- The Guide harmonizes expectations related to DTx product quality, security, clinical evaluation, and regulatory requirements
- Developed through a collaborative two-year process via interviews and workshops with industry stakeholders globally
ARLINGTON, VA – May 17, 2022 – The Digital Therapeutics Alliance (DTA), a global non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics (DTx), announced today the industry’s first guidance on digital therapeutics best practices, the DTx Value Assessment & Integration Guide (“the Guide”).
This inaugural edition serves as a leading framework of evaluation and implementation of digital therapeutics (DTx), that use innovative, clinically-validated disease prevention, management, and direct treatment technologies to enhance, complement, and in some cases replace, current medical practices and treatments.
The Guide harmonizes expectations related to DTx product quality, security, clinical evaluation, and regulatory requirements and was developed through a collaborative two-year process incorporating insights from payors, clinicians, and manufacturers to ensure applicability across settings.
This Guide focuses on digital therapeutics—products that deliver clinical interventions directly to patients via software to treat, manage, or prevent a disease or disorder. DTx products may also integrate a variety of other digital capabilities into their product offerings, such as wearables and biometric sensors, diagnostic capabilities, the delivery of health information to patients, and clinical decision support features for clinicians.
Given the growth of the DTx industry, and as more healthcare decision makers (HCDMs) across the world review, assess, approve, and implement DTx products, it is important for clinicians, policy makers, and payors to have access to a reliable framework and industry guidance that enable consistent evaluation of DTx products across local, national, and regional settings.
DTA developed the DTx Value Assessment & Integration Guide to provide a common language and process for HCDMs and DTx manufacturers to jointly use throughout DTx product evaluation processes. By providing the building blocks of DTx product review and economic assessment pathways, this Guide serves as a tool for HCDMs and DTx manufacturers to use in assessing baseline information about DTx products, their value, and their impact in real-world settings.
We founded the Digital Therapeutics Alliance to ensure that patients in every part of the world will be able to access and trust the safety, quality, and impact of DTx therapies,” said Megan Coder, DTA Chief Policy Officer. “In the last decade, the DTx industry has matured significantly, and this framework provides a timely blueprint to advance the digital therapeutics industry into the next era of innovation.
The Guide incorporates feedback from payors, clinicians, and manufacturers from key international markets. It assists HCDMs, including payors, employers, governments, evaluators, health system administrators, clinical leaders, patients, and other individuals, in assessing, integrating, and scaling DTx products across clinical-use settings.
This new guidance highlights the important role of private-public collaboration in a robust digital therapeutics economy,” said Trina Histon, PhD, Senior Principal Consultant Prevention, Wellness & Digital Health at Kaiser Permanente. “As clinicians, healthcare systems, employers, and payors continue integrating these products into patient care, digital therapeutics will increasingly augment the delivery and consumption of healthcare globally. The DTA guidance will serve as a reference for DTx companies to adopt a consistent set of recommended industry standards to bring more innovation to patients.
For over 5 years, Digital Therapeutics Alliance has led national-level policymaking and its direct impact on the life sciences industry,” said Owen McCarthy, Chair Board of Directors, DTA and President & Co-Founder, MedRhythms. “This inaugural guidance offers a much-needed framework for the public, policymakers, and others to understand the many elements that are necessary to continue to drive the digital therapeutics industry forward.
This Guide serves as a critical step in product access and contracting discussions. It addresses a wide spectrum of HCDM considerations across various settings—ranging from individual health systems and employers to single-payor government systems, and multi-payor public/private settings—and will continue to be updated to ensure ongoing relevance in this quickly evolving ecosystem.