{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T02:43:51Z","timestamp":1785206631427,"version":"3.55.0"},"reference-count":70,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T00:00:00Z","timestamp":1697673600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:p>Connected Health solutions are ubiquitous in providing patient centered care and in responding to a new paradigm of care pathways where Health Information Technology is being introduced. This paper defines Connected Health, and, in particular, describes standards and regulations which are important to the implementation of safe, effective and secure Connected Health solutions. This paper provides: a holistic view of Connected Health; provides a standards and regulations based view of the lifecycle of the Health IT system; and identifies the relevant roles and responsibilities at the various stages of the lifecycle for both manufacturers of connected health solution and healthcare delivery organization solutions. We discuss how the implementation of standards and regulations, while implementing and using Health IT infrastructure, requires close collaboration and ongoing communication between Healthcare Delivery Organizations and Accountable Manufacturers throughout the lifecycle of the health IT system. Furthermore, bringing technology into the healthcare system requires a robust and comprehensive approach to Clinical Change Management to support the business and clinical changes that the implementation of such solutions requires. Ultimately, to implement safe, effective, and secure Connected Health solutions in the healthcare ecosystem, it requires that all those involved work together so that the main requirement\u2014patient-centered care\u2014is realized.<\/jats:p>","DOI":"10.3389\/fdgth.2023.1057518","type":"journal-article","created":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T07:48:20Z","timestamp":1697701700000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Pathways, technology and the patient\u2014connected health through the lifecycle"],"prefix":"10.3389","volume":"5","author":[{"given":"Silvana Togneri","family":"MacMahon","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ita","family":"Richardson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,10,19]]},"reference":[{"key":"B1","author":"Kihlstrom","year":""},{"key":"B2","author":"MacMahon","year":""},{"key":"B3","doi-asserted-by":"publisher","first-page":"64","DOI":"10.1377\/hlthaff.20.6.64","article-title":"Improving chronic illness care: translating evidence into action","volume":"20","author":"Wagner","year":"2001","journal-title":"Health Aff"},{"key":"B4","doi-asserted-by":"publisher","first-page":"4995","DOI":"10.3390\/ijerph18094995","article-title":"A narrative review of factors historically influencing telehealth use across six medical specialties in the United States","volume":"18","author":"Rangachari","year":"2021","journal-title":"Int J Environ Res Public Health"},{"key":"B5","volume-title":"Chronic care in America: A 21st century challenge","author":"Hoffman","year":"1996"},{"key":"B6","doi-asserted-by":"publisher","first-page":"569","DOI":"10.1136\/bmj.320.7234.569","article-title":"The role of patient care teams in chronic disease management","volume":"320","author":"Wagner","year":"2000","journal-title":"Br Med J"},{"key":"B7","year":""},{"key":"B8","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1109\/MC.2006.180","article-title":"High-confidence medical device software and systems","volume":"39","author":"Lee","year":"2006","journal-title":"Computer"},{"key":"B9","author":"Hamilton","year":""},{"key":"B10","year":""},{"key":"B11","year":""},{"key":"B12","year":""},{"key":"B13","author":"Milenkovich","year":""},{"key":"B14","doi-asserted-by":"publisher","first-page":"18","DOI":"10.2345\/0899-8205-44.1.18","article-title":"Connecting devices and data on the healthcare network","volume":"44","author":"Casta\u00f1eda","year":"2010","journal-title":"Biomed Instrum Technol"},{"key":"B15","year":""},{"key":"B16","author":"Comstock","year":""},{"key":"B17","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1136\/bmjhci-2020-100166","article-title":"Digital health and care in pandemic times: impact of COVID-19","volume":"27","author":"Peek","year":"2020","journal-title":"BMJ Health Care Inform"},{"key":"B18","author":"Porter","year":""},{"key":"B19","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s40290-021-00412-w","article-title":"Digital transformation in medical affairs sparked by the pandemic: insights and learnings from COVID-19 era and beyond","volume":"36","author":"Furtner","year":"2022","journal-title":"Pharmaceut Med"},{"key":"B20","doi-asserted-by":"publisher","first-page":"10195","DOI":"10.3390\/su131810195","article-title":"Digital transformation and the new normal in China: how can enterprises use digital technologies to respond to COVID-19?","volume":"13","author":"Lee","year":"2021","journal-title":"Sustainability"},{"key":"B21","doi-asserted-by":"publisher","first-page":"102547","DOI":"10.1016\/j.technovation.2022.102547","article-title":"Digital transformation of healthcare during the COVID-19 pandemic: patients\u2019 teleconsultation acceptance and trusting beliefs","volume":"120","author":"Baudier","year":"2023","journal-title":"Technovation"},{"key":"B22","year":""},{"key":"B23","volume-title":"Health information technology","author":"Jen","year":"2022"},{"key":"B24","author":"Whitehead","year":""},{"key":"B25","author":"Venkatasubramanian","year":"2010"},{"key":"B26","volume-title":"Baby\u2019s death spotlights safety risks linked to computerized systems","author":"Graham","year":"2011"},{"key":"B27","year":""},{"key":"B28","author":"Talbot","year":""},{"key":"B29","year":""},{"key":"B30","year":""},{"key":"B31","first-page":"36","volume-title":"Are electronic health records medical devices?","author":"Konnoth","year":"2016"},{"key":"B32","year":""},{"key":"B33","year":""},{"key":"B34","year":""},{"key":"B35","article-title":"Safety critical software development \u2013 extending quality management system practices to achieve compliance with regulatory requirements","volume-title":"Communications in computer and information science","author":"Bujok","year":"2016"},{"key":"B36","year":""},{"key":"B37","year":""},{"key":"B38","year":""},{"key":"B39","year":""},{"key":"B40","doi-asserted-by":"publisher","first-page":"16","DOI":"10.2345\/0899-8205-45.1.16","article-title":"80001: new era dawns for medical devices","volume":"45","author":"Cooper","year":"2011","journal-title":"Biomed Instrum Technol"},{"key":"B41","author":"Eagles","year":""},{"key":"B42","year":""},{"key":"B43","doi-asserted-by":"crossref","DOI":"10.2345\/9781570204081","volume-title":"Getting started with IEC 80001: Essential information for healthcare providers managing medical IT-networks","author":"Cooper","year":"2011"},{"key":"B44","author":"Fuchs","year":""},{"key":"B45","first-page":"148","article-title":"Development of a process assessment model for assessing medical IT networks against IEC 80001-1","volume-title":"Communications in computer and information science","author":"MacMahon","year":"2012"},{"key":"B46","first-page":"305","author":"MacMahon","year":"2013"},{"key":"B47","doi-asserted-by":"publisher","first-page":"64","DOI":"10.2345\/0899-8205-48.1.64","article-title":"Assessing a hospital\u2019s medical IT network risk management practice with 80001-1","volume":"48","author":"Hegarty","year":"2014","journal-title":"Biomed Instrum Technol"},{"key":"B48","first-page":"67","year":""},{"key":"B49","doi-asserted-by":"publisher","DOI":"10.1016\/j.csi.2018.04.013","article-title":"Revising IEC 80001-1: risk management of health information technology systems","author":"MacMahon","year":"2018","journal-title":"Comput Stand Interfaces"},{"key":"B50","year":""},{"key":"B51","year":""},{"key":"B52","year":""},{"key":"B53","year":""},{"key":"B54","year":""},{"key":"B55","year":""},{"key":"B56","year":""},{"key":"B57","year":""},{"key":"B58","year":""},{"key":"B59","year":""},{"key":"B60","doi-asserted-by":"crossref","first-page":"e30691","DOI":"10.2196\/30691","article-title":"Digital contact tracing applications for COVID-19: a citizen-centred evaluation framework","volume":"10","author":"Tsvyatkova","year":"2021","journal-title":"JMIR Mhealth Uhealth"},{"key":"B61","year":""},{"key":"B62","year":""},{"key":"B63","year":""},{"key":"B64","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1111\/1468-0009.00206","article-title":"Improving the quality of health care in the United Kingdom and the United States: a framework for change","volume":"79","author":"Ferlie","year":"2001","journal-title":"Milbank Q"},{"key":"B65","first-page":"1135","author":"MacMahon","year":"2019"},{"key":"B66","volume-title":"The gold standard: The challenge of evidence-based medicine","author":"Timmermans","year":"2003"},{"key":"B67","doi-asserted-by":"publisher","first-page":"106","DOI":"10.1177\/1460458217702943","article-title":"Mapping a careflow network to assess the connectedness of connected health","volume":"25","author":"Carroll","year":"2019","journal-title":"Health Informatics J"},{"key":"B68","doi-asserted-by":"publisher","first-page":"719","DOI":"10.1038\/s41551-018-0305-z","article-title":"Artificial intelligence in healthcare","volume":"2","author":"Yu","year":"2018","journal-title":"Nat Biomed Eng"},{"key":"B69","first-page":"623","author":"Yang","year":"2015"},{"key":"B70","year":""}],"container-title":["Frontiers in Digital Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2023.1057518\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T07:48:59Z","timestamp":1697701739000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2023.1057518\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,19]]},"references-count":70,"alternative-id":["10.3389\/fdgth.2023.1057518"],"URL":"https:\/\/doi.org\/10.3389\/fdgth.2023.1057518","relation":{},"ISSN":["2673-253X"],"issn-type":[{"value":"2673-253X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,19]]},"article-number":"1057518"}}