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A Path to Better-Quality mHealth Apps.
1School of Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, United States.
JMIR Mhealth and Uhealth
|August 1, 2018
Summary
Mobile health (mHealth) apps lack clear quality standards, causing confusion. A Clinical Laboratory Improvement Amendment-like system could ensure safe, high-quality mHealth apps for diagnosis and treatment.
Area of Science:
- Health Informatics
- Medical Device Regulation
- Digital Health
Background:
- The proliferation of mobile health (mHealth) applications has created uncertainty regarding their medical validity and safety.
- A significant gap exists in the regulatory oversight of mHealth apps, with only a fraction subject to US Food and Drug Administration (FDA) regulation.
Purpose of the Study:
- To address the need for quality and safety standards in mHealth apps.
- To propose a regulatory model for mHealth apps based on existing laboratory accreditation systems.
Main Methods:
- Analysis of the current regulatory landscape for mHealth apps.
- Evaluation of the Clinical Laboratory Improvement Amendment (CLIA) as a potential model for mHealth app oversight.
Main Results:
- A small proportion of mHealth apps are currently regulated by the FDA.
- The CLIA system presents a viable framework for establishing quality and safety benchmarks for mHealth applications.
Conclusions:
- Implementing a CLIA-like accreditation system could ensure the reliability of mHealth apps.
- Physicians and consumers should advocate for robust oversight to guarantee safe and effective mHealth tools for diagnosis and treatment.
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