The Health Information Technology for Economic and Clinical Health (“HITECH”) Act modified the Health Insurance Portability and Accountability Act (“HIPAA”) by expanding the definition of Business Associates (“BA”) and their responsibilities and liabilities. A BA includes:
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Health Information Organizations
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E-Prescribing Gateways
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Persons/entities that for, or on behalf of, a Covered Entity:
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Create or received PHI
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Maintain or store PHI even if they do not or cannot access the PHI
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Offer personal health records
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Provide data transmission services if they routinely access the PHI
Pursuant to HITECH and HIPAA, BAs are required to do the following:
Designate Security Officer
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Perform Security Risk Assessment
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Implement Administrative, Physical, and Technical Safeguards
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Identify and Report Breaches and Security Incidents
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Develop Polices for HIPAA/ HITECH Compliance Program
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Impose Disciplinary Actions for HIPAA/HITECH Violations
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Have Business Associate Agreements with Subcontractors
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Maintain Documentation 6 Years
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The Federal Office for Civil Rights (“OCR”) enforces HIPAA and HITECH. BAs are under great scrutiny from the OCR as BAs have been identified as one of the OCR’s top three enforcement priorities in 2016. Under HIPAA and HITECH, BAs are directly liable for compliance and subject to these monetary penalties:
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Violation Category
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Each Violation
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Maximum Penalty per Identical Provision Violated in Calendar Year
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Did Not Know
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$100 - $50,000
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$1,500,000
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Reasonable Cause
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$1000 - $50,000
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$1,500,000
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Willful Neglect – Corrected
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$10,000 - $50,000
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$1,500,000
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Willful Neglect – Not Corrected
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$50,000
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$1,500,000
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Key Considerations for BAs:
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Determine if you are a BA
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Designate person to oversee a HIPAA/HITECH Compliance Program
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Identify high risks, e.g., mobile devices, emails, texting, medical devices
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Respond timely and effectively to breaches and security incidents
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Monitor, audit, and update privacy and security on ongoing basis
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Know the terms of Business Associate Agreements
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Prepare contingency/disaster plan
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Maintain adequate cyber insurance
