• The drive to develop standards and identify best practices to drive rapid growth in the emerging field of digital therapies has been supported by 25 technology companies ranging from Google Health in HP Lil Livongo, Philips, in ResMed.
• The companies joined an initiative by the Consumer Technology Association to define performance requirements for digital therapy, which the group describes as a new branch of digital health that integrates software applications in healthcare.
• The FDA is working to remove regulatory barriers during the public health emergency for digital therapy devices designed to treat psychiatric disorders.
Digital therapeutic applications go beyond wellness monitoring and support the treatment of pain, allergies, and mental illness. Patient data can be monitored in real-time, with applications sometimes used to optimize drug doses or even to replace traditional pharmaceutical treatments.
Before COVID-19, the use of digital therapies became increasingly important to enable treatments for a variety of diagnoses. Investments in the segment grew an average of 40% annually over a seven-year period to reach more than $ 1 billion in McKinsey’s 2018 research report. However, developers were sometimes challenged to gather enough evidence clinic to support the use of interventions.
As stated in the latest FDA guidance, regulatory requirements that arose during the pandemic included the need for 510 (k) documents, certain standards for clinical trials, and registration and listing requirements for low-risk technologies. The policy should not involve undue risk as long as the products are validated, follow cybersecurity best practices and require the user to consult a doctor before use, the agency said.
CTA said the current challenge for the industry is to create an industrial base to share and apply digital therapies and educate consumers on the technologies used for interventions. The group says the technologies have the potential to improve patient outcomes and lower the cost of care.
Earlier this year, the CTA published digital health standards for the use of artificial intelligence in healthcare, performance requirements for physical activity, and stress management. The association plans to host a session on digital therapies during the Fall Standards and Technology Forum, which will explore the science and applications of the field.
The Digital Therapeutics Alliance, an industry group that promotes the integration of evidence-based digital therapies in general healthcare, published its code of ethics and a list of best practices in 2019 to lead the industry in product development and commercialization.
The action was taken by the industry stem from the fact that the FDA’s pilot program for digital health software precertification, of which Apple and Fitbit are members, is still ongoing. Bakul Patel, associate director of the FDA’s Center for Digital Health, told MedTech Dive in late March that the agency will continue the program until 2020 to “test and build” the program and that it will eventually go to Congress to do this the legislative speech that eventually became the final phase of the program.
Digital therapy developer Pear Therapeutics announced in late March that its app-based treatment for chronic insomnia had received FDA approval. This is the first product to be shipped via the 510 (k) route during FDA’s pilot program review for precertification.