FDA Regulation of Wireless and Mobile Health

The emerging potential of wireless and internet communications technologies to assist on the three big health care problems–better access, lower cost, higher quality–will be greatly affected by whatever regulatory requirements are enacted, particularly if they are impediments to quick market access.  The mHealth Regulatory Coalition is a group of industry participants and advisers that is working  proactively to ensure the FDA handles these issues in a speedy and rational manner.  It has released a paper identifying the key areas in which FDA guidance, sooner rather than later, would be helpful.   (MRC Paper)

The underlying fundamental issues are what products will be regulated and at what level.  The Coalition identified three significant areas it would like the FDA to address:  could aiming at  just general wellness as opposed to diagnosis or treatment of a specific disease lead to an exemption from regulation; does a mobile phone or other piece of hardware become an FDA-regulated device just because it is used as a passive or flow-through communication mechanism to another device; and to what extent is software that is a communication vehicle or provides minimal decision software going to be regulated.

The Coalition intends to put forward a proposed guidance document for FDA and seek a public meeting to discuss that proposal.  No one thinks the FDA would actually adopt the guidance but it might provide a shortcut for the FDA, an agency which sometimes takes years to address very important issues, and then releases guidance which is quickly outdated by technological or other developments.  Clarity is needed not only by manufacturers of products which might be regulated, but also by providers and consumers who would be primary users of these products.  The number of potential uses of communications technology to aid in health management is proliferating rapidly and regulatory certainty is needed to allow those ideas the chance to show they can be beneficial.