// June 16, 2020

Quality Concerns and Future Steps into the Era of “Digital Medicines”


For nearly 200 years, USP’s public standards have served to establish a common foundation upon which the quality of medicines can be evaluated, building trust in the healthcare system and enabling innovation to thrive. During that time, medicine has evolved tremendously. From tinctures and potions that were mixed, to small molecule medicines that are chemically synthesized in a lab and large molecule therapies that are grown in living systems. These technological advancements required USP’s quality standards to also evolve.

With the COVID-19 pandemic, new regulatory developments have accelerated the use of digital health technologies. For example, an FDA Guidance published in April 2020 stated that “the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. In addition, the use of such technologies has the potential to facilitate ‘social distancing’ by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 public health emergency.” This guidance, and other such developments could drive the adoption of digital health technologies, including digital therapeutics (DTx). The new regulatory guidance to meet the medical needs of the current pandemic situation reflects the need for public standards to ensure quality products and support for all stakeholders including developers, regulators and patients.

With the rise of digital therapeutics as a new therapeutic modality, quality standards may again have to evolve. That is why in 2018, USP, in collaboration with the Digital Therapeutics Alliance (DTA), hosted a roundtable to engage thought leaders in a discussion to examine the potential quality challenges that DTx may present, and how USP’s approach to standards development may contribute to ensure the quality of these therapies. That discussion was the start of a series through which we gathered feedback from stakeholders to continue to explore the need for public standards in DTx. The culmination of these discussions resulted in a white paper - The role of public standards in assuring quality of digital therapeutics - aimed at describing the value of public standards, and proposing how USP’s existing quality framework for chemical medicines and biologics could be adopted by digital therapeutics.

Specifically, we are proposing that key attributes that define quality (i.e. identity, strength, purity, and performance) in USP’s approach to quality standards development can be applied to DTx. This includes the notion of the finished product being made up of ingredients (coding, algorithms, etc.), each of which may benefit from public quality standards. We provide initial thoughts regarding necessary modifications to how these key attributes could be used with digital therapeutics products, such as ways to think about the identity of software components. We will continue to have robust dialogue with our stakeholders, and have also laid out questions to help collectively deepen our understanding of where standards are critical to ensure quality.

We welcome feedback from all stakeholders, including industry, academia, providers, regulators, and patient groups to help continue to shape the thinking and approach. If you would like to submit your comments, please send them to DTxWhitePaper@usp.org. A roundtable is planned to take place in Fall of 2020 as a follow-up once feedback is gathered