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1
855-85-HIPAA
© 2016 Compliancy Group, LLC
HIPAA Compliance for
Business Associates: The
Value of compliance, how to
acquire and retain clients!
2
855-85-HIPAA
© 2016 Compliancy Group, LLC
§  HIPAA
•  Protect patient confidentiality while
furthering innovation and patient care.
§  Omnibus
•  Business Associates must protect PHI.
§  HITECH/Meaningful Use
•  Accelerate adoption of EHR(electronic
Health records).
§  Penalties or Incentives for adherence
HIPAA & HITECH
HIPAA
OMNIBUS
HITECH/
Meaningful
Use
3
855-85-HIPAA
© 2016 Compliancy Group, LLC
Before/After Omnibus Rule
§  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
§  Substantially increased the magnitude
of HIPAA enforcement risk and liability
4
855-85-HIPAA
© 2016 Compliancy Group, LLC
BAAs
Business Associate Agreements: 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
5
855-85-HIPAA
© 2016 Compliancy Group, LLC
The Seven Fundamental Elements of an
Effective Compliance Program
Compliance according to HHS:
1.  Implementing written policies, procedures and standards of conduct.
2.  Designating a compliance officer and compliance committee.
3.  Conducting effective training and education.
4.  Developing effective lines of communication.
5.  Conducting internal monitoring and auditing.
6.  Enforcing standards through well-publicized disciplinary guidelines.
7.  Responding promptly to detected offenses and undertaking corrective action.
*Source HHS & OIG
6
855-85-HIPAA
© 2016 Compliancy Group, LLC
§  Audits
•  Security/Administrative/Privacy
§  Gap identification and Remediation
§  Policies & Procedures
§  Employee Training & Attestation
§  Incident Management
§  Business Associate Management
§  Security Risk Analysis
§  Penetration Testing
§  Vulnerability Scan
§  Network Security
§  Managed Services
§  IT Consulting
§  Cloud Services
REPUTATION
Security Risk Assessment
Compliance + Security
7
855-85-HIPAA
© 2016 Compliancy Group, LLC
Trends in HIPAA Enforcement
HIPAA compliance as a differentiator
§  Fitbit Inc. – announces its HIPAA compliance, stock price soared (26%)
Violation Settlements in 2015
Nonprofit
Alaska
$150k
Pharmacy
Colorado
$125k
PhysicianPractice
Indiana
$750k
Hospital
Texas
$4.4M
Dentist
Indiana
$12k
$80k
Hospital&BA
Connecticut
1 in 4 Americans
Affected by
Anthem Breach
$3.5M
MedicalSchool
Washington
$750k
TeachingHospital
Massachusetts
$850k
§  THREE Prison Sentences
§  Medical License Revoked
§  State Attorney General levying fines
InsuranceCompany
PuertoRico
Campus
NewYork
$15k
8
855-85-HIPAA
© 2016 Compliancy Group, LLC
Phase 2 Audits - NOW
§  Began: March 22, 2016
§  Covered Entities will receive an email from OCR
to verify their contact information; Business
Associates as well
§  Failure to respond will not exclude you from
potentially being audited, OCR will simply use
publicly available information
"The 2016 Phase 2 HIPAA Audit Program will review the
policies and procedures adopted and employed by
covered entities and their business associates to meet
selected standards and implementation specifications
of the Privacy, Security, and Breach Notification Rules.”
9
855-85-HIPAA
© 2016 Compliancy Group, LLC
Why Should I Care?
§  Your clients are at risk
§  You are at risk
§  Limit your liabilities
•  Protect PHI, reputation damage, $$$ penalties
This is a Federal Mandate, NOT optional
10
855-85-HIPAA
© 2016 Compliancy Group, LLC
What Are My 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
11
855-85-HIPAA
© 2016 Compliancy Group, LLC
Insurance Holding Company
§  Insurance company, Triple-S (Puerto Rico)
§  Widespread non-compliance
•  Failure to implement Administrative, Privacy, and Technical
safeguards
•  Lack of appropriate Business Associate Agreements
•  Failure to conduct accurate/thorough Risk Analysis
§  Settlement: $3.5 Million (11/30/15)
“This case sends an important message for HIPAA Covered Entities not only about
compliance with the requirements of the Security Rule, including risk analysis, but
compliance with the requirements of the Privacy Rule, including those addressing
business associate agreements and the minimum necessary use of protected health
information.” said OCR Director Jocelyn Samuels.
http://www.hhs.gov/about/news/2015/11/30/triple-s-management-corporation-settles-hhs-charges.html
12
855-85-HIPAA
© 2016 Compliancy Group, LLC
But…It Probably Won’t Happen To Me
§  In a recent study, more than half of
business associates (59%) reported a
data breach in the last two years that
involved the loss or theft of patient
data. More than a quarter (29%)
experienced two breaches or more.
§  Of the 345 incidents reported by HHS
and listed on their site under Breaches
Affecting 500 or More Individuals, 74
involved a business associate (21%).
Fifth Annual Benchmark Study on Privacy & Security of Healthcare Data conducted by Ponemon Institute
http://media.scmagazine.com/documents/121/healthcare_privacy_security_be_30019.pdf
13
855-85-HIPAA
© 2016 Compliancy Group, LLC
HHS Wall of Shame
14
855-85-HIPAA
© 2016 Compliancy Group, LLC
Importance of BAA & Complete Risk Analysis
§  North Memorial Health Care of Minnesota
§  Laptop theft, 6,497 patient records
§  No BAA with Billing firm
§  Failed to complete a risk analysis to address all
potential risks and vulnerabilities to ePHI
§  Settlement: $1,550,000 (3/19/16)
“Two major cornerstones of the HIPAA Rules were overlooked by this entity,” said
Jocelyn Samuels, Director of OCR. “Organizations must have in place compliant
Business Associate Agreements as well as an accurate and thorough risk analysis that
addresses their enterprise-wide IT infrastructure.
http://www.hhs.gov/about/news/2016/03/16/155-million-settlement-underscores-importance-executing-hipaa-business-
associate-agreements.html
15
855-85-HIPAA
© 2016 Compliancy Group, LLC
The NEED for BAAs
§  Raleigh Orthopaedic (North Carolina)
§  17,300 patient records
§  Handed over x-rays and associated PHI to
potential business partner without first executing
a business associate agreement.
§  Settlement: $750,000 (4/20/16)
“HIPAA’s obligation on covered entities to obtain business associate agreements is
more than a mere check-the-box paperwork exercise,” said Jocelyn Samuels, Director
of OCR. “It is critical for entities to know to whom they are handing PHI and to obtain
assurances that the information will be protected.”
http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/raleigh-orthopaedic-clinic-bulletin/
index.html
16
855-85-HIPAA
© 2016 Compliancy Group, LLC
What’s The Big Deal About HIPAA?
§  Federal Mandate “LAW”
•  Heavy Enforcement
§  In the News
§  Reputation & Fines
§  2015 Fastest
growing sector
3-5
Million
CE’S & BA’S
70-79%
Are NOT
Compliant
$44
Billion
Incentive
Dollars Paid
17
855-85-HIPAA
© 2016 Compliancy Group, LLC
Benefits Of Being Compliant
§  Differentiate yourself: You become more credible than your
competitors
•  Announce your compliance
§  Retain current clients
§  New revenue streams
18
855-85-HIPAA
© 2016 Compliancy Group, LLC
Differentiate Your Company
HIPAA compliance as a differentiator
§  Fitbit Inc. – announces its HIPAA compliance, stock price soared (26%)
19
855-85-HIPAA
© 2016 Compliancy Group, LLC
MSP/ Service Provider
§  Beat the competition
§  New Market Opportunities
§  Recurring Revenue
§  Scalable offering
§  Higher Margins
“We see The Guard as a solution that remedied our concerns about providing compliance support for our clients that also
suited their needs to a tee. Liability has never been an issue, and Compliancy Group’s proven track record of not having a
single client ever fail an OCR audit has proven true with our clients as well. They cared about fitting The Guard into our
pre-existing business, and with the marketing and sales support they’ve even held private webinars just for the benefit of
our clients. Compliancy Group and their team of Compliance Coaches has let us focus on the security work we’ve always
provided while enhancing our offerings with a powerful total compliance solution that we know will work for our clients.”–
George Passidakis, Director of Sales and Market
20
855-85-HIPAA
© 2016 Compliancy Group, LLC
Adding Compliance To Your Offerings
§  Increase stickiness of clients
§  Added value to your offerings
§  Your clients are compliant and so are you!
•  Limit liability for all parties
§  New revenue stream
21
855-85-HIPAA
© 2016 Compliancy Group, LLC
How Do I Become Compliant?
Business Associate Compliance Requirements:
q  Audits
q  Security Risk Assessment and Administrative Assessment
q  Identify deficiencies
q  Create remediation plans
q  Security and Administrative
q  Policies and Procedures
q  Employee Training
q  Identify CEs and BAs (BAAs)
q  Incident Management
q  Review of compliance – Annual/periodic
22
855-85-HIPAA
© 2016 Compliancy Group, LLC
Solving The HIPAA Compliance Puzzle
Audits
SRA (Security Risk
Assessment),
Administrative,
Privacy
Remediation
Plan
Policies,
Procedures
& Training
Business
Associate
Management
Incident
Management &
Remediation
Document
Version
Employee
Attestation &
Tracking
23
855-85-HIPAA
© 2016 Compliancy Group, LLC
Compliance
Questions?
For more information, contact:
Marc Haskelson
855.854.4722 ext 507
marc@compliancygroup.com

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HIPAA compliance for Business Associates- The value of compliance, how to acquire and retain clients!

  • 1. 1 855-85-HIPAA © 2016 Compliancy Group, LLC HIPAA Compliance for Business Associates: The Value of compliance, how to acquire and retain clients!
  • 2. 2 855-85-HIPAA © 2016 Compliancy Group, LLC §  HIPAA •  Protect patient confidentiality while furthering innovation and patient care. §  Omnibus •  Business Associates must protect PHI. §  HITECH/Meaningful Use •  Accelerate adoption of EHR(electronic Health records). §  Penalties or Incentives for adherence HIPAA & HITECH HIPAA OMNIBUS HITECH/ Meaningful Use
  • 3. 3 855-85-HIPAA © 2016 Compliancy Group, LLC Before/After Omnibus Rule §  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 §  Substantially increased the magnitude of HIPAA enforcement risk and liability
  • 4. 4 855-85-HIPAA © 2016 Compliancy Group, LLC BAAs Business Associate Agreements: 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
  • 5. 5 855-85-HIPAA © 2016 Compliancy Group, LLC The Seven Fundamental Elements of an Effective Compliance Program Compliance according to HHS: 1.  Implementing written policies, procedures and standards of conduct. 2.  Designating a compliance officer and compliance committee. 3.  Conducting effective training and education. 4.  Developing effective lines of communication. 5.  Conducting internal monitoring and auditing. 6.  Enforcing standards through well-publicized disciplinary guidelines. 7.  Responding promptly to detected offenses and undertaking corrective action. *Source HHS & OIG
  • 6. 6 855-85-HIPAA © 2016 Compliancy Group, LLC §  Audits •  Security/Administrative/Privacy §  Gap identification and Remediation §  Policies & Procedures §  Employee Training & Attestation §  Incident Management §  Business Associate Management §  Security Risk Analysis §  Penetration Testing §  Vulnerability Scan §  Network Security §  Managed Services §  IT Consulting §  Cloud Services REPUTATION Security Risk Assessment Compliance + Security
  • 7. 7 855-85-HIPAA © 2016 Compliancy Group, LLC Trends in HIPAA Enforcement HIPAA compliance as a differentiator §  Fitbit Inc. – announces its HIPAA compliance, stock price soared (26%) Violation Settlements in 2015 Nonprofit Alaska $150k Pharmacy Colorado $125k PhysicianPractice Indiana $750k Hospital Texas $4.4M Dentist Indiana $12k $80k Hospital&BA Connecticut 1 in 4 Americans Affected by Anthem Breach $3.5M MedicalSchool Washington $750k TeachingHospital Massachusetts $850k §  THREE Prison Sentences §  Medical License Revoked §  State Attorney General levying fines InsuranceCompany PuertoRico Campus NewYork $15k
  • 8. 8 855-85-HIPAA © 2016 Compliancy Group, LLC Phase 2 Audits - NOW §  Began: March 22, 2016 §  Covered Entities will receive an email from OCR to verify their contact information; Business Associates as well §  Failure to respond will not exclude you from potentially being audited, OCR will simply use publicly available information "The 2016 Phase 2 HIPAA Audit Program will review the policies and procedures adopted and employed by covered entities and their business associates to meet selected standards and implementation specifications of the Privacy, Security, and Breach Notification Rules.”
  • 9. 9 855-85-HIPAA © 2016 Compliancy Group, LLC Why Should I Care? §  Your clients are at risk §  You are at risk §  Limit your liabilities •  Protect PHI, reputation damage, $$$ penalties This is a Federal Mandate, NOT optional
  • 10. 10 855-85-HIPAA © 2016 Compliancy Group, LLC What Are My 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
  • 11. 11 855-85-HIPAA © 2016 Compliancy Group, LLC Insurance Holding Company §  Insurance company, Triple-S (Puerto Rico) §  Widespread non-compliance •  Failure to implement Administrative, Privacy, and Technical safeguards •  Lack of appropriate Business Associate Agreements •  Failure to conduct accurate/thorough Risk Analysis §  Settlement: $3.5 Million (11/30/15) “This case sends an important message for HIPAA Covered Entities not only about compliance with the requirements of the Security Rule, including risk analysis, but compliance with the requirements of the Privacy Rule, including those addressing business associate agreements and the minimum necessary use of protected health information.” said OCR Director Jocelyn Samuels. http://www.hhs.gov/about/news/2015/11/30/triple-s-management-corporation-settles-hhs-charges.html
  • 12. 12 855-85-HIPAA © 2016 Compliancy Group, LLC But…It Probably Won’t Happen To Me §  In a recent study, more than half of business associates (59%) reported a data breach in the last two years that involved the loss or theft of patient data. More than a quarter (29%) experienced two breaches or more. §  Of the 345 incidents reported by HHS and listed on their site under Breaches Affecting 500 or More Individuals, 74 involved a business associate (21%). Fifth Annual Benchmark Study on Privacy & Security of Healthcare Data conducted by Ponemon Institute http://media.scmagazine.com/documents/121/healthcare_privacy_security_be_30019.pdf
  • 13. 13 855-85-HIPAA © 2016 Compliancy Group, LLC HHS Wall of Shame
  • 14. 14 855-85-HIPAA © 2016 Compliancy Group, LLC Importance of BAA & Complete Risk Analysis §  North Memorial Health Care of Minnesota §  Laptop theft, 6,497 patient records §  No BAA with Billing firm §  Failed to complete a risk analysis to address all potential risks and vulnerabilities to ePHI §  Settlement: $1,550,000 (3/19/16) “Two major cornerstones of the HIPAA Rules were overlooked by this entity,” said Jocelyn Samuels, Director of OCR. “Organizations must have in place compliant Business Associate Agreements as well as an accurate and thorough risk analysis that addresses their enterprise-wide IT infrastructure. http://www.hhs.gov/about/news/2016/03/16/155-million-settlement-underscores-importance-executing-hipaa-business- associate-agreements.html
  • 15. 15 855-85-HIPAA © 2016 Compliancy Group, LLC The NEED for BAAs §  Raleigh Orthopaedic (North Carolina) §  17,300 patient records §  Handed over x-rays and associated PHI to potential business partner without first executing a business associate agreement. §  Settlement: $750,000 (4/20/16) “HIPAA’s obligation on covered entities to obtain business associate agreements is more than a mere check-the-box paperwork exercise,” said Jocelyn Samuels, Director of OCR. “It is critical for entities to know to whom they are handing PHI and to obtain assurances that the information will be protected.” http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/raleigh-orthopaedic-clinic-bulletin/ index.html
  • 16. 16 855-85-HIPAA © 2016 Compliancy Group, LLC What’s The Big Deal About HIPAA? §  Federal Mandate “LAW” •  Heavy Enforcement §  In the News §  Reputation & Fines §  2015 Fastest growing sector 3-5 Million CE’S & BA’S 70-79% Are NOT Compliant $44 Billion Incentive Dollars Paid
  • 17. 17 855-85-HIPAA © 2016 Compliancy Group, LLC Benefits Of Being Compliant §  Differentiate yourself: You become more credible than your competitors •  Announce your compliance §  Retain current clients §  New revenue streams
  • 18. 18 855-85-HIPAA © 2016 Compliancy Group, LLC Differentiate Your Company HIPAA compliance as a differentiator §  Fitbit Inc. – announces its HIPAA compliance, stock price soared (26%)
  • 19. 19 855-85-HIPAA © 2016 Compliancy Group, LLC MSP/ Service Provider §  Beat the competition §  New Market Opportunities §  Recurring Revenue §  Scalable offering §  Higher Margins “We see The Guard as a solution that remedied our concerns about providing compliance support for our clients that also suited their needs to a tee. Liability has never been an issue, and Compliancy Group’s proven track record of not having a single client ever fail an OCR audit has proven true with our clients as well. They cared about fitting The Guard into our pre-existing business, and with the marketing and sales support they’ve even held private webinars just for the benefit of our clients. Compliancy Group and their team of Compliance Coaches has let us focus on the security work we’ve always provided while enhancing our offerings with a powerful total compliance solution that we know will work for our clients.”– George Passidakis, Director of Sales and Market
  • 20. 20 855-85-HIPAA © 2016 Compliancy Group, LLC Adding Compliance To Your Offerings §  Increase stickiness of clients §  Added value to your offerings §  Your clients are compliant and so are you! •  Limit liability for all parties §  New revenue stream
  • 21. 21 855-85-HIPAA © 2016 Compliancy Group, LLC How Do I Become Compliant? Business Associate Compliance Requirements: q  Audits q  Security Risk Assessment and Administrative Assessment q  Identify deficiencies q  Create remediation plans q  Security and Administrative q  Policies and Procedures q  Employee Training q  Identify CEs and BAs (BAAs) q  Incident Management q  Review of compliance – Annual/periodic
  • 22. 22 855-85-HIPAA © 2016 Compliancy Group, LLC Solving The HIPAA Compliance Puzzle Audits SRA (Security Risk Assessment), Administrative, Privacy Remediation Plan Policies, Procedures & Training Business Associate Management Incident Management & Remediation Document Version Employee Attestation & Tracking
  • 23. 23 855-85-HIPAA © 2016 Compliancy Group, LLC Compliance Questions? For more information, contact: Marc Haskelson 855.854.4722 ext 507 marc@compliancygroup.com