Other key findings

• Many digital health companies that originally designed tools such as digital therapeutics as standalone products are now adapting their solutions to support multiple business models in parallel, expanding potential routes to commercial success.
• In addition to products, digital product developers now offer health services as digital care providers or diagnostic laboratories, repurpose their platforms to deliver custom offerings for providers, employers, and life sciences companies, and adapt remote monitoring tools to support clinical development and patient support programs.
• As competition intensifies, companies are consolidating to lead in specific segments while expanding horizontally and vertically to deliver comprehensive end-to-end solutions that better meet the needs of employers and other stakeholders.
• For instance, leading digital care providers have begun to offer solutions that include self-guided wellness apps for condition self-management alongside medical-grade therapeutic products — allowing them to move patients between different levels of care — and sometimes use AI-driven clinical decision support tools to personalize recommendations.

• Billing codes in the United States have been instrumental in supporting the use of digital tools in clinical practice and digital care — enabling providers to request reimbursement and expanding adoption.
• Currently, more than 300 billing codes support the use of digital health solutions and digital care, including 117 specific to software-based technologies such as SaMD, SiMD, and AI-SaMD, but reimbursement opportunities vary by solution type, payer, therapy area, and care setting.
• In 2025, the Centers for Medicare & Medicaid Services introduced new codes to facilitate Medicare reimbursement of digital mental health treatment devices (i.e., digital therapeutics) provided “incident to” care and has signaled it may extend this approach to other software-based solutions.

• Growing use of AI-enabled diagnostic tests in the private sector has prompted the creation of the first Category I CPT codes for inclusion in the 2026 Medicare Physician Fee Schedule.
• These codes will help providers analyze coronary arterial plaque to prevent blockages, assess heart disease risk by analyzing fat around blood vessels, determine burn severity via imaging, and identify heart problems using acoustic and ECG signals.
• This development signals that these technologies are now viewed as established rather than experimental, increasing the likelihood of reimbursement by Medicare and other payers and generating significant industry excitement.

• Accelerated access and reimbursement pathways have opened opportunities for faster market entry and reimbursement of digital health to products of increasingly diverse types and applications.
• Several countries — including the UK, Belgium, and the Netherlands — conduct health technology assessments of multiple digital health solutions for a specific medical purpose and may then recommend and/or reimburse several within the category.
• In the UK, NICE is leading efforts to identify the optimal care setting for digital technologies and has published over 20 Early Value Assessments, recommending more than 47 solutions for use within the NHS.
• These assessments highlight where digital health use cases have matured and started to gain traction in clinical practice.

• Payers increasingly require developers to demonstrate clinical benefit through randomized controlled trials, include local populations in studies, and benchmark solutions against the standard of care — driving the need to develop a global evidence strategy.
• Despite their growing importance to payers, health economic studies demonstrating cost-effectiveness remain scarce in published evidence, leading payers to prioritize evidence generation on real-world impact—such as resource utilization and provider workload—within early reimbursement pathways.
• Payers and care organizations also assess operational fit, seeking solutions that align with benefit structures, integrate seamlessly into existing systems, scale effectively, and come from partners with proven financial stability and experience.

• Health system adoption of new innovations is often slow, as integration into traditional care models takes time.
• In digital health, embedding complex solutions into care requires delivering value to a broad range of stakeholders, making it essential to understand the multidimensional needs of providers, payers, and payers alike.
• Health system integration is also a critical success factor, with providers expecting solutions to minimize added workload, integrate smoothly into existing workflows and feed data back into patient records, making it critical for developers to ensure interoperability with EHRs.