September 10, 2015
by Bradley Merrill Thompson
Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
August 5, 2015
By Bradley Merrill Thompson
Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
January 20, 2015
Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.
The FTC announced an administrative complaint against Focus Education, a company that makes a brain training game for children called Jungle Rangers. The...
December 1, 2014
Bradley Merrill Thompson testifying before Congress last year.
Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with mobile health startups about FDA clearance, is launching a new venture called Aventor that aims to bring discounted regulatory consulting and advocacy services to companies that use mobile health and connected health to help the poor.
April 4, 2014
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...
April 19, 2013
The Department of Health and Human Services has formed a new workgroup, charged with "identifying key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications." The group has been selected by HHS and the FCC and will report to the Health IT Policy Committee which advises the ONC.
This is the same workgroup...
February 15, 2011
By Bradley Merrill Thompson, Epstein Becker & Green, P.C.
To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, a middle and an end. They paint an entire picture. Unfortunately, reading the MDDS rule is like reading just the middle of the story --...
June 15, 2010
If you have been following MobiHealthNews' series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is unfortunately about as murky as the Gulf Coast right now.
In order to at least draw a line for those companies that believe they do not fall into an FDA regulated device...