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SIPPs and FOS - does the Rowanmoor decision change anything?
Last week FOS published a decision it reached last year in a complaint against a SIPP provider involving advised sales. The FOS upheld the complaint, finding that the SIPP provider should have rejected business from the regulated financial adviser, CIB Life and Pensions Limited (CIB), given, broadly, red flags available to the SIPP provider with respect to the operation of CIB's business model including that CIB was not advising on the ultimate investment within the SIPP and as a result such introductions involved a significant risk of consumer detriment. The decision has received quite a bit of press attention - but has it moved the dial for SIPP complaints before FOS or not?
Read moreThe Future of Insolvency Regulation
On 21 December 2021 the Government launched a consultation into the future of insolvency regulation. The changes proposed in the consultation document will have a wide ranging impact on the insolvency profession (and its insurers) with the proposals including: the direct regulation of insolvency firms, the introduction of a single regulatory body with powers to order compensation against insolvency practitioners and firms, a new additional requirements regime, changes to the bond regime and a public register of insolvency practitioners and firms. Many of the changes proposed require primary legislation and so it may be some time before the changes to take effect (if adopted). But there does appear to be some wind behind these proposals given they follow on from the Call for Evidence in 2019 and a more general focus on insolvency issues in the wake of the Covid-19 pandemic.
Read moreUK Government wants understanding of video games to move to the next level
On 30 May 2023, the UK Government published a Video Games Research Framework which encourages research on video games and emerging game-related technologies.
Read moreNew Digital Regulators on the 2023 Horizon: the Digital Markets Unit and the European Centre for Algorithmic Transparency
For a number of years, the UK Government has been laying the groundwork to bring in a digital markets regime to regulate digital firms designated as having ‘strategic market status’ (SMS). To be designated as having SMS, a firm must have 'substantial and entrenched market power' in at least one activity. Companies having SMS are likely to include the largest tech firms such as Amazon, Apple, Google, Microsoft and Meta (the so called 'GAMMA' firms).
Read moreDigital services providers—Commission to focus on implementation phase of EU consumer protection legislation
The Digital Services Act (DSA) and the Digital Markets Act (DMA) are published in the Official Journal and the plenary vote of the European Parliament on the proposed text of the AI Act is expected once amendments are agreed by negotiators. The Commission is now turning its focus to the implementation phase of these landmark regimes. So, what does the future hold for the European tech sector and how might it differ for the UK?
Read moreThe EU Digital Markets Act - a focus on gatekeeper obligations and sanctions
What key obligations will the Digital Markets Act (DMA) impose on online platforms designated as gatekeepers?
Read moreThe summer of discontent?
What comes to mind when you hear the word "summer"? The unbridled joy of no more school for 6 whole weeks? Buckets, spades and wind-swept beaches? Perhaps the call of a sun-soaked tropical island? For most, summer means taking some time out to recharge and switch off.
Read moreAI in auditing: Embracing a new age for the profession
Artificial Intelligence (AI) is a rather new concept for many (ignoring those versed in 80’s Sci-Fi movies); it’s something many don’t know much about and certainly don’t use in our day-to-day lives (or at least appreciate we are using). However, that’s not the case for everyone. Auditors have long been reaping the benefits of AI, but are auditors just scratching the surface of what AI can offer and what impact will an increased use have on their insurance requirements and claims they face?
Read moreThaler v Comptroller [2023] UKSC 49: the UKSC rules that AI cannot be an 'inventor'
To the surprise of no one, the UK Supreme Court (UKSC) has finally ruled that an artificial intelligence (AI) cannot be an inventor for the purposes of UK patent law. This judgment accords with the decisions of the lower courts in the UK and the initial ruling of the UKIPO. It also reflects similar findings from most of courts around the world where the claimant, Dr Thaler, brought similar actions.
Read moreEU AI ACT-ion stations
The EU is forging ahead with its vision for AI. With wrapping up talks on the EU AI Act between the EU governments, the Commission and the parliamentary negotiators imminent, we bring you up to date on the EU's risk based approach, the scope of the Act, a timeline, key points that will form the basis of the discussions and next steps.
Read moreWhat To Know About AI Fraudsters Before Facing Disputes
Fraudsters are quick to weaponise new technological developments and artificial intelligence is proving no exception, with AI-assisted scams increasingly being reported in the news, including most recently one using a likeness of a BBC broadcaster.
Read moreGenerative AI and intellectual property rights—the UK government's position
The IPO is to produce a code of practice by the summer that will provide guidance to support AI firms in accessing copyright protected works as an input to their models.
Read moreUnderstanding and managing the risks in artificial intelligence (AI) technology projects
How do you go about managing the risks and challenges that might arise during the deployment of AI technology?
Read moreOfcom's 'Roadmap to Regulation' underway with its consultation on illegal harms duties under the Online Safety Act
In November, Ofcom, as new online safety regulator, published the first of four major consultations under the Online Safety Act ("OSA"), which sets out its proposals for how "user-to-user" ("U2U") services (essentially any online website or app that allows users to interact with each other) and online search services (i.e. Google, Bing and similar) should approach their illegal content duties under the new legislation. The consultation provides guidance in a number of areas including governance, content moderation, reporting and complaints mechanisms, terms of service, supporting child users, and user empowerment.
Read moreThe Online Safety Bill is set to become law
The Online Safety Bill will shortly become law in the UK as soon as it receives Royal Assent. The legislation will introduce a new regulatory regime for online platforms and search engines which target the UK, imposing wide-ranging obligations on in-scope services with serious consequences for non-compliance.
Read moreThe Online Safety Bill and the risk of unintended consequences
The Online Safety Bill was reintroduced to Parliament late last year, with new amendments receiving scrutiny in the House of Commons in December, before the bill entered the House of Lords in January. The bill continues to evolve, most notably with the government removing the requirement for user-to-user platforms and search engines to prevent adult users from encountering "legal but harmful" content, instead requiring online platforms to provide users with enhanced content controls (i.e., choice as to what content is seen), and imposing further obligations around transparency and enforcement of online platforms' terms and conditions. "Legal but harmful" obligations remain in place for under 18s. The government has recently agreed to introduce criminal sanctions for senior managers who fail to take proportionate measures to protect children from potentially harmful content.
Read moreThe Model Anti-SLAPP Law: an overview
Following the Government's response to the SLAPP consultation in the summer, the UK Anti-SLAPP coalition (a working group that includes English PEN, the Foreign Policy Centre and Index on Censorship, "the Coalition") has this week published a model Anti-SLAPP law, which has been endorsed by a collection of free speech and anti-corruption organisations, journalists, editors and lawyers.
Read moreInterim injunctions and competing public interests (Attorney General v BBC)
In Her Majesty's Attorney General for England and Wales v British Broadcasting Corporation [2022] EWHC 826 (QB), an interim injunction has been granted in favour of the Attorney General (AG) to restrain the BBC from broadcasting the identity and image of an alleged covert human intelligence source for MI5 (known only as ‘X’) who is accused of being abusive to two former partners and using his position with MI5 to terrorise and control one of the women. The injunction was granted on the basis that, while it "represented a very significant interference with the right of the BBC to freedom of expression and the correlative right of the public to receive the information the BBC wishes to publish" [23], such a measure was necessary in order to prevent a real and immediate risk to X’s life or safety, as well as the potential wider impact of publication on national security.
Read moreNeed a psychiatrist? There's an app for that!
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have commissioned research to explore the public perception of Digital Mental Health Technology (DMHT).
Read moreThe UK and EU propose bans on 'forever chemicals' (PFAs) – Great for the environment but what about the medical industry?
'Forever chemicals', which are used in countless industries worldwide, have been linked to a range of health issues.
Read moreThe results are in: Physician and Anaesthetic Associates pose "a significant risk to patient safety" according to latest BMA opinion poll
A BMA survey completed by over 18,000 UK doctors has flagged significant concerns regarding the way Physician Associates (PAs) and Anaesthetic Associates (AAs) work within the NHS. The news comes as the Government implements plans to roll out a rapid medical associate recruitment plan and regulate associates through the General Medical Council (GMC), the doctors' regulator. In this blog we look at the reasons behind the backlash and how this may impact our healthcare and insurer clients.
Read moreWeighing up the risks: Remote GP consultations
Telephone and online GP appointments risk harming patients, according to a study published by the British Medical Journal (BMJ) in November 2023. The study found that remote consultations have been linked to an increase in fatalities due to serious health conditions, that would likely have been picked up at face-to-face appointments.
Read moreWeight loss jabs – a litigation time bomb
Weight loss jabs like Ozempic are giving rise to new health concerns. Litigation is emerging in the US with firms claiming that cases will be in the thousands.
Read moreCutting the red tape: MHRA publish new guiding principles for AI-based medical devices
Developers of AI-based medical devices will benefit from the MHRA's new guiding principles which aim to reduce onerous regulatory requirements.
Read moreMental Health Act v Mental Capacity Act: How to avoid a deprivation of liberty claim
A finding that the detention of a teenager ('JS') with complex mental health issues was unlawfully deprived of her liberty highlights the importance of understanding the interaction between the Mental Capacity Act 2005 (MCA) and Mental Health Act 1983 (MHA).
Read moreMcCulloch and Others v Forth Valley Health Board [2023]: Bolam is back in the game for consent
Bolam is well and truly back in the game for consent! The Supreme Court’s decision in McCulloch confirms that the Bolam test should be applied when considering whether alternative treatment options should be discussed with a patient.
Read moreGeneral Damages Uplift: Beware
A recent decision in Coventry Combined County Court will have far -reaching impact on the valuation of all personal injury claims. The decision of Recorder Jack gives the green light for Claimants to seek higher general damages awards. In clinical negligence claims, where general damages can already be as high as £400,000, this will have significant implications for Defendants and their insurers.
Read moreNMC concerns over potentially fraudulent nurse registrations
The Nursing and Midwifery Council (NMC) is contacting more than 500 professionals who trained abroad to determine whether they could have gained fraudulent or incorrect entry to the register after unusual and concerning data emerged from one its testing sites.
Read moreMet police withdraw: a radical restructuring of mental health provision
Metropolitan police officers to be banned from responding to mental health incidents from 31 August 2023.
Read moreQOCS rule changes now in force – has the imbalance been restored?
A review of the amendments to the QOCS regime and the impact on costs recovery for defendants and insurers.
Read moreThe Pharmacist will see you now: Independent Prescribing
Pharmacist independent prescribing services will be trialled across England in 2023 – a possible game changer for our healthcare system and one to watch for insurers.
Read more'A google map of the body' – how the metaverse is transforming the healthcare industry
Twins Bernardo and Arthur Lima were born conjoined at the head in Rio de Janeiro, Brazil. At almost four years old, they have undergone seven extensive surgeries in order to be separated. The operations involved almost 100 medical staff and were led by surgeon Dr Noor ul Owase Jeelani in at Great Ormond Street Hospital in London and Dr Gabriel Mufarrej in Brazil.
Read moreWeighty issues for diet app developers
2022 is set to be the year of the diet app. The distinction between what is a mere lifestyle app and what should in fact be a regulated medical product or service can be difficult to assess.
Read moreNew guidance on Machine Learning – plenty for humans to learn too
A triumvirate of healthcare regulators has published ten guiding principles (the Principles) concerning the development of Good Machine Learning Practice (GMLP). The Principles shed light on the risks posed by artificial intelligence (AI) products that depend on machine learning. Humans should take note.
Read moreBlood Tube Shortage: Testing Times
Test tube shortage leading to delays in blood tests; protection for GPs from liability.
Read moreThe latest addition to Kwasi Kwarteng's reading list
The Regulatory Horizons Council report sets out recommendations for medical devices regulations reform in the UK
Read moreThe government responds to Cumberlege - What now for product liability risks in the life sciences sector?
The government has accepted most of Baroness Cumberlege's recommendations, with long term implications for litigation concerning medicines and medical devices.
Read moreLife sciences and the Brexit trade agreement of Christmas Eve 2020
As the nation prepared for muted Christmas celebrations at the end of last year, those in industry were able to feast on the Trade and Cooperation Agreement settled between the EU and UK on 24 December 2020 (the TCA). The TCA concluded months of uncertainty for the life sciences sector. Companies had been waiting to see how far the UK government would go in agreeing to follow EU standards concerning medicines and medical devices. By the time the EU and UK finally agreed the TCA, questions over life sciences regulations had rocketed up the agenda against a backdrop of vaccines and treatments developed to combat Covid-19.
Read moreCovid-19 vaccines: an injection of politics
A legacy of the pandemic will be greater debate, amongst politicians and the public, about how life sciences products are brought to the market.
Read moreThe Nocebo Effect: study into statins signals a timely warning
New study into statins highlights issue of the Nocebo Effect with implications for manufacturers, insurers and society
Read moreBuyer Beware: NHSX Guidance on Artificial Intelligence
NHSX Guide on AI is a useful resource for manufacturers and insurers in mitigating litigation risks
Read moreParents contest NICE Cannabis Guidelines at Court
A family is seeking judicial review of NICE guidelines in the hope that doctors are more likely to prescribe cannabis-based medicines. The outcome could have significant consequences for the healthcare sector.
Read moreBeyond the fruit and yoga: surviving or thriving?
Last week the RPC Mental Health Work Stream (our internal network) hosted an interactive session with over 60 colleagues and clients.
Read moreBack to the Future: a look ahead at medical malpractice issues for COVID-19-related claims
Future issues for Insurers to consider in assessing COVID-19 medical malpractice / clinical negligence claims.
Read moreSC double decision on vicarious liability
Handed down on 1 April, the two, separate, Supreme Court judgments on vicarious liability were no April Fool's jokes; they are serious and welcome responses to a difficult issue.
Read moreCOVID-19: the battle between fact and fiction
In the era of fake news, and at a time of global panic, how is the government responding to the daily spread of unauthorised health claims around COVID-19?
Read moreThe Archers does Insurance – a light-hearted look at coverage issues following the Grey Gables explosion
For radio aficionados, the long running radio soap The Archers is a welcome daily escape from daily life. However, the last few episodes have not been without their drama. For a medmal insurance lawyer looking to unwind after a day of (home)working, there are a number of taxing fictional issues to which one can turn one's mind.
Read moreThe "war" against Coronavirus: implications for the Life Sciences industry when regulations are loosened
Politicians have reached for military metaphors when setting out their response to the Coronavirus outbreak. Governments hope that the Life Sciences industry will win the fight against the virus by arming the healthcare sector with pharmaceutical and medical device solutions. In the first of a series of blog posts over the coming months on Coronavirus, we examine the pressures that industry must balance when responding to the call to arms.
Read morePatch Test: Is your GP watching Love Island?
The reality TV phenomenon Love Island returned to viewer's screens on 20 January 2020, opening to an audience of 4.8 million. One contestant's open display of contraceptive choice has caught the attention of viewers and, hopefully, some GPs.
Read moreGeneral Election roundtable sheds light on key issues for the Healthcare and Life Sciences sectors.
Last week RPC invited guests to a roundtable to debate the UK political parties' manifesto promises affecting the healthcare and life sciences sectors. Some policies attracted criticism whilst one party bucked the national trend to emerge a winner.
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