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Health Technology › European Union

BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

BCLP on

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Proskauer Rose LLP

Q&A: What does 2024 have in store for European M&A?

Proskauer Rose LLP on

There is a wealth of dry powder to spend but 2023 has seen M&A deal activity hampered by rising costs of debt, unstable markets, supply chain issues, general political uncertainty, and fear of global recession. So, what does...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

King & Spalding

EUROPE – New Interim Guidance on Parallel EMA-HTA Body Scientific Advice

King & Spalding on

On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more

Latham & Watkins LLP

New Regulation on Health Technology Assessment Seeks to Facilitate EU-Level Joint Clinical Assessments From 2025

Latham & Watkins LLP on

The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...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

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Hogan Lovells

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

Hogan Lovells on

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

Knobbe Martens

European Commission Proposes Stronger Cooperation for Health Technology Assessment

Knobbe Martens on

On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain...more

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