With a nod to the potential of connected digital devices such as portable data collection devices to improve medical studies while protecting consumers, the United States Food and Drug Administration (FDA) has released a new draft of guidelines for companies creating health monitoring hardware and software before new rules are adopted.
The US Federal Registry issued an advisory on Dec. 23 regarding “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft guidelines for industry, investigators and other stakeholders. “
Seeking to comment on the draft guidelines by March 23, 2022, the notice stated, “These guidelines provide recommendations to sponsors, investigators and other stakeholders on the use of digital health technologies (DHT). to acquire data remotely from participants in clinical surveys evaluating products. “
“Advances in sensor technology, general purpose computing platforms, and methods of data transmission and storage have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals,” the FDA said.
“DHTs used for remote data acquisition are playing an increasing role in healthcare and offer important opportunities in clinical research. DHTs provide the ability to record data directly from trial participants (e.g. walking, sleeping, performing daily tasks) wherever the participants are located (e.g. at home, at home, in the workplace). school, at work, outside); it can provide a broader picture of how participants function in their daily lives. DHTs can also facilitate the direct collection of information from participants who are unable to report their experiences (eg, infants, people with dementia).
The draft guidelines further identify digital health technology as “a system that uses computing platforms, connectivity, software and / or sensors for health care and related uses. These technologies cover a wide range of uses, from general wellness applications to medical device applications. They include technologies intended for use as a medical product, in a medical product or as a complement to other medical products (devices, drugs and biologicals). They can also be used to develop or study medical products.
The notice adds that “DHTs can take the form of hardware and / or software and can be used to collect information relating to the health of study participants and relay that information to study investigators and / or to other authorized parties to assess the safety and effectiveness of medical care. some products.”
Consumer health data is the vital information that vendors, platforms, and manufacturers all need to create the next wave of digital healthcare experiences – recent agreements like Oracle-Cerner and athenahealth confirm the trend – and the government is about to gain visibility on evolving innovations. faster than the ability of legislators to respond and regulate.
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The security of consumer data is at the heart of the FDA’s new draft DHT guideline. According to the opinion, “Sponsors should consider cybersecurity risks that could potentially impact DHT functionality and / or compromise patient privacy. Accordingly, sponsors should take into account FDA cybersecurity information to ensure that data can be stored and transmitted securely. “
With much of the language involving the “informed consent” of consumers and patients enrolled in clinical studies involving the collection of health data by wearable devices and other digital devices, the FDA said, “The process of informed consent should specify who can access the data collected through DHT. during or after the clinical investigation (eg, sponsor, investigator, subject, DHT manufacturer, other third parties) and for what period.
The computer platforms that store and analyze health data are also specified in the FDA notice.
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