About Us

What is the mHealth Regulatory Coalition (MRC)?

The mHealth Regulatory Coalition (MRC), formed in 2010, has become the voice of the mHealth technology stakeholders in Washington.

Why was the MRC formed?

The $2.5T healthcare industry has started to embrace the benefits and efficiencies of mobile cellular communications, products, and services. Much of today’s care could be delivered with better quality and efficiency and less cost through the use of mobile technologies, all while improving the lives of patients through treatment in the comfort of their own homes and during their daily routines. The mHealth Regulatory Coalition was formed in 2010 to help make certain the regulatory environment for mHealth technologies allows for innovation while at the same time protecting patient safety.

What is the MRC’s purpose?

The coalition’s purpose is to serve as a thought leader in the mHealth ecosystem to provide its expertise on what mHealth technologies should be regulated and how they should be regulated. Members of the Coalition appreciate the need to for balance such that regulation should be appropriately used, predictable, and as unobtrusive as possible while still promoting patient safety and innovation.

What are the issues the MRC is focused on addressing?

MRC 1.0 –Our focus for 2010-2013 was getting basic FDA guidance on mHealth.

MRC 2.0–Now our focus has evolved to:

  • Participating in the legislative process to tackle the big picture question of which agency or organization should regulate mobile medical apps
  • Tackling the tougher questions associated with the scope of FDA regulation, including the agency’s reach into:
    • apps used for wellness,
    • low risk, generic IT accessories,
    • pharmaceutical-related apps and
    • generic software modules used as parts of medical software programs
  • Improving the regulatory environment for those apps subject to FDA oversight, including
    • moderating the quality system requirements for app development
    • identifying a clear pathway for FDA clearance
    • creating a hassle-free way to keep software up-to-date
  • Expanding our horizons to other regions of the world

Who leads the MRC?

Brad Thompson serves as general counsel, and his firm, Epstein Becker Green, assists with the development of the policy and government relation strategies. Amplify Public Affairs leads the effort to broaden the discussion among patient and provider stakeholders.

In most cases, the MRC operates by consensus on policy positions, but if a vote is required, decision-making will be by 80% rule of all members.

Who is a part of the MRC?

  • Medical device manufacturers and medical app developers who will be impacted by the FDA regulatory guidance.
  • Cellular handset manufacturers, network operators, backend software service providers, data storage providers who need to understand what FDA expects and how FCC policy might affect them.
  • Healthcare providers and healthcare professional societies who need to understand how mHealth innovations facilitate advances in accountable care and patient engagement.
  • Researchers who understand that the mHealth ecosystem represents a gold mine of data for health services and public health research.
  • Patient and disease-focused advocacy groups at the forefront of advancing patient rights and access to innovative solutions.

How can my organization or I get involved?

To join the coalition, contact Jennifer Broeker at jbroeker@ebglaw.com or (202) 861-4199.

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