News & Analysis as of

Patient Privacy Rights Medical Devices Life Sciences

BakerHostetler

Healthcare Industry Team 2024 Year in Review

BakerHostetler on

As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Robinson+Cole Data Privacy + Security Insider

Neural Data Included in CCPA Amendments

As we outlined in our previous blog article, California recently became the second state to enact a law safeguarding consumer brain data, following a similar law passed by Colorado in April. Both state laws prevent the sale...more

Foley Hoag LLP

Action Plans on Diversity: Key Requirements for Certain Clinical Studies

Foley Hoag LLP on

On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Troutman Pepper Locke

FDA Issues New Draft Guidance for Unapproved Use Communications

Troutman Pepper Locke on

On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

BakerHostetler

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

BakerHostetler on

The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Baker Donelson

FDA Issues Cybersecurity Alert to Health Care Providers and Device Manufacturers

Baker Donelson on

The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

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