Maryland, MD—United States Pharmacopeia (USP) Healthcare Quality and Safety (HQS) Center of Excellence is examining the current landscape of Digital Therapeutics (DTx) to establish quality standards aimed at broadening access and ensuring appropriate use of these therapeutics.
DTx are defined by the International Organization for Standardization as “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.” The area is populated with apps and other software designed to treat various ailments including mental health disorders, diabetes, asthma, insomnia, substance-use disorders, and beyond. Patients can often use them from the comfort of their homes.
The DTx market is evolving rapidly with North America currently dominating the market with a revenue share of 40 percent in 2023. The regional market is expected to grow significantly due to increased popularity of digital health products. The global market revenue, however, is expected to grow at an accelerating rate due to the rise in internet penetration around the world. According to some estimates, the global revenue of DTx will increase from $7.7 billion in 2024 to over 32 billion in 2030. Because of this forecasted expansion, these products require robust standards to support the development of high-quality therapeutics and the delivery of comprehensive care on a large scale.
At HQS Center of Excellence, a science-based roadmap is underway to analyze the present state of DTx and to establish standards. By engaging in roundtable discussions, drafting stimuli articles, and developing work plans with HQS Expert Committees, USP is setting high-quality standards, covering aspects such as labeling, version control, classification, health equity, and accessibility.
Leveraging its long-standing expertise, USP helps ensure that DTx products enhance patient care. Further efforts include fostering interoperability among clinical systems worldwide, integrating DTx into existing healthcare delivery frameworks, and enhancing awareness and education about DTx.
These efforts encompass developing the groundwork for standards that address crucial elements such as security, privacy, technology proficiency, and data integrity. Such standards will create a comprehensive framework for seamlessly integrating DTx within the healthcare industry and supporting its development and regulation.
Additionally, USP is actively monitoring the DTx market to better understand the potential role of standards for promoting DTx product growth, to identify factors that can expedite progress for addressing barriers, and to determine the competencies needed to navigate the ever-changing, technology-driven market.
Personalized Digital Therapies: Understanding Their Regulation
Powered by advanced technology, including artificial intelligence (AI) and machine learning (ML), DTx provide personalized interventions. Many are crafted by collaborations between healthcare professionals, software developers, and engineers, guiding users through therapeutic exercises, tracking their progress, and dynamically adjusting treatments to pursue greater efficacy. With these digital solutions seamlessly integrated into daily life, healthcare can become more accessible than ever, marking a significant step forward in how we manage wellness in today's digital age.
In the United States, the US Food and Drug Administration (FDA) is the primary regulatory authority that helps to ensure the safety and efficacy of health-related products. The regulatory framework for DTx was expanded with the 21st Century Cures Act in 2016, which clarified that DTx products are regulated as medical devices based on their levels of risk.
FDA defines the scope of DTx to include Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), mobile applications, Clinical Decision Support (CDS) tools, and wireless medical devices, which undergo rigorous pre-market review and post-market surveillance. FDA’s comprehensive regulatory approach for DTx covers performance standards, special controls, and risk-based assessments, addressing additional considerations like cybersecurity, the use of artificial intelligence, and the potential for device modification to impact safety or efficacy.
USP is currently engaged with stakeholders and regulators in roundtable discussions to develop stimuli articles related to its research on developing DTx standards. These articles will be featured in the USP Pharmacopeial Forum and will solicit public comments to promote stakeholder engagement. In the meantime, USP encourages interested parties to apply to become involved in developing DTx standards as a USP Expert Volunteer in the 2025-2030 cycle.
For further information about USP’s work on DTx, visit our webpage, sign up for the HQS newsletter, or contact:
- Blaine Groat (blaine.groat@usp.org)
- Yasmin Haidarbaigi (Yasmin.haidarbaigi@usp.org)
