The U.S. Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, supports the principle of openly sharing data through efforts like the Patient Safety Movement Foundation’s Open Data Pledge. Creating a healthcare system that embraces data liquidity will help empower patients to actively engage in the development and evaluation of medical devices, enable medical device surveillance to help identify and prevent adverse events from occurring, and enrich the understanding of the benefits and risks of technology utilization.

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FDA Letter of Support for Open Data Sharing

By signing the Patient Safety Movement’s Open Data Pledge, leaders in the healthcare technology industry commit to openly sharing non-proprietary data output from their devices and systems without interference or cost. When the data is pulled together into algorithms, it can then be used to reduce preventable patient harm and deaths.

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

About Patient Safety Movement

More than 200,000 people die every year in U.S. hospitals and 4.8 million worldwide in ways that could have been prevented. The Patient Safety Movement Foundation is a global non-profit which creates free tools for patients and hospitals. The Patient Safety Movement Foundation was established through the support of the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare to reduce that number of preventable deaths to ZERO. Improving patient safety will require a collaborative effort from all stakeholders, including patients, healthcare providers, medical technology companies, government, employers, and private payers. The Patient Safety Movement Foundation works with all stakeholders to address the problems with actionable solutions for patient safety. The Foundation also convenes the World Patient Safety, Science & Technology Summit. The Summit brings together some of the world’s best minds for thought-provoking discussions and new ideas to challenge the status quo. By presenting specific, high-impact solutions to meet patient safety challenges, called Actionable Patient Safety Solutions, encouraging medical technology companies to share the data their products are purchased for, and asking hospitals to make commitments to implement Actionable Patient Safety Solutions, the Patient Safety Movement Foundation is working toward ZERO preventable deaths. Visit patientsafetymovement.org.

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David Kodama
Cook + Schmid
dkodama@cookandschmid.com
619-814-2370 x17

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