Digital health is coming of age as regulators begin to approve digital therapeutic solutions that prevent, manage or treat medical disorders or disease, sometimes complementing traditional drug therapies.
But getting the message about this new class of products over to doctors and patients is a challenge, as their approach to treating disease is so different from established conventional medicines.
With this in mind, trade association the DTA has released a code of ethics and a series of guidance documents to help build trust with patients and doctors.
The new guidance is important as the developing industry seeks to build relationships with patients and differentiate itself from lifestyle and wellness apps. In contrast, DTx products are medical interventions driven by high quality, evidence-based software programs, Shull said.
The DTA has produced a DTx Code of Ethics outlining ethical standards governing issues such as safety, privacy, and marketing guidelines. The Code reads rather like a doctor’s Hippocratic Oath, asking companies to ensure products do no harm and that they are backed with suitable evidence and patient information. Companies signing up to the Code must ensure data is secure and protected, and that they have the organizational and human resources to sustain products through their life cycle.
Shull told The Sidebar that signing up to the Code builds trust with doctors and the general public, and allows stakeholders to differentiate between health apps and digital therapeutics backed with clinical evidence.
“The ease of making apps has meant that anyone can create and make them available to the public, but there is no way to tell in the iTunes store, for instance, which ones have clinical evidence behind them and which don’t,” Shull explained.
DTx are based on evidence, often on several clinical trials, having undergone years of development, refining, testing, Randomized Controlled Trials (RCTs), and always with healthcare professionals and end users (patients) involved in the design. They have a direct effect on the user’s disease or condition, so there must be careful studies done to prove their safety, accuracy, and efficacy.