On 5th March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The EHDS enters into force on 26 March 2025 â this is the beginning of the transition phase towards application. At its core, the EHDS is about three things: (1) empowering patients with new health data rights (primary use); (2) a new pathway to access electronic health data for research and innovation (secondary…
In September 2025, the UKâs new âfailure to prevent fraudâ 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 Governmentâs 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 fourth post in our EHDS series. In this post, we focus on the new product regime for electronic health record (EHR) systems, including the impact on wellness apps, AI systems and medical devices. We examine the latest publicly available draft, dated 24…
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 whatâs the impact on the pharmaceutical and medtech industry? In one way, itâs limited…
The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch: 1. Patent (Amendment) Rules 2024: Beware shorter…
Alongside its allies, the EU has implemented a vast volume of sanctions on Russia and Belarus following Russia’s invasion of Ukraine in February 2022. The EU sanctions against both Russia and Belarus are at the core of the EU’s response to Russia’s military aggression and aim to diminish Russian resources and curb Russiaâs capacity to continue the war. On 24 June 2024, the EU introduced its awaited 14th sanctions package on Russia and not long…
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UKâs Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are now developing a proposed regulatory framework for modifications to Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a…
The conversation on psychedelics around the world continues to evolve, with more and more emerging clinical data highlighting their potential to treat mental health disorders. Last yearâs developments â see our previous blog post here – led us to anticipate an upcoming change but yet the legal landscape remains unchanged. In the UK, the independent Parliamentary Office of Science and Technology (POST), which is one of the first independent bodies of its kind in the…