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AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more

New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 21.02.2025

Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more

Panelists discuss European pharmaceutical trends and how to stay ahead of the game - Life Sciences and Health Care Horizons event...

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 Summerfield, and partners Melissa K. Bianchi,...more

Regulatory considerations on artificial intelligence for health of the WHO

The World Health Organization ("WHO") published key principles for regulating artificial intelligence (AI) for health on 19 October 2023. The document, titled ‘Regulatory Considerations on Artificial Intelligence for Health’...more

Takeaways from our Digital Deep Dive Webinar on AI & Digital Health

In this article, we share our key takeaways from our recent webinar titled "AI, Digital Health & European Health Data Space", which was part of our "AI, Big Data and Law, Digital Deep Dive" webinar series. The webinar delved...more

Medizinprodukte Update 2022

Bei unserem Medizinprodukte Update Webinar im November 2022 haben die Partner:innen Dr. Jörg Schickert, Arne Thiermann und Dr. Tanja Eisenblätter, sowie Associate Dr. Benjamin Goehl den Teilnehmenden Updates zu einer Reihe...more

Additional German guidance on the management of clinical trials during the COVID-19 pandemic

Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...more

What’s trending: The factors that can trigger supply chain disruption and litigation in the life sciences industry

Change is coming to the life sciences industry. Price pressure, new market entrants, the emergence of personalized medicine, and even climate change are adding complexity to traditional manufacturing processes and supply...more

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