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Invitation to Join the Clinical Decision Support Coalition

 Dear Interested Party:

Thank you for your interest in joining the efforts of the Clinical Decision Support (CDS) Coalition. Our mission is to work with FDA and international regulatory bodies to ensure that software used to support clinical decision-making does not become overregulated.

In September 2011, the FDA initiated a process to develop a guidance document to define those types of clinical decision support (CDS) software that the Agency will regulate. The Coalition’s focus is to develop an industry proposal for how to draw the line between regulated and unregulated CDS software. Broadly speaking, the Coalition would develop answers to two basic questions: 1. what types of CDS software should be regulated? and 2. For those types of CDS software that are regulated, to what level should they be regulated?

The Coalition is composed of both individuals and groups who want to make or use software, including artificial intelligence, to improve the quality of healthcare. All stakeholders are encouraged to participate, including patient advocacy organizations, clinical societies, healthcare providers, and healthcare payors.

To cover the Coalition’s costs, each member will be charged a monthly fee. Companies that gross over $1 billion  pay $2,500, companies that gross between $50 million and $1 billion will pay $1,250, companies that gross less than $50 million will pay $300, and start-up companies (companies without gross revenues) will pay $100. Non profits and trade associations are not assessed a fee. Membership is maintained on a month-to-month basis; members can discontinue at any time.

The benefits of joining the Coalition are numerous: members have the ability to influence the development and ultimate outcome of the Coalition’s policy positions, have the opportunity to work with others in the industry and work with regulatory agencies.

The Coalition is open to individuals and representatives of patient and physician advocacy organizations, for-profit companies and non-profit healthcare organizations interested in CDS software (this includes companies operating in the telecommunications, semiconductor, component, and medical device industries as well as hospitals, healthcare provider systems, and healthcare payors) and all trade associations with an interest in CDS software. We request that each member organization designate one representative to attend the meetings and calls.

In most cases, the coalition operates by consensus on policy positions and activities to be undertaken. In any instance in which a vote is required, decision‐making is based on an 80% vote of all member institutions, both companies and associations.

Bradley Merrill Thompson and Kim Tyrrell-Knott serve as general counsel and their firm, Epstein Becker Green, assists with policy development.

For more information or to join, contact Bradley Merrill Thompson at bthompson@ebglaw.com.