1) Accessories to regulated medical devices, and
2) Transformation of a mobile platform into a medical device (e.g. smart phone).
As mentioned in the above link, the FDA reportedly cleared about 100 mobile medical applications over the last 10 years. The link also provides information regarding the FDA-cleared mobile medical applications and guidance for mobile health device makers.
Incidentally, discussion over whether or not to include Electronic Health Records (EHR) as a regulated medical device has been discussed as recently as November 2013 as reported on Health IT Exchange. In an opinion letter to HHS Secretary Kathleen Sebelius, the HIMSS Electronic Health Record (EHR) Association expressed concern that regulation of EHRs “beyond what is currently in place is not appropriate until further analysis of data and the establishment of a risk-based framework have been completed. The association’s letter also stated that such a ‘formal, regulatory approach’ to health IT is not warranted.”
The current controversy regarding EHRs as medical devices likely originates from unintended consequences, research and testimony to federal committees raising the issue that EHRs may cause errors, as well as increased incidence of adverse events and near misses associated with their use. Given the potential for patient harm, one must consider that EHRs are tools. People use these tools, and the tool does not substitute for professional knowledge and judgment in its use. That said, certification criteria should also ensure proper functioning of applications to prevent problems as the result of improper functioning.
So what’s the point? Healthcare tools (EHRs, medical devices, and mobile applications, etc.) used in the delivery of care to patients, absolutely requires knowledge of how to use the tool and the necessary education that could prevent unintended miss-use as well as prevention of errors in the application and device.
Considering the future opportunities for national use of Telemedicine, proper functioning, knowledge and education related to use of the applications and technology are critical.
To learn more about the FDA’s final guidance for mobile medical applications, click here.
