Summary and Analysis of the Mobile Medical Applications Draft Guidance from FDA

The mHIMSS Policy and Regulatory Implications Workgroup is pleased to present this summary and Analysis of the Mobile Medical Applications Draft Guidance for Industry and Food and Drug Administration (FDA) Staff. For those developing a mobile policy, summaries regarding OCR’s HIPAA and CMS/ONC/NIST’s Meaningful Use will be particularly insightful. Additionally, the group published material related to developers and manufacturers, and includes insights from the FTC, FCC, and FDA’s Mobile Medical App Guidelines available on the www.mHIMSS.org website.

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