The draft – for which the FDA will accept comments through October 19 – has already drawn responses from a wide variety of players in the healthcare community.

“Consumers are ready to use mobile apps, text messaging, and even payment services to make health decisions and communicate with their healthcare providers. A certain level of regulation is needed to ensure that consumers have tools they can trust,” said Jay Emmet, general manager of Seattle-based OpenMarket, which operates a mobile transaction hub offering mobile payments, messaging and other services to a variety of industries. “However, the FDA typically does not administer healthcare management processes or paradigms. That said, working with the FDA to help control personal health information through the mobile system will be critical. mHealth technology has the opportunity to help save millions of dollars in healthcare costs, and offer consumers a secure way to better manage their healthcare – from monitoring nutrition to receiving text alerts for upcoming appointments.”

“As mobile evolves to create a direct communication channel between patients and healthcare providers, pharmacies and medical device manufacturers, it’s also important that mobile programs comply with the appropriate industry rules, such as HIPAA, for managing personal health information and meeting all regulatory requirements.” Emmet added. “With more people adopting mHealth practices, there will be a growing need for an industry standard such as medical or hospital grade messaging to ensure the security of these communications.”

“The FDA has drawn a line in the sand and signaled that mHealth doesn’t get a special pass; the same old rules apply that have always applied,” said Chris Bergstrom, chief strategy and commercial officer for WellDoc, a Baltimore-based developer of chronic disease management tools. “This is not surprising, and clearly there will be a thinning of the herd coming as the FDA intervenes and companies reevaluate which side of the line they fall on. Primarily, there will be a regulatory distinction between simple wellness apps vs. integrated solutions that diagnose, treat, or mitigate a disease or integrate with other medical devices.”

“WellDoc applauds the FDA for quickly and aggressively tackling this complex area as the explosion of mobile applications has created confusion for both manufacturers and consumers,” Bergstrom added. “The FDA’s actions underscore how serious they are taking mHealth, as this guidance document came out relatively quickly (by FDA standards), and we know for a fact they are actively inspecting mobile medical companies.”

“For any mobile medical application that deals with, or has the potential to deal with, data related to patients, security must be the primary consideration,” said Jeff Tangney, a former Epocrates executive who co-founded Doximity, a San Mateo, Calif.-based startup offering a LinkedIn-style network for physicians over mobile devices. “Security for mobile apps needs go well beyond the baseline practices around user authentication and data encryption. This class of mobile apps must be designed so that access control is implemented in several layers, and the information used by the app is agnostic to the physical device itself.”

While not applicable outside the United States, the FDA directive did draw the attention of the mHealth Alliance, which pointed out that many developing nations will look to U.S. agencies like the FDA to set the standard for global telemedicine.

“The applications that fall under the purview of the FDA’s Draft Guidance are largely smartphone-specific and mobile applications that either connect to currently regulated medical devices or render the mobile phone into a medical device, while most mHealth initiatives in developing nations are SMS based and untethered to medical devices,” said Jody Ranck, director of thought leadership, policy and advocacy at the mHealth Alliance. “While sophisticated applications are not currently widely used in the areas that the mHealth Alliance focuses on, smartphone applications and peripherals that do perform medical functions will become more important in the next several years.”

The FDA’s draft document can be found here.