- The Digital Therapeutics Alliance has developed a Code of Ethics and Best Practices intended to serve as guidelines for industry in product development and marketing.
- The two-year-old group, which promotes adoption of evidence-based digital therapeutics (DTx) into healthcare, said the frameworks were created for products that claim to prevent, manage or treat a medical disease and therefore carry a higher level of risk than broader digital health tools such as wellness apps, clinical decision support or products that deliver static, automatic interventions.
- DTA also released an updated product claims categorization chart for DTx products, as well as a broader outline of the digital health, medicine and therapeutic industries developed in collaboration with the Digital Medicine Society, HealthXL and NODE.Health.
The alliance's efforts address the growing pains of an industry that continues to expand as healthcare providers find ways to leverage the technologies to improve quality of care and cut costs. A report from Rock Health earlier this year found that pharmaceutical companies want to partner with digital therapeutics startups, but payers and other stakeholders are still warming up to the benefits of the treatment category.
DTA said it wants to clear up confusion about what types of products exist in digital health and reassure patients, clinicians and payers that those making higher-risk medical claims must be backed by greater levels of clinical evidence and have more regulatory oversight.
Formed in 2017 with a mission to integrate the emerging field of digital therapeutics into mainstream healthcare, the the group contends clinically validated disease management and treatment technologies can improve and sometimes replace current medical practices.
Founding members include cognitive therapeutics firm Akili Interactive, digital asthma and chronic obstructive pulmonary disease management firm Propeller Health, which was later acquired by ResMed, digital diabetes company Voluntis and chronic disease management firm WellDoc. The alliance now counts among its members Novartis, Sanofi, Bayer, Pear Therapeutics and many others.
Under the Code of Ethics, every company engaged in the design, evaluation and deployment of digital therapeutics should adhere to the 10 principles, which include a focus on patient safety in all decision-making processes, protections for patients' privacy and data, appropriate product claims and availability of credible evidence to support those claims.
The Best Practices fact sheet encourages robust design, evaluation and delivery of DTx products. It builds on Core Principles established last year, to provide more clarity about its work in the areas of product quality, privacy and security, consumer engagement and clinical evaluation.
DTA also streamlined information on DTx product claims to better show how products making high-risk medical claims are supported by greater levels of clinical evidence and regulatory oversight. For example, products that claim to treat or manage a disease or improve a health function must deliver a therapeutic intervention and use evidence such as clinical trials to support those claims.