In brief In September 2024, Texas’ Attorney General announced a “first-of-its-kind” settlement with a healthcare generative artificial intelligence (âGen AIâ) company over what it said were “false, misleading, or deceptive” Gen AI products that aid physicians and medical staff in drafting clinical notes and charts. Per the Attorney General, the Companyâs advertised hallucination rate was âvery likely inaccurateâ which “may have deceived hospitals about the accuracy and safety of the Company’s products.” The settlement provides…
The UKâs Information Commissionerâs Office (ICO) has launched a public consultation on its draft guidance on data privacy transparency in the health and social care sector. The proposed guidance emphasises the importance of going beyond the legal requirements of the GDPR in order to build trust with patients, and builds on themes of openness, honesty and patient engagement. The consultation is open until 7 January 2024, and is essential reading for tech companies providing services…
The UKâs Health Research Authority (HRA) has unveiled new guidance which signposts the three essential steps to access health and care data for research purposes. The guidance delves into a point that researchers often miss: the common law duty of confidentiality runs in parallel to data privacy laws, and each regime needs to be considered separately to ensure data access requests can stand up to regulatory scrutiny. Step 1: Scoping – What are the data…
How will pharma use health data for clinical trials in the future? The power of clinical trial tokenisation On 25 October 2022 leading researchers and executives from some of the world’s pioneering drug and pharmaceutical companies came together at a Financial Times Live Webinar event to discuss “The Power of Clinical Trial Tokenisation”. Tokenisation of healthcare data is likely to be one of the next great innovations for developing life-saving drugs and treatments through the…
The NHSâs 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. Weâve set out our top 5 takeaways below: Whatâs in a name? Data Sharing Agreement is a misnomer â 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 isnât easy. Weâve 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…