The latest legal updates for the healthcare, digital health and life sciences sector

This newsletter addresses the legal and regulatory issues and evolving areas of law affecting healthcare, digital health and/or life sciences businesses.

Our sector experts from across the firm provide you with updates including steps that healthcare employers need to take regarding the skilled worker visa changes, the transparency obligations guidance for the health and social care sector and what healthcare providers need to know regarding the new Care Quality Commission regulation.

As well as providing the good news of a pilot scheme for parties engaged in patent disputes, we also highlight the post-market surveillance rules for medical devices, along with the EU Artificial Intelligence Act and its impact on the healthcare sector.

In addition to this, we share insight on how to address the potential presence of RAAC in healthcare settings, and introduce the new duty holder and competency regime in relation to building regulations and the changes it will bring for NHS trusts and operators, contractors and designers.


Our latest insights and regulatory updates

The use of RAAC – a complex issue

The presence of reinforced autoclaved aerated concrete (RAAC) has been confirmed in numerous hospitals and may also be an issue in other healthcare settings.

Our article explores the issue and the potential for claims to seek to recover the costs of remediation works.

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Aerated Concrete Raac

Post-market surveillance rules for medical devices in the UK

On 9 January 2024, the Medicines and Healthcare Products Regulatory Agency produced a roadmap towards the future regulatory framework for medical devices, which sets out intended timescales for the delivery of future core regulations. 

This article highlights how the UK Medical Devices Regulations 2002 is changing and what this means for manufacturers.

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Medical Device

What effect will the EU Artificial Intelligence Act have on the healthcare, digital health and life sciences sector?

The EU Artificial Intelligence Act introduces a comprehensive set of rules to regulate AI in the EU and thus will have a significant effect on the healthcare, digital health and life science sector.

This article highlights the key proposals of the act, the issues for the sector and the consequences of not complying.

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Abstract Curly Tendrils

Good news - pilot scheme for capping costs in patent cases

Parties can now benefit from a 3-year pilot scheme, which provides for capped costs when engaged in patent disputes before the Patents Court. 

This article investigates the history of patent disputes and explores the aim of the new pilot scheme.

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Intellectual Property Gears And Idea Concept

Health and social care organisations: are you meeting your transparency obligations?

The Information Commissioner’s Office (ICO) has published draft guidance for the health and social care sector to help organisations meet their transparency obligations.

This article provides an overview of the draft guidance in its current form.

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An introduction to the new dutyholder and competency regime

The new duty holder and competency regime was brought in by the changes to the Building Regulations 2010.

This article introduces the new dutyholder and competency regime and summarises the changes it will bring for NHS trusts and operators, contractors and designers.

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Skilled worker visa changes: steps for healthcare employers to take

Due to the home secretary’s announcement of a five-point plan on 4 December 2023 which aims to reduce net migration to the UK by 300,000 people each year, the minimum salary payable by an employer to a sponsored skilled worker is increasing by almost 50%.

Other changes will also affect skilled worker sponsorship, such as an increased immigration health surcharge as part of the skilled worker’s visa application.

This guide describes the changes in detail and advises on next steps for healthcare employers.

Find out more
Close Up Of A Visa

New Care Quality Commission regulation: what do healthcare providers need to know?

Following a public consultation in 2023, the government has amended the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, to include a new Care Quality Commission regulation.

This guide explores the new regulation in detail, highlighting how it will benefit patients and care home residents, who it applies to and what will happen if healthcare providers do not meet the requirements.

Read the guide
Elderly Person In Care Home

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