Raje Devanathan

Digital Health Technology (DHT) for Clinical Investigations – FDA Draft Guidance Analysis

 FDA DHT Clinical Investigations Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
The FDA thinks we can use these kinds of data for better and safer medical devices. They have built a set of rules around what and how that data can be generated and used.This blog examines their draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. You should also read our previous blog on the future of DHT.

Digital Health Technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. There is a compelling need to leverage the use of such devices in clinical investigations/trials and collect patient data with compliance.

DHT enables use of small devices to measure important patient clinical parameters like clinical, physiological, psychological, behavioral, or functional data for clinical trials. DHT spans devices like smartwatches, sensors, and wearables which can collect data from the patient and can transmit it to clinical trials investigators. DHTs used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research.

The draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, published in January 2022 by FDA, provides recommendations to sponsors, investigators, and other stakeholders regarding the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products. This defines digital health technology (DHT) as a system that uses computing platforms (such as a mobile phone, tablet, or smartwatch), connectivity, software, and/or sensors for healthcare and related uses.

This guidance is targeted at sponsors, investigators, and other interested parties on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products.

If a sponsor wants to use DHT in their clinical trial what kind of information is required during the application process?

These recommendations address the following topics:

  • Selection of DHTs that are suitable for use in the clinical investigation
  • Verification and validation of DHTs for use in the clinical investigation
  • Use of DHTs to collect data for trial endpoints
  • Identification of risks associated with the use of DHTs during the clinical investigation Management of risks related to the use of DHTs in clinical investigations

What are possible risks when DHT is used?

FDA highlighted two types of risks with DHTs: clinical security risks (e.g., cybersecurity/hacking) and privacy-related risks to the data collected on the DHT (e.g., end-user agreements/terms of service).

In addition to the risks that are listed above, there could be ergonomic issues such as the device may be too large or too small or may not be convenient to carry around. If this is the case, device size and shape may affect the treatment and collection and transmission of the data. For example, sensors are often worn with an anchorage.

The size and weight of sensor may cause discomfort or inconvenience to patients and as a result they may choose to remove it resulting in lack of the data continuity. This is a risk in terms of the clinical data collection point.

Cybersecurity risks that may impact DHT operation, and privacy-related risks, could include disclosure of identifiable information of the end-user. Licensing agreements can provide some security and safeguards to protect the data by addressing the licensee’s obligations to promptly notify when a breach occurs, to investigate and remediate it, and communicate results.

How is DHT affecting the data collection from clinical trials?

Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection. This may provide a broader picture of how participants feel or function in their daily lives. DHTs provide opportunities to record data directly from trial participants (e.g., the performance of activities of daily living, sleep) wherever the participants may be (e.g., home, school, work, outdoors). Some DHTs may also facilitate the direct collection of information from participants who are unable to report their experiences (e.g., infants, cognitively impaired individuals).

It enables additional behavioural or location specific data to be captured in a timely manner and be associated with health events. Often with intermittent trial visits the moment may have passed to be able to associate these additional pieces of information with the health status of the participant.

Is DHT only a device? Can it be software?

Yes, DHTs can be software applications that are run on general-purpose computing platforms, such as tablets, laptops or smartphones. These DHTs may be used to administer electronic clinical outcome assessments including electronic patient-reported outcome (ePRO) instruments and electronic performance outcome (ePerfO) instruments. It is important to consider the software application, along with the platform on which it runs, to determine if it is appropriate for use in a clinical investigation.

Can DHT include both hardware and software?

Yes, e.g., a continuous glucose monitoring device that includes a sensor and a mobile application that is required for the intended purpose and function.

Can we use multiple DHTs In clinical trials?

Yes, clinical investigations can choose to use multiple DHTs to measure one or more clinical characteristics or events.

Do the DHT devices used in the clinical trial need premarket approval or clearance?

Some DHTs that may be appropriate for use in a clinical investigation, may also meet the FDA’s definition of a device[1]. Devices intended for use in clinical investigations are exempt from most requirements applicable to devices, including premarket clearance or approval, as long as the investigation complies with applicable requirements under 21 CFR Part 812.14. Therefore, DHTs used in clinical investigations of medical products typically would be exempt from applicable requirements to obtain marketing authorization and other device requirements, as long as the clinical investigation is compliant with Part 812.

Can “bring your own device” be acceptable for the trials?

Participants will likely have their own personal DHT or a general-purpose computing platform. Trial sponsors can consider if participants may be permitted to use a personal DHT or general-purpose computing platform for remote data acquisition in clinical investigation. Some considerations the sponsor should think about when designing a bring your own device approach include performance specifications for measuring clinical events or characteristics.

One very important thing is that you should have confidence that the DHT will measure the data to support the endpoint of interest for clinical investigation and the measurements will be consistent across the DHT.

How do you ensure consistency in data collection?

You will need to define the mechanical specification, operational specification, operation system, storage capacity, and sensors to ensure consistency in your data collection. The sponsor should identify specific defects or general-purpose computing platforms. For example, these might include the brand, the model, or version that meet the minimum technical requirement and performance specifications.

Sponsors should also ensure the availability of telecommunication technologies such as broadband or cellular network to ensure data collection.

How can sponsors decide if the device is fit for the purpose?

The key to this question is verification, validation, and usability.

During verification, we are checking to see if the DHT is measuring the physical parameter of interest accurately and precisely over time. Validation on the other hand, is making sure that it does appropriately access the clinical event or characteristics in the population of interest for investigation.

Usability determines if the enrolled patient is efficiently interacting with the device to provide the quality of data to access the endpoint. Are they in an environment to use the device and is the data collection and transmission done correctly? Is the user trained to use the device in the required way? We must see if it is clinically meaningful, and does it relate to the endpoint of effectiveness?

What are the things that we need to ensure when using a general-purpose computing platform?

The general-purpose computing platform should be appropriately selected for the reliable collection of data during the clinical investigation. When using a general-purpose computing platform to administer electronic clinical outcome assessment, content validation, construct validation or normative testing must be performed. Interoperability of DHT should be evaluated to see that interactions are correct within the electronic interface and that the intended results are measured correctly and interpreted appropriately.

What programs within the FDA are available to approve DHTs?

FDA has a voluntary qualification program. CDRH’s MDDT Qualification Program is aimed at qualifying the DHT as a Medical Device Development Tool (MDDT) for a specific context of use.

When using DHTs to record and transmit data during a clinical investigation, the relevant data captured from the DHT, including all relevant associated metadata, should be securely transferred to and retained in a durable electronic data repository as part of the record of the clinical investigation.

Summary

DHTs have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals. They have the potential to greatly expand the scope and availability of clinical investigations by enabling capabilities such as 24-hour monitoring and geographically dispersed trials. Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection.

DHTs provide opportunities to record data directly from trial participants (e.g., the performance of activities of daily living, sleep) wherever the participants may be (e.g., home, school, work, outdoors). Some DHTs may also facilitate the direct collection of information from participants who are unable to report their experiences (e.g., infants, cognitively impaired individuals. FDA highlighted two types of risks with DHTs: clinical security risks (e.g., cybersecurity/hacking) and privacy-related risks to the data collected on the DHT (e.g., end-user agreements/terms of service).

With all the above being said, as we allow more technology in our lives, we can look forward to more guidance from FDA on how we can leverage it.

[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues#:~:text=For%20a%20medical%20product%20also,primary%20intended%20purposes%20through%20chemical

Image: 111489030 © Pop Nukoonrat | Dreamstime.com

Rajeswari (Raje) Devanathan is a QA/RA Consulting Services Manager at StarFish Medical. Raje is a certified lead auditor and regulatory affairs professional with 20 Years of experience in medical devices, IVD, combination products, and Biologics. She has worked with regulatory authorities across Europe, North America, UK, Australia, and Asia. She works with clients in providing Regulatory strategies and Intelligence, enabling hassle-free regulatory pathways for global markets.

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