By: Joseph McMenamin, JD, MD
[Ed. We are honored to present this guest post by Dr. McMenamin, who was a practicing emergency physician before turning his sights to the practice of law. He is currently a partner at McGuireWoods LLP specializing in health-related litigation.]
The dictionary definition of interoperability is the ability of a system to work with or use the parts or equipment of another system. In the information systems, this refers to the ability of software and hardware on different machines from different vendors to share data. HIMSS (Healthcare Information and Management Systems) defines interoperability in healthcare as
“the ability of health information systems to work together within and across organizational
boundaries…to advance the effective delivery of healthcare for individuals and communities”.
Interoperability thus permits digitized data collected from two or more different sources to be exchanged and compared. For mHealth, interoperability is so fundamental that it could represent the difference between success and failure.
Many malpractice claims arising in conventional care settings are based on allegations of inadequate communication. If the correct provider fails to learn in a timely manner of an abnormal Pap finding, a chest film demonstrating a lung mass or the worrisome fetal heart monitor strip, opportunities to intervene may be lost and patients may be harmed. Lawyers are not bashful about claiming that these “failures to communicate” constitute breaches of the standard of care. When the communication device relied upon is relatively novel, the theory may be embellished to make it seem as though the patient is the unwitting subject of an unconsented experiment with untried technology.
The explosion in new medical knowledge that began in the second half of the last century shows no sign of slowing down. While greater knowledge has brought great benefit, it comes at a cost: no one physician can possibly keep track of all the developments even within one sub-specialty, never mind all of medicine. So, doctors tend to specialize in progressively narrower fields, and care becomes increasingly fragmented. The need for accurate, prompt communication between providers grows in proportion to this fragmentation, which itself grows in proportion to the expansion of knowledge. A doctor needs to be able to communicate with colleagues but a doctor relying on a mobile platform cannot help the patient if his device will not work with others’ systems and devices.
Electronic Health Records (“EHR”) have the potential to improve access to histories, physical findings, and imaging and lab data in ways that paper records cannot match. EHRs may improve the quality of care and decrease the risk of error by improving communication not only between patients and providers but between and among providers collaborating in the care of the same patient. See “The interoperable health record: preserving its promise by recognizing and limiting physician liability,” Jones, SC et al, Food & Drug L.J. (2008).
Many of the leading uses associated with the interoperable electronic health records are common to use of mobile health devices. Hence, many of the benefits anticipated from more widespread deployment of EHRs might apply to use of mobile health devices as well — but only so long as device A can “talk” to device B. Consider what happens when a system creates unique patient identifiers for a cohort of patients, some of whose members are assigned different unique identifiers by another system. System A recognizes its unique identifiers, but not System B’s, and vice-versa. A patient who is cared for under both systems is potentially a patient whose providers are blinded to the efforts of each other.
Mobile health devices are comparatively inexpensive and yet are capable of transmitting substantial amounts of data. They are, by definition, portable and increasingly ubiquitous. For those and other reasons, mobile health devices might be especially useful in the event of emergencies, particularly mass disasters/mass casualty situations where speed is of the essence and logistics are difficult.
On the other hand, where interoperability is inadequate, technologies that ought to improve care may impede it, and raise liability concerns in the process. Suppose, for example, a physician using mobile healthcare devices to store and transmit patients’ health information gets a request from another doctor not equipped in the same way, nor with devices that can communicate with the first doctor’s. The potential for error is obvious. The lack of interoperability of the record could contribute to risk in any clinical setting, but in emergent cases most of all.
The solution generally proposed to cope with this problem is reliance upon technical standards. That idea seems logical enough, but there are many competing standards, and so far none has emerged as dominant. Ironically, this plethora of standards is functionally similar to an absence of standards, because both situations result in the same problem of interoperability. For better or worse, government might mandate a set of standards to which all must conform under law. There is no way to predict when that might happen however. FDA’s Draft Guidance on Mobile Medical Applications, published July 19, 2011, is silent on interoperability. Alternatively, one system may on the basis of its technical advantages emerge as dominant.
Until then, however, interoperability may be problematic, and we may need to determine in advance of use that mobile platforms for health care, especially in critical care settings, can indeed communicate with each other. Even apart from clinical adequacy, the efficiencies that mobile health ought to bring are not likely to be realized so long as interoperability is questionable. Does that mean we should avoid mHealth technology? No, but it does mean that where interoperability is likely to be important, as it usually will be, a measure of caution is in order.