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Regulatory Requirements Electronic Protected Health Information (ePHI) Medical Devices

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

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

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

Stinson LLP on

The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

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