FCC, FDA to work on effective mHealth regulation

By Brian Dolan
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Within the healthcare chapter of the FCC's National Broadband Plan, which the agency published this morning, the FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic smartphone apps and wearable, wireless biometric sensors as examples of the products in need of regulatory clarification.

The FCC noted that while it has solely regulated general purpose devices like smartphones, videoconferencing equipment and wireless routers, the FDA has had sole regulation over life-critical wireless devices like remotely controlled drug release mechanisms. The FCC wrote that the two agencies should work together because emerging connected health devices pose a challenge to the legacy regulatory structure.

Read on for the relevant excerpt from the FCC's National Broadband Policy:

Recommendation 10.3: The FCC and the Food and Drug Administration (FDA ) should clarify regulatory requirements and the approval process for converged communications and health care devices. The use of communications devices and networks in the provision of health care is increasing. Smartphones have become useful tools for many physicians managing patient care on the go. Medical devices increasingly rely on commercial wireless networks to relay information for patient health monitoring and decision support. Some examples of the convergence between communications and medicine include the following:

> Mobile applications that help individuals manage their asthma, obesity or diabetes
> A Smartphone application that displays real-time fetal heartbeat and maternal contraction data allowing obstetricians to track a mother’s labor
> An iPhone application that presents images for clinicians making appendicitis diagnoses
> Wearable wireless patch-like sensors that transmit health data over commercial wireless networks to practitioners, caregivers and patients

These and other products cover a broad range of health IT solutions. At one end, general-purpose communications devices such as smartphones, videoconferencing equipment and wireless routers are regulated solely by the FCC when not created or intended for medical purposes. At the other, medical devices including life-critical wireless devices such as remotely controlled drug-release mechanisms are regulated by the FDA. However, the growing variety of medical applications that leverage communications networks and devices to transmit information or to provide decision support to both clinicians and consumers presents challenges to the current federal regulatory regime. Potential lack of clarity about the appropriate regulatory approach to these convergent technologies threatens to stifle innovation, slow application approval processes and deter adoption.

The FCC and the FDA should collaborate to address and clarify the appropriate regulatory approach for these evolving technologies. As part of this process, the FCC and the FDA should seek formal public input within the next 120 days and hold a workshop with representatives from industry and other relevant stakeholders to examine real case studies. Through this joint, transparent process the agencies should seek to answer questions such as: “Which components of a health solution present risk that must be regulated?” “How can the process for introducing products to the market be improved?” and “What are the characteristics needed for ‘medical-grade’ wireless?” After public input is received, the agencies should offer joint guidance to address these and other relevant questions.

The FCC and the FDA are committed to working together to facilitate innovation and protect public health in the continued development of safe and effective convergent devices and systems.

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