Liability concerns of Remote Patient Monitoring and ‘what happens if’?
I. A reading indicates that something is wrong with the patient; my office doesn’t see it and an adverse event occurs?
II. A device isn’t working properly and readings aren’t accurately being recorded?
III. The patient isn’t taking their vital signs as prescribed and experiences an adverse event?
IV. There is a data breach?
Liability risk is always an overarching concern for physicians and the uncertainty of these risks and what might arise by including remote patient monitoring in their practice is no exception.
There are several ways to treat and consider this risk for your practice:
The first is to ignore it, which is probably not a viable or smart option for the type of physicians that are reading this article. On this point however, it is important to note that large institutional bodies such as the American Medical Association have actively supported the use of digital healthcare tools to reduce inefficiencies in health care delivery, improve patient access, lower costs and increase quality of care. Further, a large number of very large medical institutions and insurance plans have been conducting remote patient monitoring programs for very sick patients across the country for several years and found ways to mitigate/overcome this concern.
The second, and probably most productive way to address the litigation risk is to put steps into place that will mitigate them. These steps should include:
1. Information: Ensure that you are always aware of FDA recalls, manufacturer’s warnings, the devices safety record etc. The difficulty of this is that it this places a large burden on the provider who is already busy seeing patients and does not have the time or inclination to ensure that they are always aware of the latest news on each device. In recognizing this as an opportunity, Paquin has stepped in and takes on these responsibilities. Doctors can be comfortable knowing that by utilizing Paquin’s iRemedyRemote platform it will stay up to date on the latest information for each of the devices registered for their software, including manufacturer’s warnings, the device’s safety record, and the device’s approved uses. Paquin will also ensure it is always aware and responsive to any FDA alerts or recalls.
2. Alert fatigue: This occurs when there is an overwhelming number of alerts that indicate a patient is not within their threshold range for vital signs and they become so common that staff members begin to ignore, override, or disable them. It is important that a protocol be put in place that anytime an alert or a potential patient problem is ignored, the reason for that decision is documented. Fortunately, Paquin’s iRemedyRemote software has the ability to record notes at each instance within the patients file.
3. Patient Selection: Successful remote patient monitoring is dependent on each patient’s motivation to actively manage his or her health, as well as the patient’s ability to understand and use the technology, as such, patients who are not tech-savvy are likely not be good candidates for remote monitoring. However, this is quickly becoming less of an issue as both devices become easier and more intuitive to uses and an increasing number of the population migrate to smartphones.
To help ensure patients effectively use remote patient monitoring, they should be:
- Educated on how to use the device with an explanation of the treatment plan which might include things like the times the device will be monitored and how alerts will be handled by the healthcare team
- Able to identify what device failure or malfunction looks like, and what the patient should do if that happens
- Instructed on how to properly maintain the device
- Recognizing this is not within the realm of expertise for physician practices, Paquin provides customer service, training and instruction to patients as part of their service
4. Complete and document an informed consent process with the patient
5. Ensure that all data is being transferred in a HIPAA compliant environment – which is yet another aspect of the iRemedyRemote software