News & Analysis as of

Electronic Protected Health Information (ePHI) Medical Devices Food and Drug Administration (FDA)

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 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. To help companies and investors navigate the many evolving...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...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: Fall 2019

Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Summer 2019

Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more

Troutman Pepper Locke

Health Sector Cybersecurity Guidance Provides Best Practices Applicable Across Industries

Troutman Pepper Locke on

While cyberattacks continue to increase in number, health care organizations face some of the greatest risks. According to the Health Sector Coordinating Council (HSCC) — a coalition of industry associations that operates in...more

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