Regulatory barriers blocking standardization of interoperability

Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD...

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Bibliographic Details
Published in:JMIR mHealth and uHealth 2013-07, Vol.1 (2), p.e13-e13
Main Authors: Zhong, Daidi, Kirwan, Michael J, Duan, Xiaolian
Format: Article
Language:English
Subjects:
Blood pressure
Cellular telephones
Communication
Consumer health information
Data transmission
Ecosystems
Glucose
Health care
Health services
Interoperability
Medical equipment
Medical technology
Personal health
Regulation
Software
Viewpoint
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Summary:Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD WG) and Continua Health Alliance, are striving for this purpose. However, factors like the medial device regulation, health policy, and market reality have placed non-technical barriers over the adoption of technical standards throughout the industry. These barriers have significantly impaired the motivations of consumer device vendors who desire to enter the personal health market and the overall success of personal health industry ecosystem. In this paper, we present the affect that these barriers have placed on the health ecosystem. This requires immediate action from policy makers and other stakeholders. The current regulatory policy needs to be updated to reflect the reality and demand of consumer health industry. Our hope is that this paper will draw wide consensus amongst its readers, policy makers, and other stakeholders.
ISSN:2291-5222
1438-8871
2291-5222
DOI:10.2196/mhealth.2654