News

March 20, 2014

“The MMA Roadshow”

Managing mHealth App Development Under FDA Regulation

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.

We have selected some of the world’s leading engineering universities – in the US and in the EU – to be our partners in this program. We have sought out not only the best schools, but those located in population centers near where developers are working.

We will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space.

Locations include:
  • University of Illinois at Chicago
  • Johns Hopkins University
  • University of California San Diego
  • Stanford University
  • University of Texas at Austin
  • Massachusetts Institute of Technology (MIT)
  • mHealth Europe Summit (Berlin, Germany)
Agenda

Over the course of a four hour 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?

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.

Who Should Attend

These workshops will focus on mobile medical apps issues that will help both the novice and experienced FDA regulatory professional alike.

Contact

For questions about the MMA Roadshow, please contact:

Lisa Blackburn
lblackburn@ebglaw.com



Sponsors
ACT Online American Telemedicine Association (ATA) Consumer Electronics Association Continua Health Alliance CTIA - The Wireless Association Epstein Becker Green FDLI GSMA MRC mHIMSS NVCA RAPS WLSA

University Sponsors
IEM   IMES   Johns Hopkins   Johns Hopkins    Stanford Biodesign    University of Illinois   University of Texas Von Liebig Center for Entrepreneurism
February 27, 2014

Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk

Alliance of Healthcare Providers, Device and Software Makers Says Congress Shouldn’t Short-Circuit FDA Progress in Parsing High Risk, Low Risk Apps

WASHINGTON — Legislation that would remove a wide range of mobile healthcare applications and other medical software from federal oversight would pose serious, potentially life-threatening risks to patients and consumers. Rather than pre-empting the ongoing Food and Drug Administration (FDA) effort to identify low risk apps that shouldn’t require FDA review, Congressional staff should participate in the FDA process, holding the agency accountable for moving quickly and achieving the right balance.

For the full release, click here Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk.


January 27, 2014

Attorneys, FDA and industry groups have teamed up to tour the country and educate innovators on how to navigate mobile medical app regulations.

The Gray Sheet, January 27, 2014

“The idea is to give innovators support by sharing experience,” Bradley Thompson, a lawyer at Epstein Becker & Green and the head of the mHealth Regulatory Coalition, wrote “The Gray Sheet” in an e-mail.

To that end, Thompson organized the tour, focusing on universities as “hubs of innovation.” Each stop will feature several speakers and groups: Bakul Patel, senior policy advisor at CDRH who spearheads the center’s mobile health policy development; a lawyer from Epstein Becker & Green; Erik Vollebregt, a lawyer from Axon Lawyers in Amsterdam, discussing the impact of European Union regulations in mobile health; and local developers who have already taken apps through FDA’s clearance and pre-market process.

For the full article: http://www.elsevierbi.com/publications/the-gray-sheet/40/4/attorneys-fda-hit-the-road-to-instruct-on-mobile-health-regs



January 24, 2014

FDA, Industry Groups Launch mHealth Educational Outreach Tour

FDA Week, January 24, 2014

Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition and chairman of the steering committee for the program, noted that the MMA Roadshow is an efficient way for FDA to speak to a large number of mobile app developers about its guidance. There is probably a greater need for FDA education in mHealth than elsewhere, he added.

“Basically there are 12 national organizations promoting these meetings to their members, so rather than go to individual meetings with each individual association, (Patel is) able to cover all 12 of them at once,” he said. “They will be very large meetings, probably all of them over 100, and all specific to the FDA guidance.” …

Thompson said industry roadshow speakers intend to give innovators support by sharing their experiences with FDA regulation. The goal of the program is to encourage the development of apps that are higher in risk but that also offer higher benefits, he said.

“Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness, and so far developers have barely scratched the surface,” he said. “We hope to help more companies enter this space.”

https://healthpolicynewsstand.com/FDA-Week/FDA-Week-01/24/2014/menu-id-315.html



January 17, 2014

MMA Roadshow explains the ins and outs of FDA app regulation

mHealthNews, January 17, 2104

Bradley Merrill Thompson, a partner with Epstein Becker Green, adviser to the MHRC and chairman of the roadshow’s steering committee, said the goal of the roadshow “is to advance patient care by encouraging the development of apps at the higher benefit/high risk end of the spectrum.”

“Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness and efficiency, and so far developers have barely scratched the surface,” he said. “We hope to help more companies enter this space.”

http://www.mhealthnews.com/news/mma-roadshow-explains-ins-and-outs-fda-app-regulation?single-page=true

January 16, 2014

Nationwide ‘roadshow’ to educate mHealth app developers about FDA regulations

FierceMobileHealthcare, January 16, 2014

“It’s really all about innovation and regulation, and showing that they can be  compatible,” Bradley Merrill Thompson, the mHealth Regulatory Coalition’s  general counsel and the chairman of the steering committee for the MMA Roadshow  program, told FierceMobileHealthcare. “We need innovation. Patients  need innovation. Our economy needs innovation. But, we also need product safety  and we need discipline. And, these are not mutually exclusive. What’s so  exciting is that there are so many people, many of them from the IT industry  with no healthcare background, now innovating in healthcare. So, we want to  reach out to those people to help them.”

http://www.fiercemobilehealthcare.com/story/nationwide-roadshow-educate-mhealth-app-developers-about-fda-regulations/2014-01-16?utm_medium=nl&utm_source=internal





January 16, 2014

CEA Joins Industry Groups in Sponsoring Educational Series on Health App Development under FDA Regulation

Arlington, Va., January 16, 2014 –Today, the Consumer Electronics Association (CEA)® announced its sponsorship of an educational program series called the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation,” joining a consortium of six leading universities, more than a dozen industry trade associations and professional societies, and the U.S. Food & Drug Administration (FDA). The MMA Roadshow events, taking place at universities across the U.S., aims to demystify the FDA requirements for new entrant app developers and identify best practices among those already producing regulated apps.

“There are huge opportunities for healthcare providers to monitor and diagnose remotely, and for individuals to take a major role in their own healthcare with fewer trips to the doctor,” said Gary Shapiro, president and CEO, CEA. “Consumers are increasingly using electronics to manage their health, and we are thrilled to support a program that aims to spur innovation by bringing more mobile apps into the healthcare space.”

Late last year, the FDA published its final guidance on mobile medical apps, clarifying that the administration regulates the higher-risk portion of mobile apps, those intended for use in the diagnosis or treatment of diseases or other conditions. Since then, companies have been examining the final guidance in an effort to determine how it impacts their particular apps and business plans.

“Mobile apps offer incredible opportunities to improve the quality of patient care, as well as its effectiveness and efficiency, and so far developers have barely scratched the surface,” said Bradley Merrill Thompson, the chairman of the steering committee for the program. “We hope to encourage and help more companies enter this space.”

With a focus on entrepreneurs and innovators, the MMA Roadshow and its content are both geographically and economically accessible. The consortium members, industry trade groups and professional societies all volunteered to do their part to connect these educational opportunities with budding entrepreneurs. Consortium members collectively have hundreds of thousands of members interested in mobile health, representing the vast majority of technology developers in this mobile space, and hope to spur economic development in an area where the U.S. has a clear advantage globally.

The first workshop takes place today, January 16, at the University of Illinois at Chicago. For more information about the program, dates, agenda and participating organizations, visit www.mHealthregulatorycoalition.com/.

About CEA:
The Consumer Electronics Association (CEA) is the technology trade association representing the $208 billion U.S. consumer electronics industry. More than 2,000 companies enjoy the benefits of CEA membership, including legislative advocacy, market research, technical training and education, industry promotion, standards development and the fostering of business and strategic relationships. CEA also owns and produces the International CES – The Global Stage for Innovation. All profits from CES are reinvested into CEA’s industry services. Find CEA online at www.CE.org, www.DeclareInnovation.com and through social media.

September 29, 2013

Bradley Merrill Thompson was featured in an article titled “FDA Issues Final Guidance on Mobile Medical Apps.”

HealthWorks Collective, 9/29/2013

Bradley Merrill Thompson was featured in an article titled “FDA Issues Final Guidance on Mobile Medical Apps.”
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