News & Analysis as of September 17, 2024

Healthcare

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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 +

Akin Intelligence - June 2024

Akin Gump Strauss Hauer & Feld LLP on 7/15/2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

ML Strategies Outlook for 2024

Mintz - ML Strategies on 1/12/2024

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...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

Health Care and Life Sciences Practice Newsletter

Buchalter on 9/16/2015

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Alert: Key Regulatory Considerations for Digital Health Companies

Cooley LLP on 9/11/2015

Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

Baker Donelson on 8/17/2015

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...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

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

McDermott Will & Emery on 6/26/2014

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

Proposed health IT strategy aims to promote innovation

Sheppard Mullin Richter & Hampton LLP on 6/13/2014

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

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

Sheppard Mullin Richter & Hampton LLP on 6/11/2014

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

Regulation of Health IT: A Risk-Based Approach

Mintz - Health Care Viewpoints on 5/8/2014

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

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

FCC Will Work to Implement mHealth Task Force Report

Mintz on 10/5/2012

In a move he says will improve the quality of health care and cut health system costs, FCC Chairman Julius Genachowski announced the Commission will work toward implementing recommendations proposed by the mHealth Task Force,...more

The Regulatory Future of mHealth: FCC, FDA and the United States Congress

Fenwick & West Life Sciences Group on 6/19/2012

As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more

mHealth Alert: Text4baby: Texting Health Messages to Pregnant Women and New Moms

Mintz - Health Care Viewpoints on 2/18/2010

Furthering the use of commercial wireless networks to deliver health information, the Obama Administration recently announced its new Text4baby campaign, which sends free regular text messages with health information to...more

mHealth Alert: FCC Extends Boston Scientific's Authority for Implanted Cardiac Devices

Mintz - Health Care Viewpoints on 7/20/2009

The Federal Communications Commission (FCC) recently granted a rule waiver requested by Boston Scientific Corporation (Boston Scientific), allowing it to continue to manufacture and market its Contak Renewal TR product line...more

mHealth Alert: mHealth Raise New FCC and FDA Issues

Mintz - Health Care Viewpoints on 6/25/2009

Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new “mHealth” (mobile...more

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