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Healthtech

The Impact of the new EU AI Act on the Healthcare Sector: Part One - Scope and a Risk-Based Approach

Almost three years after the publication of the EU Commission's proposal for a Regulation on Artificial Intelligence (AI Act), the EU institutions involved in the legislative process have finally reached a consensus. With its vote on the AI Act, the Permanent Representatives Committee presented a compromise text on 26 January 2024. On the 13th March 2024 the European Parliament adopted the AI Act, with final confirmatory votes by all institutions to be taken in April 2024 - before the European elections in June 2024 – to pass what will be the world's first comprehensive regulation on AI. The AI Act shall enter into force on the 20th day after publication in the EU Official Journal and generally apply 24 months later (i.e. by 2026), except for a few provisions that shall become applicable six and 12 months after the AI Act will have entered into force, respectively. To facilitate compliance with the new legal framework for AI in Europe, the Commission has recently launched an AI Pact, a voluntary initiative that calls on AI developers from Europe and beyond to make themselves acquainted and comply with the key obligations under the AI Act ahead of time. But what exactly are these obligations? We will focus on various key aspects of the new AI Act and its impact on the healthcare sector in several posts over the coming weeks, starting with the scope of application and the risk-based approach of the new European law.
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Healthcare & life sciences

Doing Business in the United States? Steps to Comply with Washington's My Health My Data Act by March 31, 2024

The MHMDA passed in 2023, contains several mandates that will require many organizations doing business in the United States to update their operational and legal processes by March 31, 2024. Washington's unique approach may also set a precedent for laws in other states and is worth tracking for U.S. and global businesses that want to stay ahead of evolving health data privacy regimes.
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Healthtech

Remote Health Treatment - The Legal Challenges

Some medical treatment can be carried out using digital technology without a doctor being physically present. But what legal challenges does the use of digital technologies entail? This is an issue faced by stakeholders across the global healthcare sector.There is not currently any specific legal framework for inpatient treatment where doctors are physically separated from their patients and potential legal challenges are faced by all stakeholders involved .

Healthcare & life sciences

ABPI trade association member suspended for two years

The Association of the British Pharmaceutical Industry (ABPI) is a major trade association for the British pharmaceuticals industry. The ABPI represents companies involved in the research, development and use of new medicines in the UK. The ABPI's Code of Practice for the Pharmaceuticals Industry (Code) sets out the requirements that the pharmaceuticals industry must comply with, and it supports companies' commitment to self-regulation and to operate in a professional, ethical and transparent manner.

Healthtech

AI in US Healthcare Outsourcing – It's Time to Check Your Contracts

If you are a health insurer that outsources your claims processing functions, you are likely leveraging your service providers' artificial intelligence (AI) and have been for quite some time. The rapid growth in generative AI and concerns about its use are cause to re-examine your outsourcing agreements.

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HealthTech Trends 2024

What is on the horizon for the use of data and technology in the healthcare and life sciences sectors? Where do opportunities lie, and what should participants be thinking about before making the next big move? We provide an outlook on Health Tech trends to watch in 2024.

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Environmental technology, ecological concept

The Rise of Consumer Complaints, Litigation and Enforcement Actions to Curb Greenwashing

The investor-led boom in green products and services presents opportunities for growth. However, whether claims of green, climate-friendly, sustainability or support for biodiversity are borne out in practice is increasingly questioned. Regulators are turning their attention to investigating and regulating firms which may be ‘greenwashing’.

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Data

Issues arising from the use of technology for contract tracing

In this article, we discuss the increasing use of contact tracing technology in the APAC region and the legal concerns surrounding the use of such technology.

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Healthtech

Is ChatGPT a medical device?

ChatGPT can provide medical information, but should it be classified a medical device? It's a question that Germany's Federal Institute for Drugs and Medical Devices (BfArM) was confronted with in an open letter from a Hamburg-based law firm which suggests that ChatGPT – a human-trained OpenAI-based chatbot that feeds its knowledge via freely accessible online sources – falls under the regulations applicable to medical devices in Germany and Europe.

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Healthtech

Bio-banking: digitalization of the healthcare market

We look at the major challenges of the digitalization of the European healthcare market, this article focuses on the challenges of data protection in bio-banking - with a special view to Germany

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Latest podcast

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AI: Artificial intelligence in healthcare, where is the journey heading?

Partner Gunnar Sachs and Senior Associate Yannick Frost talk about the EU Commission's regulatory approach to AI in the second part of Clifford Chance's German podcast series "Talking Tech - AI" with journalist Pia Lorenz. [In German]

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Upcoming events

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30 April: AI Series: Regulating AI – examining global developments (online)

This session will look at the global development of regulatory frameworks for AI, including emerging trends and diverging approaches being taken in different jurisdictions. This will include the EU’s AI Act, US developments at federal and state level, the UK perspective and the measures being taken in China to tackle regulation of generative AI and deepfakes.

Time:  08:00 EDT / 13:00 BST / 14:00 CEST / 20:00 HKT

To Register, please complete the online registration form.

Video recordings Video recordings are available following each session and can be accessed on the Clifford Chance Client Portal and the Financial Markets Toolkit. 
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