[author: Jo Ellen Whitney]
The Office of the National Coordinator (ONC) frequently speaks about the "ubiquitous connected platform" that is being created by the ongoing use of private electronic devices, like smart phones and tablets, in a medical setting. The intersection of these devices with hospital and clinic-based electronic medical records systems (EMRs), as well as patient access to various medical applications and technologies, including phone apps that track everything from your sleep patterns to your blood pressure, is gaining national attention.
Other agencies have also become increasingly interested in this crossroads of medical care and wireless technology, including the Federal Communications Commission (FCC) and the Food and Drug Administration (FDA). The FDA is also focused on medical applications that are public computerized applications such as those which are part of the "quantify self" movement and those applications that are in a limited sense "prescribed" by a physician's office.
Another area of evaluation and potential future regulation is that of patient monitoring. The FDA has estimated that patient monitoring through devices such as pacemakers, implanted devices, and other forms of remote monitoring will be a 4.2 billion dollar business by 2018. Other agencies and private industry groups have assessed the value of this business at different levels, but all are significant.
In recognition of the increasing use of remote and wireless monitoring of patients, as well as the ability of various implants and devices to report back to a provider, the FCC announced on Thursday, May 17, that it will vote on new rules next week which will allow the creation of "medical body-area networks" on the wireless spectrum facilitating the transmission of data internally within the hospital and from patients' homes to the hospital or clinic setting.
The M Band (Medical Body Area Network) sensors at issue here are different than implanted devices. Typically, these are disposable small patches that include a low power transmitter which admits radio waves at a frequency lower than your standard blue tooth headset. They can be used to monitor vitals and other issues. The M Band has been in discussion since at least 2009, but it points to the future. The FCC itself indicates in its statements that it anticipates this to be the beginning of greater use of devices of this type, more sophisticated devices and future FCC involvement in device structure and usage.
It is likely that we will be looking at integrating HIPPA with the increasing FCC and FDA regulations for privacy and security.