By C. Matthew Hawkins
Radiology Resident, UC Health – University of Cincinnati; @MattHawkinsMD
Extensive debate has transpired in the literature regarding the appropriateness, or lack thereof, of radiologists directly informing patients of the results of their imaging studies. Regardless of opinion, it has been tirelessly acknowledged that our current practice of rarely speaking to (or seeing) our patients needs some sort of remedy. There are, admittedly, legitimate legal concerns and collegial obstacles that have, to this point, prevented radiologists from seriously considering the practice of delivering results to patients [1, 2].
Regardless – this question is likely a reflection of my egregious naivety, but – isn’t it time we somehow started communicating results to patients?
This is not the platform to discuss the legal ramifications or moral/collegial responsibility of communicating results. I do concede that these issues present major dilemmas that must be solved prior to fully instituting a results-communication policy. But, even if we clear these hurdles, personally conveying results to patients as part of the current, RVU-driven workflow in a radiology department seems unrealistic. This is where IT can and must help.
Perhaps patients could be asked how they would like their imaging results relayed to them when they schedule their imaging exam. They could elect to speak with the radiologist in person, have their results sent to them directly from the radiologist, or be old-fashioned and get the results from their referring clinician at a separate appointment.
Our work lists could be prioritized with stat/ER studies as the top priority followed by patients being seen in an outpatient clinic on the same day (these patients are unlikely to request a personal consultation with a radiologist since they are being seen by their referring clinician the same day) and patients who have requested a personal radiologist consult. Prioritizing a work list this way would seem to provide an appropriate balance of service for referring clinicians and for patients. Consultation rooms, separate from reading rooms, with image-viewing capabilities would be necessary for face-to-face patient consults. After all, patients will want to see the images of their bodies, even if they’re normal. There would certainly be departmental design considerations required to make the process work, such as ensuring that the consult rooms are near the reading room. But, by sensibly prioritizing a work list, we can begin to see how relaying results to patients, in person, could realistically fit into a daily workflow.
Currently, patients make extra visits to their referring clinician’s office, often after extensive anxiety-provoking delays, so that results of their imaging studies can be conveyed – even for normal and unchanged studies. On the most rudimentary level, simply delivering “normal” and “stable” results to patients before they leave radiology departments would save the system significant cost and save patients enormous allotments of time. Plus, “normal” results do not take long to convey in person [1].
For patients who elect to have their results sent to them directly, rather than wait to speak to the radiologist in person, two possible communication methods come to mind. (Note: Sending a certified letter to patients, as we currently do in mammography, is an unacceptable option here. That was a great idea in 1980.) First, we could generate an electronic report on a secured web portal hosted by the department’s website. (Remember the multimedia reports I wrote about in my last post? This is where they come into play). A simple username and password is all it would require. And better yet, send them a text to notify them when their report is electronically available.
A second communication method for those truly wanting to maximize the potential of informatics would be to offer virtual video conferencing consults with patients. With remote screen control enabled, a radiologist and patient could engage in a video-chat conversation about the patient’s exam while viewing imaging findings, as the radiologist would control what images are displayed as well as cursor movement. Patients could electronically schedule these “appointments” from home, sometimes avoid unnecessary trips to physician offices, and simultaneously obtain a greater appreciation for the value provided by radiologists. (Not to peek too far down the rabbit hole, but imagine the second opinion consultation possibilities with a communication tool such as this…).
Obviously, new billing codes for clinical consultation would have to be established for a results notification process to work, particularly if the process temporarily extracts the radiologists from the traditional RVU-generating daily grind. Also, as mentioned previously, legal ramifications will have to be hashed out and the preferences of referring clinicians, regarding what results they would and would not want radiologists conveying to their patients, must be clarified. But, when the time comes, solutions for implementing a result-notification process must come from our IT community so that when we do it, we do it right.
1. Smith JN. Gunderman RB. Should we inform patients of radiology results? Radiology. May 2010. 255:317-321.
2. Berlin L. Communicating results of all radiologic examinations directly to patients: Has the time come? AJR. Dec 2007. 189(6):1275-1282.
Chair Commentary: FDA Guidance on Mobile Medical Applications
By Elizabeth A. Krupinski, PhD, FSIIM
Research Professor, Dept. of Radiology, University of Arizona
On July 21, 2011, the FDA released for comment its “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications.” Although the document addresses the use of a number of defined mobile medical applications (MMA), a significant focus appears to be on devices specific to radiologic medical imaging. Some points are very clear and specific, but in general, the guidance is quite broad and it leaves room for ambiguity and interpretation. As a consequence, users and developers must look closely at the definitions of MMAs in the context of the hardware and software applications, as well as the intended use, as this is the key determinant as to whether a given application is considered an MMA and thus subject to regulation.
The basic criteria for an MMA to be considered a “device” seem fairly straightforward: If it is intended either for use as an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device, it is a device. As the saying goes, however, the devil is in the details, and as one gets into the finer details of the document, it seems that the definition could include practically any app as an MMA if one chooses to interpret it as such. For example, there are broad definitions labeling the MMA a device, such as if the intended use is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Generously, one could interpret this as covering nearly every aspect of the healthcare enterprise, and as long as the app is in the hands of a healthcare provider (apps for patients’ use are virtually excluded from any regulation) it is a device, and thus subject to regulation.
The above set of definitions applies to a variety of general devices and examples are provided, but the next is clearly directed to radiology: If the MMA is an extension of one or more medical devices by connecting to such devices for displaying, storing, analyzing, or transmitting patient-specific medical device data including the display of medical images directly from a PACS server, it is a device. The following specifically listed apps are examples of what the FDA considers MMAs and they are clearly for radiology: Apps for viewing medical images on a mobile platform and perform an analysis or process for diagnosis; that connect to DICOM medical image servers and provide processing functions (e.g., pan, zoom, measurement, auto contrasting, automatic detection of features, and other similar functionality); that act as wireless remote controls or synchronization devices for MRI or X-Ray machines; that use pictures and sound to diagnose conditions by comparing to previously determined diagnoses of images, symptoms, sounds, or other physiological measurements; that calculate parameters associated with use of radioisotopes; that assist with patient-specific dosing (e.g., radiation planning); that provide differential diagnosis tools for a clinician to systematically compare and contrast clinical findings to arrive at possible diagnosis.
While other portions of the document offer broad definitions subject to multiple interpretations, these definitions seem quite clear – virtually any MMA for the interpretation of medical images is a device and will be regulated. The mission of the FDA is to protect public health by ensuring the safety, efficacy, and security of medical devices. There are few people who would disagree with these goals. However, the obvious primary focus of these proposed guidelines for the use of MMAs is on those designed for use in radiology. There should be some guidance on the use of MMAs in radiology, but there also must be an acknowledgement that the user of such devices, the radiologist, is a trained and expert professional who not only understands the importance of patient safety and security, but also understands the capabilities and limitations of the technology that they interact with (and rely on) on a daily basis. As they rely on them to perform every interpretation task they undertake, the radiologist also appreciates the fundamental limitations of his/her own perceptual and cognitive capabilities. The likelihood that a radiologist would use an MMA simply as a matter of convenience or in a casual manner without regard for the consequences of a decision made using the device on the patient is hopefully infinitesimally low.
We need a better balance between guidance/regulation and common sense. There are some medical image interpretation tasks that can be accomplished in a safe, effective, efficient, and appropriate fashion using an MMA. There are others that cannot. In its current form, the guidance document does not account for differences in images and tasks – it simply lumps all of radiologic image interpretation into a single box and implies that it should be regulated as a whole in the same way. In the long-run, this would seem to run counter to the FDA’s goal of advancing public health by helping speed innovations to improve health. MMAs for radiologic image interpretation need to be considered in the context within which they will be used, acknowledging the expertise, professionalism, and sense of responsibility to the patient with which the radiologist undertakes any interpretation task.