Inhalation

INH0218

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Inhalation February 2018 23 Medical Devices. 2016. https://www.fda.gov/down loads/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm482022.pdf. 23. Federal Register Volume 82, Number 160 (Mon- day, August 21, 2017)]. Pages 39591-39598. Notices. Department Of Health And Human Services. Food and Drug Administration, [Docket No. FDA- 2004-N-0451]. Food and Drug Administration Mod- ernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047. https://www.gpo.gov/fdsys/pkg/FR-2017-08-21/ html/2017-17603.htm. 24. FDA, CDRH. Wireless Medical Devices. https:// www.fda.gov/MedicalDevices/DigitalHealth/Wire l e s s M e d i c a l D e v i c e s / d e f a u l t . h t m ? e l q Tr a c k Id=3126532500D31D75B186A0EF896E223 A&elq=048e888a7be84bac9518340fa7e594c6& elqaid=1092&elqat=1&elqCampaignId=607#8. 25. FDA. Digital Health Innovation Actin Plan. 2017. https://www.fda.gov/downloads/MedicalDevices/ DigitalHealth/UCM568735.pdf. 26. Highlights from the 2017 IPAC-RS/ISAM Joint Workshop "New Frontiers in Inhalation Technology" Smyth HD, Colthorpe P, George M, Jansen P, Fuglsang A, Armstrong KE and Lyapustina S. Journal of Aerosol Medicine and Pulmonary Drug Delivery. November 2017, ahead of print. https://doi.org/10.1089/ jamp.2017.1425. 27. European Council. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Reg- ulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. http://eur- l e x . e u r o p a . e u / l e g a l - c o n t e n t / E N G / T X T / PDF/?uri=CELEX:32017R0745&from=EN. 28. European Commission. e New Regulations on Medical Devices. https://ec.europa.eu/growth/ sectors/medical-devices/regulatory-framework_ en#new_regulations. 29. National Health Service (UK). Apps: Information for Developers. https://developer.nhs.uk/apps/. 30. US Government Accountability Office. GAO-17- 75. Internet of ings. Available at https://www.gao. gov/assets/690/684590.pdf. Katherine E. Armstrong, JD is counsel in Drinker, Biddle & Reath's Government & Regulatory Affairs Practice Group, Katherine.Armstrong@dbr.com, and Svetlana Lyapustina, PhD is senior director for science, regulation and policy within DBR's Pharmaceutical Consortia Management Group, svetlana.lyapustina@dbr.com. http://dbrondata.com. 7. Blau, M. An Expert Sounds the Alarm about Unchecked Sharing of Health App Data. STAT, Octo- ber 26, 2017. https://www.statnews.com/2017/10/26/ u n c h e c k e d - s h a r i n g - h e a l t h - a p p - d a t a / ? s _ c a m p a i g n = s t a t : r s s & u t m _ s o u r c e = S TAT + Ne w s l e t t e r s & u t m _ c a m p a i g n = 4 8 2 6 4 8 5 7 1 b - S TAT _ Plus&utm_medium=email&utm_term=0_8cab1d79 61-482648571b-149674889. 8. Kramer DB and Fu K. Cybersecurity Concerns and Medical Devices: Lessons from a Pacemaker Advisory. JAMA. 2017. doi:10.1001/jama.2017.15692. 9. Mikk KA, Sleeper HA and Topol EJ. e Pathway to Patient Data Ownership and Better Health. JAMA. 2017;318(15):1433-1434. doi:10.1001/jama. 2017.12145. 10. DHHS. Examining Oversight of the Privacy & Security of Health Data Collected by Entities Not Reg- ulated by HIPAA 2016. https://www.healthit.gov/ sites/default/files/non-covered_entities_report_ june_17_2016.pdf. 11. Health Care Industry Cybersecurity Task Force. Report on Improving Cybersecurity in the Health Care Industry. 2017. https://www.phe.gov/Preparedness/ planning/CyberTF/Documents/report2017.pdf. 12. International Organization for Standardization. ISO 13485:2016. Medical Devices—Quality Manage- ment Systems—Requirements for regulatory purposes. https://www.iso.org/standard/59752.html. 13. FDA maintains a webpage on Digital Health: https://www.fda.gov/medicaldevices/digitalhealth/. 14. EMA Workshop on "Big Data." Comprehensive report: http://www.ema.europa.eu/docs/en_GB/docu ment_library/Report/2017/02/WC500221938.pdf. 15. Respiratory Drug Delivery (RDD) 2017. Podium presentations and vendor workshops on e-connected devices. www.rddonline.com. 16. "New Frontiers in Inhalation Technology," a 2017 Joint Workshop presented by the International Phar- maceutical Aerosol Consortium on Regulation and Science and the International Society for Aerosols in Medicine. Perspectives of academia, regulators and industry. www.ipacrs.org. 17. US Code of Federal Regulations. 45 C.F.R. § 106.103. See also https://www.hhs.gov/hipaa/for-pro fessionals/covered-entities/index.html. 18. US Code of Federal Regulations. 45 C.F.R. Part 160. 19. US Code of Federal Regulations. 45 C.F.R. § 106.103. 20. United States Code. 15 U.S.C. § 45(a). 21. United States Code. 15 U.S.C. § 45(n). 22. United States Food and Drug Administartion. Guidance for Industry and Food and Drug Administra- tion Staff. Postmarket Management of Cybersecurity in

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