Latest

  • FDA

    Hazards Ahead for FDA’s Drug Review Process

    In June 2025 the U.S. Food and Drug Administration (FDA) launched the Commissioner’s National Priority Voucher Program (CNPV), billing the initiative as “accelerated drug review for companies supporting U.S. national interests.” 

    Hazards Ahead for FDA’s Drug Review Process

  • Artificial Intelligence

    Simplification or Back to Square One? The Future of EU Medical AI Regulation

    As part of a recent effort to simplify and harmonize its digital framework, the European Union (EU) is considering two interlinked regulatory proposals that could fundamentally reshape the governance of artificial intelligence (AI) in medical devices.

    Simplification or Back to Square One? The Future of EU Medical AI Regulation

  • Pharmaceuticals

    Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

    Following the passage of the Inflation Reduction Act’s (IRA) provision granting Medicare the authority to negotiate drug prices, pharmaceutical companies and allied organizations have brought a dozen lawsuits challenging the legality of the negotiation program. 

    Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

  • Medical Privacy

    Rethinking Maryland v. King Amid the Changing Landscape of Technology and Privacy

    In a landmark 2013 decision, Maryland v. King, the Supreme Court upheld mandatory DNA collection from arrestees as part of booking procedures, likening cheek swabs to fingerprinting. But 13 years later, renewed public concern about genetic…

    Rethinking Maryland v. King Amid the Changing Landscape of Technology and Privacy

  • Liability

    Snow Shovel Politics

    Boston is slowly waking from its snowy slumber. Weeks after one of the snowiest storms in the city’s history, drifts still rise several feet along streets and sidewalks as residents pick their way through narrowed passages and over…

    Snow Shovel Politics

  • Medicare/Medicaid

    Why It Matters: HR1’s Change to Medicaid Waiver Budget Neutrality Rules

    The 2025 budget reconciliation bill (“HR1” or “One Big Beautiful Bill Act”) significantly amended Medicaid, the federal public health insurance program for low-income people. HR1 has garnered significant attention surrounding new rules like work reporting requirements that…

    Why It Matters: HR1’s Change to Medicaid Waiver Budget Neutrality Rules

  • Mental Health

    The Deadly Cost of Ignoring Clinical Need

    Iryna Zarutska immigrated to North Carolina in August 2022, fleeing war-torn Ukraine. Exactly three years later, she was taking the subway home from a shift at a local Charlotte pizzeria when, abruptly, Decarlos Brown fatally stabbed…

    The Deadly Cost of Ignoring Clinical Need