FDA Issues Draft Guidance on Digital Health Tech, Seeks Industry Comment By March 2022 – pymnts.com

In a nod to the potential of connected digital devices like data-collecting wearables to improve medical studies while protecting consumers, the U.S. Food and Drug Administration (FDA) issued new draft guidance for companies creating health monitoring hardware and software ahead of new rulemaking.
The U.S. Federal Register issued notice on Dec. 23 regarding “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders.”
Seeking comment on the draft guidance by March 23, 2022, the notice said, “This guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health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,” the FDA stated.
“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).”
Draft guidance further identifies a Digital Health Technology as “a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products.”
The notice adds that “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 and/or other authorized parties to evaluate the safety and effectiveness of medical products.”
Consumer health data is the vital information providers, platforms and manufacturers all need to create the next wave of digital healthcare experiences — recent deals like Oracle-Cerner and athenahealth confirm the trend — and the government is moving to gain more visibility into innovations that are moving faster than lawmakers’ ability to respond and regulate.
See also: Oracle and Cerner Deal Another Sign of Connected Healthcare via Deep Data Analytics
Consumer data security is at the heart of the FDA’s new DHT draft guidance. Per the Notice, “Sponsors should consider cybersecurity risks that could potentially impact the functionality of the DHT and/or compromise patient privacy. Accordingly, sponsors should consider FDA information on cybersecurity to ensure that data can be securely stored and transmitted.”
With much of the language involving “informed consent” of consumers and patients enrolled in clinical studies involving health data collection by wearables and other digital devices, the FDA said, “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.”
Computing platforms that store and analyze health data are also specified in the FDA Notice.
See also: athenahealth Deal Shows Promise and Potential of Connected Health

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