News & Analysis as of

Medical Devices Health Care Providers Food and Drug Administration (FDA)

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - September 2024 #1

News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #4

News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more

Alston & Bird

Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for...

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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

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - September 2024

Silence surrounding medical harms hurts patients and the medical care system - An ugly truth of 21st century medicine is that episodes that hurt and kill patients get hidden from public view in the name of patient...more

Alston & Bird

Health Care Week in Review: Texas Judge Blocked FTC Rule Banning Noncompetes; Biden Administration Announced $1.4 Billion for HIV...

Alston & Bird on

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

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #2

News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more

Alston & Bird

Health Care Week in Review: CMS Released Negotiated Medicare Part D Prices for 10 Drugs and ARPA-H Awarded $150 Million in Funding...

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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

Hogan Lovells

Breaking News for Breakthrough Devices: CMS Finalizes Transitional Coverage for Emerging Technologies Pathway

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On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway...more

Alston & Bird

Health Care Week in Review: CMS Finalizes FY 2025 Payment Rules for Inpatient Hospitals, Inpatient Rehab Facilities, Inpatient...

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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

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: CMS Issues Calendar Year 2025 Proposed Medicare Payment Rules for Physicians and Hospitals

Alston & Bird on

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

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in the Exactech Recall: A Critical Analysis

Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Provider Disincentives for Information Blocking and House Ways and Means Committee...

Alston & Bird on

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

Searcy Denney Scarola Barnhart & Shipley

Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more

Troutman Pepper

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

Troutman Pepper on

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Alston & Bird

Health Care Week in Review: Senate Democrats Released Draft Legislation to Prevent Labor and Delivery Unit Closures; CMS Announced...

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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

Gardner Law

Medtech Maturity: Assessing Regulatory Readiness

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...It takes a lot to bring a medical product to market in the United States. You need impactful technology and proper resources to develop a product for years without the assurance it will ever see a patient. Understanding...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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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

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance...

Alston & Bird on

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

Searcy Denney Scarola Barnhart & Shipley

Alternatives to the Exactech: Exploring Other Surgical Tools and Techniques

Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

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