Article | SHI 2015, Proceedings from The 13th Scandinavien Conference on Health Informatics, June 15-17, 2015, Tromsø, Norway | Do Mobile Medical Apps Need to Follow European and US Regulations or Not: Decisions Exemplified by Diabetes Management App
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Title:
Do Mobile Medical Apps Need to Follow European and US Regulations or Not: Decisions Exemplified by Diabetes Management App
Author:
Anna Holubová: Faculty of Biomedical Engineering, Czech Technical University in Prague, Kladno, Czech Republic / Department of Computer Science, University of Tromsø - The Arctic University of Norway, Tromsø, Norway Meghan Bradway: Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway Eirik Årsand: Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway Daniel Hallgren: Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway Gunnar Hartvigsen: Department of Computer Science, University of Tromsø - The Arctic University of Norway, Tromsø, Norway / Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway
Download:
Full text (pdf)
Year:
2015
Conference:
SHI 2015, Proceedings from The 13th Scandinavien Conference on Health Informatics, June 15-17, 2015, Tromsø, Norway
Issue:
115
Article no.:
009
Pages:
55-62
No. of pages:
8
Publication type:
Abstract and Fulltext
Published:
2015-06-26
ISBN:
978-91-7685-985-8
Series:
Linköping Electronic Conference Proceedings
ISSN (print):
1650-3686
ISSN (online):
1650-3740
Publisher:
Linköping University Electronic Press, Linköpings universitet


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Rapid development of medical and health-related mobile applications (apps) has caught the attention of the regulatory institutions. Despite the fact that we have valid sources of information regarding related legislative issues, it is not easy for developers to interpret specific laws, directives and definitions. To clarify this situation, we summarize the main points of EU and US medical device directives and regulations for developers of mobile medical-oriented applications. To help developers decide whether their app should be considered under these regulations or not, we describe the process of evaluating the mobile phone app called Diabetes Diary (Diabetesdagboka) for classification as a medical device. In addition, we also highlight some serious issues the developers and regulatory bodies should keep in mind when inventing or encountering a new product.

Keywords: Mobile Medical Application; mHealth regulations; classification of stand-alone software; diabetes.

SHI 2015, Proceedings from The 13th Scandinavien Conference on Health Informatics, June 15-17, 2015, Tromsø, Norway

Author:
Anna Holubová, Meghan Bradway, Eirik Årsand, Daniel Hallgren, Gunnar Hartvigsen
Title:
Do Mobile Medical Apps Need to Follow European and US Regulations or Not: Decisions Exemplified by Diabetes Management App
References:

[1] Wac K. Smartphone as a personal, pervasive health infor-matics services platform: literature review. Yearbook of medical informatics: Advances in an interdisciplinary sci-ence. 2012;7(1):83-93. ISSN 0943-4747.


[2] Klasnja P and Pratt W. Healthcare in the pocket: Mapping the space of mobile-phone health interventions. Journal of Biomedical Informatics. 2012, 45(1): 184-198. DOI: 10.1016/j.jbi.2011.08.017. ISSN 15320464. Available at: http://linkinghub.elsevier.com/retrieve/pii/S1532046411001444


[3] McGrath MJ, Scanaill CN. Sensor technologies: healthcare, wellness, and environmental applications. Apress. ISBN 978-1-4302-6014-1.


[4] Rigby M. Personal Health, Person-centred Health and Per-sonalised Medicine - Concepts, Consumers, Confusion and Challenges in the Informatics World. Yearbook of medical informatics: Advances in an interdisciplinary science. 2012, (7(1): 7-15. ISSN 0943-4747.


[5] Holopainen A., Galbiati F and Voutilainen K. Use of Smart Phone Technologies to Offer Easy-to-Use and Cost-Effective Telemedicine Services. First International Con-ference on the Digital Society (ICDS’07). IEEE, 2007, p. 1-4. DOI: 10.1109/ICDS.2007.42. Available at: http://ieeexplore.ieee.org/lpdocs/epic03/wrapper.htm?arnumber=4063766


[6] Silk A. Interoperability for Diabetes Diagnostic Devices and Diabetes Management Systems: Office of In Vitro Di-agnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA. In: Public Workshop - Regulatory Science Considerations for Software Used in Dia-betes Management [presentation]. November 13, 2014 [cit. 2015-04-13]. Available at: https://collaboration.fda.gov/p8yxaqookat/?launcher=false&fcsContent=true&pbMode=normal


[7] Brief Introduction of EU Council Directive 93/42/EEC: Medical Devices. Wellkang Tech Consulting [online]. 2009 [cit. 2015-04-23]. Available at: http://www.ce-marking.org/directive-9342eec-medical-devices.html


[8] Council Directive 93/42/EEC: concerning medical devices. 14 June 1993. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF


[9] Guidelines relating to the application of: The Council Di-rective 90/385/EEC on Active Implantable Medical Devic-es; The Council Directive 93/42/EEC on Medical Devices. Definition of "medical devices"; Definition of "accessory"; Definition of "manufacturer". In: 1994. Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1-1___04-1994_en.pdf


[10] Changing the rules of health care: Mobile health and chal-lenges for regulation. Aug 2014. Available at: http://www.aei.org/wp-content/uploads/2014/08/-fellaychanging-the-rules-of-health-care_100901289367.pdf


[11] How supportive is the regulatory framework for mobile health applications?. PwC: mHealth Insights. January 2013. Available at: http://www.pwc.com/gx/en/healthcare/mhealth/mhealth-insights/mhealth-insights-regulatory-frameworks-for-mobile-health-applications.jhtml


[12] MEDDEV 2.1/6. Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices. EU: EUROPEAN COMMISSION, Jan 2012. Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf


[13] Borderlines with medical devices: Guidance on legisla-tion. MHRA: Regulating Medicines and Medical Devices. Feb 2014, s. 12. Available at: https://www.gov.uk/government/uploads/system/uploads/attach-ment_data/file/284505/Borderlines_with_medical_devices.pdf


[14] MEDDEV 2. 4/1 Rev. 9. Medical Devices: Guidance document - Classification of medical devices: Guidelines relating to the application of the Council Directive 93/42/EEC on medical devices. European Commission, June 2010. Available at: http://ec.europa.eu/growth/sectors/medical-devic-es/documents/guidelines/files/meddev/2_4_1_rev_9_classification_en.pdf


[15] Skrøvseth SO, Årsand E, Godtliebsen F and Joakimsen RM. Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial. Diabetes Technol-ogy & Therapeutics [online]. 2015 [cit. 2015-05-26]. doi: 10.1089/dia.2014.0276.


[16] Ekker A and van Rest B. Infographic: Medical apps, is certification required?: Check whether your app requires CE marking. In: Nictiz: Betere zorg door betere informatie [online]. Nov 2013 [cit. 2015-03-20]. Available at: http://www.nictiz.nl/page/Publicaties?mod%5B360%5D%5Bi%5D=988


[17] NICTIZ. Centre of expertise for standardisation and eHealth: Providing guidance at the interface of healthcare and IT. Netherlands. Available at: http://www.nictiz.nl/module/360/1097/Corporate%20brochure%20Nictiz_EN.pdf


[18] Classify Your Medical Device. FDA: U.S. Food and Drug Administration [online]. July 2014 [cit. 2015-04-13]. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm


[19] Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA: U.S. Food and Drug Administration [online]. March 2015 [cit. 2015-04-25]. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm


[20] Understanding Medical Device Regulation for mHealth: A Guide for Mobile Operators GSMA. February 2012. Available at: http://www.gsma.com/connectedliving/wp-con-tent/uploads/2012/03/gsmaunderstandingmedicaldeviceregulationformhealthreport1.pdf


[21] General Controls for Medical Devices. FDA: U.S. Food and Drug Administration [online]. June 2014 [cit. 2015-04-23]. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguid-ance/overview/generalandspecialcontrols/ucm055910.htm


[22] Premarket Approval (PMA). U.S. Food and Drug Administration [online]. August 2014 [cit. 2015-04-25]. Availa-ble at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid-ance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm


[23] Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. February 9, 2015. Available at: http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf


[24] Mobile Medical Applications. FDA: U.S. Food and Drug Administration [online]. April 2014 [cit. 2015-04-16]. Available at: http://www.fda.gov/medicaldevices/productsandmedicalproce-dures/connectedhealth/mobilemedicalapplications/default.htm


[25] Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. February 9, 2013 [26] IBGStar® blood glucose meter. MyStar: Sanofi Dai-betes [online]. 2014 [cit. 2015-04-13]. Available at: http://www.mystarsanofi.com/web/products/glucometers/ibgstar


[27] iHealth Align. iHealth [online]. 2015 [cit. 2015-04-13]. Available at: http://www.ihealthlabs.com/glucometer/ihealth-align/


[28] Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff. February 9, 2015. Available at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf


[29] Product Classification. FDA: U.S. Food and Drug Administration [online]. 2015 [cit. 2015-04-13]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm


[30] Device -- Not a Device. FDA. U.S. Food and Drug Administration [online]. Sept 2014 [cit. 2015-04-18]. Availa-ble at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051521.htm


[31] MySugr [online]. [cit. 2015-03-19]. Available at: https://mysugr.com/


[32] Kuepper M. Startup of the Week – MySugr: the app that wants to make diabetes treatment “more fun”. In: Ven-tureVillage [online]. 13.9. 2013 [cit. 2015-03-19]. Availa-ble at: http://venturevillage.eu/startup-of-the-week-mysugr


[33] FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring: Data-sharing ca-pability allows caregivers to monitor patient’s blood sugar levels remotely. In: FDA: U.S. Food and Drug Administration [online]. Jan 2015 [cit. 2015-04-13]. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431385.htm


[34] Nightscout: We Are Not Waiting. NIGHTSCOUT PROJECT. [online]. 2015 [cit. 2015-04-25]. Available at: http://www.nightscout.info/


[35] Broussard M. Apple Watch Set to Include Third-Party Glucose Tracking App at Launch. In: MacRumors: news and rumors you care about [online]. Feb 2015 [cit. 2015-04-13]. Available at: http://www.macrumors.com/2015/02/09/apple-watch-dexcom-glucose-app/


[36] Dexcom Introduces Apps That Enable the First Ever Continuous Glucose Monitoring (CGM) on the Apple Watch™. In: Dexcom: One Step Ahead [online]. Apr 2015 [cit. 2015-04-13]. Available at: http://www.dexcom.com/news/dexcom-continuous-glucose-monitoring-cgm-apple-watch


[37] Eng DS and Lee JM. The Promise and Peril of Mobile Health Applications for Diabetes and Endocrinology. Pediatric Diabetes [online]. 2013, vol. 14, issue 4, p. 231-238 [cit. 2015-04-22]. doi: 10.1111/pedi.12034.

SHI 2015, Proceedings from The 13th Scandinavien Conference on Health Informatics, June 15-17, 2015, Tromsø, Norway

Author:
Anna Holubová, Meghan Bradway, Eirik Årsand, Daniel Hallgren, Gunnar Hartvigsen
Title:
Do Mobile Medical Apps Need to Follow European and US Regulations or Not: Decisions Exemplified by Diabetes Management App
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Last updated: 2017-02-21