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Business Associate
Assessment
Presenter’s Background
                Blair Jerome, PhD has worked in
                 public and private education for over
                 twenty years. Blair has designed and
                 taught courses for both the IT and
Pharmaceutical Industries. As an educational
administrator Blair’s experience includes working with
regulatory agencies and boards at the national,
regional and state level. Blair understands how a
changing audit landscape can impact planning,
budgeting, and decision making throughout an
organization.                                            2
Who are we
 EHR 2.0 Mission: To assist healthcare
 organizations develop and implement
 practices to secure IT systems and comply
 with HIPAA/HITECH regulations.
  Education

  Consulting

  Toolkit(Tools, Best Practices & Checklist)

Goal: To make compliance an enjoyable
 and painless experience
Webinar Objective

Understand and Perform Business
Associate Agreement & Assessment to
Secure Protected Health Information(PHI).




                                            4
Glossary

1.   PHI: Protected Health Information

2.   PHR: Personal Health Records

3.   HHS: Health and Human Services

4.   OCR: Office for Civil Rights

5.   HITECH: Health Information Technology for Economic
     and Clinical Health Act

                                                          5
HITECH Act

The Health Information Technology for Economic and
Clinical Health (“HITECH”) provisions of the
American Recovery and Reinvestment Act of 2009
(“ARRA”, also referred to as the “Stimulus Bill”) codify and
expand on many of the requirements contained in the
Health Insurance Portability and Accountability Act of 1996
(“HIPAA”) and its regulations to protect the privacy and
security of protected health information (“PHI”).




                                                               6
BA Applicability and Penalties




                                 7
BA Contracts Required




                        8
Business Associate Audit by OCR




                                  9
HITECH modifications to HIPAA

   Creating incentives for developing a meaningful use of
    electronic health records
   Changing the liability and responsibilities of Business
    Associates
   Redefining what a breach is
   Creating stricter notification standards
   Tightening enforcement
   Raising the penalties for a violation
   Creating new code and transaction sets (HIPAA 5010,
    ICD10)

                                                          10
HITECH Requirements (BA Impact)
   New Privacy Requirements for Business Associates
    i.     Breach notification
    ii.    Use and disclosure limitations apply directly to business
           associates
    iii.   Minimum necessary principle applies directly, must use limited
           datasets
   Increased penalties
   Business Associates directly liable for violations
   Business Associate Agreements must be amended
   Business Associates must impose same requirements
    on subcontractors that access PHI
HITECH Requirements (BA Impact)
   Breach:
    According to HITECH, a breach is: the unauthorized acquisition, access, use, or
    disclosure of protected health information which compromises the security or privacy of
    the protected health information, except where an unauthorized person to whom such
    information is disclosed would not reasonably have been able to retain such information.”

   Three Exceptions:
      unintentional acquisition, access, or use of protected
       health information by a workforce member
      inadvertent disclosure of protected health information
       from a person authorized to access protected health
       information at a covered entity or business associate
      covered entity or business associate has a good faith
       belief that the unauthorized individual, to whom the
       impermissible disclosure was made, would not have
       been able to retain the information.
What Is a “Business Associate?

A “business associate” is a person or entity that
performs certain functions or activities that
involve the use or disclosure of protected health
information on behalf of, or provides services to,
a covered entity.
A member of the covered entity’s workforce is
not a business associate.


                                                     13
Examples of a Business Associate

   A third party administrator that assists a health
    plan with claims processing.
   A CPA firm whose accounting services to a
    health care provider involves access to
    protected health information.
   An attorney whose legal services to a health
    plan involves access to protected health
    information.

                                                        14
Examples of No Business Associate
    Relationship

   Physician Services
   Nursing Services
   Laboratory Services
   Radiology Services
   Physical Therapy
   Occupational Therapy
   Bank Services
   Courier Services
                                        15
Responsibilities, Obligations and
    Duties of BA

   Must comply with HIPAA
   May not use or disclose PHI
   Minimum necessary use
   Civil and criminal liability directly




                                            16
Business Associate Cycle




 Covered Entity                  BA                                 HHS/OCR




      • BA Contract                         • HIPAA Privacy and
      • Breach Notification                 Security Rule
                                            • Minimum Necessary
                                            • Breach Notification
                                 Sub-
                              contractors
                                                                              17
HIPAA Titles - Overview




                          18
HIPAA Security Rule




                      19
Information Security Model

                   Confidentiality
                   Limiting information access and
                   disclosure to authorized users (the right
                   people)

                   Integrity
                   Trustworthiness of information
                   resources (no inappropriate changes)

                   Availability
                   Availability of information resources (at
                   the right time)

                                                        20
PHI


         Health
      Information



      Individually
      Identifiable
         Health
      Information




          PHI



                     21
ePHI – 18 Elements
                 Elements                                             Examples
Name                                           Max Bialystock
                                                1355 Seasonal Lane
Address                                         (all geographic subdivisions smaller than state,
                                               including street address, city, county, or ZIP code)
Dates related to an individual                 Birth, death, admission, discharge
                                               212 555 1234, home, office, mobile etc.,
Telephone numbers
                                               212 555 1234
Fax number
Email address                                  LeonT@Hotmail.com, personal, official
Social Security number                         239-68-9807
Medical record number                          189-88876
Health plan beneficiary number                 123-ir-2222-98
Account number                                 333389
Certificate/license number                     3908763 NY
Any vehicle or other device serial number      SZV4016
Device identifiers or serial numbers           Unique Medical Devices
Web URL                                        www.rickymartin.com
Internet Protocol (IP) address numbers         19.180.240.15
Finger or voice prints                          finger.jpg
Photographic images                             mypicture.jpg
Any other characteristic that could uniquely                                                          22
identify the individual
Business Associate Requirement Chart
  Requirements             Tier 1           Tier 2       Tier 3

 Right to Audit &
                            Yes            May be         No
     Review

Baseline Security
                            Yes              No           No
   Controls
  Standards and
   Certification            Yes            May be         No
     Clause
                      Every 6 months or
 Contract Review                          Every year   Every year
                      any major change

Breach Notification       Stringent       Standard     Standard

   Training and
                            Yes              Yes          Yes
    Education

  Periodic Risk
                            Yes            May be         N/A
  Assessment
Criteria for Business Associates

‐ Corporate size of the BA
‐ Volume of data accessed by BA
‐ Number of facilities serviced by BABA
‐ Type of services provided by BA
‐ Complexity of services provided by BA
‐ Location of BA
‐ Previous data breaches, complaints or
incidents involving BA
HIPAA Security Rule Standard                Implementati                                                                                         Yes/No/Comm
HIPAA Sections Implementation Specification                on           Requirement Description                       Solution                                  ents

                                                                         Policies and procedures to manage
164.308(a)(1)(i) Security Management Process               Required      security violations
164.308(a)(1)(ii)(                                                                                                    Penetration test, vulnerability
A)                 Risk Analysis                           Required      Conduct vulnerability assessment             assessment
                                                                                                                      SIM/SEM, patch management,
164.308(a)(1)(ii)(                                                       Implement security measures to reduce        vulnerability management, asset
B)                    Risk Management                      Required      risk of security breaches                    management, helpdesk

164.308(a)(1)(ii)(                                                       Worker sanction for policies and             Security policy document
C)                    Sanction Policy                      Required      procedures violations                        management

164.308(a)(1)(ii)(                                                                                                    Log aggregation, log analysis, security
D)                    Information System Activity Review   Required      Procedures to review system activity         event management, host IDS

                                                                         Identify security official responsible for
164.308(a)(2)        Assigned Security Responsibility      Required      policies and procedures

                                                                         Implement policies and procedures to
164.308(a)(3)(i) Workforce Security                        Required      ensure appropriate PHI access
                                                                                                                Mandatory, discretionary and role-
164.308(a)(3)(ii)(                                                                                              based access control: ACL, native OS
A)                    Authorization and/or Supervision     Addressable Authorization/supervision for PHI access policy enforcement
164.308(a)(3)(ii)(                                                     Procedures to ensure appropriate PHI
B)                    Workforce Clearance Procedure        Addressable access                                   Background checks

164.308(a)(3)(ii)(                                                     Procedures to terminate PHI access             Single sign-on, identity management,
C)                    Termination Procedures               Addressable security policy document management            access controls
                                                                       Policies and procedures to authorize
164.308(a)(4)(i) Information Access Management             Required    access to PHI

164.308(a)(4)(ii)( Isolation Health Clearinghouse                        Policies and procedures to separate PHI Application proxy, firewall, mandatory
A)                Functions                                Required      from other operations                   UPN, SOCKS

164.308(a)(4)(ii)(                                                     Policies and procedures to authorize           Mandatory, discretionary and role-
B)                  Access Authorization                   Addressable access to PHI                                  based access control
164.308(a)(4)(ii)( Access Establishment and                            Policies and procedures to grant access        Security policy document
C)                 Modification                            Addressable to PHI                                         management
                                                                       Training program for workers and
164.308(a)(5)(i) Security Awareness Training               Required    managers

164.308(a)(5)(ii)(                                                                                                    Sign-on screen, screen savers,
A)                    Security Reminders                   Addressable Distribute periodic security updates           monthly memos, e-mail, banners
Sample Business Associate
Agreement


 Send us an e-mail at info@ehr20.com for
 sample BAA




                                           26
Trends in Healthcare IT


        Informatics   Collaboration




         Mobile           EHR
        Computing         HIE

                                      27
Handheld Usage in Healthcare

• 25% usage with providers

• Another 21% expected to use

• 38% physicians use medical
  apps

• 70% think it is a high priority

• 1/3 use hand-held for accessing EMR/EHR
                                            28

compTIA 2011 Survey
EMR and EHR systems




                      29
Health Information Exchange (HIE)




                                    30
Social Media
   How does your practice use it?

   How do your employees use it?

   Do you have policies?




                                     31
Cloud-based services
                                 Public Cloud
                                     EHR Applications
    HIPAA regulations                Private-label e-mail
    remain barriers to full
    cloud adoption
                                 Private Cloud
                                     Archiving of Images
                                     File Sharing
Cloud Computing is taking
all batch processing, and            On-line Backups
farming it out to a huge
central or virtualized
                                 Hybrid                     32

computers.
Informatics




              33
Sample Risk Analysis Template
                                      Likelihood
                        High             Medium                 Low

          High      Unencrypted     Lack of auditing on    Missing security
                    laptop ePHI        EHR systems      patches on web server
                                                           hosting patient
                                                             information
Impact




         Medium       Unsecured      Outdated anti-virus External hard drives
                  wireless network       software        not being backed up
                  in doctor’s office



                  Sales presentation Web server backup   Weak password on
          Low       on USB thumb tape not stored in a    internal document
                         drive        secured location         server
                                                                                34
Top 5 Recommendations
 1. Ensure encryption on all protected health information
 in storage and transit.(at least de-identification)
 2. Implement a mobile device security program.
 3. Strengthen information security user awareness and
 training programs.
 4. Ensure that business associate due diligence includes
 clearly written contract, a periodic review of
 implemented controls.
 5. Minimize sensitive data capture, storage and sharing.


                                                        35
Key Takeaways
   HITECH act treats business associates as a covered
    entity

   Processing of PHI elements drives business associates
    scope, agreement and assessment

   Updated contract and controls assessment (due
    diligence) considered as best practices for mitigating
    risks

   Periodic review of your top tier business associates and
    training requirements                                    36
Additional Resources


   HHS FAQ -
    http://www.hhs.gov/ocr/privacy/hipaa/faq/busine
    ss_associates/index.html




                                                      37
How can you help us?
   Follow-us on social media
    facebook.com/ehr20 (Like)
    linkedin.com/company/ehr-2-0 (Follow us)
    https://twitter.com/#!/EHR_20 (Follow)

   Next Webinar on HIPAA/HITECH Security Assessment ( 3/28)


   http://ehr20.com/services/


      We sincerely appreciate your referrals!              38
Thank you!!

Visit us at ehr20.com
                        39

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Business Associate Assessment, Agreement and Requirements

  • 2. Presenter’s Background Blair Jerome, PhD has worked in public and private education for over twenty years. Blair has designed and taught courses for both the IT and Pharmaceutical Industries. As an educational administrator Blair’s experience includes working with regulatory agencies and boards at the national, regional and state level. Blair understands how a changing audit landscape can impact planning, budgeting, and decision making throughout an organization. 2
  • 3. Who are we EHR 2.0 Mission: To assist healthcare organizations develop and implement practices to secure IT systems and comply with HIPAA/HITECH regulations.  Education  Consulting  Toolkit(Tools, Best Practices & Checklist) Goal: To make compliance an enjoyable and painless experience
  • 4. Webinar Objective Understand and Perform Business Associate Agreement & Assessment to Secure Protected Health Information(PHI). 4
  • 5. Glossary 1. PHI: Protected Health Information 2. PHR: Personal Health Records 3. HHS: Health and Human Services 4. OCR: Office for Civil Rights 5. HITECH: Health Information Technology for Economic and Clinical Health Act 5
  • 6. HITECH Act The Health Information Technology for Economic and Clinical Health (“HITECH”) provisions of the American Recovery and Reinvestment Act of 2009 (“ARRA”, also referred to as the “Stimulus Bill”) codify and expand on many of the requirements contained in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its regulations to protect the privacy and security of protected health information (“PHI”). 6
  • 7. BA Applicability and Penalties 7
  • 10. HITECH modifications to HIPAA  Creating incentives for developing a meaningful use of electronic health records  Changing the liability and responsibilities of Business Associates  Redefining what a breach is  Creating stricter notification standards  Tightening enforcement  Raising the penalties for a violation  Creating new code and transaction sets (HIPAA 5010, ICD10) 10
  • 11. HITECH Requirements (BA Impact)  New Privacy Requirements for Business Associates i. Breach notification ii. Use and disclosure limitations apply directly to business associates iii. Minimum necessary principle applies directly, must use limited datasets  Increased penalties  Business Associates directly liable for violations  Business Associate Agreements must be amended  Business Associates must impose same requirements on subcontractors that access PHI
  • 12. HITECH Requirements (BA Impact)  Breach: According to HITECH, a breach is: the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy of the protected health information, except where an unauthorized person to whom such information is disclosed would not reasonably have been able to retain such information.”  Three Exceptions:  unintentional acquisition, access, or use of protected health information by a workforce member  inadvertent disclosure of protected health information from a person authorized to access protected health information at a covered entity or business associate  covered entity or business associate has a good faith belief that the unauthorized individual, to whom the impermissible disclosure was made, would not have been able to retain the information.
  • 13. What Is a “Business Associate? A “business associate” is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity. A member of the covered entity’s workforce is not a business associate. 13
  • 14. Examples of a Business Associate  A third party administrator that assists a health plan with claims processing.  A CPA firm whose accounting services to a health care provider involves access to protected health information.  An attorney whose legal services to a health plan involves access to protected health information. 14
  • 15. Examples of No Business Associate Relationship  Physician Services  Nursing Services  Laboratory Services  Radiology Services  Physical Therapy  Occupational Therapy  Bank Services  Courier Services 15
  • 16. Responsibilities, Obligations and Duties of BA  Must comply with HIPAA  May not use or disclose PHI  Minimum necessary use  Civil and criminal liability directly 16
  • 17. Business Associate Cycle Covered Entity BA HHS/OCR • BA Contract • HIPAA Privacy and • Breach Notification Security Rule • Minimum Necessary • Breach Notification Sub- contractors 17
  • 18. HIPAA Titles - Overview 18
  • 20. Information Security Model Confidentiality Limiting information access and disclosure to authorized users (the right people) Integrity Trustworthiness of information resources (no inappropriate changes) Availability Availability of information resources (at the right time) 20
  • 21. PHI Health Information Individually Identifiable Health Information PHI 21
  • 22. ePHI – 18 Elements Elements Examples Name Max Bialystock 1355 Seasonal Lane Address (all geographic subdivisions smaller than state, including street address, city, county, or ZIP code) Dates related to an individual Birth, death, admission, discharge 212 555 1234, home, office, mobile etc., Telephone numbers 212 555 1234 Fax number Email address LeonT@Hotmail.com, personal, official Social Security number 239-68-9807 Medical record number 189-88876 Health plan beneficiary number 123-ir-2222-98 Account number 333389 Certificate/license number 3908763 NY Any vehicle or other device serial number SZV4016 Device identifiers or serial numbers Unique Medical Devices Web URL www.rickymartin.com Internet Protocol (IP) address numbers 19.180.240.15 Finger or voice prints finger.jpg Photographic images mypicture.jpg Any other characteristic that could uniquely 22 identify the individual
  • 23. Business Associate Requirement Chart Requirements Tier 1 Tier 2 Tier 3 Right to Audit & Yes May be No Review Baseline Security Yes No No Controls Standards and Certification Yes May be No Clause Every 6 months or Contract Review Every year Every year any major change Breach Notification Stringent Standard Standard Training and Yes Yes Yes Education Periodic Risk Yes May be N/A Assessment
  • 24. Criteria for Business Associates ‐ Corporate size of the BA ‐ Volume of data accessed by BA ‐ Number of facilities serviced by BABA ‐ Type of services provided by BA ‐ Complexity of services provided by BA ‐ Location of BA ‐ Previous data breaches, complaints or incidents involving BA
  • 25. HIPAA Security Rule Standard Implementati Yes/No/Comm HIPAA Sections Implementation Specification on Requirement Description Solution ents Policies and procedures to manage 164.308(a)(1)(i) Security Management Process Required security violations 164.308(a)(1)(ii)( Penetration test, vulnerability A) Risk Analysis Required Conduct vulnerability assessment assessment SIM/SEM, patch management, 164.308(a)(1)(ii)( Implement security measures to reduce vulnerability management, asset B) Risk Management Required risk of security breaches management, helpdesk 164.308(a)(1)(ii)( Worker sanction for policies and Security policy document C) Sanction Policy Required procedures violations management 164.308(a)(1)(ii)( Log aggregation, log analysis, security D) Information System Activity Review Required Procedures to review system activity event management, host IDS Identify security official responsible for 164.308(a)(2) Assigned Security Responsibility Required policies and procedures Implement policies and procedures to 164.308(a)(3)(i) Workforce Security Required ensure appropriate PHI access Mandatory, discretionary and role- 164.308(a)(3)(ii)( based access control: ACL, native OS A) Authorization and/or Supervision Addressable Authorization/supervision for PHI access policy enforcement 164.308(a)(3)(ii)( Procedures to ensure appropriate PHI B) Workforce Clearance Procedure Addressable access Background checks 164.308(a)(3)(ii)( Procedures to terminate PHI access Single sign-on, identity management, C) Termination Procedures Addressable security policy document management access controls Policies and procedures to authorize 164.308(a)(4)(i) Information Access Management Required access to PHI 164.308(a)(4)(ii)( Isolation Health Clearinghouse Policies and procedures to separate PHI Application proxy, firewall, mandatory A) Functions Required from other operations UPN, SOCKS 164.308(a)(4)(ii)( Policies and procedures to authorize Mandatory, discretionary and role- B) Access Authorization Addressable access to PHI based access control 164.308(a)(4)(ii)( Access Establishment and Policies and procedures to grant access Security policy document C) Modification Addressable to PHI management Training program for workers and 164.308(a)(5)(i) Security Awareness Training Required managers 164.308(a)(5)(ii)( Sign-on screen, screen savers, A) Security Reminders Addressable Distribute periodic security updates monthly memos, e-mail, banners
  • 26. Sample Business Associate Agreement Send us an e-mail at info@ehr20.com for sample BAA 26
  • 27. Trends in Healthcare IT Informatics Collaboration Mobile EHR Computing HIE 27
  • 28. Handheld Usage in Healthcare • 25% usage with providers • Another 21% expected to use • 38% physicians use medical apps • 70% think it is a high priority • 1/3 use hand-held for accessing EMR/EHR 28 compTIA 2011 Survey
  • 29. EMR and EHR systems 29
  • 31. Social Media  How does your practice use it?  How do your employees use it?  Do you have policies? 31
  • 32. Cloud-based services  Public Cloud  EHR Applications HIPAA regulations  Private-label e-mail remain barriers to full cloud adoption  Private Cloud  Archiving of Images  File Sharing Cloud Computing is taking all batch processing, and  On-line Backups farming it out to a huge central or virtualized  Hybrid 32 computers.
  • 34. Sample Risk Analysis Template Likelihood High Medium Low High Unencrypted Lack of auditing on Missing security laptop ePHI EHR systems patches on web server hosting patient information Impact Medium Unsecured Outdated anti-virus External hard drives wireless network software not being backed up in doctor’s office Sales presentation Web server backup Weak password on Low on USB thumb tape not stored in a internal document drive secured location server 34
  • 35. Top 5 Recommendations 1. Ensure encryption on all protected health information in storage and transit.(at least de-identification) 2. Implement a mobile device security program. 3. Strengthen information security user awareness and training programs. 4. Ensure that business associate due diligence includes clearly written contract, a periodic review of implemented controls. 5. Minimize sensitive data capture, storage and sharing. 35
  • 36. Key Takeaways  HITECH act treats business associates as a covered entity  Processing of PHI elements drives business associates scope, agreement and assessment  Updated contract and controls assessment (due diligence) considered as best practices for mitigating risks  Periodic review of your top tier business associates and training requirements 36
  • 37. Additional Resources  HHS FAQ - http://www.hhs.gov/ocr/privacy/hipaa/faq/busine ss_associates/index.html 37
  • 38. How can you help us?  Follow-us on social media facebook.com/ehr20 (Like) linkedin.com/company/ehr-2-0 (Follow us) https://twitter.com/#!/EHR_20 (Follow)  Next Webinar on HIPAA/HITECH Security Assessment ( 3/28)  http://ehr20.com/services/ We sincerely appreciate your referrals! 38
  • 39. Thank you!! Visit us at ehr20.com 39