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Invitation to Join the mHealth Regulatory Coalition

Dear Interested Party:

On behalf of the mHealth Regulatory Coalition (MRC), we welcome your interest and invite you to join our Coalition.

Our goal is clear.  The MRC was formed to work with the Food & Drug Administration (FDA) as it begins to write Guidances in the area of mobile health, or mhealth.  Specifically, the coalition was formed to develop consensus regarding the scope of what and how FDA should and should not regulate in the area of mhealth technology.

The FDA is the primary regulatory agency responsible for protecting public health and safety through oversight of medical devices.  The agency’s regulatory authority extends into information technology integrated with medical device products, and generally wherever technology is used to diagnose or treat disease.

As the mobile health industry continues to explode, FDA will continue to pay attention.  Consider this:

  • The unique attributes and innovative ways mhealth is used can create uncertainty as these products do not fit neatly within the traditional FDA models.
  • Many of the mobile health products and applications cut across a broad range of device types and therapeutic areas, which can result in inconsistent applications of the current regulatory framework.
  • The explosive  growth in the mhealth market has the potential to challenge the efficiency and timeliness of the regulatory process.

In July 2011, the FDA released a Draft Guidance on Mobile Medical Applications in which FDA defined a small subset of mobile medical apps that may impact the performance or functionality of currently regulated medical devices and as such will require FDA oversight.

There remain a number of critically important issues that FDA did not yet address in its Draft Guidance.  The Coalition is already working on the following issues, all of which will have profound ramifications on the industry, as well as patients and providers:

  • The accessory rule
  • Intended use and
  • Modularization of software.

The mhealth Regulatory Coalition is focused not just on what gets regulated but how.  The MRC is uniquely positioned and singularly focused and works closely with its diverse group of members as well as the FDA and other regulatory bodies such as the FCC, the FTC and HHS’ ONC.

The Coalition offers Association Membership which is open to all associations and organizations with an interest in mhealth as well as Company Membership which is open to individual companies involved in mhealth.  This includes companies operating in the cell phone manufacturing, telecommunications, semiconductor, component and medical device industries.  Others, such as pharmaceutical manufacturers and medical device companies contemplating remote monitoring technologies may also wish to join.

Association membership is free to qualifying nonprofit organizations and the Coalition assesses a monthly fee (based on sales) for each member company.  Companies over one billion dollars in sales pay $2,000 per month, companies between 50 million and one billion dollars in sales pay $1,000 per month and companies under 50 million dollars in sales pay $300 per month, Start-up companies (companies without gross revenues) pay $100 per month. Companies are subject to a discount if they also join the Clinical Decision Support Coalition. Companies can leave at any time and discontinue their membership and dues.

In most cases, the Coalition operates by consensus on policy questions and activities to be undertaken by the MRC.  In any instance in which a vote is required, decision-making will be by 80% rule of all member institutions—association and company.

Epstein Becker Green’s Brad Thompson, a respected FDA attorney with experience in development of regulatory policy and Kim Tyrell-Knott serve as general counsel and assist with the development of policy and government relation strategies.  Amplify Public Affairs provides guidance on public relations strategies.

To learn more about the MRC and how to join, please contact:

Kim Tyrrell-Knott
ktyrrellknott@ebglaw.com
202.861.1816

Brad Thompson
bthompson@ebglaw.com
202.861.1817


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