News & Analysis as of September 20, 2024

Health Information Technologies

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The United States Federal Communications Commission is an independent federal agency established by the Communications Act of 1934. The Commission is charged with regulating interstate and international... more +

Regulatory Challenges for the New Frontier of Medical Imaging: Terahertz Spectrum

Mintz - Health Care Viewpoints on 11/16/2018

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC). While the Food and Drug...more

FDA Finalizes Wellness Product Guidance

King & Spalding on 8/13/2016

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on 7/27/2015

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Finally…FDASIA Health IT Regulation Report Released

Foley & Lardner LLP on 4/16/2014

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

McDermott Will & Emery on 4/10/2014

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

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