News & Analysis as of September 19, 2024

Medical Devices

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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 +

Vital Signs: Digital Health Law Update | Spring 2021

Jones Day on 5/5/2021

The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more

Vital Signs: Digital Health Law Update | Summer 2020

Jones Day on 7/21/2020

Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

Hogan Lovells on 7/11/2019

Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...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

What’s New in Washington: 10 Things You Need to Know

Akin Gump Strauss Hauer & Feld LLP on 4/3/2017

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Akin Gump Strauss Hauer & Feld LLP on 1/3/2017

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...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

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

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

FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing

Mintz on 7/13/2015

On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio...more

IMDRF Releases International Framework for Regulating Device Software

Akin Gump Strauss Hauer & Feld LLP on 10/20/2014

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

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

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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