The Patient Safety and Quality Improvement Act was enacted in 2005. It was three years before any regulations were published regarding who would qualify as a Patient Safety Organization (PSO) to which providers could report safety and quality data which would be protected from discovery in almost any setting. In thinking about the type of work that real clinical integration entails, those who engage in the required intense self scrutiny that is essential to change clinical processes to deliver safer, better, more valuable health care will have to generate highly sensitive data about their own performance. To invoke the protections of the law, the data must be generated within a Patient Safety Evaluation System (PSES) which is specific to the reporting provider. Providers include any kind of health facility or practitioner licensed or authorized under state law to provide health care services. Interestingly, providers do not include IPAs, PHOs or ACOs which are rarely licensed or authorized under state law to deliver care. This does not mean they are outside the bounds of the law. This means good lawyers can be creative about how to structure relationships between providers and these new delivery vehicles so that data can be protected through a PSES for reporting to a PSO.

When sensitive data is managed within this system, it cannot be introduced, discovered or used by anyone else in any federal, state or tribal court or administrative setting, subject to very limited exceptions. The law provides both a privilege enforced by the courts as well as broad confidentiality, the breach of which is enforced by the Office of Civil Rights of DHHS. It is both flexible and potentially sweeping in its effects. The system is reminiscent of the principles for tort reform that Alice set forth in an article in 2000. In "Physicians and Patient Safety Organizations: Furthering Clinical Integration" Alice presents the context for PSOs, what the regulations require for reporting to a PSO, what caselaw teaches us and then explores some ways in which deploying this mechanism can protect the hard work physicians will have to do to make their care better. This is an opportunity all physician groups and facilities should explore. It has the potential to bring to smaller entities the experiences and learning from others, thereby multiplying the power of engagement with the PSO. We will be working with our clients to help them develop their Patient Safety Evaluation Systems and the contracts with the PSOs to which they will report.