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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

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2024 outlook: Advancing AI innovations in patient care

Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety....

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Podcast: Talking the cure

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...

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CMS finalizes regulation specifying all covered prescriptions drugs are essential health benefits

On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies...

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FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...

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Court rules for PhRMA in challenge to Oregon drug price transparency law

On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part...

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New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic ...

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Updated OCR guidance does not solve HIPAA’s tracker uncertainty

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance concerning compliance obligations for HIPAA covered entities and business...

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US Senator's report urges congressional action to strengthen health data privacy

A new report from U.S. Senator Bill Cassidy calls on Congress to update the Health Insurance Portability and Accountability Act (HIPAA) and develop new, comprehensive privacy legislation to ...

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