144 matches.
- EventsARIO National Conference: The Use of Enterprise AI Programs to Help Streamline and Reduce the Burden of Research Misconduct Proceedings1 minute read
PublicationsCMS Seeks Broad Stakeholder Input on CLIA Regulations, Signaling Potential Modernization of Current Lab Regulatory Scheme12 minute read- BlogsWatch: Hemant Gupta Bridges the Gap Between Cutting-Edge Technology and Intellectual Property Protection7 minute read
Videos & Podcasts- EventsMeRTEC Three I's Conference: Beyond the ORI Process - False Claims Act Liability and the Evolving Landscape of Government Scrutiny Over Academic Research Integrity2 minute read
- EventsMGMA: Practice Compliance in 2026 - Regulatory Updates, Enforcement Trends, and Leadership Priorities1 minute read
- BlogsListen: DOJ’s Bulk Sensitive Data Transfer Rule: Key Insights for Health Care Compliance Teams – Diagnosing Health Care41 minute read
Videos & Podcasts- EventsBBA Higher Education Legal Conference: Navigating the Evolving Federal Research Landscape from Termination of Federal Grants to Increased DOJ Enforcement Actions1 minute read
- EventsMGMA Financial Conference 20264 minute read
- EventsAHLA Winter Institute: Advising Providers & AI in Health CareFebruary 11-13, 20263 minute read
- EventsEBG Research Collective: Navigating Federal Regulatory Challenges in 20261 minute read
- Firm AnnouncementsVeteran Health System Transactional Attorney Ben Wilson Joins Epstein Becker Green3 minute read
- Media CoverageKate Gallin Heffernan Featured in “3 Clinical Research Attorneys Talk 2026 Trends”3 minute read
- PublicationsCMS’s MAHA ELEVATE Model: Integrating Whole‑Person Care into Original Medicare10 minute read
- Media CoverageMegan Robertson Quoted in “2025 Clinical Lab Space Bookended by Demise of FDA's LDT Rule, Abbott's $23B Exact Sciences Deal”2 minute read
- Firm AnnouncementsFive Epstein Becker Green Attorneys Named to the 2025 Massachusetts Super Lawyers and Rising Stars Lists7 minute read
- PublicationsMegan Robertson Answers: How Does the Loper Decision Reshape FDA's Authority Over Lab Tests?3 minute read
- Media CoverageMartin Monaco, John Barry Featured in “On the Move: Epstein Becker Green”2 minute read
- Media CoverageKate Heffernan Discusses How Recent Policy Changes Could Impact Clinical Research2 minute read
- Media CoverageBob Hearn Quoted in “As Congress Preps PAMA Reform, Legislators Ask CMS to Delay Law’s Implementation”3 minute read
- Media CoverageMarylana Helou Quoted in “Trump Executive Order Seeks to Centralize Control of Grantmaking Under Political Appointees”2 minute read
- Firm AnnouncementsEpstein Becker Green Expands Health Care Corporate and Transactional Team with Martin L. Monaco, Jr., and John D. Barry in New Jersey3 minute read
- Media CoverageKate Heffernan Featured in Q&A on Clinical Research Compliance with Executive Orders2 minute read
- BlogsNinth Circuit Applies EKRA to Marketing Intermediaries in Lab Operator’s Allergy Testing Scheme9 minute read
- Media CoverageMarylana Helou Quoted in “HHS Devises Legal Playbook for Future Grant Terminations, Internal Memo Shows”2 minute read
- PublicationsDon’t Fall for the Call of Placebo-Controlled Vaccine Trials2 minute read
- Media CoverageElizabeth McEvoy Quoted in “NSF Plan to Slash ‘Indirect’ Science Funding: Will It Stick?”6 minute read
- PublicationsThe Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms24 minute read
- BlogsVideo: Federal Court Strikes Down FDA Rule on LDTs – Thought Leaders in Health Law2 minute read
- PublicationsNewborn Screening at Risk: Implications of Disbanding the Advisory Committee on Heritable Disorders in Newborns and Children4 minute read
Videos & Podcasts- EventsThree I’s - Biosecurity & Research Integrity 2025: PHS Final Rule on Research Misconduct – What Institutions Need to Know2 minute read
- BlogsPodcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care2 minute read
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Videos & Podcasts
- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- BlogsPodcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care2 minute read
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- PublicationsThe LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold16 minute read
- EventsAIPLA Trade Secret Summit: Trade Secret Issues Affecting Biotech, Healthcare, and Retail1 minute read
- Media CoverageKate Heffernan Featured in “Can NIH Overturn a Court Order Blocking It from Slashing Overhead Payments? Unlikely, One Expert Says”5 minute read
- EventsBBA Higher Education Legal Conference: Trending Now in Higher Ed1 minute read
- EventsCollege of American Pathologists: Reducing Risk in Pathology Practice1 minute read
- PublicationsWhat Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a False Claim16 minute read
- EventsAUTM 2025 Annual Meeting: Navigating Academic Integrity in Research - Lessons Learned from Research Misconduct1 minute read
- BlogsA Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule4 minute read
- EventsBoston Bar Association: Hot Topics in the Health Care/Life Sciences Workplace2 minute read
- Media CoverageClay Lee Quoted in “With Circuits Split, Mass. Judge Backs Tough Fraud Standard”2 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
- EventsMAGI@home 2024: Collaboration Over Confrontation - CTA Negotiation Tips & Tricks1 minute read
- EventsBreaking Barriers Toward Inclusive Health Care: New ADA Title II Regulations Require Accessible Medical Diagnostic Equipment2 minute read
- BlogsUnited States’ Complaint-in-Intervention Highlights Continuing Effort to Use the False Claims Act to Pursue Alleged Cybersecurity Violations5 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- PublicationsSumming Up the FDA's Long-Anticipated Draft Guidance on Diversity Action Plans3 minute read
- EventsNational Association of Chain Drug Stores Total Store Expo Pharmacy Compliance Roundtable1 minute read
- PublicationsCMS Issues Mandatory “TEAM Model” for Acute Care Hospitals to Improve Episode-Based Alternative Payments and Advance Accountable Care Relationships17 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
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Videos & Podcasts
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
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Videos & Podcasts
- Media CoverageMandated Coverage of Biomarker Testing: Q&A with Robert Hearn4 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 minute read
- EventsBCBS Association: The World of Emerging Therapies and Alternative Substances in Healthcare2 minute read
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Videos & Podcasts
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived8 minute read
- Media CoverageEpstein Becker Green Attorneys Elected to Law360’s 2024 Editorial Advisory Boards3 minute read
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants9 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- PublicationsSponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement13 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom”2 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
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Videos & Podcasts
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct7 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
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- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
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- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- EventsWhat's Nyoo! 30 Years of Women in Clinical Research - What It Means for You2 minute read
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- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- Media CoverageRobert Hearn Quoted in “Surveying Laboratory Tests from a Health IT Perspective”3 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
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- EventsAdvanced Topics in Clinical Research2 minute read
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Videos & Podcasts
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- EventsTrade Secrets, Restrictive Covenants, and No-Poach Agreements in Health Care2 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- Media CoverageEpstein Becker Green Expands “From Roe to Dobbs” Resource Center for Employers and Health Care / Life Sciences Professionals1 minute read
- EventsOhio Hospital Association: Impact of Dobbs Decision on Ohio Hospitals1 minute read
- BlogsDOJ Announces Enforcement Action Involving “Largest and Most Wide-Ranging” COVID-19 Fraud Detected to Date4 minute read
- BlogsUnpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA13 minute read
- BlogsVideo: Record-Shattering Year for FCA Recoveries in Health Care - Thought Leaders in Health Law3 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
- EventsAHLA Academic Medical Centers and Teaching Hospitals Law Institute 2022: Precision Medicine Studies—A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and ResearchFebruary 2, 20222 minute read
- EventsMaking Sense of the No Surprises Act and Interim Final RulesNovember 9, 20212 minute read
- BlogsFlorida Joins a Growing Number of States Requiring Licensure of Genetic Counselors6 minute read
- PublicationsThe No Surprises Act: New and Surprising Challenges for Clinical Laboratories3 minute read
- PublicationsMore Surprises on Surprise Billing: Will Federal or State Law Control?11 minute read
- EventsValue-Based Arrangements Under the Stark Law and Anti-Kickback Statute: New Rules, New Challenges, New Opportunities2 minute read
- Firm AnnouncementsFour Epstein Becker Green Attorneys Elected to Law360’s 2021 Editorial Advisory Boards4 minute read
- EventsOIG and CMS Voluntary Self Disclosures: Risks and Rewards of Self-Reporting, Implications of Stark Law Changes2 minute read
- Firm AnnouncementsHealth Care Attorney & Commercial Litigator Robert R. Hearn Joins Epstein Becker Green3 minute read
- BlogsDOJ False Claims Act Statistics 2020: Over 80% of All Recoveries Came from the Health Care Industry4 minute read
- PublicationsThe No Surprises Act: Implications for Health Plans, Health Care Facilities, and Health Care Providers19 minute read
- PublicationsStark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for Value-Based Arrangements26 minute read
- PublicationsOIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework39 minute read
- Media CoverageJames Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”3 minute read
- PublicationsFederal Court's Rejection of Some DOL FFCRA Rules May Affect Your Pandemic Leave Policies14 minute read
- PublicationsINSIGHT: Labs Must Follow Two Kickback Laws During Covid-192 minute read
- PublicationsOIG Offers an Alternative to Advisory Opinions for Emergency Arrangements During the Public Health Emergency7 minute read
- PublicationsHow Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?3 minute read
- BlogsFDA Authorizes the First Home Collection of Specimens to Be Tested for COVID-192 minute read
- PublicationsMedicare Expands Access to Genetic Diagnostic Tests for Certain Ovarian and Breast Cancers10 minute read
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- PublicationsMedicare’s Proposed National Coverage Determination: Expanding Access to Genetic Screening Tests for Certain Ovarian and Breast Cancers12 minute read
- PublicationsHHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules34 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Media CoverageAnjali Downs Quoted in "Evolution of Healthcare Industry Poses New and Ongoing Compliance Risks in 2019"4 minute read
- Media CoverageVictoria Vaskov Sheridan Featured in "On the Move"1 minute read
- PublicationsThe SUPPORT for Patients and Communities Act: Part 1: New Federal Anti-Kickback Law – Eliminating Kickbacks in Recovery Act of 201813 minute read
- BlogsSales and Marketing Compliance: New Federal Anti-Kickback Law May Alter How Clinical Laboratories Compensate Sales Personnel7 minute read
- EventsPathology Webinars: The New CMS White Paper on Healthcare Fraud Prevention – What You Need to Know, How You Can Avoid Its Consequences, and What to Do If You Are a Target of This Enforcement1 minute read
- Media CoverageJames Boiani Quoted in "The Ins and Outs of Lab-Developed Tests"4 minute read
- Media CoverageMelissa Jampol Featured in "Clinical Laboratory Compliance Practices Under Pressure as Federal Spotlight Is Aimed at Common Fraud and Abuse Schemes; Penalties for Violations Surge"3 minute read
- PublicationsHealthcare Fraud Prevention Partnership Issues a Review of Clinical Laboratory Services11 minute read
- BlogsFlorida Will No Longer Require State Laboratory Licensure2 minute read
- PublicationsObstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for Precision Medicine11 minute read
- Media CoverageJames Boiani Quoted in "Labs Hopeful for Less Severe Penalties for Referral Mishaps"2 minute read
- PublicationsD.C. District Court Clarifies Standard for Laboratory Determination of Medical Necessity9 minute read