34
views
0
recommends
+1 Recommend
1 collections
    0
    shares

      To submit your manuscript to JMIR, please click here

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Regulatory Barriers Blocking Standardization of Interoperability

      letter

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD WG) and Continua Health Alliance, are striving for this purpose. However, factors like the medial device regulation, health policy, and market reality have placed non-technical barriers over the adoption of technical standards throughout the industry. These barriers have significantly impaired the motivations of consumer device vendors who desire to enter the personal health market and the overall success of personal health industry ecosystem. In this paper, we present the affect that these barriers have placed on the health ecosystem. This requires immediate action from policy makers and other stakeholders. The current regulatory policy needs to be updated to reflect the reality and demand of consumer health industry. Our hope is that this paper will draw wide consensus amongst its readers, policy makers, and other stakeholders.

          Related collections

          Most cited references14

          • Record: found
          • Abstract: not found
          • Article: not found

          US Food and Drug Administration

          PE Clarke (2011)
            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            Food and Drug Administration

            (2010)
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              US Food and Drug Administration.

              (2013)
                Bookmark

                Author and article information

                Contributors
                Journal
                JMIR Mhealth Uhealth
                JMIR Mhealth Uhealth
                JMU
                JMIR mHealth and uHealth
                JMIR Publications Inc. (Toronto, Canada )
                2291-5222
                Jul-Dec 2013
                12 July 2013
                : 1
                : 2
                : e13
                Affiliations
                [1] 1Key Laboratory of Biorheological Science and Technology, Ministry of Education Bioengineering College Chongqing University ChongqingChina
                [2] 2DSheet LLC Leawood, KSUnited States
                [3] 3Chongqing Academy of Science & Technology ChongqingChina
                Author notes
                Corresponding Author: Xiaolian Duan dxl@ 123456cast.gov.cn
                Article
                v1i2e13
                10.2196/mhealth.2654
                4114458
                25098204
                9cd7d978-ed3c-4aa2-b2ab-0c0120a026bc
                ©Daidi Zhong, Michael J Kirwan, Xiaolian Duan. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 12.07.2013.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.

                History
                : 05 April 2013
                : 27 April 2013
                : 02 June 2013
                : 30 June 2013
                Categories
                Viewpoint
                Viewpoint

                medical device regulation,device interoperability,personal health device,standardization

                Comments

                Comment on this article