Residential programs should note that the United States Department of Health and Human Services (“HHS”) has not provided clear guidance on what records would represent records maintained by the residential program or business associate to make decisions about individual residents. HHS has stated that the designated record set includes “records that are used to make decisions about any individuals, whether or not the records have been used to make a decision about the particular individual requesting access [to records].” This suggests that the “catch-all” category could include quality assurance reports, peer review records, and other compliance reports and materials, which, on some level, are used to make decisions about individuals. HHS has also stated, however, that quality assurance records “typically would not be used to make decisions about individuals, and, thus, typically would not be part of a designated record set.” HHS has warned that it does “not agree that records in these categories are never used to affect the interests of individuals.”
Given the contradictory nature of the advice from HHS, each agency must analyze categories of records, decide to what extent the records direct treatment of individuals, and ultimately make a business decision about whether or not to include the records.