Real-world data (and real-world evidence) can also play roles outside of public health emergencies like Covid and monkeypox. They can help determine the long-term effectiveness of many treatments, especially those subject to the expedited approval process, such as those used for rare diseases, and can help determine the value of drugs in general. In many cases, clinical trials are not enough to understand how well drugs really work. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, has said that the clinical trial system is “broken” and that more use of real-world evidence could be an effective addition to the approval process.

The FDA has been taking steps toward using more real-world data outside of public health emergencies like Covid and monkeypox. In 2018, the agency issued guidance for use of such evidence in approving drugs. By 2021, when the FDA issued enhanced guidance on the topic, real-world evidence had been used in approving 90 medical devices and the new use of a drug, Prograf. But this is not happening enough in practice.

Failing to use real-world data means missing out not just on better understanding of the effectiveness of individual drugs but also on a chance to improve the entire pharmaceutical sector, including addressing issues like rising costs. The availability of more data on real-world outcomes from using drugs, especially gene therapies and other innovative and often very expensive treatments, would pave the way for pricing to take patient outcomes into account through approaches like value-based contracting, when health insurers base drug prices on how well drugs work in the people who take them, rather than just in premarket clinical trials.

While CommonSpirit declined to share specifics, a person familiar with its remediation efforts confirmed to NBC News that it had sustained a ransomware attack.

CommonSpirit, which has more than 140 hospitals in the U.S., also declined to share information on how many of its facilities were experiencing delays. Multiple hospitals, however, including CHI Memorial Hospital in Tennessee, some St. Luke’s hospitals in Texas, and Virginia Mason Franciscan Health in Seattle all have announced they were affected.

Dr. Sarita A. Mohanty, MD, MPH, MBA (https://www.thescanfoundation.org/about/board-of-directors/sarita-a-mohanty/), serves as the President and Chief Executive Officer of The SCAN Foundation, one of the largest foundations in the United States focused on improving the quality of health and life for older adults. Its mission is to advance a coordinated and easily navigated system of high-quality services for older adults that preserve dignity and independence.

The SCAN Foundation was created as an independent charitable organization in April 2008 through a $205 Million one-time contribution from the not-for-profit SCAN Health Plan, a not-for-profit, Medicare Advantage based in Long Beach, California.

Previously, Dr. Mohanty served as the Vice President of Care Coordination for Medicaid and Vulnerable Populations at Kaiser Permanente; Assistant Professor of Medicine at USC; Chief Medical Officer of COPE Health Solutions, a health care management consulting company; and Senior Medical Director at L.A. Care, the largest U.S. public health plan.

Dr. Mohanty completed her Internal Medicine residency at Beth Israel Deaconess Medical Center and research fellowship at Harvard Medical School. She earned her MD from Boston University, MPH from Harvard University, and MBA from UCLA. She completed undergraduate work at UC Berkeley. She currently is an Associate Professor at the Kaiser Permanente Bernard J. Tyson School of Medicine and is a practicing internal medicine physician with Kaiser Permanente.