By Sue Boisvert, BSN, MHSA, Senior Patient Safety Risk Manager, The Doctors Company 

Millions of Americans experienced healthcare by telemedicine during the pandemic. Although the use of telehealth for routine care is slowing down, it is gaining popularity in chronic disease management and hospital-at-home care.

Prior to the pandemic, practitioner concerns over how to conduct a physical examination during a virtual visit created a significant barrier to telehealth. Thanks to appropriate telehealth use guidelines and technological advances, however, important components of an in-office visit, such as vital signs and point-of-care testing, are now becoming an in-home reality.

Remote patient monitoring (RPM, or remote physiologic monitoring) devices facilitate clinical data collection in the patient home. In its simplest form, the patient collects RPM data using equipment such as a thermometer, blood pressure cuff, scale, portable ECG monitor with smartphone app, point-of-care blood glucose device, or oxygen saturation monitor. Before the telehealth visit, the practitioner provides the patient with a home vital signs kit (or instructions for purchasing the necessary equipment), training on the equipment’s proper use, and directions for collecting the required information and sharing it at the telehealth visit. The practitioner then assesses the information and adjusts the patient’s treatment plan as needed.

Advanced RPM is proving helpful for managing chronic conditions—such as heart failure, chronic obstructive pulmonary disease, and diabetes—and for patients with implanted cardiac defibrillators or pacemakers. The advanced monitoring equipment collects and transmits physiologic measures to the clinician with little or no input from the patient. During the pandemic, hospital critical care units used remote glucose monitoring to decrease the number of times staff members had to enter a patient’s room, thus decreasing the risk of disease transmission and preserving personal protective equipment.¹

The ability to automate data collection and transmission makes advanced RPM ideal for hospital-at-home management, particularly for patients waiting for transplants, high-risk pregnancies, and infants who need cardiac surgery but must reach developmental milestones before surgery can proceed. The equipment used for these patients tends to be highly sophisticated and may include devices that continuously monitor cardiac and respiratory status.

Simple RPM Technology

Practices with a high telehealth volume may find it convenient to provide telehealth kits or encourage all patients to purchase a core set of home equipment. Depending on the payer type, some or all of the equipment costs may be billable. Because RPM devices produce information that the practitioner relies on for decision making, it is incumbent on the organization and the practitioners who use the devices to have a comfort level with the data.

The availability of medical devices from online sellers raises safety concerns about device sources. Remote monitoring devices should be subject to a quality-control process. Providing a vetted device list is one method to achieve general standardization and reliability—an important goal for point-of-care blood testing, as there can be wide variability between the accuracy of different devices. Practitioners can gain confidence by having the patient bring the device to an office visit to evaluate appropriate use and compare results with a known standard, such as a lab draw or the in-office point-of-care testing equipment. Recommending the use of a medical equipment provider may be appropriate for higher-level monitoring needs, device quality management, and preventive maintenance. If the patient qualifies, using a home health agency increases the likelihood of appropriate RPM device maintenance and use.

Successful RPM depends on each patient’s or family’s willingness to participate in the monitoring process. Patients who are uncomfortable with technology or those lacking access to stable high-speed internet service may not be appropriate for RPM.

Advanced RPM Technology

Monitoring devices for complex chronic care and hospital-at-home management are much more sophisticated, and the practitioner must decide which device to use. Advanced devices—such as mobile medical applications, software that meets the definition of a device, and RPM equipment—are subject to FDA software guidance. Advanced RPM, which typically involves frequent or continuous monitoring, results in a flood of data. Because someone has to be responsible for receiving, reviewing, and responding to the data, it can rapidly become a significant problem when patient volume is high.

RPM developers are beginning to implement strategies to manage the flood of incoming information. Artificial intelligence (AI) and natural language processing (NLP) have shown promise in parsing and prioritizing large amounts of remote patient data. Some AI/NLP systems also make clinical recommendations to the care team based on data analysis and synthesis.

Practitioners must understand that they are ultimately responsible for the diagnosis and treatment of the patient—the machine is not the master.² As such, practitioners are cautioned to document clinical decision making in the patient record specific to whether the AI/NLP recommendations are followed. Devices that currently provide preliminary interpretations include computerized clinical decision support programs, electrocardiographs, and AI-enabled coronary computed tomography angiography.

Monitoring devices that are augmented by AI/NLP are also becoming subject to FDA medical device oversight. One of the challenges with technological innovation is that technology advances more quickly than the ability to regulate it. Practitioners and organizations considering using advanced RPM must remain current on the regulatory environment.

Privacy and Security

RPM entails cyber liability risks. Because remote monitoring devices transmit patient data, the risk of a data breach exists if the information is not adequately encrypted. HIPAA requires that all personal health information (PHI) be encrypted when transmitted. Practitioners who fail to safeguard PHI can face significant penalties.

Medical devices may be vulnerable to viruses and malware that can compromise patient privacy and device effectiveness. The FDA provides cybersecurity guidance for managing cyber risk in medical devices connected to the internet. Increasingly, manufacturers are required to address cybersecurity during the manufacturing process. During the device selection process, it is important to consider the integrated security measures between the device and the practice.

Include information on the remote monitoring technology in the notice of privacy practices to patients and obtain a business associate agreement from the device vendor.

Practice Policies

For organizations prescribing RPM to facilitate care, outline a formal written process for receiving, reviewing, and integrating different types of data into the patient record. Include the following information in the guidelines to address different types of RPM information.

Simple RPM using point-of-care devices:

• Device selection.
• Patient informed consent.
• Patient training on data collection and reporting.
• Data receipt, review, and interpretation by the practitioner.
• Documentation in the patient record.

Connected complex remote patient monitoring:

• Device selection.
• Staff and practitioner training.
• In-home process, including patient/family informed consent, training, and support by durable medical equipment service and home health.
• Details about data receipt, access, and review with assigned responsibilities between practitioners.
• Alarm and alert management during work hours, off hours, and holidays.

The pandemic helped us all to recognize the value of telehealth, its shortcomings, and the types of services appropriate for remote care. RPM is advancing the safety and accuracy of telehealth by filling in some gaps and increasing the types of care that can safely be provided in the home. AI/NLP RPM shows promise in managing the flood of data generated and aiding practitioners in using the data effectively. Perhaps the advance of RPM is a pandemic silver lining.

For assistance with RPM questions, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.