Peace of Mind At Your Fingertips: Digital Health Funding Explodes

To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of loss. We’ve also found new ways to appreciate life, like taking a longer walk during lunch breaks, or spending more time with our families. Since it’s impossible to completely diminish the virus, it’s crucial for us to learn to live with it and find silver linings. One positive change that has occurred during this difficult time is the rise of digital therapeutics (DTx) and digital health.

Digital therapeutics are defined as clinically tested tools that deliver medical intervention and/or treatment via software. DTx utilizes digital technologies and health data in support of treating a wide range of chronic conditions including mental wellness, substance use disorder, diabetes, and cancer. Digital health has existed for years, but it was not until the onset of the Covid-19 pandemic that general consumers started to embrace a more tech-savvy approach and treatment options. Digital health investment globally reached a record high of $57.2 billion in 2021. Investments in digital-therapeutics companies in the United States have grown by an average of 40% a year over the past seven years.[1] In addition, according to a new Morning Consult survey, 73% of U.S. adults described digital health tools as convenient, while 60% said they are safe, and 56% said they are accurate.[2]

However, this relatively young sector still faces regulatory challenges that could slow its adoption and application. Since 2017, roughly 40 digital therapeutics have been approved by the FDA, though the agency doesn’t have a specific definition for the products.[3] During the pandemic, FDA has loosened some requirements in order to increase access to digital health products, leading to the temporary commercialization of more DTx that are currently under development. The director of Digital Health at the Center for Devices and Radiological Health at FDA, Bakul Patel, said that “FDA’s steps to relax these requirements are more in line with the needs of the public health emergency. I believe that additional therapeutic devices will provide more of these opportunities, and more evidence will be generated as we start gaining more experience with these products.”

What makes regulating DTx more challenging is that the traditional quality-control measures simply don’t apply. Although randomized clinical trials are still required during the premarket approval process for safety and efficacy reasons, lots of other elements (devices, operating systems, internet connectivity and accessories such as headphones, etc.) on which the therapy depend also need to be regulated. For example, would a patient’s digital health treatment be dependent on the quality of his or her internet connectivity? Would the internet provider also need to be approved? That being said, a detailed regulatory framework for SaMD to ensure safety and privacy for these therapies remains uncertain. Perhaps some of these DTx programs can be regulated under FDA’s Multiple Function Device Product guidance; this states that in the case of a product with multiple functions (containing both a software non-device function and a device function), FDA may assess the impact that the software non-device function has on the device function when assessing the safety and effectiveness of the device.[4]

The FDA has been open to new proposals and is receptive to introducing updated regulations. One example of their effort is the FDA’s Digital Health Software Precertification Program, which is a pilot for approving software-based medical devices. (Read more about FDA’s Pre-Cert Program.) Instead of reviewing every software release for a DTx product, the FDA uses this program to review the developers’ ability to develop digital health application throughout its product lifecycle (e.g., monitor real-world performance) following robust quality and organizational principles. As of October 2019, nine companies were included in this program.

DTx and digital health platforms are expected to transform the healthcare system as we know it. With the surge in acceptance of digital health and the continued monitoring from the regulators, the DTx wave will propel the need for innovative treatment options that more and more people can benefit from.

RookQS has extensive experience helping clients navigate the regulatory and quality landscapes for commercializing DTx and other digital health applications. Please reach out to us to discuss your needs; whether it’s pursuing a medical device or an enforcement discretion designation, RookQS’ team is here to help! 

References:

1. Digital Health Funding Database, Rock Health, October 14, 2019. rockhealth.com

2. Galvin, G. (2021, June 14). Covid-19 accelerated use of digital therapeutics, but coverage issues and regulatory questions could slow their momentum. Morning Consult. Retrieved January 10, 2022, from https://morningconsult.com/2021/06/15/digital-therapeutics-use-coverage-polling/

3. Galvin, G. (2021, June 14). Covid-19 accelerated use of digital therapeutics, but coverage issues and regulatory questions could slow their momentum. Morning Consult. Retrieved January 10, 2022, from https://morningconsult.com/2021/06/15/digital-therapeutics-use-coverage-polling/

4. Center for Devices and Radiological Health. (n.d.). Multiple function device products: Policy and considerations. U.S. Food and Drug Administration. Retrieved January 10, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-device-products-policy-and-considerations