Since most mobile apps don't require that level of sophistication, the FDA says that, for now, it intends to apply its regulatory authority to a subset of mobile apps that it is calling mobile medical applications.
To handle those new responsibilities, some federal lawmakers are proposing that an Office of Mobile Health be established at the FDA. U.S. Congressman Mike Honda (D-CA) is expected to introduce legislation soon that would create a mobile health development program at the U.S. Department of Health and Human Services to encourage companies to create new apps.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," says Honda in a statement. "The principles of competition, innovation and entrepreneurship need to be [fully] manifested in the healthcare information technology space."
Some lawmakers have taken an opposing view, suggesting the government should not get too involved in regulating or promoting the healthcare app industry. Last summer, a group of Republican lawmakers sent a letter to the Federal Communications Commission and the FDA stating that government intervention could "inhibit future growth and innovation in this promising market."