Jessica Hambidge, head of regulatory affairs, LFH Regulatory, shares insight on digital health technologies for the US market and where we are today.
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There is a broad scope when we think about digital health, categories include mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine and personalised medicine. The technology available is revolutionising healthcare to accurately monitor, diagnose, and treat disease.
The FDA states that by using digital health tools, they can empower consumers to make better-informed decisions about their own health as well as providing new options for facilitating prevention and early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional healthcare settings.
The regulatory perspective
These advances have led the FDA to putting more focus and resources into Digital Health, including the creation of the Digital Health Centre of Excellence (DHCoE) which was formed in 2020. Digital Health Technologies (DHTs) have been creating a revolution in healthcare for many years, with the potential to benefit patients in ways that we are only just beginning to understand, one of which is the use of DHTs in drug development.
In March of 2023, the FDA released a Framework for the use of DHTs in Drug and Biological product development which intends to address the challenges related to the use of DHTs in regulatory decision-making for drugs, such as data accuracy and reliability.
DHTs used in drug development have not always fallen within the definition of a medical device, or the device is a low classification and hasn’t had thorough clinical testing, which can mean the appropriate evidence needed to prove effectiveness may not be available, resulting in the data collected from them cannot be used in any meaningful way.
The new FDA Framework details the activities that the FDA will do in the coming years to provide clear guidance on the requirements for DHTs when they are intended to be used in regulatory decision making of drug development.
DHTs can be used for remote data collection purposes in drug clinical studies with goals to continuously collect data from study participants and reduce the burden of study visits and increase recruitment rates, study population diversity and more. However, in order to use the data collected by the DHTs as endpoints in clinical studies, there needs to be appropriate evidence for the DHTs, proving the clinical effectiveness of the DHT and their measure, as well as how the DHT is maintained throughout the duration of the study. Currently DHTs are mostly used for exploratory endpoints only, DHT data has yet to be used for secondary or primary endpoints in more than a few successful clinical studies.
The Framework lists several draft guidance’s that the FDA has released in recent years, including, ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’. This guidance places the responsibility on the sponsor of the clinical study to ensure that the DHT is fit-for-purpose, which includes a large number of topics to review, including design and validation.
What does this mean for manufacturers of DHTS?
This is where the manufacturers of the DHT can provide the highest benefit to the sponsors of the clinical study. If manufacturers of DHTs design and manage their DHTs in a similar way to high classification medical device development, even if their DHT isn’t a medical device, they will be able to provide the sponsor with most, if not all of the information required for the fit-for-purpose assessment, including a full validation package, processes and records of design, development and maintenance.
The industry still has a long way to go before it becomes standard practice to use DHTs for regulatory decision making in drug development, but that doesn’t mean that it isn’t possible for manufacturers of DHTs to get a head start. The Framework and the guidance’s that will be developed in the next few years will provide further clarifications on how to develop DHTs moving forward and the work needed to be done for older products to be used for secondary and primary endpoints in clinical studies.