フォーリー・アンド・ラーダーナー法律事務所は本日、急速な規制変化と技術進歩によって変革が進む医療・ライフサイエンス分野において生じる重要なビジネスおよび法的課題を分析した、第4回年次報告書「ヘルスケア＆ライフサイエンス主要動向」を発表した。
Multiple interconnected factors are driving developments and spurring companies across the health care and life sciences sectors to adjust focus and adapt to the shifting terrain. As the second Trump administration ushers in change at all levels of the federal government, health care and life sciences companies are emphasizing preparation for that transformation and its accompanying uncertainty.
New leadership in Washington comes with evolving enforcement priorities on issues like the False Claims Act (FCA), making health care litigation a key space to watch. Incoming changes at the Centers of Medicare & Medicaid Services (CMS) raise questions about the Medicare Advantage program’s future, and the fallout from the U.S. Supreme Court’s Chevron overturn continues to fuel developments in health care litigation.
Health care and life sciences companies are also keeping a close eye on M&A oversight. While the new administration’s approach on competition issues has yet to take shape, a flurry of legislative activity at the state level has introduced additional regulatory scrutiny on health care transactions to address competition, quality, access, and cost of health care.
Artificial intelligence (AI) also remains at the forefront of business disruption. With the legal and regulatory frameworks covering AI still in their infancy, health care and life sciences companies need to balance the competitive advantages AI implementation can deliver against an intricate web of requirements, challenges, and risks.
“The modern health care and life sciences environment requires businesses to continually deliver better patient care more efficiently, all while staying closely attuned to government decision making, market forces, and the relentless pace of technological advancement,” said Susan Pravda, chair of Foley’s Health Care & Life Sciences Sector.
Foley’s 2025 Health Care & Life Sciences Top Trends publication unravels this complex ecosystem, exploring these topics and more to help companies maximize opportunities and steer clear of challenges.
Articles include:
- トランプ政権の医療政策下における政府の執行と医療訴訟
- メディケア支払いモデルの動向と経済的要因：トランプ政権の指針待ち
- プライベート・エクイティとヘルスケア：2025年における医療取引審査法の対応
- 医療データ取引と取引：価値の最大化と法的リスクの回避
- Increased Scrutiny, New Regulations, and Therapy Changes: Five Trends Revolutionizing Behavioral Health
- Post-Chevron Deference: A New Era for Legal Challenges to Health Care Regulations
- 医療分野における独占禁止法執行の主要動向：プライベート・エクイティ、薬局給付管理会社（PBM）、労働者保護など
- テレヘルスとデジタルヘルス政策の今後はどうなる？ 2025年に注目すべき5つの動向
- 医療・ライフサイエンス分野における人工知能（AI）導入動向：強靭なガバナンス枠組みの定義と実行方法
- 医療機器向け人工知能（AI）特許戦略：新興医療技術企業のための知的財産プレイブック
- 医薬品・バイオ医薬品産業における人工知能（AI）の著作権法上の考慮事項
- 医療機器における人工知能（AI）/機械学習（ML）：FDAは規制アプローチの構築を継続中
- 医薬品臨床試験の多様性において人工知能（AI）が果たし得る独自の役割
Foley’s Health Care & Life Sciences Sector is comprised of more than 200 attorneys with decades of collective in-house experience at health care providers and vendors, pharmaceutical and biotechnology firms, and key state and federal government agencies. Foley is primed to strategically advise health care and life sciences companies through every step of their journey and all stages of their lifecycle. With deep regulatory experience coupled with a national transaction backbone, attorneys provide forward-looking, practical solutions to clients’ most pressing business challenges.
Access the full report here.
フォーリー・アンド・ラーダーナー法律事務所について
Foley & Lardner LLP is a preeminent law firm that stands at the nexus of the Energy, Health Care & Life Sciences, Innovative Technology, and Manufacturing Sectors. We look beyond the law to focus on the constantly evolving demands facing our clients and act as trusted business advisors to deliver creative, practical, and effective solutions. Our 1,100 lawyers across 26 offices worldwide partner on the full range of engagements from corporate counsel to intellectual property work and litigation support, providing our clients with a one-team solution to all their needs. For nearly two centuries, Foley has maintained its commitment to the highest level of innovative legal services and to the stewardship of our people, firm, clients, and the communities we serve.