Medical and life sciences
Cutting 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 moreHo v Adelekun [2021]: Supreme Court decision on QOCS spells bad news for defendants and insurers
META DESCRIPTION Think Search Engine Optimisation (SEO). Summarise your blog in 160 characters. Search engines such as Google, Yahoo, and Bing use the meta description as the search results description for that page. A review of the Supreme Court decision of Ho v Adelekun and the impact on QOCS and costs recovery for defendants and insurers.
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.
Read moreEndometriosis: painfully under-diagnosed?
Endometriosis, described as a "silent source of unnecessary misery", affects over two million women in the UK. So, why is it taking over 7 years to diagnose?
Read moreA judgment that will "benefit" manufacturers facing the "risks" of products litigation
In the Seroxat group litigation, the Court has endorsed using a risk/benefit approach in claims under the CPA and upheld the trial judge's ruling regarding the limited scope of the Claimants' case
Read moreMedicinal Cannabis – approved for NHS use
Two cannabis based medicines have now been approved for use by the NHS in England following new guidelines from NICE.
Read moreEnter the avatar - is this medicine's new "reality"?
A brief look at the use of virtual and augmented reality technology in medical treatment, and some of the legal issues that could arise
Read more"Alexa, my symptoms are…"
Amazon has announced that Alexa will now provide its users medical advice directly from the NHS website. This blog looks at the potential impacts of this change.
Read moreMPs Vote to Lift Abortion Ban in Northern Ireland
Last Wednesday MPs in Westminster voted in favour of lifting the abortion ban in Northern Ireland by a majority of 332 votes to 99. The passing of the amendment has been hailed as a historic day for women's rights but what does it mean practically?
Read moreThe Medical Devices Regulation 2017 and good business practice
When it comes to risk management, businesses in general should take note of the issues covered by the Medical Devices Regulation 2017
Read moreGovernment Consultation on Adding Folic Acid to Flour
Last week the government began a consultation on whether to introduce mandatory fortification of flour with folic acid to help reduce neural tube defects in foetuses.
Read moreRoyal College of Surgeons call for Robust Reporting in the Private Healthcare Sector
The Royal College of Surgeons (the “RCS”) has today called for independent healthcare providers to “improve standards in the independent sector and prevent the circumstances that enabled Paterson to continue practising from happening again.”
Read moreVaginal mesh: the evidence
NICE guidelines inform debate over the evidence for the risks and benefits of mesh products
Read moreA Right Royal Deadlock: Can "Crown" use unlock patented drug?
Can the Government settle the dispute between NHS and Vertex Pharmaceuticals through "Crown" use of the patented drug, Orkambi.
Read moreOrgan Donation: The New Law
An "opt-out" system for organ donation is expected to come into effect in England next year after passing the final parliamentary vote this week
Read moreMedicinal Cannabis – How far have we really come?
Cannabis, for medicinal purposes, was legalised nearly four months ago in the UK, but how many patients are actually reaping the benefits, and how far have we really come?
Read moreFrom rehabilitative robotics to automated imaging: educating the workforce for the digital future
An independent review into the future impact of digital technology identifies a pressing need for specialist training within the healthcare workforce.
Read more"Move fast and break things" (just not patients)
The AoMRC's report on Artificial Intelligence in Healthcare presents dilemmas for clinicians, hospital and industry
Read moreCould the NHS Long Term Plan mean less opportunity for NHS contracts?
The NHS's Long Term Plan includes a provision to repeal elements of the Health and Social Care Act 2012; in this blog we consider the potential impact on private providers and their opportunity to tender for NHS contracts.
Read moreHairdryer treatment for medical staff who accessed Sir Alex Ferguson's medical records
After the former Manchester United manager's medical records were accessed by staff at the Salford Royal Hospital, what are the likely GDPR and Data Protection Act consequences?
Read moreProjecting into the future of the medical products sector
In the final instalment of our vlog series, we look at recently published books by Yuval Noah Harari and Stephen Hawking to help us better understand and project into the future of the medical products sector.
Read moreArtificial intelligence and diagnostics in the medical sector
Our Medical and Life Sciences team take a look at the use of artificial intelligence and diagnostics in the second instalment of this 3 part vlog series.
Read moreThe future of the medical products sector
In the first of our vlog series we focus on the future of the medical products sector, specifically where the sector is heading and what risks and opportunities might lie ahead.
Read moreJackie Doyle-Price appointed Minister for the Prevention of Suicides
What is the role of the Minister for the Prevention of Suicides, and how will her appointment impact Insurers?
Read moreStephen Hawking's big questions for Life Sciences
Stephen Hawking's posthumously published "Brief Answers to the Big Questions" is a fascinating foretelling of legal challenges that the life sciences sector may face.
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