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Artificial intelligence in life sciences: regulating AI technologies and the product liability implications
There has been some form of regulation of AI technologies in many life sciences uses in the EU and UK for several years. The EU’s lead on AI regulation began within the medical devices sphere with the introduction of the Medical Device Regulations and In Vitro Diagnostic Regulations (IVDR) (2017/745 and 746) that, belatedly, came into force on 26 May 2021.
The State Opening of Parliament will take place on 10 May 2022, with the Queen’s Speech setting out the Government’s agenda and economic plans for the next session. We take a look at what new laws could be announced and what measures from last year’s Queen’s Speech are confirmed as being carried over.
Promoting fairness in the digital market: EU Parliament and Member States reach agreement on EU Digital Markets Act
On 24 March 2022, EU legislators reached political agreement on the long awaited Digital Markets Act (DMA) which seeks to regulate ‘gatekeeper’ technology giants and a promote fair and open digital market.
In this report, Kennedys experts highlight recent legal and regulatory developments in the product safety and product liability sphere, and provide an overview of the key topics and trends that are likely to impact upon corporates and their insurers in the months ahead.
While artificial intelligence (AI) technologies bring tremendous benefits and opportunities to life sciences businesses, the threats associated with such technologies are wide ranging and complex. This can be exacerbated if companies move too quickly to adopt such sophisticated systems without implementing appropriate securities to protect them.
Since the UK’s exit from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on the regulation of medical devices and the requirements for their entry into the UK market.
EU pharmaceutical strategy: Member States welcome European Commission’s adoption of regulation on Health Technology Assessment
The long awaited regulation on Health Technology Assessment (HTA), adopted on 13 December 2021 and published in the EU Official Journal on 22 December 2021, is a deliverable of the EU Pharmaceutical Strategy that aims to revolutionise patient access to vital and innovative technologies.
As of 1 April 2022, manufacturers or importers of plastic packaging products into the UK may be liable under Part 2 of the Finance Act 2021 to pay a tax on products that contain less than 30% recycled plastic, known as Plastic Packaging Tax (PPT).
On 2 March 2022, four regional and thirty-three national cosmetics industry associations from across the globe released a Position Paper in support of a global United Nations Plastics treaty. This comes in response to a Resolution reached on the same day at the UN Environment Assembly, with the support of 175 nations, calling for treaty implementation by 2024.
Two years into the pandemic, we consider its impact on the life science sector and how the risk landscape is evolving as the industry builds on the progress it has made.