Comments on: FDA may regulate certain mobile phones, accessories

By: The FDA is not going to kill health 2.0 - SmartPlanet

The FDA is not going to kill health 2.0 - SmartPlanet — Wed, 01 Sep 2010 15:10:57 +0000

[...] last year he wrote a three-part series for MobiHealth News on FDA device [...]

By: FDA has App Stores Under Surveillance

FDA has App Stores Under Surveillance — Tue, 31 Aug 2010 21:58:06 +0000

[...] involved in the medical process than a simple stethoscope app, but where is the line drawn? In an article written last year, Thompson notes the FDA could even regulate cell phones used for medical purposes. He points out [...]

By: Update: mHealth Regulatory Coalition’s first meeting | mobihealthnews

Update: mHealth Regulatory Coalition’s first meeting | mobihealthnews — Wed, 14 Jul 2010 23:32:39 +0000

[...] 2. The limits of FDA’s accessory rule. In a nutshell, the FDA regulates any physical items that connect to a medical device just as it regulates the “parent” device. In connected health, however, everything is connected. The beginning and end of the medical device becomes very unclear in this context so the accessory rule needs an update and clarification. (more on FDA accessory regulation here) [...]

By: Should mHealth companies want FDA regulation? | mobihealthnews

Should mHealth companies want FDA regulation? | mobihealthnews — Thu, 14 Jan 2010 19:00:31 +0000

[...] article is the fourth in a series (one, two, three) of seven planned articles about FDA regulation of mHealth. The series started off by [...]

By: How to get FDA to clear a mobile health app « Android™ Medical Applications- Is it the future?

Wed, 02 Dec 2009 01:05:31 +0000

[...] the above two questions in his article at mobilehealthnews . The article in 3rd in series where in first article, he outlined what factors FDA considers while deciding which products need to be regulated. In [...]

By: How to get FDA to clear a mobile health app | mobihealthnews

How to get FDA to clear a mobile health app | mobihealthnews — Tue, 01 Dec 2009 23:38:04 +0000

[...] article is part of a series, and in the first article I outlined the factors FDA considers generally when deciding which products need to be regulated [...]

By: When will the FDA drop the gavel? | mobihealthnews

When will the FDA drop the gavel? | mobihealthnews — Thu, 19 Nov 2009 11:41:56 +0000

[...] potential role in regulating wireless health, be sure to read Thompson’s article on Mobile Phones and Certain Accessories and also Thompson’s Step-by-Step Guide to Wireless Health [...]

By: Step-by-step: FDA wireless health regulation | mobihealthnews

Step-by-step: FDA wireless health regulation | mobihealthnews — Mon, 24 Aug 2009 17:41:25 +0000

[...] month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile pho…. This month, in the second of six planned articles, I will outline the FDA requirements that would [...]

By: When Cell Phones Become Medical Devices | Bob on Medical Device Software

When Cell Phones Become Medical Devices | Bob on Medical Device Software — Wed, 15 Jul 2009 04:39:00 +0000

[...] Merrill Thompson does a good job of outlining the factors that lead to FDA oversight in the article FDA may regulate certain mobile phones, accessories. The Components vs. Accessories distinction is an important one for manufacturers — regulatory [...]

By: MedicalQuack

MedicalQuack — Tue, 14 Jul 2009 03:13:04 +0000

No shock there to me as I have been saying this for a while with all the devices that report data, so when you have a glucose device that reports to a phone, well there you go.

Devices are getting complicated and thus the need to expand PHRs to include a physician portal so all the various makers can get their data into one API and pop it into the EMR too.