Mobile Health

FDA Proposed Guidance on Mobile Health Apps

1 Mins read

The FDA will release its proposed guidance on mobile health apps Wednesday with a 90 day comment period.  They propose overseeing those apps that: 

The FDA will release its proposed guidance on mobile health apps Wednesday with a 90 day comment period.  They propose overseeing those apps that: 

  • Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
  • Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

@FDADeviceInfo will hold a twitter chat today at 3:00 pm using #FDAApps.

This news comes as I’ve learned about the work of mHealth Regulatory Coalition and their recent white paper on FDA regulation of mHealth.  Little did I know yesterday, that progress would come so quickly.

Related posts
Artificial IntelligenceCovid-19eHealthHealth careMobile HealthTechnology

How Can AI Protect Healthcare Workers From COVID-19 Transmission?

4 Mins read
In the unprecedented time that COVID-19 is, health and care workers, especially those who operate on the frontline, have emerged as heros….
eHealthMobile Health

Advances In Telehealth In 2020 You'll Want To Know About

3 Mins read
Telehealth is quickly becoming one of the biggest trends within the health and wellness industry. From wearables to virtual doctors’ visits, patients…
eHealthMobile Health

How To Develop A Telehealth App: All You Need To Know

3 Mins read
Technology as a blessing has helped many people in different forms, and due to this reason, it has become easy to get…