News & Analysis as of

Intellectual Property Protection Food and Drug Administration (FDA) Health Insurance Portability and Accountability Act (HIPAA)

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Gardner Law

Effective Clinical Trial Agreements: What You Need to Know

Gardner Law on

Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require...more

Husch Blackwell LLP

Avoiding the Landmines on the Path to HealthTech Innovation

Husch Blackwell LLP on

Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q2 2021

In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Mintz - Health Care Viewpoints

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Arnall Golden Gregory LLP

Der Markteintritt für deutsche IT Firmen aus dem Bereich des Gesundheitswesens

With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more

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