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.


Everyday life and a glucose meter (image credit Aisling Ann O'Kane; image license CC-BY).
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figure2: Everyday life and a glucose meter (image credit Aisling Ann O'Kane; image license CC-BY).

Mentions: However, our work shows that complexities of everyday life such as people’s work life, romantic life, friendships, hobbies, travel, holidays [27], or whom they are with [28,29] impact on the use of these devices (Figure 2). Understanding these factors is incredibly complex [30], but necessary to ensure glucose meters are reliable and meet users needs. The problem is that the evaluation methods suggested by standards are not adequate in addressing everyday use, as they have been developed with a focus on technology used in clinical environments, where there is more certainty about the characteristics of the work place and levels of training.


Can standards and regulations keep up with health technology?

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

Everyday life and a glucose meter (image credit Aisling Ann O'Kane; 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

figure2: Everyday life and a glucose meter (image credit Aisling Ann O'Kane; image license CC-BY).
Mentions: However, our work shows that complexities of everyday life such as people’s work life, romantic life, friendships, hobbies, travel, holidays [27], or whom they are with [28,29] impact on the use of these devices (Figure 2). Understanding these factors is incredibly complex [30], but necessary to ensure glucose meters are reliable and meet users needs. The problem is that the evaluation methods suggested by standards are not adequate in addressing everyday use, as they have been developed with a focus on technology used in clinical environments, where there is more certainty about the characteristics of the work place and levels of training.

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.