{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T06:01:20Z","timestamp":1771999280181,"version":"3.50.1"},"posted":{"date-parts":[[2024,8,26]]},"group-title":"Health Policy","reference-count":19,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T00:00:00Z","timestamp":1724630400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.medrxiv.org\/about\/FAQ#license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2024,8,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Regulation is important for medical software, but advances in software, notably developments in artificial intelligence (AI), are developing quickly. There are concerns that regulatory processes are not keeping up and that there is a need for more pro-innovation approaches.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a survey (n = 34) and four focus groups to discuss experiences of regulation among UK-based developers.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the survey, 35% agreed\/strongly agreed that they were confident in their knowledge of relevant regulation, while 50% agreed\/strongly agreed that poor regulation was allowing bad products to come to market. The focus groups identified 10 themes around challenges with current processes: the process of obtaining regulatory approval is uncertain; lack of knowledge about regulatory approval; difficulties in obtaining reliable advice; complexity and slow pace of approvals; difficult to get NHS clinician involvement; process is costly and difficult to fund; implications for competition; international differences; incentives to develop lower classification products; and lack of harmonisation between NHS and MHRA. Respondents\u2019 suggestions for solutions to improve processes fell under four themes: financial and structural support; regulatory collaboration and commissioner involvement; process efficiency and adaptability; and education and guidance.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>Developers are unhappy with the process of regulation for medical software in the UK, finding it confusing and expensive. They feel systems compare poorly to international comparators. Integration between the MHRA system and NHS commissioning is considered poor.<\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2024.08.25.24312551","type":"posted-content","created":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T12:10:15Z","timestamp":1724674215000},"source":"Crossref","is-referenced-by-count":3,"title":["A foggy minefield: Experiences of regulation among developers of AI and other medical software in the UK, survey and focus group study"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6200-8804","authenticated-orcid":false,"given":"Henry WW","family":"Potts","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0096-1234","authenticated-orcid":false,"given":"Paulina","family":"Bondaronek","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7107-7211","authenticated-orcid":false,"given":"Ana Lu\u00edsa","family":"Neves","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9966-7558","authenticated-orcid":false,"given":"Alex","family":"Bolotov","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6601-7196","authenticated-orcid":false,"given":"Lucie","family":"Burgess","sequence":"additional","affiliation":[]},{"given":"Jona","family":"Shehu","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1717-7868","authenticated-orcid":false,"given":"Gabriella","family":"Spinelli","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2422-9104","authenticated-orcid":false,"given":"Emanuela","family":"Volpi","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8772-4938","authenticated-orcid":false,"given":"Austen","family":"El-Osta","sequence":"additional","affiliation":[]}],"member":"54368","reference":[{"key":"2024082901351618000_2024.08.25.24312551v1.1","unstructured":"Department for Science, Innovation & Technology (2024). A pro-innovation approach to AI regulation: Government response. London: The Stationery Office (CP 1019)."},{"key":"2024082901351618000_2024.08.25.24312551v1.2","unstructured":"Department of Health and Social Care, Office for Life Sciences & Department for Business, Energy & Industrial Strategy (2023). Bioscience and health technology sector statistics 2021. https:\/\/www.gov.uk\/government\/statistics\/bioscience-and-health-technology-sector-statistics-2021\/bioscience-and-health-technology-sector-statistics-2021 [accessed 25 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.3","unstructured":"Department of Health and Social Care, Office for Life Sciences & Department for Business, Energy & Industrial Strategy (2023). Bioscience and health technology sector statistics 2021 to 2022. https:\/\/www.gov.uk\/government\/statistics\/bioscience-and-health-technology-sector-statistics-2021-to-2022\/bioscience-and-health-technology-sector-statistics-2021-to-2022 [accessed 25 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.4","unstructured":"European Parliament legislative resolution of 13 March 2024 on the proposal for a regulation of the European Parliament and of the Council on laying down harmonized rules on Artificial Intelligence (Artificial Intelligence Act) and amending certain Union Legislative Acts (COM(2021)0206\u2014C9-0146\/2021\u2014 2021\/0106(COD)). https:\/\/www.europarl.europa.eu\/doceo\/document\/TA-9-2024-0138_EN.pdf (2024)"},{"key":"2024082901351618000_2024.08.25.24312551v1.5","doi-asserted-by":"publisher","DOI":"10.4135\/9781526421036"},{"key":"2024082901351618000_2024.08.25.24312551v1.6","doi-asserted-by":"publisher","DOI":"10.1186\/2110-5820-2-2"},{"key":"2024082901351618000_2024.08.25.24312551v1.7","unstructured":"Goldacre B , Morley J (2022). Better, Broader, Safer: Using health data for research and analysis. A review commissioned by the Secretary of State for Health and Social Care. Department of Health and Social Care. https:\/\/www.gov.uk\/government\/publications\/better-broader-safer-using-health-data-for-research-and-analysis [accessed 19 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.8","unstructured":"Mazzucato M (2013). The Entrepreneurial State. London: The Anthem Press."},{"key":"2024082901351618000_2024.08.25.24312551v1.9","unstructured":"McLean A (2023). Pro-innovation Regulation of Technologies Review: Life Sciences. HM Government, May 2023. https:\/\/assets.publishing.service.gov.uk\/media\/64706d21c38c55000c342bd5\/Life_sciences_report_-_Pro-innovation_Regulation_of_Technologies.pdf [accessed 25 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.10","unstructured":"Medicines & Healthcare products Regulatory Agency (2021). Good Machine Learning Practice for Medical Device Development: Guiding Principles. https:\/\/www.gov.uk\/government\/publications\/good-machine-learning-practice-for-medical-device-development-guiding-principles\/good-machine-learning-practice-for-medical-device-development-guiding-principles [accessed 19 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.11","unstructured":"Medicines & Healthcare products Regulatory Agency (2024). Roadmap towards the future regulatory framework for medical devices. https:\/\/assets.publishing.service.gov.uk\/media\/659d3539aaae22001356dc3c\/Roadmap_towards_the_future_regulatory_framework_for_medical_devicesJan_24.pdf [accessed 19 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.12","unstructured":"NHS Health Research Authority (no date). Is my study research? https:\/\/www.hra-decisiontools.org.uk\/research\/ [accessed 25 August 2024]"},{"key":"2024082901351618000_2024.08.25.24312551v1.13","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare12050562"},{"key":"2024082901351618000_2024.08.25.24312551v1.14","doi-asserted-by":"publisher","DOI":"10.1163\/15718093-bja10053"},{"key":"2024082901351618000_2024.08.25.24312551v1.15","unstructured":"Potts H , Death F , Bondaronek P , Gomes M , Raftery J , Public Health England, UK Health Security Agency (2021). Evaluating digital health products. GOV.UK collection, 16 Oct 2021. https:\/\/www.gov.uk\/government\/collections\/evaluating-digital-health-products [accessed 19 August 2024]"},{"issue":"3","key":"2024082901351618000_2024.08.25.24312551v1.16","doi-asserted-by":"crossref","first-page":"55","DOI":"10.12968\/bjhc.2022.0005","article-title":"Healthcare innovation: Whose job is it anyway?","volume":"28","year":"2022","journal-title":"British Journal of Healthcare Management"},{"key":"2024082901351618000_2024.08.25.24312551v1.17","unstructured":"Thierer AD (2023). Flexible, pro-innovation governance strategies for artificial intelligence. R Street Policy Study, No. 283. Available at SSRN: https:\/\/ssrn.com\/abstract=4423897"},{"key":"2024082901351618000_2024.08.25.24312551v1.18","doi-asserted-by":"publisher","DOI":"10.1101\/2024.01.28.24301885"},{"key":"2024082901351618000_2024.08.25.24312551v1.19","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-024-00628-3"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1101\/2024.08.25.24312551","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T20:10:15Z","timestamp":1768507815000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.1101\/2024.08.25.24312551"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,26]]},"references-count":19,"URL":"https:\/\/doi.org\/10.1101\/2024.08.25.24312551","relation":{},"subject":[],"published":{"date-parts":[[2024,8,26]]},"subtype":"preprint"}}