MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
JD Supra

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies ...
JD Supra

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

FDA recently released six software-related guidances, advancing the agency’s Digital Health Innovation Action Plan: 1 “Clinical Decision Support Software” 2 (revised Draft Guidance issued for comments ...
NBC News

CDS Software and Debt Resolve Launch Partnership

TARRYTOWN, N.Y., June 13, 2011 (GLOBE NEWSWIRE) -- Debt Resolve, Inc. (OTCBB:DRSV) (the "Company") announced that CDS Software, the provider of the leading CollectOne™ collection solution, and Debt ...
MobiHealthNews

FDA reneged on its promise to take a risk-based approach to CDS software

FDA does not intend to focus its oversight on CDS [in that low risk category]. … For the small subset of CDS software that are medical device health IT functionality, present higher risks, and ...