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Executive briefing: Strategic inflection points in digital health & health tech

The digital health and health tech sectors are undergoing a period of accelerated transformation amidst a fragmented regulatory landscape. Companies are looking within and to peers to determine how to pursue innovation while balancing financial and regulatory risks in this challenging landscape, while investors are waiting for leaders to emerge.  This briefing outlines four critical inflection points that are redefining the market.

1. AI in Healthcare: Building Trust and Embracing Risk Amidst Regulatory Uncertainty

Inflection Point: With no clear federal legal framework for AI in healthcare, organizations must work with internal and external stakeholders to build trust and understanding of the technology while proactively managing risk to drive adoption.  

  • Addressing Knowledge Gaps: Many patients lack the context to evaluate AI-driven decisions. Public-facing materials and clinician communication are key to bridging this gap. Empowering patients to engage with their own medical data – the information AI uses – establishes transparency and can build trust in AI-assisted care. 
  • Progress, Not Perfection: The question isn’t whether AI is perfect—it’s whether it’s better than current alternatives. Humans also make mistakes, but human error is more acceptable to the public than AI error. Framing AI as a tool for enhancement, not replacement, helps build trust. Communicating success stories to overcome negative perceptions in the court of public opinion is an important step in advancing AI within healthcare. 
  • Risk Without Regulation: The absence of federal AI regulation requires healthcare organizations to build internal frameworks for risk quantification and mitigation. 
  • Human-in-the-Loop Models as a De-Risking Strategy: At this time, AI is most often being deployed as clinical decision support—not as a replacement for clinicians. These models must be pressure-tested by competent humans to avoid hallucinations and ensure accountability. From a legal standpoint, the source of error—human or machine—doesn’t change the risk. What matters is whether the output was pressure-tested by a qualified reviewer.  

Investor Insight: Back companies that treat AI governance as a strategic asset, not just a compliance checkbox. The strongest players combine defensible frameworks, clear accountability, and alignment with emerging federal and state guidance with real-world evidence and proven use cases. Models that embed meaningful human oversight, anchored by the pedigree and expertise of the individuals in that loop, reduce both clinical and regulatory risk. That combination makes them far more investable and better positioned for long-term adoption. 

2. Payment Model Volatility: Navigating the Cash-Pay Surge and Reimbursement Gaps

Inflection Point: The traditional reimbursement ecosystem is now one of many paths for digital health companies. 

  • Cash-Pay Expansion: We see continued growth in cash-pay models given challenges with health plan coverage and consumer preferences to leverage virtual models for certain treatments, such as weight loss.  
  • Reimbursement Realities: Many digital health companies are opting out [...]

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360 Diligence for Digital Health Investments: What to Watch in Today’s Market Trends

Contributors: Dudley Baker, Managing Director, Holihan Lokey | Luiz Greca, Managing Director, Holihan Lokey | Chris Schickling, Managing Director, Gallagher

The digital health industry is complex and highly regulated, presenting unique challenges for investment in this space – especially for investors new to the healthcare industry. Healthcare companies have business lines and regulators that do not exist in other sectors of the economy, making it crucial to work with advisors that understand the value proposition of a healthcare business, where value resides amongst potential targets, and how valuations may vary. These complexities, coupled with current market trends, amplify the need for comprehensive diligence strategies to stratify risk and maximize value from advisors that understand the nuances of the healthcare sector.

In this article, we discuss the top three trends we’re seeing in digital health investment and how Gallagher, Houlihan Lokey, and McDermott Will & Emery can position your organization for success from pre-acquisition diligence to post-close operations.

Heightened Scrutiny on Healthcare Transactions and Physician Practice Management Structures

Healthcare transactions and physician practice management structures (sometimes referred to as the “friendly PC model”) are facing heightened scrutiny at both the state and federal levels. Regulators are imposing new requirements on parties and applying stricter transaction review standards, creating hurdles for healthcare investors and companies that may impact their ability to execute transactions and management relationships, and upend standard transaction timelines. For example, state laws like the recently passed and subsequently vetoed California’s AB 3129 seek to implement transaction notification and approval requirements that could present new obstacles to closing transactions and may extend pre-closing timelines. This bill would have also changed in the ways in which management companies and physician groups arrange for support services. Although Governor Newsom vetoed AB 3129, there is a newfound wave of support at both the state and federal levels to further regulate private investment in, and control of, healthcare organizations that continues to gain momentum. Oregon and Massachusetts are examples of other states that have considered similar legislation.

McDermott’s specialized focus on healthcare dealmaking and our scrutiny of the federal and state regulatory landscape helps investors and health companies stay ahead of legal developments, understand implications of proposed regulations, ensure compliance with federal and state agencies, and chart a course to move transactions through the review process efficiently.

Strengthening Cybersecurity

The healthcare sector is particularly vulnerable to cybersecurity issues and continues to be highly targeted for cybercrime. The health sector has historically under-invested in cybersecurity personnel and technology and is increasingly being targeted by sophisticated ransomware and other malicious threat actors.

In recent years, attacks on healthcare providers, insurers, and health technology vendors have resulted in catastrophic cyberattacks that have compromised patient data, resulted in a wave of class action litigation, and resulted in regulatory scrutiny and new regulations of the healthcare industry. These incidents are also incredibly expensive to contain, investigate, and remediate. In fact, according to the 2024 IBM-Ponemon Cost [...]

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