson Quoted in “Mobile Health Apps: Blackburn’s SOFTWARE Act Would Limit FDA’s Power, Ensure Regulatory Restraint”
Forbes.com
October 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Bill Provides Guidance on FDA Mobile Medical Apps Regulation”
FierceMobileHealth
October 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Bill Risks Confusion to Curb FDA’s Already-Lax App Oversight”
Law360
October 28, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Bipartisan House Bill Introduced to Curb FDA Health IT Oversight”
The Gray Sheet
October 28, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Navigating FDA’s Final Mobile App Guidelines: The Good, The Bad, The Unanswered”
PM360
October 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Bipartisan House Bill Attempts to Limit FDA’s HIT Oversight”
FDA Week
October 1, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA’s Mobile Medical Apps Guidance: Our Advisors Weigh In”
FierceMobileHealthcare
September 29, 2013 – In the News
Bradley Merrill Thompson Featured in Article, “FDA Issues Final Guidance on Mobile Medical Apps”
HealthWorks Collective
September 26, 2013 – In the News
Bradley Merrill Thompson Featured in Article, “mHealth Industry Groups Plan to Monitor FDA Enforcement, Software Regs”
FDA Week
September 26, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Plans to Use Enforcement Discretion on Low-Risk Mobile Apps”
FDA Week
September 24, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Experts Praise FDA’s ‘Expansive’ Mobile App Regulations”
mHealthNews
September 24, 2013 – In the News
itemprop="url">Bradley Merrill Thompson Quoted in Article, “With FDA Releasing Final Guidance for Mobile Health Apps, Innovators Have Clarity on Regulatory Policy”
Medivo BTP Insights
September 24, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Developers, IT Groups React to FDA’s Mobile Health App Guidance”
iHealthBeat
September 24, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “7 Takeaways from FDA’s Mobile Medical Apps Guidance”
Law360
September 24, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Final FDA Guidance Provides Clarification and Confusion”
FierceMobileHealthcare
September 23, 2013 – In the News
Bradley Merrill Thompson Featured in Article, “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance”
The Gray Sheet
September 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Releases Final Mobile App Guidance, Reserves Oversight for High-Risk Products”
Bloomberg BNA
September 23, 2013 – In the News
Bradley Merrill Thompson Featured in Article, “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance”
The Gray Sheet
September 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Updates Guidance on Mobile-Software Apps”
The Wall Street Journal
September 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Readers Weigh In: The FDA Should Regulate Mobile Medical Apps”
The Profitability Practice
September 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Final Mobile Medical App Guidance Mirrors 2011 Draft”
FierceMobileHealthcare
September 19, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Lack of FDA Social Media Guidance Isn’t Only Problem Facing Regulated Industry”
Bloomberg BNA's Health Care Daily Report
September 19, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Will FDA Finally Make the Call on Mobile Medical Apps?”
Medical Device and Diagnostic Industry
September 18, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Industry Advocates Call for FDA to Update, Clarify Health IT Regulations”
BNA
September 10, 2013 – In the News
Bradley Merrill Thompson Featured in Article, “Why Regulation of Mobile Medical Apps Isn’t a Bad Thing”
SwayMedical
September 3, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “HIT Stakeholders Propose Modernizing, Limiting FDA Role in Oversight”
Inside Health Policy
September 2, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Role, Safety Oversight Addressed in Health IT Framework Comments”
The Gray Sheet
August 30, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “HIT Stakeholders Propose Modernizing, Limiting FDA Role In Oversight”
FDA Week
August 30, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Urged to Modernize for Sake of mHealth Innovation”
PhysBizTech
August 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Industry Advocates Call for FDA To Update, Clarify Health IT Regulations”
Bloomberg BNA
August 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Advocates Urge FDA to Modernize to Keep Pace with Innovation”
mHealthNews.com
August 20, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Industry Groups Continue Fight over FDA Final Guidance”
FierceMobileHealthcare
August 19, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Pending Mobile Medical Apps Guidance Provokes Heated Controversy”
The Gray Sheet
August 15, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “More Health Apps Out There, But Regulation Lagging”
Congressional Quarterly
August 13, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Groups Divided Over Whether FDA Should Delay Final Mobile Medical Apps Guidance”
BNA Bloomberg
July 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Coalition Proposes FDA Regulatory Framework for Clinical-Decision Support”
Gray Sheet
July 19, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Oversight Suggestions Nearing End of the Beginning”
Government Health IT
July 18, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Stakeholders Divided on House Draft Clarifying FDA’s mHealth Authority”
FDA Week
July 15, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Draft Bill Aims to Clarify FDA Regulation of Mobile Medical Apps”
The Gray Sheet
July 15, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Who Should Oversee mHealth Regs?”
Healthcare IT News
July 15, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “New Regulatory Environment Needed for Mobile Apps”
Medical Device and Diagnostic Industry
July 12, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Who Should Regulate mHealth?”
Government Health IT
June 28, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Regs Spark Debate”
Government Health IT
June 24, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Rep. Honda Reintroduces Bill to Create FDA Office of Wireless Health”
The Gray Sheet
June 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “‘Voice of Mobile Health’ Predicts FDA’s Final Guidance Will Not Mean More Rules”
MedCity News
June 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Mobile Health Groups Say the FDA’s Final Guidance Will ‘Unlock Investment'”
Venture Beat
June 21, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Group Urges FDA to Publish Final Guidance”
mHIMSS
June 21, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Regulatory Coalition Urges FDA to Release Final Apps Guidance”
Fierce Mobile Healthcare
June 11, 2013 – In the News
itemprop="url">Bradley Merrill Thompson Quoted in Article, “FDASIA Workgroup Narrows Focus to Avoid Overregulation, Duplication Food and Drug Administration Logo”
Bloomberg BNA's Medical Devices Law & Industry Report
June 3, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Can’t Hold Back Stream of Mobile Health Apps”
Wired
May 31, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “UChek’s Response to an FDA Letter: An Unfolding Saga”
Medical Device and Diagnostic Industry
May 31, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Letter on Mobile App May Bring Welcome Clarity to Field”
The QMN Weekly Bulletin
May 31, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA’s Mobile App Letter Doesn’t Spell Out Broader Policy”
FDA Week
May 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Warns Mobile Health Apps Makers”
InformationWeek
May 29, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Telemedicine: Mobile App Maker Biosense Receives FDA ‘It Has Come to Our Attention’ Letter”
Bloomberg BNA's Medical Devices Law & Industry Report
May 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Busy Week for FDA and Mobile Health, But No Final Guidelines Yet”
Mobihealthnews.com
May 22, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “FDA Shows Deft Touch with 1st Mobile App Enforcement”
Law360
May 20, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “99 Cent Urinalysis App Raises Questions About mHealth Standards”
The Gray Sheet
May 2, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Health IT Stakeholders Call for New FDA Regulatory Framework, Enforcement”
FDA Week
April 30, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Expert: Don’t Be Too Hands-Off with Medical Apps”
Politico Pro
April 30, 2013 – In the News
itemprop="url">Bradley Merrill Thompson Quoted in Article, “iPads, iPhones, Androids, and Smartphones: FDA Regulation of Mobile Phone Applications as Medical Devices”
Indiana Health Law Review
April 8, 2013 – In the News
Bradley Merrill Thompson Featured in Blog Segment “More Mobile Health App Guidance from FDA for Pharma to Worry About”
Pharma Marketing Blog
April 5, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA’s Light Touch with Medical Apps May Let Industry Bloom”
Law360
April 3, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Telemedicine: FDA Will Not Regulate Consumers’ Mobile Devices, Official Tells Panel”
Bloomberg BNA's Medical Devices Law & Industry Report
April 1, 2013 – In the News
Bradley Merrill Thompson Featured in Podcast About FDA’s Final Guidance on the Regulation of Mobile Medical Apps
Pharma Marketing Talk Blog Radio
April 1, 2013 – In the News
Bradley Merrill Thompson Featured in Podcast About the Regulation of Mobile Medical Apps
Mobihealthnews Podcast
March 28, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Congress Explores Potential Regulation of Mobile Health Apps”
SearchHealth IT
March 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Reiterates Intention to Regulate Only a Small Portion of Mobile Medical Apps”
The Gray Sheet
March 21, 2013 – In the News
Bradley 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, 2013
Various
March 21, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Device Official Defends mHealth Oversight Amid Lawmakers’ Concerns”
FDA Week
March 21, 2013 – In the News
Bradley 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”
Pharma Marketing Blog
March 20, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “House Subcommittee Chairman Fears Medical Device Tax on Mobile Health Apps”
Elsevier Business Intelligence: Health News Daily
March 18, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “European Regulation Looms Over Mobile Health”
The Gray Sheet
March 7, 2013 – In the News
At HIMSS, Interoperability Calls Shotgun, in Medical Device and Diagnostic Industry
Medical Device and Diagnostic Industry
March 1, 2013 – In the News
Bradley Merrill Thompson Quoted in Article, “Public vs. Private Oversight of Mobile Health”
Chilmark Research
January 28, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Industry Seeks More Clarity Following Combo Product GMP Final Rule”
The Gray Sheet
January 25, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Modification Guide Could Up-Classify Devices in Combo Products, Lawyer Says”
FDA Week
January 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “FDA Issues Long-Awaited Combo Product GMPs, Industry Seeks Further Guidance”
InsideHealthPolicy.com
January 23, 2013 – In the News
Bradley Merrill Thompson Quoted in Article “Off-Label Promotion, Enforcement, 510(k) Revisions Are Key Issues for Industry in 2013″
Bloomberg BNA's Medical Devices Law & Industry Report
January 23, 2013 – In the News
itemprop="url">Bradley Merrill Thompson Quoted in Article, “Combination Products: FDA Issues Final Rule on cGMP Requirements for Combination Products, Draft Guidance”
Bloomberg BNA's Medical Devices Law & Industry Report
December 18, 2012 – In the News
Bradley Merrill Thompson Quoted in Article “Combo Products May See Double ACA Tax Under IRS Rule, But Kits Exempt”
Inside Health Policy, 12/17/12
October 19, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Attorney: Proposed mHealth Bill Will Do Little Without More FDA Funding”
FDA Week
October 4, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Social Media Use Presents Challenges for Drug Manufacturers, Experts Say”
Bloomberg BNA's Health Care Daily Report
October 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Should Reassess Hacking Risk in Medical Devices, GAO Says”
The Gray Sheet
October 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Challenges Abound in Creating Regulatory Framework for Mobile Medical Apps, Health IT”
The Gray Sheet
October 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Panel Discusses How New User Fee Law Changes Interactions Between FDA, Industry”
Bloomberg BNA
October 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Federal Task Force Recommends Stepped up Role for FCC in mHealth Policy”
Bloomberg BNA
September 27, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FCC to Hire Health Director, Improve mHealth Collaborations with FDA”
FDA Week
September 26, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Judge Vacates Finding That Prevor Skin Wash Is Drug, Not Device, Sends Case Back to FDA”
Bloomberg BNA
September 18, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Guidance on Mobile Medical Apps Could Come in Early Fall, Attorney Says”
Bloomberg BNA's Medical Device Law
September 12, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “The FDA Takes On Mobile Health Apps”
IEEE Spectrum: Inside Technology
August 7, 2012 – In the News
Bradley Merrill Thompson Quoted in Article “Attorney Says Clarification of FDA Mobile Health Application Guidelines Needed”
Bloomberg BNA's Medical Device Reporter
August 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Voices of Frustration, Uncertainty in Medtech Election Perspective”
Medical Device and Diagnostic Industry
July 26, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Medical App Regulations, Device Security Share the Spotlight at mHealth World Congress”
mHIMSS
July 25, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Congress: Some Mobile Apps Unduly Burdened by Regulation”
HealthImaging
July 25, 2012 – In the News
Bradley Merrill Thompson Featured on Radio Segment Discussing mHealth and Telemedicine
mHealthZone
July 10, 2012 – In the News
Bradley Merrill Thompson Featured in NPR Segment, “When Does an App Need FDA’s Blessing?”
NPR
June 26, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Legislation Clears House, Moves Closer to Final Senate Approval”
Bloomberg's BNA Medical Device Reports
June 22, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Health-Care Apps for Smartphones Pit FDA Against Tech Industry”
The Washington Post
June 20, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Path Opens Up for FDA Regulation of Mobile Medical Apps”
Healthcare Finance News
June 20, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Tweaked FDA Bill Removes Hurdle to Medical App Guidance”
FierceMobileHealthcare
June 19, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Can Go Ahead With Mobile App Guidance”
POLITICO Pro
June 18, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Combination Products Coalition Zeroes in on Autoinjectors and Personalized Medicine”
The Gray Sheet
June 1, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “New Law Cuts Medicare Payments for Clinical Tests”
IVD Technology
May 28, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Mobile Medical App Guidance Faces Delay to 2013″
FierceMobileHealthcare
May 21, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Latest Senate FDA Reform Bill Would Delay Guidance on Mobile Health Apps”
The Gray Sheet
May 17, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA: Bill Has Indirect Moratorium on Apps”
POLITICO Pro
May 15, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Senator Seeks Halt to FDA Moves on Mobile Medical Apps”
POLITICO Pro
April 16, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Tangles with Wireless Medical-App Makers”
Politico
March 28, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Bill Proposes Modernizing IVD Regulations”
IVD Technology
February 23, 2012 – In the News
David Matyas, Bradley Merrill Thompson Quoted in Article, “Regulatory Demands to Spur Health M&A in 2012: Report”
Health Law360
January 30, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Urged to Issue New Draft Guidance on Mobile Medical Apps”
The Gray Sheet
January 27, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Coalition Presses FDA to Revamp Mobile App Guide, Seek More Input”
FDA Week
January 26, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “MRC Pushes for More Time on FDA’s Mobile Medical App Guidance”
FierceMobileHealthcare
January 11, 2012 – In the News
Bradley Merrill Thompson Quoted in Article, “Industry Tax, Changes at FDA, ACOs Among Key Issues for Industry in 2012″
BNA's Medical Device Law & Industry Report
January 4, 2012 – In the News
Bradley Merrill Thompson Provided Commentary in Article, “Examining IVD-Related Election Year Issues”
IVD Technology
December 12, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “iPad: ‘Wild West’ of Medical Apps Seeks Sheriff”
Wired
December 5, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Mobile Health
Wired
December 2, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Releases Guidance on Companion Diagnostics”
IVD Technology
November 29, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “New Coalition Will Attempt to Unite Stakeholders on Clinical Software Regulation”
BNA's Medical Device Law & Industry Report
November 14, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Next Up for Washington Attorney: Regulatory Clarity for Clinical Decision Support Tools”
The Gray Sheet
November 7, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Part I: If You Write an App, the FDA Will Come”
FierceMobileHealthcare
November 7, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Part II: What Does the FDA Want?”
FierceMobileHealthcare
November 6, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Hospitals, Vendors Team to Influence FDA, HHS on Decision Support”
FierceMobileHealthcare
November 1, 2011 – In the News
Mark Lutes Quoted in Article, “Payers Gain Influence Over the Delivery Side of Healthcare Through Acquisition Deals”
Managed Healthcare Executive
October 24, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Would a Fixed-Term FDA Commissioner Help Industry? Maybe, Maybe Not”
The Gray Sheet
October 3, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “mHealth Reg Coalition Creates Risk Assessment Tool for FDA”
FierceMobileHealthcare
September 21, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “FTC Settles Cases Alleging Unsubstantiated Claims by Developers of Apps to Cure Acne”
BNA Medical Device Law Reporter
September 15, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA’s Deferral to FTC on mHealth Enforcement Raises Questions”
FDA Week
September 15, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “Mhealth Advocates Press FDA to Consider Risk in Assessing Apps”
FDA Week
September 13, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Mobile Apps Workshop: When Is a Car a Medical Device Accessory?”
CMIO.net and Cardiovascular Business
September 13, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “FDA Forum Explores Regulation of Mobile Medical Apps”
DrBicuspid.com
September 9, 2011 – In the News
Bradley Merrill Thompson Quoted in Article, “US Regulators Remove Two Acne Medical Apps”
Mobilehealthnews.com
September 2, 2011 – In the News
Bradley Merrill Thompson Quoted in an Article About Hacking Mobile Devices
FDA Week
August 31, 2011 – In the News
Bradley Merrill Thompson and Jason Brooke Coauthor Chapter on In Vitro Diagnostic Devices, in Medical Devices Answer Book
Medical Devices Law and Regulation Answer Book
August 10, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA’s Mobile Health Care Application Guidelines
BNA Medical Devices Law & Industry Report
August 1, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Mobile Medical Apps
The Gray Sheet
July 26, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA’s Mobile Apps Guidance
BNA Medical Device Law and Industry
July 25, 2011 – In the News
Bradley Merrill Thomson Quoted in Blog About FDA Draft Guidance
Pharmaphorum Blog
July 25, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Mobile Medical Apps
The Gray Sheet
July 21, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA’s Mobile App Guidance
FDA Week Today
July 21, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Proposed Rule for Mobile Apps
InformationWeek
July 20, 2011 – In the News
Bradley Merrill Thompson Quoted in an Article About FDA’s Proposed Guidance for Certain Mobile Medical Apps
Medscape Today News
July 20, 2011 – In the News
Bradley Merrill Thompson Comments on Device Apps Guidance
Medical Device & Diagnostic Industry Blog
July 19, 2011 – In the News
Bradley Merrill Thompson Featured in Article About Mobile Medical Apps
FierceMobileHealthcare
July 19, 2011 – In the News
Bradley Merrill Thompson Appeared in Article About FDA’s Mobile Apps Guidance
Inside Health Policy
July 7, 2011 – In the News
Bradley Merrill Thompson Featured in Article About Classification for mHealth Devices
FierceMobileHealthcare
July 7, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About mHealth Software Apps
FDA News
June 15, 2011 – In the News
Bradley Merrill Thompson Featured in Article About FDA Draft Guidance on “Research Use Only” for Diagnostic Devices
BNA's Medical Devices Law & Industry Report
June 6, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Research- Only Test
The Gray Sheet
May 22, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Regulatory Issues Health IT Firms Face
The Washington Post
May 19, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Proposing That FDA Regulate mHealth Accessory Products
FDA Week
May 15, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About In-Vehicle Mobile Health Concept
The Gray Sheet
May 9, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Guidance on Research-Use Tests
The Gray Sheet
May 9, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Mobile Health App Guidance
The Gray Sheet
April 25, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Rules for Combination Products
Health News Daily
April 21, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Device Data Systems
Medical Device + Diagnostic Industry
March 15, 2011 – In the News
Bradley Merrill Thompson, Leah Kendall: Article on Top Ten FDA Development Issues for 2011
Drug Development & Delivery
March 15, 2011 – In the News
Bradley Merrill Thompson Quoted in Report About New Medical Devices
PharmaLive's New Medical Device Report
February 24, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Final Rule for Reclassification of Medical Devices
BNA Medical Device Law & Industry Report
February 18, 2011 – In the News
Bradley Merrill Thompson Comments on Article About FDA Rule of Mobile Health
FierceMobileHealthcare
February 15, 2011 – In the News
Bradley Merrill Thompson Writes on Understanding the FDA’s New MDDS Rule
mobihealthnews.com
February 10, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Clearance of First Diagnostic Radiology App
FDA Week
February 9, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About Radiology Mobile Apps
MedCity News
February 1, 2011 – In the News
Bradley Merrill Thompson Quoted in Article About FDA Processes
BNA's Medical Devices Law & Industry Report
January 14, 2011 – In the News
Bradley Merrill Thompson Comments on Mobile Health Regulatory Plan
The Gray Sheet
January 2, 2011 – In the News
Bradley Merrill Thompson Quoted on mHealth Issues
FDA Week
December 22, 2010 – In the News
Bradley Merrill Thompson Comments on Impact of Midterm Elections on the IVD Industry
IVD Technology
October 20, 2010 – In the News
Thompson Comments on FDA Probe on Recalled Devices
Bloomberg News
October 15, 2010 – In the News
Thompson Quoted in E-book About mHealth
Fierce Wireless
September 14, 2010 – In the News
Thompson Comments on m-Health Regulation
FierceMobileHealthcare
September 13, 2010 – In the News
Thompson Quoted on FDA Guidance on Mobile Health Technology
The Gray Sheet
September 8, 2010 – In the News
Thompson Comments on How FDA Is Evaluating Medical Smartphone Apps
eWeek
August 31, 2010 – In the News
Thompson Interviewed on App Store Monitoring by the FDA
Future Tense with John Moe, of American Public Media
August 31, 2010 – In the News
Thompson Quoted in Article About FDA Surveillance of App Stores
GIGAOM
August 25, 2010 – In the News
Thompson Featured in Article About FDA Regulation of Mobile Health Products
BNA's Medical Devices Law & Industry Report
July 14, 2010 – In the News
Thompson Comments on Formation of mHealth Regulatory Coalition
MobiHealthNews
June 17, 2010 – In the News
Thompson Quoted in Article About Medical Smartphone Apps Industry
DOTmedbusiness
June 15, 2010 – In the News
Thompson Comments on Formation of Mobile Health Coalition
BNA Publications
June 1, 2010 – In the News
Thompson Quoted in Article About Radiological Devices
IVD Technology
May 17, 2010 – In the News
Thompson Quoted in Article About Mobile Medical Devices
Device & Diagnostic Letter
April 9, 2010 – In the News
Thompson Quoted On Expected Regulation Of Mobile Health Devices
Federal Computer Week
March 26, 2010 – In the News
Thompson Interviewed On FDA and FCC Approvals For Smart Phones
FDA Week
February 26, 2010 – In the News
Thompson Quoted On Possible FDA Oversight Of Health Information Technology
BNA's Health IT Law & Industry Report
February 15, 2010 – In the News
Thompson Quoted On Benefits For Health IT Software Developers of FDA Oversight
The Gray Sheet
February 8, 2010 – In the News
Thompson Quoted On Need For Regulatory Clarity In Mobile Health Devices Field
The Gray Sheet
February 1, 2010 – In the News
Thompson Quoted On FDA’s Proposed Adverse Event Reporting Requirements
The Gray Sheet
January 28, 2010 – In the News
Thompson Quoted On FDA’s ‘Streamlined Approach’ To Combination Products
The Gray Sheet
November 25, 2009 – In the News
Thompson Quoted On Need To Expedite OIVD Review Process
IVD Technology, November/December 2009
November 19, 2009 – In the News
Thompson Discusses How FDA May Regulate Mobile Health Technology
MobileHealthNews.com
October 2, 2009 – In the News
Thompson Quoted On FDA’s Proposed Rule on Postmarket Safety Reporting Requirements For Combination Products
BNA's Health Care Daily Report
September 24, 2009 – In the News
Thompson Quoted On New FDA Framework for Combination Products
BNA 's Health Care Daily Report
September 23, 2009 – In the News
Thompson Quoted On FDA Rule On Good Manufacturing Practices For Combo Products
Health News Daily
September 18, 2009 – In the News
Thompson Quoted On FDA Rules To Be Issued For Comments
Health News Daily
September 11, 2009 – In the News
Thompson Quoted On Planned FDA, Industry Meeting
FDA Week
September 7, 2009 – In the News
Bradley Thompson Quoted On FDA Good Guidance Practices
The Gray Sheet, Medical Devices Today
August 26, 2009 – In the News
Bradley Thompson Quoted On FDA Regulation of Mobile Phones
Medical Device Daily
August 1, 2009 – In the News
Bradley Thompson Quoted on Rise of Adverse Events Reported for Medical Devices
MD&DI Medical Device & Diagnostic Industry
July 1, 2009 – In the News
Bradley Thompson Quoted on Regulatory Issues for Convergent Technologies
MD&DI Medical Device & Diagnostic Industry
June 17, 2009 – In the News
Bradley Thompson Quoted On Move Toward Transparency At FDA
BNA's Medical Devices Law & Industry Report
June 5, 2009 – In the News
Bradley Thompson Quoted On Priorities Of Combination Product Industry
BNA's Pharmaceutical Law & Industry Report
June 1, 2009 – In the News
Bradley Thompson Quoted On FDA Regulation of Laboratory Developed Tests
IVD Technology
February 16, 2009 – In the News
Bradley Thompson Quoted on FDA Review Process for High-Risk Medical Devices
BNA's Health Care Daily Report
November 20, 2008 – In the News
Thompson Quoted on Gunvalson Case and Drug Companies
Nature Biotechnology
October 10, 2008 – In the News
Bradley Thompson Quoted on Impact of Gunvalson Case on Medical Trials
The Regulatory Affairs Journal
September 4, 2008 – In the News
Brad Thompson Quoted on ‘Unique’ Case Over Access to Experimental Drug
Pinksheets Weekly
May 5, 2008 – In the News
Bradley Thompson Quoted On Labs’ Compliance With FDA Guidelines
The Gray Sheet
February 25, 2008 – In the News
Bradley Thompson quoted on Drug Companies’ Hopes for Combination Product Policy Development
The Pink Sheet
October 16, 2007 – In the News
Thompson Interviewed on Medical Technology Regulation
MX Magazine
June 15, 2007 – In the News
Bradley M. Thompson Named as Co-Chair of ABA’s Food and Drug Law Committee
Attorney Highlight
May 2, 2007 – In the News
HealthLaw360 Profiles EBG ClinTrials Law Initiative
Firm Highlight
May 2, 2007 – In the News
Epstein Becker & Green Announces Launch of EBG ClinTrials Law Initiative
Firm Highlight