With limited exceptions, the HIPAA Privacy Rule gives individuals the right to access, upon request, the medical and health information (protected health information or PHI) about them in one or more designated record sets maintained by or for the individuals’ health care providers and health plans (HIPAA covered entities). See 45 CFR 164.524. Designated record sets include medical records, billing records, payment and claims records, health plan enrollment records, case management records, as well as other records used, in whole or in part, by or for a covered entity to make decisions about individuals. See 45 CFR 164.501. Thus, individuals have a right to access a broad array of health information about themselves, whether maintained by a covered entity or by a business associate on the covered entity’s behalf, including medical records, billing and payment records, insurance information, clinical laboratory test reports, X-rays, wellness and disease management program information, and notes (such as clinical case notes or “SOAP” notes (a method of making notes in a patient’s chart) but not including psychotherapy notes as explained below), among other information generated from treating the individual or paying for the individual’s care or otherwise used to make decisions about individuals. In responding to a request for access, a covered entity is not, however, required to create new information, such as explanatory materials or analyses, that does not already exist in the designated record set. Further, while individuals have a right to a broad array of PHI about themselves in a designated record set, a covered entity is only required to provide access to the PHI to which the individual requests access. Individuals do not have a right to access PHI about them that is not part of a designated record set because this information is not used to make decisions about individuals. This may include certain quality assessment or improvement records, patient safety activity records, or business planning, development, and management records that are used for business decisions more generally rather than to make decisions about individuals. For example, peer review files, practitioner or provider performance evaluations, quality control records used to improve customer service, and formulary development records may be generated from and include an individual’s PHI but may not be in the covered entity’s designated record set(s) to which the individual has access. However, the underlying PHI from the individual’s medical or payment records used to generate such information remains part of the designated record set and subject to access by the individual. For example, an individual would not have the right to access internal memos related to the development of a formulary; however, an individual does have the right to access information about prescription drugs that were prescribed for her, and claims records related to payment for those drugs, even if that information was relied on in, or helped inform, the development of the formulary. Individuals also do not have a right to access the psychotherapy notes that a mental health professional maintains separately from the individual’s medical record and that document or analyze the contents of a counseling session with the individual. In addition, individuals do not have a right to access information about the individual compiled in reasonable anticipation of, or for use in, a legal proceeding (but the individual retains the right to access the underlying PHI from the designated record set(s) about the individual used to generate the litigation information). However, a covered entity has the discretion to share this information with the individual if it chooses. See 45 CFR 164.524(a)(1) – (a)(3) for a complete list of exceptions to the right of access.