ACT | The App Association urges FDA to encourage use of apps in clinical trials

Today, ACT | The App Association urged the Food and Drug Administration to encourage the adoption of apps in clinical investigations. Mobile app-enabled telehealth and remote monitoring of patient generated health data (PGHD) is an incredibly promising avenue for improving healthcare quality while lowering costs. But, significant statutory and regulatory burdens prevent widespread use of these innovations.

To increase the use of apps in clinical investigations, ACT | The App Association asks the FDA to do the following:

• Update the FDA clinical trial guidance, some of which dates back to the 1990s
• Hold a series of publicly-accessible workshops, and make publicly available technical resources and educational materials on how to embrace the use of new technologies and innovations in clinical trials
• Work with the wide range of stakeholders involved in the healthcare technology community on public-private partnerships, grants, and other means to increase the use of innovative technologies in clinical trials

Despite barriers that exist today, we are already seeing remarkable use of these technologies in clinical trials. We highlight many of these examples in our comments.

Image: NEC Corporation of America / image cropped / license