Mobile Medical App Roadshow

January 28, 2014 8:15 AM - 12:30 PM Clark Center Auditorium [directions] 318 Campus Drive Stanford University Information: christine.kurihara@stanford.edu Event has ended. Listen to the audio recording: See agenda below	Documents Provided at Event Guidance from FDA Slides from Event Summary of FDA Clearance of Mobile Apps FDA Regulation of Mobile Health(booklet)
Audio of 1st Half of Meeting o Audio 1st Half or download [right click link to save]	Audio of 2nd Half of Meeting [post break] o Audio 2nd Half or download [right click link to save]

FDA recently published its final guidance on mobile medical apps, and while helpful, the guidance leads to more questions. This workshop will focus on answering those questions for app developers in or close to FDA regulated territory. Over the course of four hours, we will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space, to help both the novice and experienced FDA regulatory professional alike.

In this mHealth regulatory program, we will examine topics such as:

1. How to develop mobile apps that come as close to the FDA line as possible, but don’t cross over into regulated territory.
2. For those apps that FDA does regulate, how to figure out the appropriate classification in a system that frankly hasn’t been updated in a long time.
3. If your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence.
4. Practical steps for developing an FDA quality system that is nuanced to fit mobile apps, and is designed to be as economical as possible.
5. In a global economy, what are the differences between the US regulatory system and the EU system, and how can a company efficiently enter both markets?
6. From the perspective of seasoned executives, what are the management challenges you can anticipate in mobile app development in a regulated environment?

In assembling our speakers for this program, we drew heavily from the over 100 companies that have mobile apps cleared by FDA.  You will hear directly from the experts, including regulatory attorneys, regulatory affairs specialists, quality system experts, European law attorneys, experienced mHealth executives and of course, the FDA.

To make the program financially accessible to entrepreneurs, nearly all of the speakers are absorbing their own costs. We were therefore able to keep the admission price to $100. Fortunately, faculty, staff and students of the University will be allowed free admission by using the following promo code: MMA#0comp, and by showing the University ID during on-site registration.

AGENDA (Complete Slide Set)

8:15 a.m. – 8:25 a.m.		Welcome and Introductions Speakers: Paul G. Yock, MD, Director, Stanford Biodesign Kim Tyrrell-Knott, Epstein Becker Green
8:25 a.m. – 8:45 a.m.		FDA Introductory Comments on the Final Mobile Medical Applications Guidance Speaker:  Bakul Patel, Senior Policy Advisor, U.S. Food and Drug Administration
8:45 a.m. – 9:40 a.m.		Scope of FDA Regulation: Analyzing the New FDA Guidance Speaker: Kim Tyrrell-Knott, Epstein Becker Green
9:40 a.m. – 10:10 a.m.		EU Regulatory Update: Strategies for Global Regulatory Compliance Speaker: Erik Vollebregt, Axon Lawyers, Amsterdam, The Netherlands
10:10 a.m. – 10:30 a.m.		Break
10:30 a.m. – 11:15 a.m.		Panel Discussion: Regulatory Strategies Pre-Market Strategy Predicate devices for mobile medical app premarket notifications Additional features: strategies for getting apps cleared Post-Market Strategy Cost-effective ways to meet design control and other requirements in the production of mobile medical aps Moderator:  Bethany Hills, Epstein Becker Green Panelists:       Jafar Shenasa, Proteus Digital Health Shilpa Mydur, Glooko Marianne Smith, Novartis, Health and Regulatory Affairs Peggy McLaughlin, Clinical and Regulatory Consultant
11:15 a.m. – 12:00 p.m.		Panel Discussion: Business Strategies for Bringing New Apps to Market Is going into FDA regulated territory worth it? Are there strategies for partnering with others to share the regulatory burdens? Is using contract manufacturing with an experienced medical device company a good option? What are business strategies for reducing regulatory risk? Moderator:  Bethany Hills, Epstein Becker Green Panelists:      Tapan Mehta, Cisco Systems Walter De Brouwer, Scanadu Mohit Kaushal M.D., Aberdare Ventures Sudhi Gautam, Vector Asset Management Morgan Reed, Association for Competitive Technology (ACT)
12:00 p.m. – 12:30 p.m.		FDA Q&A Speaker:  Bakul Patel, Senior Policy Advisor, Food and Drug Administration
12:30 p.m.		Adjourn

Several other universities in the US and EU are also hosting this program.

• January 16, 2014 – University of Illinois at Chicago
• January 23, 2014 – Johns Hopkins University
• January 27, 2014 – University of California San Diego
• January 28, 2014 – Stanford University
• January 31, 2014 – University of Texas at Austin
• March 20, 2014 – Massachusetts Institute of Technology (MIT)
• May 6-8, 2014 – mHealth Europe Summit
• June 12-13, 2014 – HIMSS Innovation Center

* The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on Sept 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and the their focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.