Avoiding Regulatory Pitfalls in mHealth R&D
mHealth devices and apps are being developed at a fast pace, making it a challenge to understand what data and clinical studies may be required for technology approval by the FDA and other entities managing compliance. Last Fall, the FDA issued final guidance related to mHealth technology development that is required during research and development, however, understanding these guidelines can be daunting task for those unfamiliar with regulatory nuances.
In addition to the FDA other stakeholders require clinical data when evaluating mHealth technology. These requirements can become complicated for the entrepreneur and developer making it crucial that there is an understanding of when studies and data are required and what type of data may be required in order for the technology to be accepted and marketable. Further, staying compliant when working within the healthcare setting requires a keen awareness of rules and regulations.
In this session, panelists will discuss:
- General FDA Regulatory Requirements – including recently issued guidance on mHealth apps
- Building and administering an effective clinical trial
- Long-term use of an mHealth technology generally requires FDA approval — What is needed?
- Capturing, managing, and storing data
- Working directly with health care providers and consumers
- Monica Chmielewski, Partner, Foley & Lardner LLP
- Nathan Beaver, Partner, Foley & Lardner LLP
Join Us for Future Programs
Foley’s breakfast briefing series are roundtable discussions designed to address critical issues in the development and commercialization of mHealth devices and apps.
Tuesday, June 3, 2014: mHealth Venture Capital Roundtable
September 2014: IP Protection Strategy in mHealth Technologies
October 2014: mHealth Risk Management and User Privacy Regulation
For more information regarding the mHealth Breakfast Briefing Series, please contact Meg Ryan at [email protected].