{"data":{"id":"us/42-cfr-3.408","jurisdiction":"us","citation":"42 CFR 3.408","heading":"Factors considered in determining the amount of a civil money penalty.","body":"In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:\n(a) The nature of the violation.\n(b) The circumstances, including the consequences, of the violation, including:\n(1) The time period during which the violation(s) occurred; and\n(2) Whether the violation caused physical or financial harm or reputational damage;\n(c) The degree of culpability of the respondent, including:\n(1) Whether the violation was intentional; and\n(2) Whether the violation was beyond the direct control of the respondent.\n(d) Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:\n(1) Whether the current violation is the same or similar to prior violation(s);\n(2) Whether and to what extent the respondent has attempted to correct previous violations;\n(3) How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and\n(4) How the respondent has responded to prior complaints.\n(e) The financial condition of the respondent, including:\n(1) Whether the respondent had financial difficulties that affected its ability to comply;\n(2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and\n(3) The size of the respondent.\n(f) Such other matters as justice may require.","path":["Title 42—Public Health","CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL PROVISIONS","PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT","Subpart D—Enforcement Program"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"baac7cfb0b0f75e393ec969efb2f17434cbcf3fff3cfd0326ca3f1d89462794c","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-3.404","next":"us/42-cfr-3.414"},"notice":"GroundRules: Original legal text. Not legal advice."}