The mHealth Regulatory Coalition (pdf) and Healthcare Information & Management Systems Society have separately submitted comments on the FDA's draft guidance for mobile medical applications, according to a news release.
The mHealth Regulatory Coalition urged the FDA to create a regulatory framework for mHealth that eliminates unnecessary regulations and promotes innovation. The coalition commented on four areas they believe require the greatest attention by the FDA: clarity of intended uses; application of the accessory rule; roles and responsibilities of entities involved in mHealth systems; and regulation of software in mHealth.
HIMSS' comments encouraged the FDA to educate hospitals, health systems, providers and developers on FDA policies and procedures, noting that many people in these groups do not have experience with being regulated as a mobile medical device manufacturer by the FDA. HIMSS also made recommendations on clinical decision support systems and software assurance.
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The mHealth Regulatory Coalition urged the FDA to create a regulatory framework for mHealth that eliminates unnecessary regulations and promotes innovation. The coalition commented on four areas they believe require the greatest attention by the FDA: clarity of intended uses; application of the accessory rule; roles and responsibilities of entities involved in mHealth systems; and regulation of software in mHealth.
HIMSS' comments encouraged the FDA to educate hospitals, health systems, providers and developers on FDA policies and procedures, noting that many people in these groups do not have experience with being regulated as a mobile medical device manufacturer by the FDA. HIMSS also made recommendations on clinical decision support systems and software assurance.
Related Articles on FDA's Draft Guidance and Mobile Health:
Medical Informatics Association Advises FDA on Clinical Decision Support SystemsFDA Holds Workshop on Mobile Medical Applications Draft Guidance
UCSF, QuantiaMD Create Diabetes Education Mobile App