FDA Status Update on mHealth, Wellness, and Clinical Decision Support
1 Hour and 10 Minute Video | Kim Tyrrell-Knott, Epstein Becker Green
Mobile medical apps have soared in popularity over the past 5 years, and in early 2015, the FDA released two guidance documents illustrating their intent to regulate general wellness devices and mHealth applications. Superseding the 2011 guidelines, the documents outline the FDA’s parameters on which devices will and will not be regulated. While the current guidance is yet to be finalized and stakeholder reactions have been mixed, the device industry actively awaits to see how patients will utilize mHealth devices and if the FDA’s regulation will promote innovation and safety.
- Risk classification and proposed scope for regulatory oversight
- Definitions of mobile medical apps and device accessories
- Implications for various stakeholders and overall health IT
- Takeaways from Dexcom glucose monitoring app
Participants that will find this webinar most beneficial will be those involved in medical device and diagnostics companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Operations
- Mobile Device/Product Development
This video is a 60 minute presentation with ten to fifteen minutes of Q&A.
Kim Tyrrell-Knott is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC and serves on the firm’s National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on a broad range of health care regulatory issues and developing and implementing comprehensive compliance programs. Ms. Tyrrell-Knott also has extensive experience assisting new entrants to the FDA regulated environment, from mobile app developers to compounding pharmacies, in understanding and complying with the applicable regulatory requirements.
Actively involved in policy development in the health IT industry, Ms. Tyrell-Knott serves as General Counsel to the mHealth Regulatory Coalition and the Clinical Decision Support Coalition. She also teaches a graduate course on regulatory policy and regulations for Case Western Reserve University’s Case School of Engineering. This course is part of the school’s Wireless Health graduate program.