Anticipating and Navigating Regulatory Challenges in mHealth Product Development

As the need for more efficient health care delivery continues to grow, the mobile health, or “mHealth,” industry responds by developing mobile devices and apps that connect physicians and other health care professionals with patients, facilitate patient care, and enable patients to become more engaged with their overall health care consumption. There is no question that providers utilize mHealth technology and that patients are beginning to see the value in monitoring their own health using their personal mobile devices.

Despite growing adoption of mHealth technology, questions remain on how these new tools will be regulated, posing challenges to mHealth stakeholders in the areas of research and development, attracting capital and commercialization. Anticipating and navigating such challenges in an uncertain regulatory environment will likely improve business outcomes for mHealth stakeholders, while preventing potentially debilitating costs and regulatory obstacles.

In this session, panelists will discuss:

• How to draw the line between what is and is not regulated


• What regulatory approvals or processes need to be gained and in place prior to marketing mHealth technologies


• Overview of the FDA 510(k) process for technologies deemed to be medical devices


• FDA enforcement actions to date and analysis of the issues giving rise to such actions


• Predictions on the future mHealth regulatory environment


• mHealth industry standards and certifications

Confirmed Speakers

• David L. Rosen, Partner, Foley & Lardner LLP, and former senior level FDA official


• Dr. Daniel Schultz, Senior Vice President, Medical Devices and Combination Products, Greenleaf Health, and former Director of the Center for Devices and Radiological Health, FDA

For more information about this event, please contact Meg Ryan at [email protected].

Join Us for Future Programs
Foley’s mHealth breakfast briefing series are roundtable discussions designed to address critical issues in the development and commercialization of mHealth devices and apps. Future programs include:

• Wednesday, October 9: Venture Capital Roundtable (click here to register)


• Thursday, November 14: mHealth Research and Development Roundtable (click here to register)


• Wednesday, December 4: IP Issues and Strategy for Start-Ups (click here to register)