FDA Regulation of Mobile Health Technologies

Cortez, Nathan; Cohen, I. Glenn; Kesselheim, Aaron S.

doi:10.1056/nejmhle1403384

Cited by 221 publications

(150 citation statements)

References 11 publications

Supporting

Mentioning

144

Contrasting

Unclassified

Order By: Relevance

“…Cortez et al 68 recently reviewed the FDA's ongoing efforts to determine which technologies should be federally regulated, and the FDA recently released a guidance document describing the type of mobile apps that it intends to regulate, 69 which will surely evolve over time. Those against regulation argue the process of governmental supervision may slow and stifle the development of these technologies.…”

Section: Discussionmentioning

confidence: 99%

Consumer Sleep Technologies: A Review of the Landscape

Kientz

Choe

et al. 2015

Journal of Clinical Sleep Medicine

192

148

View full text Add to dashboard Cite

Objective: To review sleep related consumer technologies, including mobile electronic device "apps," wearable devices, and other technologies. Validation and methodological transparency, the effect on clinical sleep medicine, and various social, legal, and ethical issues are discussed. C onsumer sleep technologies (CSTs) are increasingly popular computer-based systems available to the general public for the purpose of improving or self-monitoring sleep. Their primary goals include sleep induction, wake induction, selfguided sleep assessment, entertainment, social connection, information sharing, and sleep education. There is scant literature discussing these technologies.1,2 Despite a paucity of clinical validation with traditional sleep technologies (e.g., polysomnography (PSG), multiple sleep latency testing (MSLT), and clinical-grade actigraphy), CSTs are here to stay because of their innovative nature, convenience, and affordability.Although adoption rates are not available, sleep-tracking products such as Fitbit and Jawbone are top sellers in consumer health products.3,4 The highest-funded health device on Kickstarter was a sleep monitor, which garnered more than $2.4 million in fi nancial backing. 5 A recent search for "sleep" in the Apple iTunes app store returned over 500 different sleep related applications, or "apps," available for download 6 ; similar searches on Android and Microsoft's app stores return hundreds of results. 7,8 Certain apps boast more than fi ve million downloads; one of the top fi ve paid apps in 2014 on iTunes was a sleep tracker and alarm clock. 9 We use the metaphor "over-the-counter" to describe these CSTs, because they are mostly available without a prescription or clinical guidance. Clinical sleep specialists should be aware of these increasingly popular technologies, as patients may request interpretation of derived data. This paper aims to provide a general overview of CSTs and their potential social, ethical, legal, and clinical effect. Although rapid development of these technologies obviates an exhaustive review, we outline some of the more popular, illustrative, or innovative technologies to give sleep specialists an idea of the recent landscape. Consumer Sleep Technologies: A Review of the Landscape METHODSWe searched PubMed and the digital libraries of the Association for Computing Machinery and Institute of Electrical and Electronics Engineers (where technology developers publish peer-reviewed articles), with search terms including "sleep technology," "sleep app," and "sleep monitoring." We eliminated articles that were not relevant to sleep (e.g., applications for controlling a computer's hibernation mode). We ran similar searches on Google, specifi cally focusing on consumer technology-related websites such as MIT Technology Review, 10

show abstract

Section: Discussionmentioning

confidence: 99%

Consumer Sleep Technologies: A Review of the Landscape

Kientz

Choe

et al. 2015

Journal of Clinical Sleep Medicine

192

148

View full text Add to dashboard Cite

show abstract

“…1 That said, many medical apps and devices which perform organized collection of personal data are not subject to government regulation and fall short of data protection standards. 7,8 It is, therefore, immensely important that PwP define how they want their data to be used. The 2016 Rallying to the Challenge meeting was organized with this in mind.…”

Section: Discussionmentioning

confidence: 99%

Choices on selective clinical data sharing by people with Parkinson’s disease

Mursaleen¹,

Stamford²,

Schmidt³

et al. 2017

JPRLS

View full text Add to dashboard Cite

“…«Помимо бессмысленной траты денег, -писал «Меди-цинский журнал Новой Англии» про подобные риски для хронических больных, -такие устройства могут нанести реальный вред. Если вы диабетик, а ваше устройство не-правильно измеряет уровень глюкозы в крови, вы можете ввести себе больше инсулина, чем требуется, и заработать диабетический шок» [12].…”

Section: неоднозначные результаты первых шагов цифровизацииunclassified

Digital Revolution and Innovative Business Models in Healthcare: Global Trends and Russian Realities

Bereznoy

Saygitov²

2016

Annals RAMS

View full text Add to dashboard Cite

Одним из наиболее мощных глобальных трендов в современном здравоохранении выступает развертывание так называемой цифровой революции, проявляющейся прежде всего в резком усилении влияния информацион-но-коммуникационных технологий практически на все стороны функционирования этой особой сферы челове-ческой деятельности. В настоящее время миллионы лю-дей по всему миру уже активно пользуются портативными электронными устройствами для мониторинга состояния своего здоровья, применяют мобильные телефоны или планшеты для врачебных интернет-консультаций или видеоконференций. В свою очередь, врачебное сообще-ство все шире прибегает к использованию невиданных ранее возможностей электронного накопления и ком-пьютерной обработки (ускоренной аналитики) больших объемов данных для качественного повышения уровня диагностики и лечения самых разных заболеваний и, что еще важнее, для эффективного их предупреждения.Возникающие таким образом элементы нового обли-ка здравоохранения являются отражением набирающих

show abstract

FDA Regulation of Mobile Health Technologies

Cited by 221 publications

References 11 publications

Consumer Sleep Technologies: A Review of the Landscape

Consumer Sleep Technologies: A Review of the Landscape

Choices on selective clinical data sharing by people with Parkinson’s disease

Digital Revolution and Innovative Business Models in Healthcare: Global Trends and Russian Realities

Contact Info

Product

Resources

About

FDA Regulation of Mobile Health Technologies

Cited by 221 publications

References 11 publications

Consumer Sleep Technologies: A Review of the Landscape

Consumer Sleep Technologies: A Review of the Landscape

Choices on selective clinical data sharing by people with Parkinson&rsquo;s disease

Digital Revolution and Innovative Business Models in Healthcare: Global Trends and Russian Realities

Contact Info

Product

Resources

About

Choices on selective clinical data sharing by people with Parkinson’s disease