Not only do individual patients have an expectation of privacy, but healthcare systems and clinicians may also have an expectation of privacy, especially when it comes to sharing data that could contain proprietary formularies, increase risk of liability, or present reputational risks. As discussed in the Data Sharing and Embedded Research chapter, data from pragmatic trials embedded in healthcare systems might contain detailed information that could identify not only individual patients, but also participating health facilities or organizations and the clinicians within them. The risk of disclosures of these data raises a range of privacy concerns for clinicians and healthcare systems. Relevant risks include:

• Disclosure of proprietary business information
• Increasing potential liability due to gaps in care of individuals
• Reputational risk regarding perceived gaps in overall quality, including the risk that biased or misleading analyses will inappropriately characterize an institution or clinician as being of poor quality

These issues, including patient perspectives on data sharing, are described in detail in the chapter Data Sharing and Embedded Research.

Many patients, clinicians, and institutions care about privacy and about how their information is used. Because pragmatic clinical trials are embedded into care settings, and include diverse types of health information, investigators need to understand both the relevant regulations and the special considerations that we describe here.