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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Wyrick Robbins Yates & Ponton LLP

Everything Is Bigger in Texas…Except for Reproductive Privacy Rights

This is not a drill: the Texas Attorney General is coming for HIPAA. On September 4, 2024, the State of Texas sued the United States Department of Health and Human Services (DHHS) to enjoin portions of HIPAA regulations,...more

Hall Benefits Law

Courts Issue Injunctions Blocking Expansion of ACA Section 1557 to Prohibit Discrimination Based on Gender Identity

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A Mississippi federal district court has issued a nationwide injunction and stay on some of the new federal regulations concerning Affordable Care Act (ACA) Section 1557, which prohibits discrimination in specified health...more

Faegre Drinker Biddle & Reath LLP

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more

Bond Schoeneck & King PLLC

New York Requires 9-8-8 Suicide and Crisis Lifeline Information Shared and Added to College Student ID Cards

This week, Gov. Kathy Hochul signed the Student Lifeline Act amending the New York Education Law to require that degree-granting higher education institutions educate students, faculty and staff about New York’s 9-8-8 Suicide...more

Holland & Knight LLP

California Ends the Legislative Session with Expanded Reporting Requirements, Less Clarity

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Amendments made by the California Office of Health Care Affordability (OHCA) to its cost and market impact review (CMIR) regulations became effective on Aug. 22, 2024, and serve to expand the scope of the Health Care Quality...more

Maynard Nexsen

Insights from a Recent Court Decision

Maynard Nexsen on

The Eliminating Kickbacks in Recovery Act (EKRA), 18 U.S.C. § 220, is a criminal statute that prohibits knowingly and willfully soliciting or receiving remuneration for referring patients to recovery homes, clinical treatment...more

Shipman & Goodwin LLP

New Federal Regulations Strengthening Mental Health Parity Coverage

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On September 9, 2024, the U.S. Department of Labor (the “DOL”), the U.S. Department of the Treasury and the U.S. Department of Health and Human Services (“HHS”) jointly released regulations entitled “Requirements Related to...more

Goodwin

Reliance on Third-Party “Pricing” Facilitators Under Increasing Antitrust Scrutiny

Goodwin on

In the past year, healthcare systems and providers across the country have filed a series of antitrust lawsuits against MultiPlan Inc. and major US health insurers, alleging a hub-and-spoke conspiracy to fix and reduce...more

Constangy, Brooks, Smith & Prophete, LLP

FTC amendments to Health Breach Notification Rule are now in effect

On April 24, the Federal Trade Commission announced that it had finalized changes to its Health Breach Notification Rule - to address emerging technologies. Specifically, the Rule was broadened to (1) apply to entities not...more

Bressler, Amery & Ross, P.C.

The New York Department of Financial Services (DFS) considers Regulations to Promote Health Equity

DFS has developed a draft pre-proposal notice regarding proposed amendments to 11 NYCRR 52 (Insurance Regulation 62) which, if adopted, would amend the minimum standards for form, content, and sale of health insurance in New...more

IMS Legal Strategies

5 Tips for Med Mal Expert Testimony from a Hot Seat Veteran

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As a presentation technology consultant, I have been sitting in the hot seat for almost 25 years. I average one trial a month with about 75% being medical malpractice (med mal) cases. I work with both plaintiff and defense...more

Ankura

New Health Information Technology Standards for Medicare Part D

Ankura on

On June 17, 2024, the final rule for Medicare Part D introduced new health IT standards, mandating the adoption of NCPDP SCRIPT Standard version 2023011 by January 1, 2028, while the NCPDP Formulary and Benefit (F&B) Standard...more

ArentFox Schiff

Investigations Newsletter: Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations

ArentFox Schiff on

Medical Device Manufacturer THD Pays $700,000 to Resolve FCA Allegations - On September 6, the US Attorney’s Office for the District of Maryland announced that THD America, Inc., and its parent company, THD SpA of Italy,...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: What Life Sciences and Digital Health Companies Should Know

This update is part of our EU AI Act Series. Learn more about the EU AI Act here. Life sciences and digital health companies face obligations under the AI Act that vary depending on how they use AI – and the level of risk...more

Cohen Seglias Pallas Greenhall & Furman PC

ORI Unveils Final Rule on Research Misconduct: Key Changes for Institutions and Respondents

On September 12, 2024, the federal Office of Research Integrity (ORI) announced the release of the Department of Health & Human Services’ Final Rule on Public Health Service Policies on Research Misconduct. This marks the...more

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Manatt, Phelps & Phillips, LLP

CMMI Transforming Maternal Health (TMaH) Model Applications Due Soon

On June 26, the Centers for Medicare & Medicaid Services (CMS) released the Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model. TMaH is ten-year delivery and payment model designed to test...more

Robinson+Cole Data Privacy + Security Insider

Lehigh Valley Health Network Settle Class Action Case for $65M

Lehigh Valley Health Network (LVHN) has agreed to settle a class action filed against it following a February 2023 ransomware attack that compromised personal information of patients, including medical and treatment...more

Manatt, Phelps & Phillips, LLP

Government Will Seek Supreme Court Review of Preventive Services Decision

On August 27, the government filed a motion indicating that it intends to seek Supreme Court review of the U.S. Court of Appeals for the Fifth Circuit’s decision in Braidwood Management v. Becerra. In June, the Fifth Circuit...more

Robinson+Cole Data Privacy + Security Insider

CMS Notifies 946,801 Medicare Recipients of Data Breach

The Centers for Medicare & Medicaid Services (CMS) and the Wisconsin Physicians Insurance Corporation have announced that 946,801 current Medicare recipients are being notified that their personal information may have been...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Alston & Bird

California Joins the Neural Data Bandwagon

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On August 31, the California assembly passed SB1223, which amends the CCPA/CPRA to include “neural data” as a type of sensitive data.  SB1223, which is likely to become law, defines “neural data” as “information that is...more

Cooley LLP

Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

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Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

Goldberg Segalla

National Science and Technology Council’s PFAS R&D Strategy Plan Highlights Substantial Deficiencies

Goldberg Segalla on

Recently, as part of the Joint Subcommittee on Environment, Innovation, and Public Health, the PFAS Strategy Team of the National Science and Technology Council released a report titled the “Per- and Polyfluoroalkyl...more

Knobbe Martens

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

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On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

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