-
3
-
-
84893501380
-
-
U.S. Department of Health and Human Services Food and Drug Administration
-
Federal Food, Drug, and Cosmetic Act (FD&C Act), 201(h), U.S. Department of Health and Human Services Food and Drug Administration, 2006
-
(2006)
Federal Food, Drug, and Cosmetic Act (FD&C Act), 201(h)
-
-
-
4
-
-
84893436524
-
-
World Telecommunication/ICT Indicators database 2013, Mobile-cellular subscriptions, June 2013, Accessed October 28, 2013
-
World Telecommunication/ICT Indicators database 2013, Mobile-cellular subscriptions, June 2013, http://www.itu.int/ITU-D/ict/statistics/, Accessed October 28, 2013
-
-
-
-
6
-
-
84893504738
-
-
Accessed October 28, 2013
-
C. Wiltz, FDA's Regulation of Mobile Medical Apps Will Probably Confuse You, Device Talk, Medical Device and Diagnostic Industry, 2013, http://www.mddionline.com/blog/devicetalk/fdas-regulation-mobile-medical-apps- will-probably-confuse-you, Accessed October 28, 2013
-
(2013)
FDA's Regulation of Mobile Medical Apps Will Probably Confuse You, Device Talk, Medical Device and Diagnostic Industry
-
-
Wiltz, C.1
-
7
-
-
84881296386
-
-
Ubiquitous Computing Lab, University of Washington, Accessed October 28, 2013
-
Mobile Phone Spirometry, Ubiquitous Computing Lab, University of Washington, http://ubicomplab.cs.washington.edu/wiki/SpiroSmart, Accessed October 28, 2013
-
Mobile Phone Spirometry
-
-
-
8
-
-
84893513525
-
-
Accessed October 28, 2013
-
uChek Universal: The medical lab in your phone, http://www.indiegogo.com/ projects/uchek-universal-the-medical-lab-in-your-phone, Accessed October 28, 2013
-
UChek Universal: The Medical Lab in Your Phone
-
-
-
9
-
-
84893483253
-
-
Accessed October 28, 2013
-
http://www.scanadu.com/, Accessed October 28, 2013
-
-
-
-
10
-
-
84893488892
-
-
Accessed October 28, 2013
-
E. Gilmer, Developing mobile apps as medical devices: Understanding U.S. government regulations, Developer Works, IBM, 2013, http://www.ibm.com/ developerworks/mobile/library/mo-fda-med-devices/, Accessed October 28, 2013
-
(2013)
Developing Mobile Apps As Medical Devices: Understanding U.S. Government Regulations, Developer Works, IBM
-
-
Gilmer, E.1
-
20
-
-
79952299034
-
-
Z. J. Smith K. Chu A. R. Espenson M. Rahimzadeh A. Gryshuk M. Molinaro D. M. Dwyre S. Lane D. Matthews S. Wachsmann-Hogiu PLoS One 2011 6 e17150
-
(2011)
PLoS One
, vol.6
, pp. 17150
-
-
Smith, Z.J.1
Chu, K.2
Espenson, A.R.3
Rahimzadeh, M.4
Gryshuk, A.5
Molinaro, M.6
Dwyre, D.M.7
Lane, S.8
Matthews, D.9
Wachsmann-Hogiu, S.10
-
21
-
-
84862833520
-
-
S. Q. Wang X. H. Zhao I. Khimji R. Akbas W. L. Qiu D. Edwards D. W. Cramer B. Ye U. Demirci Lab Chip 2011 11 3411 3418
-
(2011)
Lab Chip
, vol.11
, pp. 3411-3418
-
-
Wang, S.Q.1
Zhao, X.H.2
Khimji, I.3
Akbas, R.4
Qiu, W.L.5
Edwards, D.6
Cramer, D.W.7
Ye, B.8
Demirci, U.9
-
22
-
-
84893435672
-
-
(Los Angeles, CA), Accessed October 28, 2013
-
Holomic LLC (Los Angeles, CA), www.holomic.com, Accessed October 28, 2013
-
Holomic LLC
-
-
-
23
-
-
84893480602
-
Mobile Image Ratiometry for the Detection of Botrytis Cinerea (Gray Mold)
-
D. C. Cooper, Mobile Image Ratiometry for the Detection of Botrytis Cinerea (Gray Mold), Nature Precedings, 2012
-
(2012)
Nature Precedings
-
-
Cooper, D.C.1
-
24
-
-
84893487541
-
Mobile Image Ratiometry: A New Method for Instantaneous Analysis of Rapid Test Strips
-
D. C. Cooper, B. Callahan, P. Callahan and L. Burnett, Mobile Image Ratiometry: A New Method for Instantaneous Analysis of Rapid Test Strips, Nature Precedings, 2012
-
(2012)
Nature Precedings
-
-
Cooper, D.C.1
Callahan, B.2
Callahan, P.3
Burnett, L.4
-
25
-
-
85022115721
-
-
Niwot, CO, Accessed October 28, 2013
-
Mobile Assay Inc., Niwot, CO, www.mobileassay.com, Accessed October 28, 2013
-
Mobile Assay Inc.
-
-
-
26
-
-
84877120340
-
-
A. Dance Nature 2013 496 387 389
-
(2013)
Nature
, vol.496
, pp. 387-389
-
-
Dance, A.1
-
27
-
-
84893482317
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
Medical Devices Technology Innovation Partnership (MD-TIP) Workshop, The Food and Drug Administration, http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/ucm224407.htm, Accessed October 28, 2013
-
Medical Devices Technology Innovation Partnership (MD-TIP) Workshop
-
-
-
28
-
-
85022125501
-
-
BME-IDEA, Seattle, WA, September 25
-
F. Kalush, National Medical Device Curriculum, BME-IDEA, Seattle, WA, September 25, 2013
-
(2013)
National Medical Device Curriculum
-
-
Kalush, F.1
-
31
-
-
84870440930
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
Premarket Approval (PMA), The Food and Drug Administration, http://www.fda.gov/medicaldevices/deviceregulationandguidance/ howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/, Accessed October 28, 2013
-
Premarket Approval (PMA)
-
-
-
32
-
-
84893439157
-
-
Workshop proceeding (National Medical Device Curriculum), the Rector and Visitors of the University of Virginia, Accessed October 28, 2013
-
Workshop proceeding (National Medical Device Curriculum), the Rector and Visitors of the University of Virginia, http://www.virginia.edu/vpr/MD-TIP/, Accessed October 28, 2013
-
-
-
-
33
-
-
84893448145
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
510(k), The Food and Drug Administration, http://www.fda.gov/ medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/ 510kclearances/default.htm, Accessed October 28, 2013
-
510(k)
-
-
-
34
-
-
84893460685
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
513(g), The Food and Drug Administration, http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm, Accessed October 28, 2013
-
513(g)
-
-
-
35
-
-
84893464369
-
-
personal communication
-
L. Borysiewicz, personal communication
-
-
-
Borysiewicz, L.1
-
37
-
-
84893446459
-
-
CEO of Happtique, Inc., Testimony of hearing on: Health Information Technologies, Hearing on: Health Information Technologies: Harnessing Wireless Innovation, Congress of the United States, U.S. House of Representatives, Committee on Communications and Technology, Washington D.C., March 19, 2013
-
B. Chodor, CEO of Happtique, Inc., Testimony of hearing on: Health Information Technologies, Hearing on: Health Information Technologies: Harnessing Wireless Innovation, Congress of the United States, U.S. House of Representatives, Committee on Communications and Technology, Washington D.C., March 19, 2013, http://docs.house.gov/meetings/IF/IF16/20130319/100525/HHRG-113- IF16-Wstate-ChodorB-20130319.pdf
-
-
-
Chodor, B.1
-
38
-
-
84893476337
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
Entrepeneurs in residence program, The Food and Drug Administration, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDRH/CDRHInnovation/InnovationPathway/ucm286138.htm, Accessed October 28, 2013
-
Entrepeneurs in Residence Program
-
-
-
39
-
-
84893439189
-
-
Health IT workgroup to discuss patient safety, innovation, and regulatory efficiency, US HHS, Accessed October 28, 2013
-
Health IT workgroup to discuss patient safety, innovation, and regulatory efficiency, US HHS, http://www.hhs.gov/news/press/2013pres/04/20130418a.html, Accessed October 28, 2013
-
-
-
-
40
-
-
84893472635
-
-
Federal Advisory Committee workgroup application, Accessed October 28, 2013
-
Federal Advisory Committee workgroup application, http://www.healthit. gov/facas/faca-workgroup-membership-application, Accessed October 28, 2013
-
-
-
-
43
-
-
85022110358
-
-
Examples of MMAs the FDA Has Cleared or Approved, Accessed October 28, 2013
-
Examples of MMAs the FDA Has Cleared or Approved, 2013, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/ MobileMedicalApplications/ucm368784.htm, Accessed October 28, 2013
-
(2013)
-
-
-
45
-
-
85022105764
-
Increase in remote patient monitoring predicts boon for home health care device
-
Frost & Sullivan, Increase in remote patient monitoring predicts boon for home health care device, Med. Devices Bull., 2009, 2: 3
-
(2009)
Med. Devices Bull.
, vol.2
, Issue.3
-
-
Frost1
Sullivan2
-
47
-
-
85022118796
-
-
Global Mobile Health Market Report 2010-2015, research2guidance, Berlin, Germany, Accessed October 28, 2013
-
Global Mobile Health Market Report 2010-2015, research2guidance, Berlin, Germany, http://www.research2guidance.com, Accessed October 28, 2013
-
-
-
-
49
-
-
84893449900
-
-
The Food and Drug Administration, Accessed October 28, 2013
-
Keeping Up with Progress in Mobile Medical Apps, The Food and Drug Administration, 2013, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm368634. htm, Accessed October 28, 2013
-
(2013)
Keeping Up with Progress in Mobile Medical Apps
-
-
-
50
-
-
85022108463
-
How Helpful are Mobile Healthcare Apps?
-
O. I. Franko, How Helpful are Mobile Healthcare Apps?, AAOS Now, 2013, 7 (3)
-
(2013)
AAOS Now
, vol.7
, Issue.3
-
-
Franko, O.I.1
-
52
-
-
84893456139
-
-
A safer place for patients: learning to improve patient safety, The Committee of Public Accounts, London: The Stationery Office.
-
A safer place for patients: learning to improve patient safety, The Committee of Public Accounts, London: The Stationery Office., 2006
-
(2006)
-
-
-
74
-
-
85022125981
-
-
Health Level Seven International (HL7) Standards, Accessed October 28, 2013
-
Health Level Seven International (HL7) Standards, www.hl7.org, Accessed October 28, 2013
-
-
-
-
75
-
-
85022118433
-
-
POCT1-A2, Point of Care Connectivity; Approved Standard-Second Edition, Accessed October 28, 2013
-
POCT1-A2, Point of Care Connectivity; Approved Standard-Second Edition, www.clsi.org, Accessed October 28, 2013
-
-
-
-
77
-
-
84877281197
-
-
K. Kallander J. K. Tibenderana O. J. Akpogheneta D. L. Strachan Z. Hill A. H. ten Asbroek L. Conteh B. R. Kirkwood S. R. Meek J. Med. Internet Res. 2013 15 e17
-
(2013)
J. Med. Internet Res.
, vol.15
, pp. 17
-
-
Kallander, K.1
Tibenderana, J.K.2
Akpogheneta, O.J.3
Strachan, D.L.4
Hill, Z.5
Ten Asbroek, A.H.6
Conteh, L.7
Kirkwood, B.R.8
Meek, S.R.9
-
79
-
-
84893436104
-
-
Accessed October 17, 2013
-
Medic Mobile, http://medicmobile.org/, Accessed October 17, 2013
-
Medic Mobile
-
-
|