Salute e nuove tecnologie: le Linee Guida della FDA

Journal title SALUTE E SOCIETÀ
Author/s Marzia Ventura
Publishing Year 2014 Issue 2014/3 Language Italian
Pages 5 P. 176-180 File size 494 KB
DOI 10.3280/SES2014-003014
DOI is like a bar code for intellectual property: to have more infomation click here

Below, you can see the article first page

If you want to buy this article in PDF format, you can do it, following the instructions to buy download credits

Article preview

FrancoAngeli is member of Publishers International Linking Association, Inc (PILA), a not-for-profit association which run the CrossRef service enabling links to and from online scholarly content.

The health care industry tends recently to an increasing development and use of "Information and Communication Technologies" (ICT) in many different fields such as activity, research, clinical practices and customers (citizens) assistance. Spread and use of mobile technologies are opening new and innovative ways to improve health and health care industry. Especially the appropriate use of the health care new technologies can be the key to enhance the efficacy of the therapy in order to guarantee the efficiency of the health care system. Potential risks related to the use of medical applications convinced 2011 and 2013 the "Food and Drug Administration" to release guidelines for developers of mobile medical applications for smartphone, tablets, etc. to protect users from these applications. New technologies, especially mobile medical applications, can be efficient tools to help users to manage and supervise their health. In the following pages, the author, deals with the relationship between technology and health analyzing the issue through the proposed guidelines by the FDA about the mobile medical applications.

Keywords: Mobile Medical Applications; Health, Information and Communication Technologies; User; Medical Device; FDA

  1. Barometro Salute 7°, a cura di (2013). Istituto di Ricerca C.S.A., Gruppo Europ Assistence. Testo disponibile al sito, data di consultazione marzo 2014
  2. Breslauer D.N., Maamari R. N., Switz N.A., Lam W.A., Fletcher D.A. (2009). Mobile phone based clinical microscopy for global health applications. Mobile Phone Based Clinical Microscopy, vol. 4, issue 7. Testo disponibile al sito DOI: 10.1371/journal.pone.0006320,datadiconsultazionemarzo201
  3. Daft R. (2013). Organizzazione Aziendale. Milano: Maggioli
  4. FDA’s 1989 Draft Software policy, 1991 Pre Market Software Guidance, 1999 Off the Shelf Software guidance, 2002 General Principles of software validation and the 2005 Cybersecurity Software Guidance Francesconi A. (2007). Innovazione organizzativa e tecnologia in sanità. Milano: FrancoAngeli
  5. Government Accountability Office (2012)., data di consultazione marzo 2014
  6. Inman T. (1960). Fondation for a new theory and practice of medicine. In Hays I., a cura di, The American journal of the medical sciences. Philadelphia: Blanchard and Lea Institute of Medicine (2012): Health IT and patient safety: building safer systems for better care. Washington, DC: The National Academies Press, data di consultazione marzo 2014
  7. International organization for standardization (2012). ISO/IEC guide upgrades safety aspects in medical device standards. http//, data di consultazione marzo 2014
  8. Kabachinski, J. (2011). IT world. Mobile medical apps changing healthcare technology. Biomedical Instrumentation & Technology, vol. 45(6): 482-486, DOI: 10.2345/0899-8205-45.6.48
  9. Ministero della Salute (2013)., data di consultazione marzo 2014
  10. Mikalajunaite E., a cura di (2010). Research2guidance. 500m people will be using healthcare mobile applications in 2015. Testo disponibile al sito www.research2guidance. com\500m-people-will-be-using-healthcare-mobile-applicationsin-2015September 2011, data di consultazione marzo 2014
  11. Moreno-Jimènez J.M e Polasek W. (2005). E-Cognocracy and the participation of immigrants in e- governance. Economics Series, vol. 169. Vienna: Institute for Advanced Studies, testo disponibile al sito:
  12. Moreno-Jiménez J.M., Aguarón J., Cardeñosa J., Escobar M.T., Salazar J.L., Toncovich A. e Turón A. (2009). A collaborative platform for cognitive decision making in the knowledge society. Computers in Human Behavior, vol. 28: 1921-1928. DOI: 10.1016/j.chb.2012.05.01
  13. Mosa A.S.M., Yoo I. e Sheets L. (2012). A Systematic Review of Healthcare Applications for Smartphones. BMC Medical Informatics and Decision Making, vol. 12,1-31, DOI: 10.1186/1472-6947-12-6
  14. Reina R.(2103). Gestire la Conoscenza in Sanità. Soveria Mannelli: Rubbettino
  15. Vos J. e Parker C. (2012). Medical Device Regulation: Mhelath Policy And Position. BMC Medicine. Testo disponibile al sito: – policy – and position, vol. 10, DOI: 10.1186/1741-7015-10-46Research2Guidance,acuradi(2010).SummeryGlobalMobileHealthMarketReport2010-2015.TheimpactofsmartphoneApplicationsonthemobileHealthIndustry.testodisponibilealsito,datadiconsultazionemarzo201
  16. World health Organization Global Observatory for e-Health: health: New horizons for health through mobile technologies: second global survey on e-Health.
  17. (2011), disponibile al sito: data di consultazione marzo 2014

Marzia Ventura, Salute e nuove tecnologie: le Linee Guida della FDA in "SALUTE E SOCIETÀ" 3/2014, pp 176-180, DOI: 10.3280/SES2014-003014