In September 2025, the UK’s new “failure to prevent fraud” offence will come into force. The new offence, introduced under the Economic Crime and Corporate Transparency Act 2023, marks a key step in the UK Government’s longstanding efforts to enhance the economic crime enforcement toolkit in the UK, and the offence will impose significant new obligations on a range of companies with UK touchpoints. In November 2024, the UK Government published detailed guidance on the…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the third post in our EHDS series. In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. We examine the impact of this pathway…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. So what can you expect? This is the second post in our EHDS series, and we…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for you? This is the first post in our series on the EHDS. This post focuses on new health data rights, and we examine the latest publicly available draft, dated 24 April 2024. So what’s the impact on the pharmaceutical and medtech industry? In one way, it’s limited…
The UK’s Information Commissioner’s Office (ICO) has launched a public consultation on its draft guidance on transparency in the health and social care sector.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. We’ve set out our top six takeaways on the proposed guidance…
We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…
In brief 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 method of privacy-preserving record linkage (PPRL). This allows pharmaceutical companies to “tokenise” and link previously scattered…
In brief The UK’s Health Research Authority (HRA) has unveiled new guidance that 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…
In brief In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking to harmonise telemedicine from the draft European Health Data Space (EHDS). The (now-removed) Article 8 was aimed at encouraging the cross-border provision of telemedicine services across the EU. However, the reality is that there are vast national differences between Member States on telemedicine-related laws. It is going to require a far more concerted legislative effort to harmonise this area…