News & Analysis as of

The United States Federal Communications Commission › Food and Drug Administration (FDA) › ONC

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 +
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 communications by radio, wire, satellite, and cable. less -
Akin Gump Strauss Hauer & Feld LLP

IMDRF Releases International Framework for Regulating Device Software

Akin Gump Strauss Hauer & Feld LLP on

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

McDermott Will & Emery

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

McDermott Will & Emery on

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

Sheppard Mullin Richter & Hampton LLP

Proposed health IT strategy aims to promote innovation

Sheppard Mullin Richter & Hampton LLP on

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft...more

Sheppard Mullin Richter & Hampton LLP

House committee questions authority of a DHHS staff division to regulate health IT

Sheppard Mullin Richter & Hampton LLP on

Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...more

Mintz - Health Care Viewpoints

Regulation of Health IT: A Risk-Based Approach

Mintz - Health Care Viewpoints on

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

Foley & Lardner LLP

Finally…FDASIA Health IT Regulation Report Released

Foley & Lardner LLP on

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

McDermott Will & Emery

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

McDermott Will & Emery on

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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