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Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Digital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and minimising risk in medicines development. This review is comprised of four case studies of DHTTs used throughout the lifecycle of medicinal products, starting from their development. These cases illustrate how the regulatory requirements of DHTTs used in medicines development are based on two European regulatory frameworks (medical device and the medicinal product regulations) and highlight the need for increased collaboration between various stakeholders, including regulators (medicines regulators and device bodies), pharmaceutical sponsors, manufacturers of devices and software, and academia. As illustrated in the examples, the complexity of the interactions is further increased by unique challenges related to DHTTs. These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current regulatory approach; they were selected by a group of authors, including regulatory specialists from pharmaceutical sponsors, technology experts, academic researchers and employees of the European Medicines Agency. For each case study, the challenges faced by sponsors and proposed potential solutions are discussed, and the benefit of a structured interaction among the different stakeholders is also highlighted.<\/jats:p>","DOI":"10.1038\/s41746-023-00790-2","type":"journal-article","created":{"date-parts":[[2023,3,29]],"date-time":"2023-03-29T11:03:59Z","timestamp":1680087839000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":53,"title":["Evolving regulatory perspectives on digital health technologies for medicinal product development"],"prefix":"10.1038","volume":"6","author":[{"given":"Seya","family":"Colloud","sequence":"first","affiliation":[]},{"given":"Thomas","family":"Metcalfe","sequence":"additional","affiliation":[]},{"given":"Scott","family":"Askin","sequence":"additional","affiliation":[]},{"given":"Shibeshih","family":"Belachew","sequence":"additional","affiliation":[]},{"given":"Johannes","family":"Ammann","sequence":"additional","affiliation":[]},{"given":"Ernst","family":"Bos","sequence":"additional","affiliation":[]},{"given":"Timothy","family":"Kilchenmann","sequence":"additional","affiliation":[]},{"given":"Paul","family":"Strijbos","sequence":"additional","affiliation":[]},{"given":"Damien","family":"Eggenspieler","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9270-4061","authenticated-orcid":false,"given":"Laurent","family":"Servais","sequence":"additional","affiliation":[]},{"given":"Chlo\u00e9","family":"Garay","sequence":"additional","affiliation":[]},{"given":"Athanasios","family":"Konstantakopoulos","sequence":"additional","affiliation":[]},{"given":"Armin","family":"Ritzhaupt","sequence":"additional","affiliation":[]},{"given":"Thorsten","family":"Vetter","sequence":"additional","affiliation":[]},{"given":"Claudia","family":"Vincenzi","sequence":"additional","affiliation":[]},{"given":"Francesca","family":"Cerreta","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,3,29]]},"reference":[{"key":"790_CR1","doi-asserted-by":"publisher","first-page":"897","DOI":"10.1007\/s10389-020-01370-4","volume":"30","author":"L Affinito","year":"2022","unstructured":"Affinito, L., Fontanella, A., Montano, N. & Brucato, A. 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Hoffmann-La Roche Ltd., Switzerland. T.M. is an employee of, and owns shares in, F. Hoffmann-La Roche Ltd., Switzerland. S.A. is an employee of Novartis Pharma AG, Basel, Switzerland. S.B. is an employee of Biogen Digital Health, Biogen International GmbH, Baar, Switzerland. J.A. is an employee of, and holds shares and stocks in, F. Hoffmann-La Roche Ltd., Switzerland. E.B. is an employee of F. Hoffmann-La Roche Ltd., Switzerland. T.K. is an employee of F. Hoffmann-La Roche Ltd., Switzerland. P.S. is an employee of, and owns shares in, F. Hoffmann-La Roche Ltd., Switzerland. D.E. is an employee of SYSNAV, Vernon, France. L.S. is an employee of the University of Oxford, UK, and holds a patent without financial return on a method to assess upper limb function using a wearable device; he has consulted for Biogen, F. Hoffmann-La Roche Ltd., Novartis, Scholar Rock, Pfizer, BioHaven Therapeutics, Sarepta, Santhera, Biophytis, Affinia and Regenexbio; he chairs the DSMB of Lupin therapeutics and FibroGen; he is also the secretary of the World Muscle Society and the Vice Chair of the scientific board of Spinal Muscular Atrophy (SMA) Europe. C.G. is an employee of, and owns shares in, Eli Lilly and Company Ltd., Basingstoke, UK; and is a member of The European Federation of Pharmaceutical Industries and Associations as an Eli Lilly and Company Ltd. representative. A.K. was an employee of, and owned shares in, Eli Lilly and Company Ltd., Basingstoke, UK, during the conceptual design, drafting and review of the manuscript. A.R. is an employee of Bristol Myers Squibb, UK. T.V. is an employee of the European Medicines Agency, Amsterdam, The Netherlands. C.V. is an employee of the European Medicines Agency, Amsterdam, The Netherlands. 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