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Volume: 2 Issue: 2
(February 2015)

us 21st century cures act draft proposes wave legal changes us house representatives panel published 27 january 21st century


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US 21st Century Cures Act draft proposes wave of legal changes

A US House of Representatives panel published on 27 January the 21st Century Cures Act, a discussion draft containing proposals to accelerate the approval of medical drugs and devices; the document is the result of an initiative of the House Energy and Commerce Committee.

“The draft reflects the widespread recognition that changes are required to update and harmonise various state and federal approaches to research, quality improvement and data collection and aggregation in order to be responsive to the changing biomedical and healthcare delivery landscape,” said Jennifer Geetter, Partner at McDermott Will & Emery.

The document proposes a number of changes including to amend the Social Security Act to offer payment for coverage of telehealth services under certain circumstances, and another to amend the Food, Drug and Cosmetic Act’s definition of medical software to create two new definitions: health software and medical software, only the latter of which could be FDA-regulated. “From our perspective, a new regulatory framework for mobile medical apps and health software is not necessary,” said Mark Gardner, Associate at DuVal & Associates. “The existing approval system can accommodate the technological advances taking place now and into the future.”

The document also suggests requiring the FDA to permit the use of links for companies to provide risk information to consumers when advertising on social media.

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