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Healthtech

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The NHS’s New Data Sharing Agreement NHSX has published a new Data Sharing Agreement (DSA) template. The template is a great tool for companies collaborating with NHS organisations to access and use data for R&D, and for companies which access and use data as part of their provision of services to the NHS. We’ve set out our top 5 takeaways below: What’s in a name? Data Sharing Agreement is a misnomer – this is not…

NHSX recently launched a brand new information governance portal, providing a ‘one-stop shop’ for NHS policies and guidance. The new portal covers everything from GDPR in research to records management. But even with the new portal, navigating NHS guidance on data isn’t easy. We’ve picked out 6 essential items to have on your radar if your organisation accesses or uses NHS data: 1. The Caldicott Principles The Caldicott Principles apply to the use of confidential…

The MHRA has issued guidance on managing access to electronic personal health data processed during clinical trials. Clinical trials sponsors, via clinical research associates (CRAs) or monitors, verify and oversee the data collected and analysed during clinical trials (Source Data Verification). They review medical records to ensure this matches the data collected by the sponsor. The guidance addresses the challenges posed to patient confidentiality by electronic health records (EHRs) during this review process. The guidance…

Digital healthcare, a globally booming market, has been catalyzed by the events of COVID-19. In Asia Pacific, in particular, a rapidly expanding population, an empowered and tech-savvy middle class and physician shortage has created the perfect conditions for digital health innovation. A new era of digital healthcare innovation looms on the horizon where there is now greater imperative to develop future-proof digital health solutions and systems in a “next-generation” ecosystem that channels hybridity and multi-functionality.…

Patient registries are where big data meets new and exciting regulatory opportunities in pharma, and regulators are keen to address the gaps between regulation and innovation in this space. The European Medicines Agency (EMA) has published new draft guidelines on registry-based studies (Guidelines) for a three-month public consultation period. The Guidelines make the case for optimising the use of registry-based studies as a source of real-world evidence. The new Guidelines will be an essential tool…

What are the legal challenges of bringing such innovative and scalable products to the market?  In this webinar, we will explore a case study on a drug-device combination product with a strong digital component. These types of products are becoming increasingly sophisticated and they raise new opportunities, but also new challenges from a legal point of view. We will discuss the legal challenges for a company bringing a digital health product to market with a specific focus…

The challenge Digital technologies have become integral to all sectors, and none more so than the healthcare industry. Companies in the healthcare industry are investing significantly in the conception, development, manufacturing, sale and distribution of “HealthTech”. It is important to protect and ensure a return on this investment through a strategic use of the available IP and trade secrets laws. In particular, it is important to take a holistic approach to the use of IP…

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…

For some time now, start-ups, health care and tech companies have been experimenting with smaller video games to have people around the world help with categorizing or analyzing big data sets that typically take months or even years to analyze. The idea is that if everybody invests only a few minutes, the work could be done in days or weeks instead of years. A player who participates has to solve a few simple matchmaking or…