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FDA Shows Support for Open Data Sharing to Protect Patient Safety


Healthcare information exchange could empower patients to participate in the development and evaluation of med tech.


The U.S. Food and Drug Administration (FDA) has released a letter in support of open data sharing through efforts like the Patient Safety Movement Foundation’s Open Data Pledge, according to an announcement today.

While the FDA did not sign the Open Data Pledge, which is meant for companies, it supports the principles of it.

“We encourage policymakers, healthcare entities including hospitals, digital health technology companies, medical device manufacturers and others to share data to support patient safety,” Jeffrey Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, wrote in a letter to Joe Kiani, founder of the Patient Safety Movement Foundation, which aims to eliminate preventable deaths.

The Center for Devices and Radiological Health supports data sharing to protect patients and promote public health, Shuren noted. He wrote that openly sharing data with patients, providers and researchers could:

  • Empower patients to participate in the development and evaluation of medical devices that meet their needs
  • Facilitate medical device surveillance and help identify and prevent adverse effects
  • Increase the FDA’s knowledge of the benefits and risks of technologies, which could enhance patient safety

When individuals and companies sign the Open Data Pledge, they agree to allow anyone who wants to improve patient safety to interact with their products and access the data that are collected. The agreement is subject to privacy laws.

“We are grateful for FDA’s recognition of our work and thank the nearly 100 enlightened companies that have signed the Open Data Pledge,” Kiani said. “Patient harm can be avoided with predictive algorithms and decision support using data from the myriad of products that touch the patient.”

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