ArticleJMIR mHealth and uHealth2015
Can standards and regulations keep up with health technology?
Article in JMIR mHealth and uHealth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- Innovative Approach in Nursing Care: Artificial Intelligence-Assisted Incentive Spirometry.Healthcare (Basel, Switzerland) · 2025Article
- Competencies required to make use of Information Science and Technology among Japanese medical students: a cross-sectional study.BMC medical education · 2024Article
- The standard problem.Journal of the American Medical Informatics Association : JAMIA · 2023Article
- Virtual reality as a means to explore assistive technologies for the visually impaired.PLOS digital health · 2023Article
- Exploring the Role of Active Assisted Living in the Continuum of Care for Older Adults: Thematic Analysis.JMIR aging · 2023Article
- Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals.BMC health services research · 2023Article
- Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring.JMIR biomedical engineering · 2021Article
- Functionality of Top-Rated Mobile Apps for Depression: Systematic Search and Evaluation.JMIR mental health · 2020Review
- Use of Smartphone Apps, Social Media, and Web-Based Resources to Support Mental Health and Well-Being: Online Survey.JMIR mental health · 2019Article
- Article
- User Experience of Cognitive Behavioral Therapy Apps for Depression: An Analysis of App Functionality and User Reviews.Journal of medical Internet research · 2018Article
- A survey of eMedia-delivered interventions for schizophrenia used in randomized controlled trials.Neuropsychiatric disease and treatment · 2017Article
- Open-source hardware for medical devices.BMJ innovations · 2016Article
- Turning to Peers: Integrating Understanding of the Self, the Condition, and Others' Experiences in Making Sense of Complex Chronic Conditions.Computer supported cooperative work : CSCW : an international journal · 2016Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.