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Publications

News

UK King’s Speech 2024: Key takeaways on data protection, AI, and cyber security

On 17 July 2024, the King’s Speech and associated background briefing notes were presented and published. These contain a summary of the new government’s plans, including two...

News

Implications of the EU AI Act on medtech companies

The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that...

News

Global impact of the EU AI Act for health stakeholders

We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new...

News

Panelists discuss European pharmaceutical trends and how to stay ahead of the game

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane...

News

Tortoise and Hare: Congress may overtake CMS in years-long race to set Medicare breakthrough device coverage

On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee. This action brings Medicare...

News

FDA summarizes LDT rule requirements in new compliance guide

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small...

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First salvo fired against FDA’s laboratory developed test rule

In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and...

Insights and Analysis

European Parliament Elections 2024: Explainer and Policy Takeaways

As the EU gears up for its upcoming elections, stakeholders across sectors are closely monitoring potential shifts in policy and governance. With an anticipated right-ward shift of the...

News

Reform urged to facilitate payment & coverage of AI medical services in the U.S.

We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new...

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