Viewpoint: Consumer devices will only improve outcomes if they can guarantee data integrity

For every medical device backed by valid, peer-reviewed clinical tests, there are just as many based on faulty studies and even more sourcing their claims from nothing more than pseudoscience.

But even those devices that can actually make good on their promises to improve outcomes can fall short if they do not prioritize the security, validity and usability of their data, according to Eric Dy, PhD, the co-founder and CEO of Bloomlife, which produces contraction monitors for pregnant women. In a recent op-ed for STAT, Dr. Dy proposed a new set of standards to ensure data integrity for his and other potentially life-saving device companies.

Because devices are typically used without physician supervision and outside the clinical setting, it is on device makers to guarantee their products can accurately collect data, then utilize it in trustworthy ways. To do so, per Dr. Dy, makers should comply with the following criteria:

  • Field advancement: The data you intend to collect serves a purpose in academic research, clinical practice and patient education.
  • Benchmarking: Your device has been tested against the gold standards used in laboratory or hospital settings.
  • Usability: The design of the device eliminates or minimizes user errors that jeopardize data integrity.
  • Signal quality: Your system separates good data from bad data in real-world environments where poor signal quality is at times unavoidable.
  • Outcomes: You collect reliable data on the outcomes people experience as a result of using your technology.

 When these standards are upheld, he wrote, "connected health can transform outcomes not just by empowering patients to better care for themselves, but by aggregating longitudinal health data to improve doctor-patient communication and seed discoveries of digital biomarkers for breakthrough screening and diagnostic tests."

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