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1Copyright 2007-2015
Business Associates: 
How to become HIPAA
compliant, increase 
revenue, and gain 
new clients
2Copyright 2007-2015
Federal Regulations
§  HIPAA: Health Insurance and Portability Accountability
Act of 1996
•  Purpose: to protect confidential information through
improved security and privacy standards
§  HITECH: The Health Information Technology for Economic
and Clinical Health Act, enacted as part of the
American Recovery and Reinvestment Act of 2009
§  Omnibus Rule of 2013
3Copyright 2007-2015
Entities Defined
§  Covered Entity (CE): Health care providers, health plans,
health care clearinghouses who electronically transmit
any Protected Health Information (PHI)
§  Business Associate (BA): Create, receive, maintain or
transmit PHI on behalf of a Covered Entity (CE)
§  Subcontractor: Create, receive, maintain or transmit PHI
on behalf of a BA
4Copyright 2007-2015
Are You A Business Associate?
Examples:
§  IT Support and Software Vendors
§  IT Equipment Vendors
§  Leasing firms
§  Telephone CPE Vendors
§  Shredding Vendors
§  Data Centers
§  Cloud Computing Providers
§  Answering Services for Medical Offices
§  Medical Billing Services
§  Medical Transcriptions Services
§  Medical Collection Agencies
§  Temporary Employment Agencies
5Copyright 2007-2015
Omnibus Rule
§  Substantially increased the magnitude of HIPAA
enforcement risk and liability
§  Before Omnibus: BAs/Subcontractors regulated through
Business Associate Agreements (BAAs)
§  After Omnibus: BAs/Subcontractors are now regulated
directly under HIPAA:
•  Comply with HIPAA Security Rule
•  Comply with a specific section of the HITECH Breach
Notification Rule
•  Comply with all applicable provisions of the Privacy Rule
•  Still need to provide BAA
6Copyright 2007-2015
Business Associate Agreement
Agreement between the CE and BA to govern the
BA’s creation, use, maintenance and disclosure of PHI.
§  Must comply with HIPAA Security and Privacy Rules
§  BAAs have ALWAYS been required by HIPAA
§  After Omnibus – Require reciprocal monitoring by the BA  CE
§  Subcontractors of BAs are treated as BAs as well
7Copyright 2007-2015
Your Liabilities
Business associates are directly liable for:
1.  Impermissible uses and disclosures
2.  Failure to provide breach notification to the CE
3.  Failure to provide access to a copy of ePHI to either the
CE the individual, or the individual’s designee
4.  Failure to disclose PHI where required by the HHS to
investigate or determine the BA’s HIPAA compliance
5.  Failure to follow Minimum Necessary standard when
using or disclosing
6.  Failure to provide an accounting of disclosures
8Copyright 2007-2015
Penalties For Non-Compliance
Violaon	
  Category	
  
Secon	
  1176(a)(1)	
  	
  	
  
Each	
  Violaon	
   All	
  such	
  violaons	
  of	
  an	
  
idencal	
  provision	
  in	
  a	
  
calendar	
  year
(A)	
  Did	
  Not	
  Know	
   $100	
  to	
  Max	
  $50,000 $1,500,000
(B)	
  Reasonable	
  Cause	
   $1,000	
  to	
  Max	
  $50,000 $1,500,000
(C)(i)	
  Willful	
  Neglect-­‐
Corrected	
  
$10,000	
  to	
  Max	
  $50,000 $1,500,000
(C)(ii)	
  Willful	
  Neglect-­‐Not	
  
Corrected
$50,000 $1,500,000
Before Omnibus: No more than $100 per violation or $25,000
for all identical violations
After Omnibus: Violations é, no more “Did Not Know” defense
9Copyright 2007-2015
Willful Neglect
§  NO plan to show you are working towards FULL compliance
despite not being compliant at the moment.
§  NO visible demonstrable evidence that you are either in
compliance or making a serious attempt at compliance
§  You have legal documents but they do not meet the specific
requirements of the regulations
§  You have are legal documents/manuals but NO policies and
procedures to support said documents
10Copyright 2007-2015
What You NEED To Do
Your Compliance Requirements as a Business Associate:
1) Security Management
§  Risk assessment, Risk management
2) Assigned Security Responsibility
3) Information Access Management
4) Workforce Security
5) Employee Training
6) Security Incident Plan
7) Contingency Plan
8) Evaluation – Annual/periodic evaluation
11Copyright 2007-2015
Compliance Plan
Step 1. Assess where you are against the regulation
(GAP)
•  The key to a risk analysis is auditing yourself against
the administrative, technical, and physical aspects of
HIPAA
Step 2. Remediation Plan
•  Prove that you remediated the deficiencies identified in
the risk analysis
•  Policies  Procedures, Training, and Attestation
12Copyright 2007-2015
Compliance Plan (Continued)
Step 3. How do you prove it? Successful compliance
plans address:
•  Administration and Technical
§ Policies and Procedures
•  IT security
§ Devices installed and maintained within your organization
•  Physical
§ Security within physical locations of your practice(s)
Step 4. Maintain your compliance
•  As the regulations, staff, and practice changes
13Copyright 2007-2015
14Copyright 2007-2015
To Be, Or Not To Be…
§  Protect you and your clients’ reputations
§  Limit your liabilities
•  Protect PHI
§  Differentiate your company
•  Retain Clients
•  Obtain New Clients
This is a Federal Mandate
15Copyright 2007-2015
Health Care Industry
$44
BillionIncentive
Dollars Paid
3-5
Million
CE’S  BA’S
70-79%
Are NOT
Compliant
§  Heavy Enforcement
§  In the News
§  Reputation vs. Fines
16Copyright 2007-2015
Nonprofit
(Alaska)
Pharmacy
(Colorado)
Hospital
(Texas)
Anthem
§  Indiana Dentist – License
Permanently Revoked for
“Mishandling medical records”
§  Denver Pharmacy – “ failed to
provide training as required by
the Privacy Rule.”
§  Alaskan Nonprofit – “policies
and procedures were not
followed and/or updated.”
§  Wellpoint Inc. – $1.7 Million
settlement caused by a BA
performing software upgrade
Trends in HIPAA Enforcement
Dentist
(Indiana)
17Copyright 2007-2015
A Risk Assessment is only a part of HIPAA compliance.
ALL aspects of HIPAA are needed to pass an audit.
•  70% of Covered Entities are not compliant
•  79% of Covered Entities fail their Meaningful Use audit
CEs fail to understand the difference between HIPAA and HITECH.
The Big Misconception
“I completed a Risk Assessment, I’m HIPAA Compliant.”
1:	
  CMS	
  Compliance	
  Reviews,	
  “HIPAA	
  Compliance	
  Review	
  Analysis	
  and	
  Summary	
  of	
  Results”	
  
2:	
  hQp://www.healthcare-­‐informaTcs.com/arTcle/ocr-­‐audits-­‐forewarned-­‐forearmed	
  	
  
	
  
“Problems were discovered with
most or all CE’s policies and
procedures including those for
performing Risk Assessments”1
“89% of the entities audited were non-
compliant in one or more areas. Security
Rule issues accounted for 60% of the
findings and observations, while the
Privacy and Breach Notification
Rules yielded 30% and 10%
respectively”2
18Copyright 2007-2015
*:	
  Stats	
  compiled	
  from	
  2015	
  Webinar	
  “A	
  Risk	
  Assessment	
  is	
  Not	
  Enough.”	
  
	
  
19Copyright 2007-2015
Partnership Program
§  Best solution in the market
•  Designed by Auditors for HIPAA, PCI  GLB
•  Culture of Compliance for the end user
•  TOTAL compliance solution
•  Compliance Coaching
§  Sales  Marketing Support
§  Flexible options for New Revenue
Streams
•  Affiliate Referral
•  Reseller
20Copyright 2007-2015
For more information, contact:
Sales  Demo Scheduling
Questions
Marc Haskelson
855.854.4722 ext 507
marc@compliancygroup.com
HIPAA Questions
Bob Grant
855.854.4722 ext 502
bob@compliancygroup.com
21Copyright 2007-2015
www.compliancy-group.com
855.85 HIPAA (855.854.4722)
HIPAA Compliant
Audits
Security,
Administrative,
Privacy
Remediation
Planning
Policies,
Procedures
 Training
Business
Associate 
Management
Document 
Version
Employee 
Attestation  
Tracking
Incident
Management
Illustrate
Seal of Compliance
Maintain
HIPAA Hotline
Achieve 
Compliance Coaching
Compliance
Simplified
Find out more now:
The Total Compliance Solution
The Guard
u  All aspects of
compliance satisfied
u  Compliance
simplified!
u  Compliance Coach
walks the client
through the whole
journey
u  No client has ever
failed an audit!
22Copyright 2007-2015

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Business Associates: How to become HIPAA compliant, increase revenue, and gain new clients

  • 1. 1Copyright 2007-2015 Business Associates: How to become HIPAA compliant, increase revenue, and gain new clients
  • 2. 2Copyright 2007-2015 Federal Regulations §  HIPAA: Health Insurance and Portability Accountability Act of 1996 •  Purpose: to protect confidential information through improved security and privacy standards §  HITECH: The Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009 §  Omnibus Rule of 2013
  • 3. 3Copyright 2007-2015 Entities Defined §  Covered Entity (CE): Health care providers, health plans, health care clearinghouses who electronically transmit any Protected Health Information (PHI) §  Business Associate (BA): Create, receive, maintain or transmit PHI on behalf of a Covered Entity (CE) §  Subcontractor: Create, receive, maintain or transmit PHI on behalf of a BA
  • 4. 4Copyright 2007-2015 Are You A Business Associate? Examples: §  IT Support and Software Vendors §  IT Equipment Vendors §  Leasing firms §  Telephone CPE Vendors §  Shredding Vendors §  Data Centers §  Cloud Computing Providers §  Answering Services for Medical Offices §  Medical Billing Services §  Medical Transcriptions Services §  Medical Collection Agencies §  Temporary Employment Agencies
  • 5. 5Copyright 2007-2015 Omnibus Rule §  Substantially increased the magnitude of HIPAA enforcement risk and liability §  Before Omnibus: BAs/Subcontractors regulated through Business Associate Agreements (BAAs) §  After Omnibus: BAs/Subcontractors are now regulated directly under HIPAA: •  Comply with HIPAA Security Rule •  Comply with a specific section of the HITECH Breach Notification Rule •  Comply with all applicable provisions of the Privacy Rule •  Still need to provide BAA
  • 6. 6Copyright 2007-2015 Business Associate Agreement Agreement between the CE and BA to govern the BA’s creation, use, maintenance and disclosure of PHI. §  Must comply with HIPAA Security and Privacy Rules §  BAAs have ALWAYS been required by HIPAA §  After Omnibus – Require reciprocal monitoring by the BA CE §  Subcontractors of BAs are treated as BAs as well
  • 7. 7Copyright 2007-2015 Your Liabilities Business associates are directly liable for: 1.  Impermissible uses and disclosures 2.  Failure to provide breach notification to the CE 3.  Failure to provide access to a copy of ePHI to either the CE the individual, or the individual’s designee 4.  Failure to disclose PHI where required by the HHS to investigate or determine the BA’s HIPAA compliance 5.  Failure to follow Minimum Necessary standard when using or disclosing 6.  Failure to provide an accounting of disclosures
  • 8. 8Copyright 2007-2015 Penalties For Non-Compliance Violaon  Category   Secon  1176(a)(1)       Each  Violaon   All  such  violaons  of  an   idencal  provision  in  a   calendar  year (A)  Did  Not  Know   $100  to  Max  $50,000 $1,500,000 (B)  Reasonable  Cause   $1,000  to  Max  $50,000 $1,500,000 (C)(i)  Willful  Neglect-­‐ Corrected   $10,000  to  Max  $50,000 $1,500,000 (C)(ii)  Willful  Neglect-­‐Not   Corrected $50,000 $1,500,000 Before Omnibus: No more than $100 per violation or $25,000 for all identical violations After Omnibus: Violations é, no more “Did Not Know” defense
  • 9. 9Copyright 2007-2015 Willful Neglect §  NO plan to show you are working towards FULL compliance despite not being compliant at the moment. §  NO visible demonstrable evidence that you are either in compliance or making a serious attempt at compliance §  You have legal documents but they do not meet the specific requirements of the regulations §  You have are legal documents/manuals but NO policies and procedures to support said documents
  • 10. 10Copyright 2007-2015 What You NEED To Do Your Compliance Requirements as a Business Associate: 1) Security Management §  Risk assessment, Risk management 2) Assigned Security Responsibility 3) Information Access Management 4) Workforce Security 5) Employee Training 6) Security Incident Plan 7) Contingency Plan 8) Evaluation – Annual/periodic evaluation
  • 11. 11Copyright 2007-2015 Compliance Plan Step 1. Assess where you are against the regulation (GAP) •  The key to a risk analysis is auditing yourself against the administrative, technical, and physical aspects of HIPAA Step 2. Remediation Plan •  Prove that you remediated the deficiencies identified in the risk analysis •  Policies Procedures, Training, and Attestation
  • 12. 12Copyright 2007-2015 Compliance Plan (Continued) Step 3. How do you prove it? Successful compliance plans address: •  Administration and Technical § Policies and Procedures •  IT security § Devices installed and maintained within your organization •  Physical § Security within physical locations of your practice(s) Step 4. Maintain your compliance •  As the regulations, staff, and practice changes
  • 14. 14Copyright 2007-2015 To Be, Or Not To Be… §  Protect you and your clients’ reputations §  Limit your liabilities •  Protect PHI §  Differentiate your company •  Retain Clients •  Obtain New Clients This is a Federal Mandate
  • 15. 15Copyright 2007-2015 Health Care Industry $44 BillionIncentive Dollars Paid 3-5 Million CE’S BA’S 70-79% Are NOT Compliant §  Heavy Enforcement §  In the News §  Reputation vs. Fines
  • 16. 16Copyright 2007-2015 Nonprofit (Alaska) Pharmacy (Colorado) Hospital (Texas) Anthem §  Indiana Dentist – License Permanently Revoked for “Mishandling medical records” §  Denver Pharmacy – “ failed to provide training as required by the Privacy Rule.” §  Alaskan Nonprofit – “policies and procedures were not followed and/or updated.” §  Wellpoint Inc. – $1.7 Million settlement caused by a BA performing software upgrade Trends in HIPAA Enforcement Dentist (Indiana)
  • 17. 17Copyright 2007-2015 A Risk Assessment is only a part of HIPAA compliance. ALL aspects of HIPAA are needed to pass an audit. •  70% of Covered Entities are not compliant •  79% of Covered Entities fail their Meaningful Use audit CEs fail to understand the difference between HIPAA and HITECH. The Big Misconception “I completed a Risk Assessment, I’m HIPAA Compliant.” 1:  CMS  Compliance  Reviews,  “HIPAA  Compliance  Review  Analysis  and  Summary  of  Results”   2:  hQp://www.healthcare-­‐informaTcs.com/arTcle/ocr-­‐audits-­‐forewarned-­‐forearmed       “Problems were discovered with most or all CE’s policies and procedures including those for performing Risk Assessments”1 “89% of the entities audited were non- compliant in one or more areas. Security Rule issues accounted for 60% of the findings and observations, while the Privacy and Breach Notification Rules yielded 30% and 10% respectively”2
  • 18. 18Copyright 2007-2015 *:  Stats  compiled  from  2015  Webinar  “A  Risk  Assessment  is  Not  Enough.”    
  • 19. 19Copyright 2007-2015 Partnership Program §  Best solution in the market •  Designed by Auditors for HIPAA, PCI GLB •  Culture of Compliance for the end user •  TOTAL compliance solution •  Compliance Coaching §  Sales Marketing Support §  Flexible options for New Revenue Streams •  Affiliate Referral •  Reseller
  • 20. 20Copyright 2007-2015 For more information, contact: Sales Demo Scheduling Questions Marc Haskelson 855.854.4722 ext 507 marc@compliancygroup.com HIPAA Questions Bob Grant 855.854.4722 ext 502 bob@compliancygroup.com
  • 21. 21Copyright 2007-2015 www.compliancy-group.com 855.85 HIPAA (855.854.4722) HIPAA Compliant Audits Security, Administrative, Privacy Remediation Planning Policies, Procedures Training Business Associate Management Document Version Employee Attestation Tracking Incident Management Illustrate Seal of Compliance Maintain HIPAA Hotline Achieve Compliance Coaching Compliance Simplified Find out more now: The Total Compliance Solution The Guard u  All aspects of compliance satisfied u  Compliance simplified! u  Compliance Coach walks the client through the whole journey u  No client has ever failed an audit!