Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was featured in a blog segment titled "FDA Urged to Take 'Small Steps' in Developing Final Guidelines for Mobile Medical Apps. Good Advice for Social Media Guidelines As Well."
Following is an excerpt::
Bradley Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, spoke about the need for FDA regulations of mobile health apps that obviously should be classified as medical devices. As an example, he cited an "innovative app" that allows you to do urinalysis with your iPhone.
To use the app, you do NOT pee on your iPhone! "You do the test mostly the old-fashioned way of collecting urine in a cup and then inserting a test strip," said Thompson. "All the app does is objectively read the results using the camera on the phone."
"The company website presents the app as able to help patients understand and manage diseases like diabetes, urinary tract infections and pre-eclampsia, a high blood pressure pregnancy complication," said Thompson.
"But here is the problem," said Thompson, "this app falls within longstanding FDA regulation for urinalysis. It seems to me that the company must be aware of the potential for FDA regulation, because on its home page, at the very bottom, after extolling the clinical uses of its product to monitor disease, the company tries to simply disclaim FDA medical device status."
