Health industries quarterly insights: PwC 

Welcome to our latest quarterly industry insights for pharmaceutical, life sciences, medtech, healthcare, and not-for-profit sectors. This edition features new insights on women’s healthcare and AI in finance, updates on the recently released SEC proposed rules, and other regulatory and accounting updates.

Spotlight

Closing gaps in female-specific cancers

Women’s oncology represents a significant and growing opportunity to improve outcomes and address persistent gaps in care. While breast cancer has benefited from decades of investment and innovation, gynecologic cancers including ovarian, endometrial and cervical cancers, remain comparatively underfunded despite significant disease burden and unmet need. The market for female-specific oncology is expected to grow with opportunities spanning therapeutics, devices and diagnostics, and care delivery. Investment is also broadening beyond breast cancer as advances in precision medicine, earlier detection and integrated, longitudinal care create new avenues for innovation. Healthcare organizations can help close these gaps by prioritizing targeted therapies and diagnostic tools for underserved indications while developing care models that address patients’ needs across treatment, survivorship, fertility and quality of life.

Health policy and regulatory developments continue to reshape the health sector

Recent federal actions spanning Medicare coverage for breakthrough devices, vaccine policy, 340B reform, FDA user fee priorities and Medicaid waivers could have significant implications for pharmaceutical and life sciences companies, payers and providers. Explore the latest developments and what they could mean for organizations across the health ecosystem.

The CFO as the enterprise decision engine

Pharma and medtech finance functions are evolving from traditional reporting and cost centers into enterprise decision engines. The modern pharma and medtech CFO is expected to influence strategic decisions beyond traditional finance, including R&D investment, manufacturing strategy, product launches, pricing and M&A. Addressing these questions requires a more agile, forward-looking finance function. AI and automation can help address rising cost pressures by streamlining routine activities and shifting finance talent toward higher-value analysis and business partnering. However, fragmented systems and inconsistent data often limit an organizations’ ability to scale these capabilities. Leading finance organizations are strengthening their data foundations, deploying AI where returns are measurable, and embedding finance earlier in strategic decisions.

The next 24 months represent a critical window for finance transformation as advances in AI and automation coincide with growing demands on the CFO organization. Decisions made now around the operating model, data foundation and deployment of technology can shape the finance function for the next decade.

The cost of waiting: Why healthcare portfolio decisions matter now

Waiting for greater certainty may come at a cost for healthcare organizations. As financial, policy and market pressures continue to converge, leaders may need to rethink traditional approaches. Rather than relying on conventional cost-reduction strategies or waiting for conditions to stabilize, leaders may need to reassess their portfolios and make deliberate decisions about where to invest, partner, grow or exit. This latest insight examines why acting now with a disciplined strategy can help organizations preserve value, strengthen their position and prepare for what’s ahead.

Regulatory and accounting updates

Semiannual Reporting

On May 5, the SEC issued a proposal that would provide an optional semiannual reporting framework that would allow public companies to replace quarterly reporting on Form 10-Q with a new Form 10-S covering the first half of the fiscal year. The proposal would also revise how registrants evaluate the age of financial statements in registration statements and certain other filings. The proposal would not change Form 8-K requirements and triggering events, including those related to furnishing any earnings releases. For further information refer to our In brief.

The SEC received over 200,000 comment letters from a wide range of institutional and individual stakeholders during the comment period that ended on July 6. Investors broadly opposed the proposal, with concerns focusing on reduced transparency and less timely information available for decision-making. Registrants were generally in favor of the increased optionality provided by the proposal, citing varied business models, seasonality and maturity, as well as investor expectations. While other stakeholders in the accounting profession were largely supportive of the objective to reduce regulatory burden, they did not express a view on the appropriate frequency of required reporting but emphasized the importance of addressing implementation, operational, and investor-protection considerations.

Filer Status

On May 19, the SEC issued a proposal that would simplify the public company filer status framework, resulting in two primary filer categories, large accelerated (LAF) and non-accelerated (NAF). Reporting requirements for LAFs would largely remain the same, but the threshold to qualify would be raised. NAFs would receive the scaled disclosure accommodations currently provided to smaller reporting and emerging growth companies, and new registrants, including IPOs, would be classified as NAFs for a minimum of 60 months. For further information refer to our In brief.

The SEC received over 160 comment letters during the comment period that ended on July 20. While the simplification of filer statuses and the modernization of regulatory and disclosure obligations were generally supported, some stakeholders felt that the potential cost savings for companies would not adequately offset any losses of transparency and comparability in reporting. There was also feedback that the 60-month seasoning period for new public companies may be too long, especially for larger new registrants.

Registered Offering Reform

On May 19, the SEC issued a proposal to modernize the registered securities offering framework to expand access to public capital markets. If adopted, the changes would broaden eligibility to use Form S-3, providing more registrants access to shelf registration statements, At-The-Market programs, and registration and communication benefits currently reserved for well-known seasoned issuers, while also expanding Form S-1 incorporation-by-reference rules. The proposal would also remove the baby-shelf cap on smaller issuers with less than $75 million public float. Refer to our In brief for further information.

During the public comment period that ended on July 27, feedback was generally supportive of modernizing the registered offering framework, including broader Form S-3 eligibility, removal of the baby-shelf cap, and expanded incorporation by reference. Commenters also identified areas where additional refinement may be helpful, including the scope of automatic shelf registration statement eligibility and investor protection considerations.

Next Steps

The comment periods for the proposals discussed above have closed. The SEC staff is currently in the process of evaluating public comments, conducting stakeholder outreach and considering potential revisions before recommending final rules to the Commission. Any final rules approved by the Commission would specify effective and compliance dates. Until such approval, existing financial reporting rules and requirements remain in effect.

The SEC and FDA recently entered into a memorandum of understanding (MOU) designed to strengthen coordination and information-sharing between the agencies. The MOU establishes a framework for exchanging information, including certain non-public information that the SEC may use in public company filing reviews and in connection with enforcement investigations and proceedings. The MOU underscores the importance of ensuring that disclosures regarding clinical trials, the status of FDA review, product approvals and other FDA-related developments are accurate, timely and consistent with information provided to the FDA. For further details, refer to the SEC press release.

SEC comment letter trends for health industries

Our analysis of SEC comment letters has been updated for letters made public through June 30, 2026.  Please see the following link for a summary of the SEC comments for each Top 5 trend in Health Industries.

_{⁽¹⁾This analysis was performed based on topical areas assigned by research firm Audit Analytics for comment letters publicly issued in the 12 months ended June 30, 2026 (Current Period) and the 12 months ended July 01, 2025 (Prior Period) in relation to Form 10-K and Form 10-Q filings.}

Additional Insights

The FASB has added a project to its technical agenda intended to simplify and improve the operability of equity method accounting. The project will clarify when investors in partnerships and similar entities should apply the equity method, including eliminating the separate “virtually no influence” threshold and instead applying a single significant influence threshold for all entities. Updates will also address accounting for complex profit and loss allocation structures by incorporating existing real estate industry guidance on the hypothetical liquidation at book value (HLBV) method into Subtopic 323-10. Additionally, proposed updates will add illustrative examples on the application of HLBV. Proposed transition approaches vary depending on the nature of the change, with early adoption expected to be permitted. An exposure draft is anticipated in the fourth quarter of 2026 and will be subject to a 75-day comment period.

On August 18, 2026, the FASB issued a proposed Accounting Standards Update intended to clarify how the existing definition of cash equivalents applies to certain digital assets, including stablecoins. The proposal would not change the definition of a cash equivalent, but would add illustrative examples demonstrating how the definition of cash equivalents applies to certain digital assets. The proposal would also require entities to disclose the significant components and related amounts comprising cash equivalents, regardless of whether they include digital assets, providing greater transparency into an entity’s most liquid assets. Comments on the proposal are due November 19, 2026. For more information, check out our In brief.

Healthcare and not for profit updates

On August 27, 2026 we published updates to our not-for-profit (NFP) entities guide. This guide addresses the accounting and reporting for not-for-profit entities under US GAAP. Noteworthy changes include new guidance for interim reporting and crypto assets, and additional discussion and examples illustrating common NFP transactions. Please refer to the ' About the Not-for-profit entities guide’ section of the NFP Guide for a listing of key changes made to the guide.

Register now: Health industries accounting and reporting year-end hot topics webcast

Join our Health industries accounting and reporting hot topics year-end webcast on December 16, 1 – 2:30pm ET for timely insights on the healthcare policy and regulatory landscape, US Deals 2027 outlook, SEC developments and other key considerations as we look ahead to 2027.

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Note: This webcast is eligible for CPE credit.

Thought leadership

Explore how payers and providers can navigate the evolving Medicare Advantage risk adjustment landscape, from regulatory changes to the growing role of AI and data.

Learn how Medicare Advantage plans can evolve their sales strategies through a more personalized, multichannel approach focused on member engagement and retention.

See how boards can strengthen accountability and effectiveness by addressing underperformance, reassessing board composition and fostering more open and honest dialogue.

Health industries accounting and reporting quarterly insights: September 2026

Health industries accounting and reporting quarterly insights

June 2026

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