Moe Alsumidaie Chief Editor, Clinical Trials Vanguard features Aktiia and the impact FDA Guidelines have on devices.
Digital Health Technologies (DHTs) use in clinical research is no longer a futuristic concept—it’s quickly becoming the norm. Recognizing this shift, the FDA issued comprehensive guidance in 2023 on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This guidance sets critical standards for validating, deploying, and monitoring these tools in clinical trials. The guidance stresses the importance of reliability, data quality, patient safety, and privacy—key factors as trials become more decentralized and reliant on technology.
Throughout this article, we’ll use Aktiia’s continuous blood pressure (BP) monitoring technology as a reference to illustrate the FDA’s key recommendations. While Aktiia’s device provides cutting-edge BP tracking, we will focus on how its use aligns with the FDA’s detailed framework for DHTs in clinical investigations to help you better navigate the guidance on existing DHTs in the marketplace.
What Are Digital Health Technologies?
According to the FDA, Digital Health Technologies encompass many tools designed to collect health data remotely. These include wearables, sensors, mobile applications, and software transmitting health-related data in real-time. The goal of the FDA’s guidance here is to clarify what qualifies as a DHT and, more importantly, to establish how these technologies can contribute to clinical trials.
The FDA recognizes that data collected in traditional clinical settings can be limited. In-person visits provide only a snapshot of a patient’s condition, often missing the broader picture of their daily health patterns. This is where DHTs, like Aktiia’s continuous BP monitoring bracelet, come in. By enabling constant, real-world monitoring, Digital Health Technologies allow researchers to gather data on how a patient’s health fluctuates in their natural environment. This continuous data provides richer insights into conditions that require hypertension management, such as cardiovascular disease, diabetes, and chronic kidney disease, which often benefit from precise, long-term blood pressure tracking to inform clinical outcomes better.
The FDA emphasizes DHTs because they offer a more holistic view of patient health, moving beyond the confines of the clinic. However, with this new capability comes the responsibility to ensure that the data collected remotely is just as reliable and accurate as that collected in a controlled environment.
Key Considerations for Selecting DHTs in Clinical Trials
A significant point of emphasis in the FDA’s guidance is the concept of fit-for-purpose—ensuring that the selected DHTs are appropriate for the specific trial’s objectives and the patient population involved. The FDA doesn’t just want sponsors to use technology for technology’s sake; it wants to ensure that these tools effectively serve the trial’s intended goals.
The term “fit-for-purpose” is central to the FDA’s guidance, and it essentially means that a DHT should be appropriately validated and capable of addressing the specific objectives of a clinical trial. The technology must be well-suited for the patient population, the studied condition, and the data required for meaningful analysis. When the FDA urges sponsors to consider whether a DHT is “fit-for-purpose,” it’s pushing for a thoughtful selection process. This involves ensuring that the chosen technology can reliably collect data relevant to the trial’s endpoints, functions appropriately in the intended setting, and fits within the broader clinical context. Validation for the specific population also ensures that the DHT can accurately measure the health outcomes of interest.
For instance, Aktiia’s BP monitor is fit for purpose in trials where continuous blood pressure monitoring is essential, such as in chronic kidney disease or hypertension-related studies. However, in trials focused on mental health or sleep disorders, where different metrics are crucial (e.g., brain activity or sleep patterns), a DHT designed for cardiovascular monitoring wouldn’t be fit for purpose unless adapted to the specific needs of those studies.
Ensuring Data Integrity and Endpoint Evaluation
One of the key pillars of the FDA’s guidance is ensuring data integrity. For the FDA, this means that DHTs must not only collect data but do so in a consistent, reliable manner that can withstand scrutiny. The guidance outlines how sponsors should validate DHTs to ensure that remotely collected data meets the same standards as data gathered through traditional, in-person means.
As the FDA opens the door to more remote data collection, the agency remains aware of the risks associated with collecting data outside controlled environments where inconsistencies or errors could arise. Aktiia, however, has undergone rigorous testing and validation to meet these stringent requirements. Its blood pressure monitoring technology has been proven to track blood pressure accurately across different patient demographics, environmental conditions, and health statuses. This includes testing in real-world scenarios where patients may have comorbid conditions or varying physical states, such as during physical activity or periods of rest. Aktiia’s system still reliably collects accurate blood pressure measurements under these varied conditions.
Furthermore, the FDA emphasizes that trial endpoints must be directly tied to the data collected, and data integrity is paramount. In the case of Aktiia’s device, the company has implemented robust mechanisms to reduce noise and ensure the clarity of the data it collects. Aktiia’s technology effectively filters out potential data inconsistencies—such as those caused by patient movement or environmental factors—so that the blood pressure readings are accurate and precise.
Aktiia can support reliable and clinically meaningful endpoints in trials where blood pressure is a primary measure by ensuring that the data is clean and clear. The FDA requires that the data not only be collected but also processed and analyzed to retain its clinical relevance. This is critical for informing real-world medical decisions. Aktiia’s system can handle large volumes of data, process it to ensure that the resulting insights are valid and actionable, and maintain the high level of data integrity the FDA expects to support study endpoints.
Patient Safety Risk and Data Privacy Concerns
The FDA’s guidance also focuses heavily on risk management, particularly regarding patient safety and data privacy. While the benefits of DHTs are significant, the risks are also higher—both in terms of potential harm from the device itself and the increased exposure to cybersecurity threats.
Devices that patients wear continuously must be physically safe and comfortable for long periods. The FDA guidance suggests that sponsors evaluate the potential physical risks—like skin irritation or discomfort—from prolonged use of wearables. If patients stop using the device due to discomfort, it could lead to data loss and, worse, patient harm. On the digital side, data privacy is paramount. DHTs often transmit sensitive health data over wireless networks, and the FDA stresses the need for strong encryption and data security protocols. This is crucial not only to comply with regulations like HIPAA but also to maintain patient trust. If participants fear their data could be compromised, it could affect their willingness to participate, undermining the trial. The FDA’s focus on risk mitigation is about ensuring that while we expand the use of DHTs, we do so without compromising the safety of patients or the integrity and privacy of their data.
For example, Aktiia’s wristband is designed with patient comfort in mind, allowing for prolonged usage without discomfort, which minimizes the risk of patients removing the device and disrupting data collection. Moreover, Aktiia’s encryption policies and cybersecurity protocols meet the FDA’s stringent requirements, ensuring patient data is securely transmitted and stored. By providing both comfort and strong data protection, Aktiia maintains patient trust and ensures that its device supports accurate, reliable data collection throughout clinical trials.
Regulatory and Submission Considerations
The FDA encourages sponsors to engage with them early, often when incorporating DHTs into clinical trials. Early engagement allows the FDA to ensure that the DHT meets all necessary regulatory standards before it becomes a core part of a trial’s data collection.
In many cases, Digital Health Technologies are gathering data that will be used to support key regulatory decisions. These technologies must be rigorously validated for the FDA before trial data is submitted for review. The earlier sponsors can demonstrate the reliability of their DHT, the smoother the regulatory process will be. The FDA is also keen to ensure that sponsors include comprehensive documentation in their submissions, covering everything from device design and performance characteristics to data security measures. For example, Aktiia has been rigorously validated as a medical device (it has a CE mark in Europe); submitting this documentation to the FDA provides the necessary evidence that the device meets the validation requirements of the agency. This isn’t just about checking boxes—it’s about ensuring that the FDA fully understands how the DHT will be used and its impact on the trial results.
raining and Technical Support for DHT Users
The FDA’s guidance highlights the importance of proper training and technical support for trial participants and investigators. This ensures that everyone involved knows how to use the DHT correctly and that the data collected is reliable.
Even the most advanced DHT can fail if it’s not used correctly. The FDA emphasizes that patients and staff must receive clear technology operation instructions. For example, Aktiia’s BP monitor has training in the app that is simple and easy for patients to navigate; it trains patients on how to wear the device correctly, sync the data, and troubleshoot any potential issues. Likewise, trial staff must be equipped to assist patients and monitor the incoming data for accuracy and completeness. Training is a key safeguard to ensure that data is collected consistently and that any issues that arise during the trial can be resolved quickly, minimizing disruptions.
Future Implications of the Guidance
Finally, the FDA’s guidance on Digital Health Technologies points to a future where clinical trials are increasingly decentralized and patient-centered. The agency sees DHTs as a way to make clinical trials more inclusive and reflective of real-world conditions. Trials that rely solely on clinic-based visits may exclude certain populations or fail to capture how treatments work in everyday life. By encouraging the use of Digital Health Technologies, the FDA is promoting a model of clinical research that is more flexible, accessible, and capable of capturing richer data and more reflective of patient experiences. The FDA’s forward-looking guidance sets the stage for a future where real-world evidence plays a more significant role in clinical research, ultimately speeding up drug development and improving patient outcomes.