Actionable insights on the regulatory and policy shifts shaping health industries

Health Policy and Intelligence Institute 

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Insight that keeps you ahead of the curve to make informed decisions

Stay informed on key healthcare policy updates and regulatory alerts, including CMS proposed rules, Medicare and Medicaid changes, and FDA regulatory updates, helping leaders navigate the evolving healthcare market.

As regulatory requirements evolve in the health industry, PwC’s Health Policy and Intelligence Institute helps drive proactive decision making where it matters most. The Institute brings together policy, risk and regulatory specialists to distill what’s happening now, what’s on the horizon, and where uncertainty remains, so you can move forward with clarity and confidence.


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Go Beyond the Headlines with concise primers on the business impact of recent policy shifts and regulatory trends.

Stay in the know with Regulatory Alerts that spotlight the latest developments — so you never miss a beat.

Unpack complex topics with deeper-dives to shape strategy, identify risk and optimize operations.


Explore policy updates and business implications by sector

Payers are experiencing sustained cost pressure driven by inflation, higher-acuity care, increased GLP-1 utilization, and rising behavioral health demand. These trends are contributing to increased utilization and margin compression across the health insurance market. Federal policy changes, including the expiration of enhanced ACA subsidies and OBBBA-related reforms, are shifting beneficiary enrollment and product mix. As a result, payers are reassessing product strategies across employer, individual, and Medicaid markets. These combined pressures are accelerating the need for operating model transformation and strategic repositioning.

PwC can help executives and organizations navigate these shifts, translating policy signals into strategic actions that strengthen resilience and reduce operational risk as the traditional health insurance model shifts.

Hospitals and health systems are facing sustained financial strain driven by rising costs, workforce shortages, and capacity constraints. Coverage volatility, including OBBBA-related eligibility changes and shifts to non-qualified health plans, is expected to increase uncompensated care. While care delivery continues to shift toward lower-cost settings, with increased investment in ambulatory surgery centers, multispecialty clinics, and home-based services.

These dynamics are placing additional pressure on emergency departments and safety net providers. Providers must balance cost containment with strategic investments in workforce redesign, automation, and partnerships to maintain access and operational stability.

PwC can help executives and organizations navigate these pressures, translating policy changes into strategic implications for reimbursement, workforce planning, and site‑of‑care strategy.

Pharmaceutical and life sciences companies are operating in a complex environment defined by rapid scientific advancement, rising consumer expectations, and increasing regulatory scrutiny. The patient journey is becoming more consumer-driven, as digital health platforms, at-home diagnostics, and direct-to-patient prescribing reshape how therapies are accessed and managed. These shifts are converging with modern regulatory expectations and require new models that integrate patient engagement, real-world evidence, and market access plans earlier in the product lifecycle.

Global dynamics, including drug pricing reforms and the expanding role of China in early-stage innovation, are also reshaping competition and M&A strategy. At the same time, supply chain vulnerabilities and national security considerations are increasing the need for geographic diversification and resilience.

Together, these forces are driving tighter alignment across R&D, regulatory, and market access functions, as companies navigate pricing volatility, contracting complexity, and faster innovation cycles.

PwC can help pharma leaders anticipate and navigate these changes by translating policy shifts into R&D decisions, evidence generation considerations, and market strategy.

MedTech companies and manufacturers are entering a period of rapid innovation driven by the acceleration of AI-enabled tools, digital health technologies, and a growing number of consumer-facing devices. As investment flows into these areas, product development cycles are accelerating and blurring the boundaries between traditional medical devices and everyday consumer health products. This convergence is reshaping how devices are developed, regulated, and brought to market. At the same time, policymakers are removing regulatory barriers for lower-risk AI and technology-enabled tools, enabling faster market entry and expanding the range of products that can reach consumers directly. Together, these trends are increasing competition, shortening innovation timelines, and requiring more agile product, regulatory, and commercialization strategies.

PwC can help medtech leaders stay ahead by distilling these regulatory pivots and translating emerging FDA/CMS expectations into strategic actions for product design, evidence planning, and market execution.

Regulatory alerts

Never miss a beat with the latest health policy developments

Beyond the headlines

Concise primers on the business impact of recent policy shifts and regulatory trends


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Kelly Griffin, PhD, RAC

Kelly Griffin, PhD, RAC

Director, Health Policy and Intelligence Institute, PwC US

Michelle Horton

Michelle Horton

Health Industries Risk and Regulatory Leader, PwC US

Tamil Sriram

Tamil Sriram

Principal, Health Industries Risk & Regulatory, PwC US

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