settlement

HIPAA Settlement Reinforces Lessons for Users of Medical DevicesCorrective action / RA

Resolution Nov 2015

Penalty

Corrective action / RA

Action type

Settlement

Entity profile

Case number

What went wrong

HIPAA Settlement Reinforces Lessons for Users of Medical Devices - November 24, 2015

  • 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 HIPAA Settlement Reinforces Lessons for Users of Medical Devices Lahey Hospital and Medical Center (Lahey) has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules with the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR). Lahey will pay $850,000 and will adopt a robust corrective action plan to correct deficiencies in its HIPAA compliance program. Lahey is a nonprofit teaching hospital affiliated with Tufts Medical School, providing primary and specialty care in Burlington, Massachusetts. Read the Press Release Read the Resolution Agreement Content last reviewed November 24, 2015

Timeline

  • ResolutionNov 2015
  • 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.