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Remote Patient Monitoring: Real-Time Patient Data, Real Liability Risks
Remote medical devices help doctors catch potential problems earlier, when they’re easier to treat, and can reduce the number of hospitalizations, improving patient health and containing healthcare costs.
Despite the many advantages, remote patient monitoring has liability risks. Because remote monitoring devices transmit patient data over the Internet or through phone lines, there is a risk of a data breach if the information is not properly encrypted.
Medical devices may be vulnerable to viruses and malware. The U.S. Food and Drug Administration (FDA) noted that providers must take steps to safeguard patient information within their network, such as ensuring antivirus software and firewalls are up to date, monitoring the network for unauthorized use, and reporting any medical device cybersecurity problems to the device manufacturer.
If a remote device fails or malfunctions, physicians may be named in the lawsuit against the manufacturer, under the claim that the physician failed to use the device properly. Physicians should stay up to date on the latest information for the device, including manufacturer’s warnings, the device’s safety record, and the device’s approved uses. Providers should also be aware of any FDA alerts or recalls.
Providers should also be aware of the need for additional staff members to handle the incoming data. In the case of a potential problem, these staff members should respond either directly to the patient or alert the appropriate professional for intervention. Each practice should have written guidelines for:
- At what times the device will be monitored.
- Which members of the care team will monitor the data at each point in time.
- Under what circumstances the appropriate clinician will be alerted to a potential problem.
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. To help ensure patients effectively use remote devices:
- Complete and document a thorough informed consent process.
- Educate the patient on:
- How to use the device. Explain the treatment plan, such as at what times the device will be monitored and how alerts will be handled by the healthcare team.
- What device failure or malfunction looks like, and what the patient should do if that happens.
- How to properly maintain the device.
References
- Report: 19 million will use remote patient monitoring by 2018. MEDCITY News. http://medcitynews.com/2014/06/biggest-market-remote-patient-monitoring/. Accessed December 1, 2014.
- Remote monitoring proven to help prolong life in patients with pacemakers. Heart Rhythm Society. http://www.hrsonline.org/News/Press-Releases/2014/05/Remote-Monitoring-Pacemakers#_edn1. Accessed December 1, 2014.
Contributed by The Doctors Company. For more patient safety articles and practice tips, visit www.thedoctors.com/patientsafety.