Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).
What Clinical Investigations are Affected?
Importantly, the only clinical investigations affected by the Proposed Rule are those that are FDA-regulated and ...
The 21st Century Cures Act (“Cures Act”) was enacted in December of 2016. Among other things, the Cures Act includes provisions to encourage the interoperability of electronic health records. Specifically, the Cures Act provides for civil penalties for those who engage in “information blocking.” The Cures Act defines “information blocking” broadly as a “practice that . . . is likely to interfere with, prevent, or materially discourage access, exchange or use of electronic health information” if that practice is known by a developer, exchange, network, or ...
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