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Chris Salmen joined McDermott+Consulting earlier this month as a senior director, bringing his unique blend of medical device, diagnostic and digital health experience to advise clients on their go-to-market strategy.
Exploring the applicability of its enablement law to life sciences, the Supreme Court of the United States issued a unanimous opinion, concluding that patent claims covering a genus of antibodies defined in part by functional limitations were not enabled by the specification as required by 35 U.S.C. § 112.
On May 19, 2023, Novitas Solutions and First Coast Options sent an email to certain interested parties, with whom they had engaged following the multijurisdictional contractor advisory committee (CAC) meeting, explaining that they have decided to not pursue at this time a local coverage determination for remote physiological monitoring (RPM) and remote therapeutic monitoring (RTM).
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision, finding that under the harmless error rule, the challenged claims were invalid as obvious even if the Board erred in claim construction.
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities occur at locations other than traditional in-person clinical trial sites, along with the technologies and other offerings that typically support them.
As the COVID-19 Public Health Emergency comes to an end May 11, Amy Kelbick and Rachel Stauffer explore the future of at-home testing and telehealth flexibilities, while offering advice for healthcare stakeholders moving forward.
The US Court of Appeals for the Federal Circuit reiterated that intrinsic evidence trumps extrinsic evidence in determining the meaning of claim terms.
The US Court of Appeals for the Federal Circuit affirmed a jury’s noninfringement verdict, finding that the district court correctly interpreted the article “a” and antecedent “said” in the asserted claims to require that a single microprocessor be capable of performing every one of the recited microprocessor functions.
Data protection authorities worldwide, including France’s Commission Nationale de l’Informatique et des Libertés (CNIL), the California attorney general (CAG), and the U.S. Federal Trade Commission (FTC), recently have indicated their intention to increase privacy enforcement efforts against mobile apps.
During the COVID-19 pandemic, a public health emergency (PHE) was declared.
Most employment-based permanent residency applications require the applicant to go through the PERM labor certification process where the U.S. Department of Labor (DOL) certifies that there are not sufficient U.S. workers able, available, and qualified to fill a position.
On May 18, 2023, the United States Supreme Court issued its long-awaited decision in Andy Warhol Foundation for the Visual Arts, Inc. v. Goldsmith, a case that presented the Court with an opportunity to bring clarity to the often highly subjective standards lower courts apply when deciding the issue of fair use of visual works of art under copyright law.
It is more important than ever that employers understand the serious long-term, non-monetary consequences of settling or accepting Occupational Safety and Health Administration (OSHA) citations.
A new Washington law regulating employers’ use of production quotas or production standards for employees working at warehouse distribution centers (House Bill 1762) will go into effect on July 1, 2024.
As a part of the Consolidated Appropriations Act, 2023 (CAA), Congress passed new exceptions to the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute (AKS) allowing certain healthcare entities to provide mental health or behavioral health improvement and/or maintenance programs to physicians and other clinicians.
On May 17, 2023, the Texas Senate approved Senate Bill No. 14 (SB 14), prohibiting physicians from providing gender-affirming medical care to minors experiencing gender dysphoria (distress that results from having one’s gender identity not match one’s sex assigned at birth).
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