Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC office, Kim Tyrell-Knott, a Member of the Health Care and Life Sciences practice in San Diego and the Washington, DC office, and Matthew Driver, a Summer Associate, wrote an article titled "MMA Roadshow: 10 Lessons for Developers."
Following is an excerpt:
The mobile health industry is dynamic and rapidly changing. Novel technologies are being introduced that raise new questions for entrepreneurs and regulators alike. In the fall of 2013, the US Food & Drug Administration Agency (FDA) took an important first step in addressing some of these questions by publishing Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (Final MMA Guidance). However, many questions still remain. There also has been continued discussion regarding the scope of FDA's jurisdiction and how health information technology, including mobile apps, should be regulated, leaving many developers uncertain about how best to proceed.
