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FDA/FCC Meeting On Wireless Health Devices

By August 6, 2010Commentary

The uses of wireless communication technology in health care are manifold, from text messaging in support of disease management programs, to equipment tracking in hospitals, to the sending of information from devices on or in the patient’s body to providers.  Initially, many in the industry thought they might avoid FDA regulation for a number of services and devices, but the FDA has now made it clear that it takes an expansive view of when a device or service may be used to diagnose or treat disease or improve health.  At the same time, the FDA appears to recognize the potential of wireless technologies to improve health care quality and lower costs.

Partly in response to concerns about its regulatory stance, the FDA held a joint public meeting in late July with the FCC to discuss the use of wireless technologies in health care.   At the same time the two agencies issued a Memorandum of Understanding expressing their intention to work together on regulatory issues affecting mobile health products and services.  (MOU) The MOU really doesn’t say much of anything,  just a general recognition that each agency may have some impact on the same products and therefore it makes sense to share expertise.

At some point the presentations and a transcript of the meeting should be available.  Comments from interested parties are already on the federal regulation website under docket number FDA-2010-N-0291.  Most revealing will be any statements from FDA officials regarding their perspective on wireless health.  While there are genuine safety concerns surrounding wireless technology in health care, the FDA should be able to issue guidance on how to minimize those and hopefully will proactively facilitate expanded health care use of mobile communication.

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