News & Analysis as of

Cybersecurity Digital Health Regulatory Requirements

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

McDermott Will & Schulte

European Health Data Space Regulation enters into force

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Hogan Lovells

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

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