Lacktman Comments on the FDA’s CDS Draft Guidance

Partner Nate Lacktman was quoted in a MobiHealthNews article, “Clinical Decision Support Coalition Letter Criticizes FDA’s Stance on CDS,” as one of the supporters of the FDA’s recent Clinical Decision Support draft guidance. This guidance outlines forms of CDS which won’t be regulated based on the degree of human involvement instead of based on risk.

Lacktman said, “Digital health companies and telemedicine providers should take a moment today and tweet a big thank you to Commissioner Scott Gottlieb (@SGottliebFDA) and the FDA for this long-awaited guidance. Not only has the FDA made great leaps to educate digital health software developers, Commissioner Gottlieb's direction clearly recognizes the need not to over-regulate our industry and instead maintain the delicate balance between protecting patient safety and promoting health innovation.”