Regulation of digital health technologies after unwinding of pandemic guidances

The COVID-19 pandemic brought about temporary relaxations in regulations for digital health technologies (DHTs), encouraging their use due to restricted in-person healthcare. With the end of the public health emergency (PHE), certain pandemic-related guidelines affecting DHTs are set to expire. The FDA's stance, however, suggests continued recognition of the value of DHTs, especially in clinical trials and home-based patient monitoring.

One crucial guideline set to sunset is the "Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 PHE." This guideline permitted the distribution and use of digital health therapeutic devices for psychiatric disorders during the PHE. It aimed to expand access to mental healthcare while minimising patient-provider contact during the pandemic.

This guideline will remain in effect until November 7, 2023, unless replaced by a revised version. DHT companies may need to take action for compliance, and there could be implications for patients and providers concerning access to mental health care. The the industry needs to engage with the FDA as it develops a long-term regulatory framework for DHTs.