Digital Therapeutic Industry Leaders Promote Ethical Standards and Product Development Best Practices

Trust is crucial as patients increasingly use digital therapeutic products for the delivery of high quality, evidence-based medical treatments

Washington, D.C. — Today, the Digital Therapeutics Alliance (DTA) released an Industry Code of Ethics, a series of Best Practices, and an updated product claims categorization chart for digital therapeutic (DTx) products. DTA is also proud to collaborate this week with the Digital Medicine Society, HealthXL, and NODE.Health to release a broad categorization of the Digital Health, Digital Medicine, and Digital Therapeutic industries.

DTx products deliver personal and adaptive medical interventions to patients and are driven by high quality, evidence-based software programs. As such, they make claims to prevent, manage, or treat a medical disease, and therefore carry a higher level of risk than other products in the broader digital health landscape. Digital therapeutics do not include lifestyle and wellness apps, clinical decision support, or products that deliver static, automatic interventions to patients.

“DTx products provide a monumental opportunity to improve how healthcare is delivered by increasing therapeutic options for unmet medical needs and expanding patient access and engagement. Given the importance of these therapies, DTA members appreciate the responsibility of protecting patients and end users every step of the way,” shares Megan Coder, DTA Executive Director. “In many ways, digital therapeutics are an extension of a clinician in a patient’s everyday life as they receive active treatment outside of a clinic. This is why these documents are so important.”

In order to reinforce the foundations of the digital therapeutic industry, DTA is proud to release the following:

• DTx Code of Ethics: As the DTx industry continues to expand and deliver medical interventions directly to patients, it is important for end users to know that the companies working to develop, evaluate, and market digital therapeutics are acting in the best interest of patients. Therefore, DTA member companies collaborated with fellow leaders in the healthcare industry to develop a DTx Industry Code of Ethics. This Code demonstrates DTA Member Companies’ dedication to developing and bringing DTx products to market in a responsible way.
• Industry Best Practices: Last year, DTA published Industry Core Principles to which all DTx products should adhere. These principles address topics such as robust product quality and design, privacy and security, end user engagement, and clinical evaluation. In order to provide better clarity for patients, clinicians, and payors on how to assess product alignment with these principles, DTA compiled a series of Best Practices that products may utilize to demonstrate robust design, evaluation, and delivery of interventions.
• DTx Product Claims: In 2018, DTA published an Industry Report that provided the definition of a DTx product, industry principles, and a chart representing DTx product claim types. In order to provide a more appropriate representation of the industry, DTA recently developed a more streamlined approach to the DTx Product Claims categorization.
• Industry Categorization: Clarity and trust are crucially important in this quickly evolving industry. With this mission, DTA collaborated with other organizations to outline the landscape of digital health products available to end users and clinicians. This Digital Health Industry Categorization demonstrates how products making higher-risk medical claims must undergo greater levels of clinical evidence and regulatory oversight.

“Currently there is tremendous confusion among patients, clinicians, and payors about the types of products that exist across the broader digital health landscape,” said Coder. “It is important for patients and other users to understand what types of digital products they are using, what products’ primary functions are, and the levels of clinical outcomes and regulatory oversight that are required of them.”

These resources demonstrate that not all digital products are the same, and those products that are delivering medical interventions and making medical claims are taking a serious approach to ensuring patient safety, protection, and care.

Access these materials on https://dtxalliance.org/aboutdtx/.

About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payers in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.

Updated: 13 November 2019