What is wearable technology in healthcare?

Wearable technology in healthcare refers to electronic devices or sensors that can be worn or attached to the body and which measure physiological parameters. These devices are designed to record data about an individual's physiological condition over periods of time, often passively and automatically, meaning that it isn’t necessary to record snapshots at specific timepoints. Other names for such apparatuses utilizing biosensing technology can include health tech wearables, wearable medical devices, and wearable biometric devices. Biosensing technology has already been used in biometric wearables to measure parameters such as heart rate, activity levels, sleep patterns, blood oxygen saturation, blood glucose levels, and more.

What issues does wearable healthcare technology address?

Wearable technology in healthcare addresses several limitations associated with the traditional model of occasional health checkups/healthcare visits, wherein data was captured only intermittently. These limitations include:

• Health data is captured only in sparse intervals, and then the ‘larger picture’ about the patient’s health status is extrapolated based on this data. This can be highly prone to inaccuracies.
• Patients are often required to recall their health status, symptoms, etc., from specific timepoints or periods in the past. This situation lends itself readily to recall bias.
• There are other forms of biases and inconsistencies related to subjective self-reporting, where a patient may misrepresent the information, either intentionally or unintentionally.
• “White coat hypertension” describes the situation wherein patients often have higher blood pressure readings at the doctor’s office than at home, which has been associated with nervousness when in clinical settings. This exemplifies the potential for altered readings due to the data being recorded in settings that may be uncomfortable for the patient (or at least which are not representative of the places they frequent day-to-day).

How do healthcare wearables address these issues?

Responding to the list above in order, we can get a clearer picture of why wearables in healthcare have increased so dramatically in popularity:

• Health data can be captured continuously, allowing healthcare providers to gain deeper and more accurate insights into the patient’s real health status.
• Data is captured in real-time, eliminating the influence of recall bias.
• Data can be captured automatically, eliminating potential for errors due to misinterpretation or bias and improving the accuracy of measurements.
• Patients can enter data from the comfort of their home, often passively – after the device is set up, they may not have to do anything at all (or might only be required to charge it/change batteries, log-in, or other simple tasks)

Wearables thus offer advantages to both healthcare providers and patients, largely related to convenience, data accuracy, and the depth and quality of health insights that can be gained. However, the potential benefits of wearable devices go even further than that, especially when we consider the new opportunities they enable in the context of clinical trials.

Advantages offered by wearable technology in clinical trials

In the world of clinical trials, technology is causing rapid and significant shifts in how trials are conducted and what is possible. Wearable devices in healthcare represent one of these significant advances. First and foremost, the continuous monitoring and direct data capture enabled by wearable devices changes the game entirely from the traditional situation wherein patient data would be recorded periodically during in-person healthcare visits. This development opens up the door to the collection of many more data points, providing much higher-resolution insights into the health outcome(s) being monitored as part of a clinical trial. It also enables other potentially advantageous changes to the way trials can be conducted, such as:

1. Real-time patient monitoring (early detection)

Wearable devices enable real-time monitoring of vital signs and other health parameters in a continual manner. This means that data can be collected instantaneously and constantly, not just when patients visit a healthcare facility or trial site.

The real-time nature of incoming data allows for improved management of chronic conditions, and early detection of potential health issues or adverse events in the context of clinical trials. This can significantly improve patient safety in trials, as it enables researchers to respond promptly and proactively to potential concerns. For instance, a heart monitor might detect abnormalities long before a patient consciously notices any symptoms.

2. Remote data collection

Relatedly, wearable devices allow for patients' health parameters to be monitored and recorded remotely, reducing the need for frequent in-person visits to medical centers or research sites. This offers benefits for patients in terms of convenience, less travel time and scheduling burden, and reduced out-of-pocket trial expenses. For sponsors and sites, the reduced burden can improve recruitment and retention rates, and it significantly reduces logistical tasks related to appointment scheduling and costs related to continually staffing the study sites.

3. Direct and objective measurements (improved data accuracy)

As a form of direct data capture (DDC) or electronic data capture (EDC), wearables provide direct and objective measurements of various physiological parameters, not requiring any human intervention or interpretation of the readings, nor transcription from manual records. Eliminating or minimizing the reliance on subjective self-reporting by participants reduces potential sources of bias and improves the accuracy of data. Further, inputting data directly into the electronic system eliminates the risk of transcription errors, and edit checks can automatically validate data and flag errors. Of course, devices and software systems need to be carefully calibrated, validated, and maintained in order for this benefit to be realized.

4. Higher-resolution insights into patient health

Traditional data collection schedules limited the amount of data that could be collected during a trial, thus limiting the depth and resolution of insights that researchers could glean from the data. Automated and remote data collection through medical wearables supports the collection of far more data points, without increasing the burden placed on the patient. With more data, insights into the patient’s health outcomes or overall health status can be much deeper, and also have higher temporal resolution.

For example, rather than only being able to conclude that a patient’s blood pressure increased sometime over the span of 2 weeks, between study visits 5 and 6, a researcher could specify that blood pressure increased sharply on day 65 of the trial, beginning 12 hours after the 8th dose of study treatment was taken (hypothetical example). The troves of data collected via wearables can enable detection of subtle changes in health parameters that may indicate early signs of disease progression or adverse events linked to treatments.

5. Improved patient engagement

By getting involved in tracking their own health data using wearable devices and apps, individuals can become more actively engaged in their participation in a trial, as well as in managing their health overall. Increased patient engagement often leads to better adherence to treatment regimens and reduces the likelihood of drop-outs. It can also improve the patient’s experience of participating in the trial, and may help them make healthier lifestyle choices, both momentarily and in the long-term.

6. Personalized healthcare

Since wearable devices can capture data on various parameters such as physical activity levels, sleep quality, stress levels, biomarkers, and more, the data can be used to synthesize comprehensive personalized treatment plans and lifestyle recommendations, based on each individual’s unique needs, lifestyle/habits, and desired health outcomes.

7. Real-world evidence (RWE)

Data collected through wearable devices can sometimes be considered real-world data (RWD). Although clinical trials inherently involve some degree of control over confounding factors through the application of eligibility criteria, data collected through wearables can be considered to better represent real-world conditions, since the measurements can be taken more frequently and from the comfort of the patient’s home or regular life conditions. Real-world data captured outside of the context of clinical trials, under “regular” uncontrolled conditions, can be analyzed in observational studies to generate real-world evidence (RWE), which can in turn inform healthcare policy and patient care decisions (see next point). Certain clinical trials are also incorporating real-world evidence generated through wearable devices as supplementary data alongside the trial’s specific endpoints, to provide more comprehensive insights into the study intervention’s safety and efficacy in the context of other influencing factors.

8. Data-driven decision-making

Relatedly, the vast amount of data generated through wearable devices can be used outside of the context of clinical research, for broader population-level health analysis. By analyzing aggregated data from multiple users over extended periods of time, researchers can gain insights into disease patterns, effects of health interventions, and more. For example, data collected through wearables could be utilized in health economics and outcomes research (HEOR).

Types of wearables used in clinical trials

Wearable and connected devices have solidified their spot in the ever-expanding list of clinical trial technologies. Various types of wearables can be utilized in clinical trials, according to the specific research objectives and the trial design. Common examples include:

1. Activity trackers/fitness bands: These devices, often worn around the wrist, can monitor physical activity levels, steps taken, calories burned, sleep patterns, heart rate, heart rate variability (HRV), and other metrics related to body movement.

2. Smartwatches: Smartwatches can offer a range of features beyond simple activity tracking, such as ECG recording capabilities, blood pressure measurement (when used with compatible devices), fall detection alerts, medication reminders, etc. These devices can thus also be used as part of patient engagement strategies, sending appointment and medication reminders to trial participants to keep them on protocol.

3. Biosensors/patches: These small adhesive patches contain sensors capable of measuring physiological parameters like body temperature, heart rate, or even biochemical markers such as blood glucose levels. They often work via sweat analysis or interstitial fluid extraction.

4. Smart clothing/garments: “Smart garments” like shirts and shorts have been developed with embedded sensors that can track vital signs such as heart rate or breathing patterns without the need for additional accessories.

Selecting the type of wearable device that is most appropriate for a trial depends on factors including study design, the parameter(s) being measured, considerations of feasibility and patient comfort, costs, maintenance requirements, etc. In general, sponsors should keep in mind that in order for wearable devices to produce high-quality data, they need to be adequately calibrated, validated, and maintained, which could be more labor-intensive for certain devices. Similarly, the device should be excessively simple for the patient to use (i.e., intuitive and uncomplicated), and should not require too much maintenance, adjustment, or involvement on the part of the patient, in order not to burden them with complex technical operations, and further so as not to exclude those who are not technologically adept.

Trends in the use of wearable healthcare technology in clinical trials

It has been projected that 50% of all clinical trials will use wearable healthcare technology in some way or another by 2025. There were already about 1,600 clinical trials conducted in 2020 that made use of wearable devices.[1] In general, there is an industry-wide trend toward increased adoption of technological tools that help streamline trial operations and data management, and also toward the consolidation of services into comprehensive end-to-end solutions. Thus, it is common for eClinical software providers to have their own line of wearable and connected devices, or for their product to support direct integration with many popular wearables, or for them to offer support in selecting wearable devices and setting them up to function smoothly with their product.

Regulations and privacy clarifications

The use of third-party devices and/or software platforms for collecting personal health information (PHI) raises concerns about patient data privacy and regulatory compliance. As we’ve discussed in our article on data privacy and confidentiality, the main relevant regulations in the US are HIPAA and FDA’s 21 CFR Part 11. The simple answer is that, in the context of the use of wearables in clinical trials, sponsors and investigators do indeed need to consider HIPAA and FDA regulations.

Are wearables FDA regulated?

The first thing to note is that wearable technology for health and general wellness use – which is to say that the data is not incorporated into patients’ health records or used for any research purposes – is currently not subject to FDA regulations, nor HIPAA. When the device is used to collect data as part of a clinical trial, then the device (including the use of the device and the data that’s collected) is subject to compliance with FDA 21 CFR Part 11 pertaining to electronic records.

Does HIPAA apply to wearables?

The landscape surrounding the relationship between wearable devices and HIPAA is still being defined. In the most simple answer, anytime the data collected by a patient’s wearable medical device is submitted as part of any type of health evaluation (whether for routine care or in the context of a clinical trial), HIPAA regulations come into play. If the wearable interfaces with the patient’s electronic health record (EHR), HIPAA also becomes relevant.[2]

When an individual uses biosensing technology for their own personal information, there is currently no direct regulation that applies. However, there are still concerns related to data security, as many apps associated with such devices may not integrate particularly strong security measures, and can be subject to data breaches or hacks. In that case, sensitive personal health information (PHI) could be leaked.

Conclusion

Although a relatively recent development, wearable devices in clinical trials have firmly established their position as a tool offering many potential benefits to both sponsors and patients. Their use is expected to continue increasing, which opens up new possibilities for clinical trials and facilitates the shift toward decentralized and remote trials and increased patient centricity. At the same time, it places a demand on research organizations to remain up-to-date with trends and to dedicate time to becoming familiar with these tools, selecting those which best fit their organization’s or trial’s needs and integrating them into their trial workflows if they wish to remain competitive in the clinical research space. This carries additional requirements related to staff training, updating standard operating procedure documentation, and navigating the regulatory landscape covering the use of digital tools and electronic records in healthcare.