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The U.S. Food and Drug Administration has released a draft guidance focused on using digital health technologies to acquire data remotely from participants in clinical investigations of medical products.  

“Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection, humira reaction to nexium ” said FDA officials. “This may provide a broader picture of how participants feel or function in their daily lives.”  

At the same time, it said, sponsors and stakeholders should ensure their technology of choice is fit for its intended purpose.  

“Sponsors are encouraged to engage with the DHT manufacturer or other parties in order to leverage any existing information, as appropriate, to support the DHT’s suitability for use in the specific clinical investigation,” according to the draft guidance.  

WHY IT MATTERS  

The FDA notes that digital health tools used for remote data acquisition can offer an important role in clinical research. Their ability to transmit data across distances can increase opportunities for patients to participate in trials, particularly those who may not have been able to overcome geographic or transportation hurdles.  

“This may provide a broader picture of how participants feel or function in their daily lives,” officials said.  

“DHTs provide opportunities to record data directly from trial participants … wherever the participants may be,” they added. “Some DHTs also may facilitate the direct collection of information from participants who are unable to report their experiences.”  

Such tools often consist of sensor hardware, but can also include software applications.  

The draft guidance touched on regulatory considerations, noting that DHTs used in clinical investigations of medical products would usually be exempt from applicable requirements to obtain marketing authorization and other device requirements.  

It also outlined considerations for study sponsors when using digital health tools in this fashion. The considerations included:

  • Technology selection, factoring in investigation population, DHT design and the appropriateness of participants’ own tools, as well as how to explain the tools’ suitability in submissions
  • Verification, validation and usability of the technology
  • Using tools to collect data for clinical endpoints
  • Technology risks, such as those concerning physical well-being, privacy and informed consent
  • Record protection and retention  

Comments are due on the draft guidance by March 22.  

THE LARGER TREND  

The FDA has released a handful of draft guidances and “guiding principles” over the past year aimed at offering clarity on medical devices.  

Arguably the most notable has been for its Content of Premarket Submissions for Device Software Functions, posted in November. The final version would replace its current guidance, which is now more than 16 years old.  

“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices,” said Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health, in a statement in November.   

“The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices,” he said.  

ON THE RECORD  

“This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115),” said agency representatives in their Federal Register posting just before Christmas.   

“The draft guidance, when finalized, will represent the current thinking of FDA on ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,'” they said. “It does not establish any rights for any person and is not binding on FDA or the public.”

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Email: [email protected]
Healthcare IT News is a HIMSS Media publication.

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