AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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