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NEWS
The Association of British HealthTech Industries (ABHI) has published a Power of Testing report, developed by the Institute of Biomedical Science with Roche Diagnostics in partnership with the Institute of Biomedical Science (IBMS), and supported by the Royal College of Pathologists and the Association for Laboratory Medicine. This report builds on the government’s recent 10 Year Plan for the NHS. It calls for the urgent need to better prioritise and fund in vitro diagnostics (IVDs). It also calls for equitable funding for IVDs which currently receive less than 1% of planning and funding despite influencing over 70% of clinical decision-making in the NHS. Moreover, the report includes a roadmap setting out how mandated funding can be scaled up with the biomedical workforce and suggests establishing a cross-sector working group of stakeholders collaborating on implementation. It further advocates for raising awareness of the critical significance of the role of non-imaging IVDs play in delivering effective health care such as through key organisations like IBMS.
NEWS
The Association of British HealthTech Industries (ABHI) has published its response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on proposals to update the MHRA’s statutory fees, which ran between August and October 2024. In the response, the ABHI does not support the proposal of the statutory fees to be increased as it believes it will make the UK significantly more expensive than jurisdictions such as the EU and the US, making the UK less attractive to businesses and discouraging clinical research taking place in the country. The ABHI is also against the existing registration fee being amended to include the costs for post-market work as this would likely have an adverse impact on HealthTech industry in the UK by limiting the number of devices available due to prohibitive costs, and unevenly distribute costs across products and businesses. The ABHI did note that its members were ‘cautiously in favour’ of new regulatory advice meetings for medical devices being created, however, the proposed fee of £987 per hour would need to be lowered.
NEWS
The Association of British HealthTech Industries (ABHI) has submitted a comprehensive response to the UK government's Industrial Strategy Green Paper, focusing on the HealthTech sector. ABHI has proposed significant reforms to regulatory processes, including recognition of approvals from trusted jurisdictions, and improvements to NHS procurement and adoption pathways. The association has also highlighted barriers to investment and growth, suggesting measures to enhance data sharing, infrastructure, and alignment with devolved governments' strategies. ABHI emphasizes the need for a tailored approach to HealthTech within the broader Life Sciences sector, advocating for dedicated representation and policy considerations to unlock the sector's full potential for economic growth and healthcare innovation.
NEWS
The Association of British HealthTech Industries (ABHI) has published its manifesto, The Plan for Health Tech, which sets out a ten-point programme for the government to ensure that the health sector’s potential is fully realised to benefit patients, clinicians and the economy. The manifesto recommends a focus on regulatory alignment, fostering innovation in healthcare practices and ensuring a long-term investment to support sector growth. The manifesto also calls for increased collaboration with NHS England and other healthcare providers to streamline technology adoption and expanded digital infrastructure to enhance early diagnosis and patient care.
NEWS
The Association of British HealthTech Industries (ABHI) has published its response to the European Commission’s call for evidence on the targeted revision of the Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746. ABHI supports the Commission’s objectives to improve device availability and simplify regulatory processes. It advocates for: (1) risk-based, proportionate regulation; (2) streamlined requirements for low-risk and legacy devices; and (3) platform-based certification for combination products. The response also calls for harmonised approaches to clinical evidence generation, ethics review and data collection, recognising the role of medical devices, IVDs, software, and AI within broader clinical research frameworks.
NEWS
The Association of British HealthTech Industries (ABHI) has published guidance on 17 April 2025 explaining the United States Food and Drug Administration (FDA) 510(k) medical device approval process. The document aims to inform UK policymakers considering regulatory alignment with the US system post-Brexit. It addresses 12 common misconceptions about the 510(k) pathway and outlines how elements such as risk-based classification and recognition of prior assessments could be incorporated into UK reforms. The guidance specifically examines the process's application to both medical devices and in vitro diagnostics.
NEWS
The Association of British HealthTech Industries (ABHI) has released a report on the economic impact of the HealthTech policies drawn up by ABHI in collaboration with Lord Sainsbury’s Gatsby Foundation and Imperial College London at the beginning of 2024. While the report found that HealthTech has had a significant impact on the economy, adding £13bn to the biopharmaceutical sector, it also noted that HealthTech’s growth potential should be increased through policy measures on tax incentives, regulatory reforms, and collaboration with the NHS. The report also outlines short, medium, and long-term recommendations to increase NHS efficiency, investment in research and development, and enhance ABHI’s Global Export Programme.
NEWS
The Association of British HealthTech Industries (ABHI) has released a survey revealing significant financial pressures on the UK's HealthTech sector. The organisation reports that 70% of respondents have experienced substantial cost increases, with half anticipating annual rises above £100,000 due to the National Insurance Contributions (NIC) increase.
ABI
GLOSSARY
The Association of British Insurers is a trade association representing the vast majority of UK insurers (both general and life). It has a decreasing influence in pensions policy but is active on institutional investment matters such as shareholder action and remuneration policies of quoted companies. It does not always agree with the Pensions and Lifetime Savings Association (formerly the NAPF) which looks after the interests of company pension funds.
GLOSSARY
Form of performance guarantee bond produced by the Association of British Insurers (ABI) and commonly used in relation to construction projects, although it is often amended.
NEWS
The Association of British Insurers (ABI) and Lloyd’s of London have co-published: the Components of a Major Cyber Event: A (Re)Insurance Approach, as a guide for (re)insurers on how to approach defining a major cyber event. The guide sets out factors re(insurers) should consider and provides a framework to follow when defining what constitutes a major cyber event.
NEWS
Law360: The Association of British Insurers (ABI) has said it has signed a memorandum of understanding with a trade group for insurance technology companies to support and promote innovation on artificial intelligence, open finance, data ethics and operational resilience.