Building a Rapid Learning Health Care System for Oncology: The Regulatory Framework of CancerLinQ

Today is a time of unprecedented opportunity and challenge in health care generally and cancer care in particular. An explosion of scientific knowledge, the rapid introduction of new drugs and technologies, and the unprecedented escalation in the cost of health care challenge physicians to quickly assimilate new information and appropriately deploy new advances while also delivering efficient and high-quality care to a rapidly growing and aging patient population. At the same time, big data, with its potential to drive rapid understanding and innovation, promises to transform the health care industry, as it has many others already. CancerLinQ is an initiative of the American Society of Clinical Oncology (ASCO) and its Institute for Quality, developed to build on these opportunities and address these challenges by collecting information from the electronic health records of large numbers of patients with cancer. CancerLinQ is, first and foremost, a quality measurement and reporting system through which oncologists can harness the depth and power of their patients' clinical records and other data to improve the care they deliver. The development and deployment of CancerLinQ raises many important questions about the use of big data in health care. This article focuses on the US federal regulatory pathway by which CancerLinQ will accept patient records and the approach of ASCO toward stewardship of the information. (C) 2014 by American Society of Clinical Oncology