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European Union › Digital Health

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Hogan Lovells

EU moves closer to a unified digital health system with the European Health Data Space Regulation (EHDS)

Hogan Lovells on

The European Health Data Space (EHDS) Regulation seeks to overcome significant obstacles in digital health by creating a comprehensive framework for sharing electronic health data. It aims to establish clear rules, common...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

Orrick, Herrington & Sutcliffe LLP on

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...more

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

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Hogan Lovells

Creation of a Health Data Agency in Belgium – A key agency for the future European Health Data Space

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On January 17th, 2024, Belgium welcomed the official launch of the Belgian Health Data Agency. This Agency aims to enhance the availability and utilisation of health data and healthcare data with the objective to drive...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2023 | Key Takeaways

McDermott Will & Emery on

200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. Privacy Briefs: February 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy Volume 23, no 2 (February 2023) DCH Health Systems, based in Tuscaloosa, Ala., said it fired an employee in December after a routine privacy audit revealed evidence that the worker had accessed some...more

McDermott Will & Emery

HPE Europe 2022 | Key Takeaways

McDermott Will & Emery on

Key Trends & Opportunities in Life Sciences and Healthcare Investing - The current macroeconomic environment is creating challenges for healthcare and life sciences businesses, which have been impacted hard by wage...more

WilmerHale

The European Commission publishes its proposal on the European Health Data Space (EHDS)

WilmerHale on

On May 3, 2022, the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS) (“EHDS Regulation”, or “Proposal”). With the Proposal, the European Commission aims to make significant...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

Latham & Watkins LLP on

Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

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The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

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Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

McDermott Will & Emery

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

McDermott Will & Emery on

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 1 Of 6)...

MoFo Life Sciences on

The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more

McDermott Will & Emery

BVCA Healthcare Sector Forum 2020: Rounding Up

McDermott Will & Emery on

McDermott was delighted to partner with the BVCA (British Venture Capital Association) on its recent virtual Sector Forum Series: Healthcare event. The event gathered industry experts – from entrepreneurs, to investors and...more

McDermott Will & Emery

Transfers of Health Data from France to the United States Not Prohibited... but Must be Protected by Strong Safeguards

McDermott Will & Emery on

On October 9, 2020, there were media reports that the French Data Protection Authority (CNIL) had expressed concerns regarding the hosting by Microsoft (EU) of the French centralized public health database (the Health Data...more

Morgan Lewis

Life Sciences International Review | August 2020

Morgan Lewis on

Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more

Hogan Lovells

Outlook on a common liability framework for high-risk AI systems in the EU

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In May 2020, the European Parliament’s Committee on Legal Affairs took the initiative and published a draft report with recommendations to the Commission on a civil liability regime for artificial intelligence (AI) (the Draft...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

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Akin Gump Strauss Hauer & Feld LLP on

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Hogan Lovells

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective...

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Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more

Hogan Lovells

French legal and regulatory update - July/August 2019

Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more

Sheppard Mullin Richter & Hampton LLP

Processor or Controller? It Really Depends

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The European Data Protection Board and the European Data Protection Supervisor recently issued a joint opinion on the processing of personal data and the role of the European Commission within the eHealth Digital Health...more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Emery on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

McDermott Will & Emery

2018 Digital Health Data Developments – Navigating Change in 2019

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Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

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