Covered Entities & Business Associates — Corrective action / RA
Resolution —
Penalty
Corrective action / RA
Action type
Resolution agreement
Entity profile
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Case number
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What went wrong
Covered Entities & Business Associates Business Associate Contracts Business Associates
- Navigate to: HIPAA for Professionals Regulatory Initiatives Privacy Summary of the Privacy Rule Guidance Combined Text of All Rules HIPAA Related Links Security Security Rule NPRM Summary of the Security Rule Security Guidance Cyber Security Guidance Breach Notification Breach Reporting Guidance Reports to Congress Regulation History Compliance & Enforcement Enforcement Rule Enforcement Process En
CFR citations
Full description
Navigate to: HIPAA for Professionals Regulatory Initiatives Privacy Summary of the Privacy Rule Guidance Combined Text of All Rules HIPAA Related Links Security Security Rule NPRM Summary of the Security Rule Security Guidance Cyber Security Guidance Breach Notification Breach Reporting Guidance Reports to Congress Regulation History Compliance & Enforcement Enforcement Rule Enforcement Process Enforcement Data Resolution Agreements Case Examples Audit Reports to Congress State Attorneys General Special Topics Parental Access Mental and Behavioral Health Change Healthcare Cybersecurity Incident FAQs HIPAA and COVID-19 HIPAA and Reproductive Health HIPAA and Final Rule Notice HIPAA and Telehealth HIPAA and FERPA Research Public Health Emergency Response Health Information Technology Health Apps Patient Safety Covered Entities & Business Associates Business Associate Contracts Business Associates Training & Resources FAQs for Professionals Other Administrative Simplification Rules Substance Use Disorder Confidentiality Covered Entities and Business Associates The HIPAA Rules apply to covered entities and business associates. Individuals, organizations, and agencies that meet the definition of a covered entity under HIPAA must comply with the Rules' requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information. If a covered entity engages a business associate to help it carry out its health care activities and functions, the covered entity must have a written business associate contract or other arrangement with the business associate that establishes specifically what the business associate has been engaged to do and requires the business associate to comply with the Rules’ requirements to protect the privacy and security of protected health information. In addition to these contractual obligations, business associates are directly liable for compliance with certain provisions of the HIPAA Rules.If an entity does not meet the definition of a covered entity or business associate, it does not have to comply with the HIPAA Rules. See definitions of “business associate” and “covered entity” at 45 CFR 160.103.View an easy-to-use question and answer decision tool to find out if an organization or individual is a covered entity.Fast Facts for Covered EntitiesA Covered Entity is one of the following:A Health Care ProviderA Health PlanA Health Care ClearinghouseThis includes providers such as:DoctorsClinicsPsychologistsDentistsChiropractorsNursing HomesPharmacies...but only if they transmit any information in an electronic form in connection with a transaction for which HHS has adopted a standard.This includes:Health insurance companiesHMOsCompany health plansGovernment programs that pay for health care, such as Medicare, Medicaid, and the military and veterans health care programsThis includes entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.Learn more about business associatesLearn more about business associate contracts Content last reviewed August 21, 2024
Timeline
- Resolution—
- Incident and investigation milestones are not consistently published by OCR in machine-readable form.
Key takeaways for your organization
- Treat internet-facing systems and vendor-hosted environments as in-scope for HIPAA risk analysis and technical safeguards testing.
- Maintain an actionable risk analysis tied to remediation milestones; evidence should map to Security Rule implementation specifications.
- Align policies, procedures, and evidence with the specific CFR provisions cited in OCR resolutions affecting your entity type.
- Run tabletop exercises for breach response, OCR inquiry handling, and privilege-preserving communications with counsel.
Related actions
Source
U.S. Department of Health and Human Services release
Source: U.S. Department of Health and Human Services, Office for Civil Rights. medcomply.ai aggregates public materials for educational use — not legal advice.