FDA Guidance on Digital Health Technologies Highlights Risks

Decentralized Clinical Trials (DCTs) and the use of new technologies bring many potential benefits. They also bring new types of risk. The FDA Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations highlights the types of risks that need to be considered.


A Digital Health Technology (DHT) is described as ‘a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related issues’. The guidance describes two general risk categories for DHTs, clinical risks and privacy-related risks.


Clinical risks can relate to the physical features of a DHT causing injury, for example a wrist band restricting blood supply, or a wearable causing skin irritation. If the DHT is to be reused, procedures need to be in place for cleaning to prevent infection.


Where measurements made by DHTs (e.g., glucometers) are used to modify the trial, or the treatment of patients, it is critical to evaluate the risk of erroneous measurements from the DHT that could lead it inappropriate treatments.


Cybersecurity risks need to be considered that could impact the functionality of the DHT, and/or compromise patient privacy. Special consideration needs to be given to privacy risks relating to the use of “general-purpose” devices such as mobile phones for data collection and transmission.


The guidance goes into some detail about the informed consent process. For clinical-related risks the informed consent process ‘must describe any reasonable and reasonably foreseeable risks or discomforts to the subject’. The process must also include the measures taken to protect a subject’s privacy and data, and the limitations of those measures.


Data quality and integrity considerations include developing a risk management plan to address potential problems such as the loss, damage, and replacement of DHTs during the investigation. Other factors to be considered include collecting data at appropriate intervals, connecting to wireless networks, uploading, and syncing data. Contingency plans should also made for changes to the DHT during the investigation, for example where a manufacturer discontinues a specific model. Procedures need to be put in place to identify and address DHT errors, including for alternative data collection and recording mechanisms.


Identifying and managing risks related to DCTs and DHTs requires a different type of thinking. While lessons can and should be learned from every clinical trial, each new trial is different. That means thinking through what could possibly go wrong with your technology, and what you’re going to do about it when it does.


For those companies who are following RBQM processes already, the introduction of DCTs is going to be a new set of considerations which fit into an existing set of processes, and the mindset of critical thinking should already be well established. For those who haven’t implemented RBQM yet, it is my opinion that the move towards greater patient centricity and the use of DHTs will be a strong driver of adoption.