In early February 2020, before many people realized what the COVID-19 pandemic would become, 57 US citizens were removed from Wuhan, China, and quarantined at a Nebraska military base. The government engaged an experienced infectious disease specialist from the University of Nebraska Medical Center for help. The expert asked the Center for Disease Control and Prevention (CDC) for permission to test the quarantined group for the virus. According to a Reuters article, an email from an official at the quarantine site on February 8, 2020, stated that the “CDC does not approve this study… Please discontinue all contact with the travelers for research purposes.” An expert clinician responsible for the care of 57 people possibly infected with a deadly virus wants to have the people tested (and they wanted to be tested), and a government official, not a clinician, prevented the testing based on the protections provided in the laws of human-subjects research? This seems absurd. And it contributed to the ongoing spread of the virus in the US, where there have been 47,919,627 diagnosed infections and 783,575 deaths as of November 15, 2021.
Transparency and data availability will be critical to improving patient outcomes and managing people infected in a pandemic, or with any medical problem. A significant part of the lack of transparency and data availability is our fragmented system for patient care and poorly designed medical records. However, we could implement a solution to our data management problem, but like the CDC, we have administrators and lawyers (non-clinicians) who have not recognized the need and/or who actively inhibit clinicians’ access to data. Since the inception of the HIPAA law in 1996, hospitals have misinterpreted the law preventing access to data that could be used to improve outcomes. Additionally, hospitals have also required onerous human-subjects research processes, such as IRB submission, for performing quality improvement activities that, in most instances, should not require IRB submission. The administrators and lawyers often require inappropriate IRB submission “just to be safe.” Making decisions in healthcare “just to be safe” may be one of the most significant contributors to unintentional medical harm and waste in our world.
It’s time to change our thinking and interpret laws through the lens of what is best for patients and the clinicians who care for them, not through the lens of a defense made by a lawyer, administrator, or company. By making important patient and treatment data, including value-based outcomes, available for clinicians in each local clinical environment and providing the appropriate tools for data visualization and analysis, improved outcomes, lower costs, and overall improved value can be achieved. Without access to essential data and analytical tools, it is like pilots attempting to fly a plane with no instruments. Transparent data, appropriate analysis, and feedback loops for ongoing improvement of value-based outcomes will transform our healthcare system into one that is sustainable. We currently don’t have a data and analytics infrastructure (also called a Learning Health System) in each local clinical environment in healthcare. Until we do, we will continue to be flying blind, which is not healthy for patients or the clinicians who care for them.
By: Bruce Ramshaw, MD | Co-Founder & CEO of CQInsights