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Former: Founded @profitwell
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Articles by Patrick Campbell
Patrick Campbell Co-Chairs, Artie McConnell Leads Panel at 5th Annual Compliance Conference 2026
Partner Patrick Campbell serves as co-chair and Partner Artie McConnell will lead a panel titled “Enforcement Priorities, Developments and Trends” at the New York City Bar 5th Annual Compliance Conference 2026, Oct. 21, 2026, in New York, New York. The conference brings together leading in-house compliance officers and other ethics and compliance professionals to discuss how organizations and their compliance professionals can navigate this rapidly changing environment.
Treatment Patterns and Attrition in Metastatic Castration-Resistant Prostate Cancer
Supplement 1. eTable 1. Baseline Patient Demographic Characteristics Overall and by Year of First-Line Initiation in Patients With mCRPC eTable 2. Treatment Patterns and Attrition Rates Across 5 Lines of Therapy for Patients With mCRPC eTable 3. Treatment Patterns in mCRPC in First Line Based on Year of Initiation From 2021 to 2025 eFigure. Treatment Patterns in First Line Based on Disease Setting Before mCRPC Diagnosis Supplement 2. Figure 1.
Enhancing Clinical Laboratory Innovation and Access (CLIA) ActÂ
On May 19, 2026, Representative Neal Dunn, M.D. introduced the Enhancing Clinical Laboratory Innovation and Access Act, also referred to as the “Enhancing CLIA Act." In a press release announcing the proposed legislation, Representative Dunn stated that “[t]he Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory-developed testing services”.
FinCEN’s Proposed AML Regime Changes Focus on Results Not Paper
On April 7, the Financial Crimes Enforcement Network (FinCEN) issued a Notice of Proposed Rulemaking (NPRM) that would fundamentally reform how banks design, implement, and are supervised on anti‑money laundering and countering the financing of terrorism (AML/CFT) programs under the Bank Secrecy Act (BSA).
FinCEN’s Proposed AML Regime Changes Focus on Results Not Paper
Key Takeaways On April 7, the Financial Crimes Enforcement Network (FinCEN) issued a Notice of Proposed Rulemaking (NPRM) that would fundamentally reform how banks design, implement, and are supervised on anti‑money laundering and countering the financing of terrorism (AML/CFT) programs under the Bank Secrecy Act (BSA).
Sustained remission after discontinuation of ALK inhibition in ALK-positive histiocytosis
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Dear Editor, ALK-positive histiocytosis is a rare histiocytic neoplasm first described in 2008 and recently classified as a distinct entity [1, 2]. The disease is typically driven by KIF5B::ALK fusions and often involves the neurologic system [3, 4]. We previously conducted the largest study of ALK-positive histiocytosis to date, investigating 31 children and 8 adults with the disease [4].
By Paul G. Kemps, Jennifer Picarsic, Sébastien Heritier, Jean Donadieu, Julien Haroche, Laure Farnault, Stefania Gaspari, Dmitry Evseev, Daria S. Osipova, Alexander E. Druy, Milen Minkov, Robert Möhle, Milos Kuzmanovic, Hitomi S Okuma, Chung W Chow, Martin Campbell, Gregory Phillips, Yuhang Zhou, Gaurav Goyal, Ronald S. Go, Kee Kiat Yeo, Bryan Sisk, Joanna Weinstein, Patrick Campbell, Eli L. Diamond, Jean-François Emile, Susan Picton, Andreas Beilken
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Nature
Verified
HHS OCR launches civil enforcement program for Part 2: What SUD providers and lawful holders need to do now | JD Supra
On Feb. 13, 2026, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the launch of a new civil enforcement program for the confidentiality of substance use disorder (SUD) patient records under 42 C.F.R. Part 2 (Part 2). Civil enforcement authority begins today, Feb.16, 2026, which is also the deadline for compliance with the 2024 Final Rule implementing Section 3221 of the CARES Act.
HHS OCR Launches Civil Enforcement Program for Part 2
On Feb. 13, 2026, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the launch of a new civil enforcement program for the confidentiality of substance use disorder (SUD) patient records under 42 C.F.R. Part 2 (Part 2). Civil enforcement authority begins today, Feb.16, 2026, which is also the deadline for compliance with the 2024 Final Rule implementing Section 3221 of the CARES Act.
Feb. deadline approaches for Part 2 compliance and NPP updates: What providers need to know
Healthcare providers and others who create, receive or maintain substance use disorder (SUD) patient identifying information should be aware of an upcoming compliance deadline on February 16, 2026, which will require many providers to update their Notice of Privacy Practices (NPP), among other things. In 2024, the Department of Health and Human Services (HHS) issued a Final Rule, which published regulations as required by the CARES Act.
MAPLE-HCM: CPET Data Support Aficamten over Metoprolol as Monotherapy
Information from a prespecified analysis of the MAPLE-HCM trial offers evidence positioning aficamten as a more effective monotherapy than metoprolol for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
C3G Breakthroughs: First FDA-Approved Targeted Therapies Redefine Care
Published on: C3 glomerulopathy (C3G) has historically been challenging to manage, often leading to severe proteinuria, progressive kidney function loss, and kidney failure. Many patients, frequently diagnosed in adolescence or early adulthood, faced the prospect of dialysis or transplant, with high rates of disease recurrence.
What Star Wars Gets Right About Leadership
Let me confess something I probably shouldn’t say as an educator and Star Wars fan: sometimes, I envy the Empire. Not for the uniforms (white, grey, and black are too drab for me) or their workplace culture (they’ve constructed a planet killer), but for one thing they nail: alignment.
Delgocitinib (Anzupgo) Scores FDA Approval for Chronic Hand Eczema
The US Food and Drug Administration (FDA) has approved delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema. Announced by LEO Pharma on July 23, 2025, the approval indicates delgocitinib cream for the topical treatment of chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable based on data from the DELTA 1 and DELTA 2 clinical trials.
The DOJ Announces Administration’s Revised Corporate Enforcement Strategy | JD Supra
Key Takeaways The DOJ announced a revised corporate enforcement strategy that aligns with the Administration’s priorities in areas such as national security, trade and customs offenses, fraud in U.S. markets and government programs, narcotics trafficking and terrorism, and it also revised certain previously issued policies to make them consistent with the Administration’s priorities.
The DOJ Announces Administration’s Revised Corporate Enforcement Strategy
The DOJ announced a revised corporate enforcement strategy that aligns with the Administration’s priorities in areas such as national security, trade and customs offenses, fraud in U.S. markets and government programs, narcotics trafficking and terrorism, and it also revised certain previously issued policies to make them consistent with the Administration’s priorities.
Enforcement Priorities May Change, But Deciding Whether to Self-Report Is Always a Balancing Act
One of the most difficult decisions for any corporate general counsel — whether to voluntarily disclose potential misconduct to the federal government — may have become more complicated with the change of administration, but the basic analytical framework remains the same. Over the past several years, the Department of Justice (DOJ) and other government agencies have encouraged voluntary and early self-disclosure.
Travere Therapeutics Plans FSGS Submission for Sparsentan
Travere Therapeutics has announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) with the US Food and Drug Administration (FDA) for the treatment of focal segmental glomerulosclerosis (FSGS).
Amazon Pharmacy's RxPass Saves Patients Money, Improves Medication Adherence
A new study in a major U.S. medical journal suggests Amazon’s pharmacy prescription program, RxPass, saved patients money while simultaneously improving medication adherence. Results of the study indicate subscribers to Amazon Pharmacy’s RxPass pharmacy program had more refills, fewer days without medication, and reduced their monthly cost of medications by nearly 30% compared to those who were not participating in the Amazon program.
Diabetes, Obesity Drugs at Center of Latest CMS Medicare Part D Negotiation List
The US Department of Health and Human Services (HHS) announcement of the next 15 drugs covered under the Medicare Part D price negotiations offers a glimpse into the current state of health among the aging US population. With 20% of the list boasting indications for type 2 diabetes or obesity, headlined by the GLP-1 receptor agonist semaglutide (Ozempic, Rybelsus, Wegovy), the list is a reflection of the growing obesity, metabolic illness crises gripping the US.
Making Sense of the CMS Drug Price Negotiation: What's Included and Why
The what, when, and why behind the 15 drugs up for Medicare Part D price negotiation under the Inflation Reduction Act. By | Published on January 17, 2025 8 min read On January 17, 2025, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the next 15 drugs covered under the Medicare Part D price negotiations.
Doctor Reacts to "Clearly Not Evidence-Based" Ban of Red Dye No. 3
On January 15, 2024, the US Food and Drug Administration announced it was repealing the color additive regulations that permit the use of Federal Food, Drug, and Cosmetic Act (FD&C) Red No. 3 in foods (including dietary supplements) and in ingested drugs—a move receiving applause from many but also drawing the ire of others.
Does Your Corporate Compliance Program Reasonably Prevent Fraud? New UK Guidance Demands It
By Jonathan B. New, Patrick T. Campbell and Jamie Reiner In October 2023, the United Kingdom created a new strict liability crime as part of its ongoing effort to clamp down on corporate fraud.
A Pillared Approach: A Suite of Therapies for a Spectrum of Metabolic Disease
For nearly a decade now, an evolution in the management of metabolic conditions has been happening in plain sight. At a time when US public health systems are experiencing a historic burden of metabolic disease, including obesity, type 2 diabetes, heart failure, and chronic kidney disease, this evolution, which includes revelations of benefits from established classes and the introduction of new agents, comes at a time when health systems are in dire need.
DOJ Antitrust Division Adds To Guidance On The Evaluation Of Corporate Compliance Programs In Criminal Antitrust Investigations
B BakerHostetler More Recognized as one of the top firms for client service, BakerHostetler is a leading national law firm that helps clients around the world address their most complex and critical business and regulatory issues. With five core national practice groups — Business, Labor and Employment, Intellectual Property, Litigation, and Tax — the firm has more than 970 lawyers located in 14 offices coast to coast.
DOJ Antitrust Division Adds to Guidance on the Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations | JD Supra
Key Takeaways Under recent revisions to the DOJ Antitrust Division’s guidelines on the Evaluation of Corporate Compliance Programs, prosecutors now consider additional criteria when making charging and sentencing decisions in criminal antitrust investigations. These additions are consistent with DOJ’s broader guidance, including revised guidance issued by the DOJ Criminal Division in March 2023 and September 2024.
Newly updated CMS-855A forms significantly expands reporting of ownership and control information for skilled nursing facilities
Alert Skilled nursing facilities (SNF) will soon be required to significantly expand their reporting of ownership and control information on newly updated CMS-855A forms. The CMS-855A is the Medicare Enrollment Application used by “Institutional Providers” such as hospitals, home health agencies, and SNFs, among others. Initially, the Centers for Medicare & Medicaid Services (CMS) had issued regulations which were to go into effect on January 16, 2024.
Navigating DOJ's Patchwork Whistleblower Regime
By Patrick Campbell, Jonathan New and Jimmy Nguyen ( November 14, 2024, 4:43 PM EST) -- Over the past year, the U.S. Department of Justice's Criminal Division and various U.S. attorney's offices have issued different pilot programs geared toward encouraging individuals with knowledge of certain corporate criminal misconduct to report to the government in exchange for monetary awards or nonprosecution agreements.... Law360 is on it, so you are, too.
Navigating DOJ's Patchwork Whistleblower Regime
By Patrick Campbell, Jonathan New and Jimmy Nguyen ( November 14, 2024, 4:43 PM EST) -- Over the past year, the U.S. Department of Justice's Criminal Division and various U.S. attorney's offices have issued different pilot programs geared toward encouraging individuals with knowledge of certain corporate criminal misconduct to report to the government in exchange for monetary awards or nonprosecution agreements.... Law360 is on it, so you are, too.
Navigating DOJ's Patchwork Whistleblower Regime
By Patrick Campbell, Jonathan New and Jimmy Nguyen ( November 14, 2024, 4:43 PM EST) -- Over the past year, the U.S. Department of Justice's Criminal Division and various U.S. attorney's offices have issued different pilot programs geared toward encouraging individuals with knowledge of certain corporate criminal misconduct to report to the government in exchange for monetary awards or nonprosecution agreements.... Law360 is on it, so you are, too.
Navigating DOJ's Patchwork Whistleblower Regime
By Patrick Campbell, Jonathan New and Jimmy Nguyen ( November 14, 2024, 4:43 PM EST) -- Over the past year, the U.S. Department of Justice's Criminal Division and various U.S. attorney's offices have issued different pilot programs geared toward encouraging individuals with knowledge of certain corporate criminal misconduct to report to the government in exchange for monetary awards or nonprosecution agreements.... Law360 is on it, so you are, too.
Navigating DOJ's Patchwork Whistleblower Regime
By Patrick Campbell, Jonathan New and Jimmy Nguyen ( November 14, 2024, 4:43 PM EST) -- Over the past year, the U.S. Department of Justice's Criminal Division and various U.S. attorney's offices have issued different pilot programs geared toward encouraging individuals with knowledge of certain corporate criminal misconduct to report to the government in exchange for monetary awards or nonprosecution agreements.... Law360 is on it, so you are, too.
The US DoJ updates its Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations guidelines to address emerging risks and enhance guidance on ethical practices
Previous article Next article Share on | DoJ Antitrust Division Adds to Guidance on the Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations* Key Takeaways Under recent revisions to the DOJ Antitrust Division’s guidelines on the Evaluation of Corporate Compliance Programs, prosecutors now consider additional criteria when making charging and sentencing decisions in criminal antitrust investigations.
Kristen L. Jackson
Kristy Jackson is a partner at Baker & Hostetler, based in the firm Chicago office. She is a litigator and member of the company and Investigations and Securities Enforcement and Litigation team. She focuses her practice on internal and government investigations, regulatory compliance matters and criminal defense.
Top Regulators Speak At The New York City Bar Association's Compliance Institute
On October 23, 2024, the New York City Bar Association hosted its third annual Compliance Institute with noteworthy keynote remarks from U.S. Securities and Exchange Commission (SEC) Commissioner Hester Peirce and Principal Associate Deputy Attorney General (PADAG) Marshall Miller.
Top Regulators Speak at the New York City Bar Association’s Compliance Institute | JD Supra
Key Takeaways On October 23, 2024, the New York City Bar Association hosted its third annual Compliance Institute with noteworthy keynote remarks from U.S. Securities and Exchange Commission (SEC) Commissioner Hester Peirce and Principal Associate Deputy Attorney General (PADAG) Marshall Miller.
FCC National Security and Law Enforcement Rules for Team Telecom Review are Now Effective
Recently the Federal Communications Commission (the “Commission” or “FCC”) issued a Public Notice announcing that certain rules adopted in its September 2020 “Executive Branch Review Order” and September 2021 “Executive Branch Standard Questions Order” have finally become effective and codified in Title 47 of the US Code of Federal Regulations.
7 More US Attorneys’ Offices Issue Whistleblower Non-Prosecution Pilot Programs | JD Supra
Key Takeaways Within the past two weeks, seven U.S. Attorneys’ Offices launched whistleblower non-prosecution pilot programs (Whistleblower Programs) geared toward encouraging individuals involved in certain corporate criminal misconduct to report the misconduct to the government in exchange for non-prosecution agreements (NPAs).
The DOJ's Whistleblower Pilot Program Adds Incentives for Robust Corporate Compliance Programs Original
As Deputy Attorney General (DAG) Lisa Monaco recently observed, “[g]oing back to the days of ‘Wanted’ posters across the Old West, law enforcement has long offered rewards to coax tipsters out of the woodwork.” On Aug. 1, 2024, the Department of Justice (DOJ or Department) joined the club of federal law enforcement agencies that have adapted this approach to white-collar crime by launching its own three-year Whistleblower Pilot Program.
The Intersection Of Data Centers And Power Supply - Trends, Challenges And Opportunities
As reported across news outlets on a near-constant basis, advances in artificial intelligence (AI) are driving demand for construction of new data centers that will house the infrastructure necessary to support AI advancement. This demand for computational power is in turn driving sharp increases in projected demand for electric power nationally, thereby fueling rapid deployment of capital to fund projects of unprecedented magnitude.
The Intersection Of Data Centers And Power Supply - Trends, Challenges And Opportunities
As reported across news outlets on a near-constant basis, advances in artificial intelligence (AI) are driving demand for construction of new data centers that will house the infrastructure necessary to support AI advancement. This demand for computational power is in turn driving sharp increases in projected demand for electric power nationally, thereby fueling rapid deployment of capital to fund projects of unprecedented magnitude.
DOJ Corporate Whistleblower Awards Pilot Program | JD Supra
As foreshadowed by Deputy Attorney General Lisa Monaco during the ABA White Collar Crime conference last March,[1] on August 1, 2024. the Department of Justice’s (DOJ or Department) Criminal Division launched the Corporate Whistleblower Awards Pilot Program (Pilot Program).
Dupilumab Maintains Effectiveness in AD for Up to 5 Years, But 1 in 4 Still Discontinue Treatment
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DOJ Corporate Whistleblower Awards Pilot Program
As foreshadowed by Deputy Attorney General Lisa Monaco during the ABA White Collar Crime conference last March,[1] on August 1, 2024. the Department of Justice’s (DOJ or Department) Criminal Division launched the Corporate Whistleblower Awards Pilot Program (Pilot Program).
Healthcare Providers And Preparing For The Impact Of The FTC Final Rule Prohibiting Non-compete Agreements
It has been three months since the Federal Trade Commission (FTC) announced its rule to ban certain workplace non-competition agreements (FTC Rule).The McDonald Hopkins Healthcare Practice Group recognizes that the healthcare industry has unique challenges and has been working with healthcare clients over these past few months to help them prepare to comply with the rule if it takes effect in its current form on September 4, 2024.
Total Fish Intake in Pregnancy Could Alter Risk of Juvenile Arthritis in Offspring
Data from a study presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress suggests increased intake of fish, whether oily or lean, was associated with an elevated risk of offspring with juvenile idiopathic arthritis (JIA).
FIRST Questionnaire Can Help Detect Fibromyalgia in RA Patients
Welcome to NewsBreak, an open platform where diverse perspectives converge. Most of our content comes from established publications and journalists, as well as from our extensive network of tens of thousands of creators who contribute to our platform. We empower individuals to share insightful viewpoints through short posts and comments.
Can Clients Protect Communications Between Their Lawyers and PR Firms?
In today’s world of around-the-clock global news and social media coverage, stories of corporate misconduct often take center stage. These stories not only capture headlines but also shape public opinion about the companies involved. And once news of an investigation into corporate misconduct becomes public, regulators, law enforcement, shareholders, and customers expect swift responses.
FDA Approves First Interchangeable Biosimilars to Eylea
The US Food and Drug Administration has approved a pair of biosimilar products, aflibercept-jbvf and aflibercept-yszy, as interchangeable biosimilars to aflibercept (Eylea), making them the first interchangeable biosimilars to Eylea. Announced by the FDA on May 20, 2024, the approval indicates both biosimilars for the treatment of neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy.
NOTUS Trial Confirms Dupixent Benefit in COPD with Type 2 Inflammation
Welcome to NewsBreak, an open platform where diverse perspectives converge. Most of our content comes from established publications and journalists, as well as from our extensive network of tens of thousands of creators who contribute to our platform. We empower individuals to share insightful viewpoints through short posts and comments.
Montgomery inks with Campbellsville
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