settlement

Five breaches add up to millions in settlement costs for entity that failed to heed HIPAA’s risk analysis and risk management rulesCorrective action / RA

Resolution Feb 2018

Penalty

Corrective action / RA

Action type

Settlement

Entity profile

Case number

What went wrong

Five breaches add up to millions in settlement costs for entity that failed to heed HIPAA’s risk analysis and risk management rules - February 1, 2018

  • 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

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 Five breaches add up to millions in settlement costs for entity that failed to heed HIPAA’s risk analysis and risk management rules Fresenius Medical Care North America (FMCNA) has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), and to adopt a comprehensive corrective action plan, in order to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. FMCNA is a provider of products and services for people with chronic kidney failure with over 60,000 employees that serves over 170,000 patients. FMCNA’s network is comprised of dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as hospitalist and post-acute providers. Read the Press Release Read the Resolution Agreement and Corrective Action Plan Content last reviewed February 1, 2018

Timeline

  • ResolutionFeb 2018
  • 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.