Essential Questions Before Selecting a Remote Patient Monitroing and Wearable Device

SUMMARY:

The use of remote patient monitoring (RPM) and wearable devices have increased at a rapid rate.
RPM and wearables allow for monitoring of patients outside typical clinical settings.
Patient generated health data are to be collected and managed to ensure accurate decision making. This is typically done in an asynchronous manner.

1. Who has access to the data (both within and outside the healthcare setting) and Who owns the raw and processed data?

RPM data ownership has yet to be clearly defined. Is it:
- The patient
- The clinician
- The device company
Is a particular set of data stored across different platforms?
Is a mechanism in place for patients to change permission of clinician or family accessibility?

2. How can I trust the accuracy of the patient data gathered?

Consumer wearables are not regulated for clinical use.
Trends over time provide better insights than single data points
Which data elements are collected automatically via sensing algorithms?
- Automation improves:
  - Accuracy
  - Timely data filtering
  - Aids the patient with low digital literacy
- Synchronization between different types of medical and consumer wearables are barriers to automation
Are manual data entry formats free text or pick list options?
Can automated or manually added data be annotated for clarity/accuracy?
Are patients notified of incorrect values?
Can the RPM or wearable calibrate to ensure accurate sensing (if so – how often, when should calibration occur)?

3. Does the RPM or wearable identify and report incomplete data?

Incomplete data may be due to:
- Technical: battery failure; wearable dysfunction; lack of synchronization in different time zones; internet connectivity
- Behavioral: Patient demotivation; lack of digital literacy; physiologic pain; perception of no change over time.
Is there acceptable or “pre-defined “downtime” when patients can stop data collection?
What is the least amount of time the patient must wear the RPM or wearable (i.e. 80%)?

4. Does the RPM or wearable data integrate with the electronic medical record (EMR)?

Most EMR systems are not designed to efficiently gather and incorporate data elements from outside systems.
Standards are most likely needed to drive accurate and effective data exchange.

5. Is the data interpretable?

Interpretability is impacted by the method of data collection and incorporation of contextual information.
Lack of supplemental contextual data can lead to misinterpretation of the data.
Patient contextual data should also be collected automatically.
Can the relevant contextual data needed/desired be identified for each health condition.
Is data visualization available offering a graphical snapshot?
RPM and wearable data should activate alarms during data collection, when the data is outside the acceptable range.
- However, further explanation of the meaning of the data, the normal range, the potential impact on patients health and what action should be taken.

6. Is there a shared understanding between patient and clinician of what is “relevant” data for the health condition?

The lack of data relevancy is one of the greatest barriers to adoption of wearables in clinical practice.
Can the device capture the identified relevant data?

7. Does the device provide real-time access to the patient during data collection?

Data access (real-time or periodic) needs to be defined based on the standard of care for the health condition.
Timeliness of data to the clinician is a major challenge.
If real time access is available, does it:
- Integrate into the EMR
- Generate alerts
- Incorporate into clinical workflow
Patients receiving real time data may also need clinical advice quickly.

RPM and wearable devices should not be considered stand alone clinical tools, but rather one mechanism within the healthcare system.
Regulatory approval as a medical grade device does not ensure it will provide quality data impacting outcome.