title: The regulation of mobile medical applications.
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.
authors.affiliation: Department of Chemical Engineering and Biotechnology, University of Cambridge, Tennis Court Road, Cambridge, CB2 1QT, UK. ay283@cam.ac.uk.
authors.forename: Ali Kemal
authors.initials: AK
authors.lastname: Yetisen
authors.forename: J L
authors.initials: JL
authors.lastname: Martinez-Hurtado
authors.forename: Fernando
authors.initials: F
authors.lastname: da Cruz Vasconcellos
authors.forename: M C Emre
authors.initials: MC
authors.lastname: Simsekler
authors.forename: Muhammad Safwan
authors.initials: MS
authors.lastname: Akram
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Lowe
mesh_terms: D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D020407:Internet; D016347:Medical Records Systems, Computerized / Q000592:standards; D063731:Mobile Applications / Q000191:economics / Q000592:standards*; D010361:Patients / Q000523:psychology; D010820:Physicians / Q000523:psychology; D018570:Risk Assessment; D012984:Software