The AI Shakeup: New Tech Innovations and the Future of Corporate Law
Regulatory Ramblings: Episode 44 - The Dangers of Non-Technically Trained Lawyers Advising on Technological Matters with Ronald Yu and Donald Day
Tips and Trends in Thought-Leadership Marketing
Guidepost in Motion EP27: Privacy Matters Part 2: “TMI”-The Privacy Dilemma of Social Media
Innovation in Compliance - Lessons About Leadership and Security with Paul Clayson
RPA As A Digital Transformation Catalyst
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
31 Days to a More Effective Compliance Program - Originating a Compliance Ecosystem
The Importance of Knowing Your Industry and Business Leadership
I-17 – Engaging Your Employees in Today’s Workplace, Featuring Rick Turner at Whirlpool Corporation
Frenemies: Gaining Efficiency Through Shared Services
The Ever-Expanding Scope of Social Media Discovery
Is the Patent Litigation Boom Coming to an End?
Convergence: Growing Dissatisfaction with Biglaw and the Rise of the Alternatives
IP|Trend: Starting Up Your Protection of Intellectual Property
Richard Susskind (@RichardSusskind) Discusses His Lifetime Interest in the Future of Law
Polsinelli Podcasts - The Virtual World and Wage and Hour Issues
How Fenwick Partners Caught the Tech Wave
Allen Matkins/UCLA Anderson Forecast Summer/Fall 2014: Tech Sector Continues to Drive Bay Area Commercial Real Estate
Allen Matkins/UCLA Anderson Forecast Summer/Fall 2014: San Diego Joins Southern California Real Estate Recovery
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more
Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...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
On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more
(March 11, 2016) The U.S. Senate Health, Education, Labor & Pensions committee approved a bill to expand an expedited review program for FDA approval of certain medical devices. The bill, S. 1077 “A bill to provide for...more
Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more
The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more
In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more
In the late 1980s, the Food and Drug Administration (FDA) began publicly suggesting that electronic medical records were within its jurisdiction. A lot has changed in 20+ years. The proliferation of mobile computing platforms...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more