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Jaspreet Takhar

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New guidelines have been published on clinical trials for AI health solutions. The SPIRIT-AI extension relates to clinical trials protocols, and the CONSORT-AI extension is a new reporting guideline for clinical trial reports. These new guidelines are aimed at addressing some of the chronic issues which often underlie trial standards for AI, including the use of retrospective datasets, poor standards of reporting and lack of transparency. We’ve described these issues below: 1. Retrospective reports do…

The UK’s National Data Guardian for Health and Social Care (NDG) is carrying out a consultation seeking views on proposed revisions to the seven Caldicott Principles. The consultation is open until 3rd September. We’ve set out a summary of 4 key changes proposed in the NDG’s consultation paper. What are the Caldicott Principles? In 1997, Dame Fiona Caldicott chaired a committee which produced a report containing six principles on patient confidentiality after reviewing the transfer…

Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…

Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…

NHS AI Lab has released a short buyer’s checklist to guide organisations through procuring AI solutions. It’s been published in light of COVID-19 – the pandemic presents a huge opportunity to accelerate the uptake of innovative digital solutions at scale. In the UK, healthcare organisations are receiving multiple proposals for AI healthcare applications. This could ease the burden on hospitals facing enormous demands on time and clinical resource. The guide focuses on providing assurance that…

NHSX, the technology and digital unit of the UK’s National Health Service (NHS), recently published its draft Digital Health Technology Standard. The Standard aims to accelerate how digital health technologies (DHTs) are reviewed, commissioned and scaled for use across the wider health and care system, and provides guidance to support digital health technology developers. The Standard is in draft form at the moment, and NHSX are seeking feedback via a short survey until 22 April (although…

Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID-19, here are our top 5 legal issues to bear in mind as you embark on your journey. COVID-19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world. Companies are innovating at lightning speed to adapt to new needs: patients are being treated remotely through mobile doctor apps,…

Manufacturers are being urged by governments around the world to expand production to include life-saving medical technology to tackle COVID-19. We’ve produced an alert (here) to help guide manufacturers which are new to this space on key legal challenges. As COVID-19 infections increase globally, health systems face a shortage of life-saving equipment and essential supplies to tackle the virus. Until a pharmacological treatment is developed, ventilators are vital treatment for the minority of COVID-19 patients…

A new report provides a bold roadmap for the NHS to maximise the impact of its health data. The report, titled NHS data: Maximising its impact on the health and wealth of the United Kingdom, advocates for the UK government to take action now, before the UK is leapfrogged by other countries in health innovation. The report (available here) is from Imperial College London’s Institute of Global Health Innovation. The report examines some of the…