Policy Positions

September 13, 2013

Enhancing Innovation in eHealth Systems Approach

This white paper outlines some factors related to innovation that the agencies, and in particular FDA, should consider as they put together the government’s strategy. More specifically, it identifies outdated aspects of the existing FDA regulatory framework and suggests significant changes to address the unique aspects of health IT. It also advocates for a holistic approach among FDA, FCC and ONC to avoid confusion, duplication and regulatory conflict.


July 18, 2013

Clinical Decision Support Proposed Regulatory Framework

CDS is a critical and growing part of healthcare. It includes a broad range of products with varying degrees of risks, from body mass index calculators to complex radiation dosage. The CDS Coalition believes that all CDS cannot be treated the same way from a regulatory perspective – and many low risk CDS products should not be actively regulated at all.

In 2011, FDA announced it is developing guidance on the regulation of clinical decision support software. For the past year and a half, the CDS Coalition has been working on a proposed regulatory framework that takes into account the unique aspects of CDS and helps ensure that CDS software will not become over-regulated.  On July 17th the Coalition held a webinar to gather additional input on their framework so that the Coalition can provide FDA a comprehensive proposal that reflects the views of patients, provider and others in the industry.

Slides from the webinar are available here: http://cdscoalition.org/wp-content/uploads/2013/07/CDS-Webinar-Slides.pdf. If you have feedback on the framework please direct them to Kim Tyrrell-Knott at ktyrrellknott@ebglaw.com.

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