The regulation of mobile medical applications
The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications...
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| Published in | Lab on a chip Vol. 14; no. 5; pp. 833 - 84 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
07.03.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1473-0197 1473-0189 1473-0189 |
| DOI | 10.1039/c3lc51235e |
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| Abstract | The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.
The article explains the regulation of mobile medical applications and evaluates their impact on academia, industry, patients and clinicians. |
|---|---|
| AbstractList | The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested. The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested. The article explains the regulation of mobile medical applications and evaluates their impact on academia, industry, patients and clinicians. The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested. |
| Author | da Cruz Vasconcellos, Fernando Lowe, Christopher R Simsekler, M. C. Emre Yetisen, Ali Kemal Akram, Muhammad Safwan Martinez-Hurtado, J. L |
| AuthorAffiliation | Department of Engineering University of Cambridge Department of Chemical Engineering and Biotechnology |
| AuthorAffiliation_xml | – name: Department of Chemical Engineering and Biotechnology – name: Department of Engineering – name: University of Cambridge |
| Author_xml | – sequence: 1 givenname: Ali Kemal surname: Yetisen fullname: Yetisen, Ali Kemal – sequence: 2 givenname: J. L surname: Martinez-Hurtado fullname: Martinez-Hurtado, J. L – sequence: 3 givenname: Fernando surname: da Cruz Vasconcellos fullname: da Cruz Vasconcellos, Fernando – sequence: 4 givenname: M. C. Emre surname: Simsekler fullname: Simsekler, M. C. Emre – sequence: 5 givenname: Muhammad Safwan surname: Akram fullname: Akram, Muhammad Safwan – sequence: 6 givenname: Christopher R surname: Lowe fullname: Lowe, Christopher R |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24425070$$D View this record in MEDLINE/PubMed |
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| Snippet | The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the... |
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| SubjectTerms | Applications programs Assessments Control Government Regulation Guidelines as Topic Humans Internet Markets Medical Medical Records Systems, Computerized - standards Mobile Applications - economics Mobile Applications - standards Obstacles Patients Patients - psychology Physicians - psychology Risk Risk Assessment Software |
| Title | The regulation of mobile medical applications |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/24425070 https://www.proquest.com/docview/1499132018 https://www.proquest.com/docview/1753505170 |
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