digital health regulation

By Brian Dolan 11:41 am June 10, 2014
When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a...
By Brian Dolan 08:05 am April 10, 2014
This week the European Commission announced a consultation -- similar to a public notice from the FDA here in the US -- that asks digital health companies and others for help in identifying ways to encourage and regulate mobile health, which the Commission defines as "ways to enhance the health and wellbeing of Europeans with the use of mobile devices, such as mobile phones, tablets, patient...
By Neil Versel 04:34 am February 11, 2013
The champion of legislation to give the Food and Drug Administration (FDA) regulatory power over mobile and wireless health apps, gadgets and other tools believes his plan is something industry wants and consumers need. "The tech community needs confidence in a consistent, reliable framework for wireless health. The FDA has a critical role to play. Today, there is no confidence [among] industry....