FDA Issued a Draft Guidance on Using Digital Health Technologies in Clinical Studies

On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and all interested parties on using digital health technologies (DHT) to remotely gather data from participants in clinical investigations. 

DHT is a system comprising computing platforms, connectivity, software, and/or sensors, for healthcare and related uses, for example, an app that uses the sensors on a smartwatch to collect heart rate information. DHTs enable the transmission of data across distances, which increases opportunities for patients to participate in trials and to more frequently collect patient data. The guidance details some key considerations for study sponsors when using DHTs for clinical investigations.

Technology helps at-home-care for cardiovascular disease patients

Being one of the most essential and complex industries in present-day society, healthcare is always changing. Healthcare research is continuously funded to help us better understand human health and find better ways to prevent and treat illnesses or injuries. As technology improves, so does healthcare tech advancement.

As the healthcare sector has had to evolve and adapt to the pandemic requirements, many innovations to increase at-home heart healthcare have appeared. With cardiovascular diseases seeing an uptick worldwide and an estimated 17.9 million people succumbing to heart diseases in 2019, digital health platforms became a useful tool for understanding and managing at-home care for regularly seen cardiovascular disease patients.

A good heart monitor is a handy device and a reliable workout companion that helps consumers track their physical exercise and training intensity.

Heart monitors have hugely improved from the big, heavy, and cold devices one had to strap to their chest. Today, they are stylish, small, packed with cutting-edge features, and can do much more than monitor your heart rate. When choosing the best one for your needs, medical professional advice is key.  

Wearables play a growing role in clinical research

But monitors, whether heart or glucose one, for instance, do much more than only help the wearer. 

DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic and beyond. Though largely directed to study sponsors using DHTs, the guidance FDA recently issued is important mainly because it clears points the developers and manufacturers of these technologies need to be mindful about when it comes to their technology being used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance is available here, but we will try to sum it up for those interested in the main points.

How to choose the best DHT for the Clinical Investigation

When selecting a DHT for use in a clinical investigation, sponsors should make sure the technology is “fit-for-purpose”. This means the level of validation associated with the DHT should be enough to support its use and interpretability in the medical investigation. 

In order to determine that a DHT is fit-for-purpose, the FDA recommends that sponsors take into account the following:

• the clinical event or characteristic of disease/condition that is being measured
• the proposed trial population, including whether usability studies are necessary
• design of the clinical investigation
• characteristics of the DHT that may influence trial participant use (e.g., whether a subject would use the DHT for the duration of a trial).

The sponsor must explain why the DHT is fit-for-purpose for the clinical investigation in a premarket submission (i.e., an application for 510(k) clearance or approval). The application should contain basic information about the DHT (for instance, relevant physical characteristics, details on how it measures the clinical event or characteristics of the disease/condition), a description of features related to the usage, and an explanation on how privacy and security of data collected by the DHT are achieved.

How the technology should be verified, validated, and used

Verification and validation studies should demonstrate that the clinical event or characteristic to be assessed (e.g., heart rate) is consistently and accurately measured in the studied population.  In the example, FDA provides, a DHT that captures steps in a healthy participant may not be used for patients with Parkinson’s disease, who may have an uneven gait.   

Sponsors should take into account the DHT performance specifications, pinpoint conditions under which the DHT functions reliably (e.g., temperature range), and make sure various brands of DHTs (e.g., smartphone apps) will gather the same type of data.

Validation studies, including usability studies, should assess the use of DHTs in the intended population, including a comparison of measurements made by the DHT against reference measurements (e.g., steps counted by the DHT versus steps counted by observation), factors that may affect the precision or accuracy of the DHT (e.g., placement of a wearable sensor on a wrist versus a hip), physical interference with measurement, and other factors.  FDA notes that sponsors may leverage verification and validation data made available by DHT manufacturers.

Privacy risks and other implications 

When DHTs are used in a clinical investigation, unique privacy risks may appear.

The guidance recommends that sponsors consider the risk of potential disclosure of identifiable information via either a breach of the DHT or end-user licensing agreements or terms of service that allows sharing of data with the DHT manufacturer and/or other third parties. Sponsors should make sure the data collected and transmitted by the DHT is secure. 

The specific data elements and data format collected by the DHT, including all relevant associated metadata, may be different from what a study sponsor has handled with more traditional medical products.

Besides all mentioned above, the guidance also provides considerations and addendums with specific examples of how different types of DHTs may be used for clinical investigations. Sponsors using novel DHT technology in clinical studies, or collecting new information via DHTs, should consider contacting, before conducting the study, the FDA Center responsible for the medical product (i.e., CDER) in order to discuss the use of the DHT. This way, companies might save both time and funds, in case FDA would not approve the DHT they intended to use or the specific way it was supposed to be used within the study.