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      Can Standards and Regulations Keep Up With Health Technology?

      research-article
      , BSc, PhD 1 , , , BEng, MEng, PhD 2 , , BASc, MSc, PEng 1 , , BSc, MSc 1
      (Reviewer), (Reviewer)
      JMIR mHealth and uHealth
      JMIR Publications Inc.
      governmental regulations, health services, medical devices, mHealth, mobile phones, open source initiative, software, standards, technology

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          Abstract

          Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently. Compared with the emergence of new technologies, health technology design standards and regulations evolve slowly, and therefore, it can be difficult to apply these standards to the latest developments. For example, current regulations may not be suitable for approaches involving open source hardware, an increasingly popular way to create medical devices in the maker community. Medical device standards may not be flexible enough when evaluating the usability of mobile medical devices that can be used in a multitude of different ways, outside of clinical settings. Similarly, while regulatory guidance has been updated to address the proliferation of health-related mobile phone apps, it can be hard to know if and when these regulations apply. In this viewpoint, we present three examples of novel medical technologies to illustrate the types of regulatory issues that arise in the current environment. We also suggest opportunities for support, such as advances in the way we review and monitor medical technologies.

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          Smartphone applications for pain management.

          Smartphone applications (or apps) are becoming increasingly popular. The lack of regulation or guidance for health-related apps means that the validity and reliability of their content is unknown. We have conducted a review of available apps relating to the generic condition of pain. The official application stores for five major smartphone platforms were searched: iPhone, Android, Blackberry, Nokia/Symbian and Windows Mobile. Apps were included if they reported a focus on pain education, management or relief, and were not solely aimed at health-care professionals (HCPs). A total of 111 apps met the inclusion criteria. The majority of apps reviewed claimed some information provision or electronic manual component. Diary tracking of pain variables was also a common feature. There was a low level of stated HCP involvement in app development and content. Despite an increasing number of apps being released, the frequency of HCP involvement is not increasing. Pain apps appear to be able to promise pain relief without any concern for the effectiveness of the product, or for possible adverse effects of product use. In a population often desperate for a solution to distressing and debilitating pain conditions, there is considerable risk of individuals being misled.
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            Is Open Access

            Open-Source Syringe Pump Library

            This article explores a new open-source method for developing and manufacturing high-quality scientific equipment suitable for use in virtually any laboratory. A syringe pump was designed using freely available open-source computer aided design (CAD) software and manufactured using an open-source RepRap 3-D printer and readily available parts. The design, bill of materials and assembly instructions are globally available to anyone wishing to use them. Details are provided covering the use of the CAD software and the RepRap 3-D printer. The use of an open-source Rasberry Pi computer as a wireless control device is also illustrated. Performance of the syringe pump was assessed and the methods used for assessment are detailed. The cost of the entire system, including the controller and web-based control interface, is on the order of 5% or less than one would expect to pay for a commercial syringe pump having similar performance. The design should suit the needs of a given research activity requiring a syringe pump including carefully controlled dosing of reagents, pharmaceuticals, and delivery of viscous 3-D printer media among other applications.
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              Preventing Chronic Diseases: A Vital Investment.

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                Author and article information

                Contributors
                Journal
                JMIR Mhealth Uhealth
                JMIR Mhealth Uhealth
                JMU
                JMIR mHealth and uHealth
                JMIR Publications Inc. (Toronto, Canada )
                2291-5222
                Apr-Jun 2015
                03 June 2015
                : 3
                : 2
                : e64
                Affiliations
                [1] 1UCL Interaction Centre University College London LondonUnited Kingdom
                [2] 2Future Interaction Technologies Lab Department of Computer Science Swansea University Swansea, WalesUnited Kingdom
                Author notes
                Corresponding Author: Christopher James Vincent c.vincent@ 123456ucl.ac.uk
                Author information
                http://orcid.org/0000-0001-9058-4350
                http://orcid.org/0000-0003-3787-8194
                http://orcid.org/0000-0001-8219-8126
                http://orcid.org/0000-0001-9021-0615
                Article
                v3i2e64
                10.2196/mhealth.3918
                4526895
                26041730
                4ae1f9cb-f83b-4c12-822c-a2c93a7dbf73
                ©Christopher James Vincent, Gerrit Niezen, Aisling Ann O'Kane, Katarzyna Stawarz. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 03.06.2015.

                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
                : 04 October 2014
                : 22 February 2015
                : 07 March 2015
                : 23 March 2015
                Categories
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                governmental regulations,health services,medical devices,mhealth,mobile phones,open source initiative,software,standards,technology

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