News & Analysis as of

Regulatory Standards Medical Devices General Data Protection Regulation (GDPR)

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Hogan Lovells on

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

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

Hogan Lovells on

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more

Hogan Lovells

Digital Health: CE marking of medical devices

Hogan Lovells on

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

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