Limits...
Can standards and regulations keep up with health technology?

Vincent CJ, Niezen G, O'Kane AA, Stawarz K - JMIR Mhealth Uhealth (2015)

Bottom Line: However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: UCL Interaction Centre, University College London, London, United Kingdom. c.vincent@ucl.ac.uk.

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.

No MeSH data available.


Three-dimensional printing technology (image credit Gerrit Niezen; image license CC-BY).
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figure1: Three-dimensional printing technology (image credit Gerrit Niezen; image license CC-BY).

Mentions: Open source hardware is an emerging business model where the design files of a product, including the circuit schematics, source code, and physical design, are made publicly available under a license so that anyone can study, modify, distribute, make, and sell the design or hardware based on that design. In recent years, three-dimensional printers have made possible a rapid production of customized medical devices [8], from fitted mechanical limbs [18] and mobile phone-connected microscopes [19] to parts for syringe pumps (as shown in Figure 1). Coupled with an open source approach, more can be achieved with less cost, because production can occur in-house, based on a freely available design.


Can standards and regulations keep up with health technology?

Vincent CJ, Niezen G, O'Kane AA, Stawarz K - JMIR Mhealth Uhealth (2015)

Three-dimensional printing technology (image credit Gerrit Niezen; image license CC-BY).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4526895&req=5

figure1: Three-dimensional printing technology (image credit Gerrit Niezen; image license CC-BY).
Mentions: Open source hardware is an emerging business model where the design files of a product, including the circuit schematics, source code, and physical design, are made publicly available under a license so that anyone can study, modify, distribute, make, and sell the design or hardware based on that design. In recent years, three-dimensional printers have made possible a rapid production of customized medical devices [8], from fitted mechanical limbs [18] and mobile phone-connected microscopes [19] to parts for syringe pumps (as shown in Figure 1). Coupled with an open source approach, more can be achieved with less cost, because production can occur in-house, based on a freely available design.

Bottom Line: However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: UCL Interaction Centre, University College London, London, United Kingdom. c.vincent@ucl.ac.uk.

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.

No MeSH data available.