GLOBAL REGULATORY APPROACH TOWARDS M-HEALTH
Abstract
The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smart phone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (apps) resident on these devices. These apps raise unique challenges for regulation by the drug regulatory authorities worldwide including the Food and Drug Administration (FDA), European Medical Association (EMA) etc. The focus of this article is to shed light on the current trends and future aspects of the regulatory framework implied on the Mobile Health (mHealth).
Downloads
References
http://www.namsa.com/wp-content/uploads/2015/10/WP-FDA-Regulation-of-Mobile-Medical-Apps-7-7-2014.pdf
2. GSMA mHealth. ‘mHealth and the EU regulatory framework for medical devices’ [Internet]. United Kingdom: GSMA mHealth Magazine; 2014 [cited 2015 Nov 7] Available from:
http://www.gsma.com/connectedliving/wp-content/uploads/2012/03/mHealth_Regulatory_medicaldevices_10_12.pdf
3. US Food & Drug Administration [Internet]. United States: FDA Guidance Document 1741 – Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff; 2015 April [cited 2015 Oct 25]. Available from:
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm443133.pdf
4. Vollebregt E. Regulation of Medical Apps FDA and EU. [Internet]. JHW Editorial Info - Note 270711; 2011 [Cited 2015 Oct 27]. Available from:
http://www.medico-innovation.dk/wp-content/uploads/2011/10/JHW-Note-270711-Regulation-of-Medical-Apps-2.pdf
5. PwC Network. ‘How Supportive is the regulatory framework for mobile health applications?’ [Internet]. Japan: mHealth Insights - PwC Network; 2013 Jan [cited 2015 Nov 4] Available from:
https://www.pwc.com/gx/en/healthcare/mhealth/mhealth-insights/assets/pwc-mhealth-how-supportive-is-the-regulatory-framework-for-mobile-health-applications.pdf
6. D4 Research [Internet]. United Kingdom: ‘Regulation of health apps: a practical guide’, D4 Research; 2012 Jan [cited 2015 Nov 11] Available from:
http://www.d4.org.uk/research/regulation-of-health-apps-a-practical-guide-January-2012.pdf
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
