Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation

BMC Medicine
Now Reading:  
Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation

Transparent like glass

In this BMC Medicine article, you'll learn about:
  • In 2015, the US Food and Drug Administration released formal guidelines on its approach to regulating "Mobile Medical Apps". The guidelines prioritize monitoring and approval process of mobile apps that directly control medical devices or function as these devices on their own. Mobile apps that are educational or promote "wellness" are considered less harmful. This strategy effectively narrows the scope of mobile applications the FDA oversees and approves. The NHS and FDA are piloting novel approaches to regulating digital health apps.

  • An accelerated and less cumbersome approval process makes accreditation more appealing to developers and incentivizes them to design applications that respect basic data privacy rights. As part of the Digital Health and Innovation Plan, the FDA introduced a "Pre-Certification" program in 2017 for pilot in 2019.
Read the full article
Read the full article here > >
This is some text inside of a div block.

Community Comments