The U.S. Food and Drug Administration (FDA) has issued new draft guidance for companies creating health monitoring hardware and software.
The U.S. Federal Register issued notice on December 23. The notice said: “This guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products.
“Advances in sensor technology, general-purpose computing platforms, and methods for data transmission and storage have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals.
“DHTs used for remote data acquisition are playing a growing role in healthcare and offer important opportunities in clinical research. DHTs provide opportunities to record data directly from trial participants (e.g. ambulation, sleep, performance of everyday tasks) wherever the participants may be (e.g. home, school, work, outdoors).
“This may provide a broader picture of how participants function in their daily lives. DHTs may also facilitate the direct collection of information from participants who are unable to report their experiences (e.g. infants, cognitively impaired individuals).”
The FDA said DHTs may take the form of hardware and or software and may be used to gather health-related information from study participants. And transmit that information to study investigators or other authorised parties to evaluate the safety and effectiveness of medical products.
The FDA said consumer data security is at the heart of its new DHT draft guidance. The notice said: “Sponsors should consider cybersecurity risks that could potentially impact the functionality of the DHT or compromise patient privacy.
“Accordingly, sponsors should consider FDA information on cybersecurity to ensure that data can be securely stored and transmitted.
“The informed consent process should specify who may have access to data collected through the DHT during or after the clinical investigation (e.g., sponsor, investigator, subject, DHT manufacturer, other third parties) and during what time frame.”
It is currently seeking comment on the draft guidance.
Electronic comments can be submitted via the Federal eRulemaking Portal.
Those who wish to submit a comment with confidential information that you do not wish to be made available to the public should submit it as a written/paper submission.
Comments should be submitted by March 23, 2022.
