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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

FDA begins to update how it regulates software used as a medical device

by Dentons on

The US Food and Drug Administration (FDA) is considering changes to the regulatory pathways for software used as a medical device (SaMD). Members of Dentons' Life Sciences team attended FDA's public meeting, "Fostering...more

Express Scripts and Walgreens Expand Their Group Purchasing to Include Biosimilars

by Goodwin on

Express Scripts and Walgreens Boots Alliance announced this week that “they are expanding their group purchasing efforts to include the procurement of specialty brand drugs,” including biosimilars. According to Tim...more

Health Care Provisions in Bipartisan Budget Act of 2018

by Ropes & Gray LLP on

On Friday, February 9, President Trump signed The Bipartisan Budget Act of 2018 (the “2018 Act”) into law. Among other things, the 2018 Act makes changes to the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”),...more

Second Circuit Confirms Prior Express Consent For “Health Care” Messages Need Not Be In Writing Under TCPA

by Benesch on

On February 21, 2018, the Second Circuit Court of Appeals affirmed a lower court’s grant of summary judgment in a TCPA defendant’s favor, holding that the TCPA plaintiff provided prior express consent for a “health care”...more

Alabama CON Report

I. SHPDA Administrative Report The following projects were approved by an Administrative Law Judge and no exceptions were filed. AL2017-036, Huntsville Senior Services, LLC d/b/a Regency Remembrances, Huntsville,...more

Mandatory Flu Vaccines Land Healthcare Facility In Court

by Holland & Hart LLP on

After rescinding a job offer to an applicant, a Michigan healthcare provider finds itself in federal court defending a religious accommodation claim. If your organization requires employees to get flu vaccines, your policy...more

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

by Knobbe Martens on

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

Tennessee Health Services and Facilities Report: February 2018

by Burr & Forman on

The Tennessee Health Services and Development Agency (“HSDA”) is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need (“CON”) is a permit for the...more

The Trump Administration Proposes a Budget Increase to Fight Healthcare Fraud

by Dickinson Wright on

The Trump administration proposed a budget increase of 19 million to aid in the fight against health care fraud. This showcases the continued (and heightened) importance of anti-fraud programs, especially compared to the...more

AGG Food and Drug Newsletter - February 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Gold Dome Report - February 2018 #12

The House worked a full day today, taking up 14 measures on the floor before handling a full slate of committee meetings. Among the bills adopted by the House were provisions allowing QBE funding to follow students being...more

The State AG Report Weekly Update

by Cozen O'Connor on

2018 AG Elections- Maryland Attorney General Brian Frosh Announces Bid for Reelection- Maryland AG Brian Frosh declared his intention to run for reelection to a second term in 2018. Prior to his election to AG in 2014,...more

Significant Changes in Healthcare Laws Enacted Through the Bipartisan Budget Act of 2018: Stark, Civil and Criminal Penalties,...

by Dorsey & Whitney LLP on

On February 9, President Trump signed the Bipartisan Budget Act of 2018 (“BBA”) into law. The BBA funds the federal government through March 23 and included a bipartisan agreement to increase annual spending authority for a...more

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

by Knobbe Martens on

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device....more

Producing Patient Records: The “Designated Record Set,” the “Legal Health Record,” and Records Created by Other Providers

by Holland & Hart LLP on

Healthcare providers often misunderstand their obligation to provide patient records in response to a request from a patient or third party....more

New Therapeutic Goods legislation: what you need to know

by Dentons on

The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 passed through both Houses on 15 February 2018. The bills have yet to receive Royal Assent....more

Association Health Plans and the Sale of Group Health Insurance “Across State Lines”

In advance of issuing the Executive Order that culminated in the promulgation by the Department of Labor of proposed regulations expanding the availability of Association Health Plans, President Trump announced that one of...more

Health Update - February 2018

Hospitals and Health Systems Prepare for a Value-Based Future - Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...more

Congress Kicks the Can Down the Road Again – Cadillac Tax On High Cost Employer Health Coverage Delayed to 2022

by Snell & Wilmer on

Section 4980I, which was added to the Internal Revenue Code by the Affordable Care Act, was originally supposed to take effect in 2018. This tax is commonly called the “Cadillac tax” because it imposes a 40% excise tax on...more

Taking Pills for Pay: FDA Releases Information Sheet on Paying Research Subjects

by Baker Ober Health Law on

In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as...more

Federal Court Allows False Claims Act Case to Continue Against Medicare Advantage Insurer

by Holland & Knight LLP on

In February of 2018, a United States District Court in the Central District of California dismissed only half of the claims in a qui tam case against United Health Group, Inc. (UHG), a Medicare Advantage plan provider. United...more

Supreme Court Denies Cert Petition in CareFirst v. Attias

by Ballard Spahr LLP on

Earlier this week, the Supreme Court of the United States denied certiorari in CareFirst v. Attias, a closely watched case that some thought provided the Court with an opportunity to clarify the standing analysis under Spokeo...more

Michigan Hospital Reaches Settlement with DOJ For Marketing Pact

by King & Spalding on

On February 9, 2018, the U.S. Department of Justice (DOJ) announced it reached a proposed settlement with Henry Ford Allegiance Health (Allegiance) over allegations that Allegiance conspired with rival hospitals to engage in...more

Key Health Care Provisions of Bipartisan Budget Act of 2018

by Baker Donelson on

The wide-reaching Bipartisan Budget Act of 2018 (BBA), passed by Congress and signed by the President on February 9, 2018, extends and modifies dozens of health care programs, including extending funding for two years for...more

More Frequent Paydays Could Mean More Reliable Employees

A Florida fast food franchisee recently experimented with a pilot program which allowed employees to receive one-half of their pay for a shift the next day via a debit card (without any fees or other costs to the employee). ...more

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