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Business Associate Assurance:
What covered entities need to know
Webinar Objective

Understand the risks associated with
business associates and implement the
steps required to mitigate the risks to
secure Protected Health Information(PHI).



E-mail: info@ehr20.com

                                            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(Training, Webinar & Workshops)

 Consulting Services

 Toolkit(Tools, Best Practices & Checklist)


Goal: To make compliance an enjoyable and painless
experience, while building capability and confidence.
Glossary
1.   PHI: Protected Health Information

2.   HHS: Health and Human Services

3.   OCR: Office for Civil Rights

4.   CIA: Confidentiality, Integrity and Availability

5.   HIE: Health Information Exchange

6.   HITECH: Health Information Technology for Economic
     and Clinical Health Act
                                                          4
The American Recovery and
Reinvestment Act of 2009 and HITECH




                                      5
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)

                                                              6
BA Applicability and Penalties




                                 7
BA Contracts Required




                        8
Business Associate Audit by OCR




                                  9
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 Sub-contractors that Access PHI
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.



                                                     11
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.

                                                        12
Examples of No Business Associate
Relationship

   Physician Services
   Nursing Services
   Laboratory Services
   Radiology Services
   Physical Therapy
   Occupational Therapy
   Bank Services
   Courier Services
                                    13
Responsibilities, Obligations and
    Duties of BA

   Must comply with HIPAA
   May not use or disclose PHI
   Minimum necessary use
   Breach Notification to CE and HHS
   Direct civil and criminal liability




                                          14
Business Associate Scope




Covered Entity                    BA                                 HHS/OCR



       • BA Contract                         • HIPAA Privacy and
       • Breach Notification                 Security Rule
                                             • Minimum Necessary
                                             • Breach Notification

                                  Sub-
                               contractors

                                                                               15
HIPAA Titles - Overview




                          16
HIPAA Security Rule




                      17
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)

                                                        18
PHI


         Health
      Information



      Individually
      Identifiable
         Health
      Information




          PHI



                     19
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                                                          20
identify the individual
Criteria for Business Associates

‐ Corporate size
‐ Volume of data accessed
‐ Number of facilities serviced
‐ Type of services provided
‐ Complexity of services provided
‐ Location
‐ Previous data breaches, complaints or
incidents involving BA
BA Engagement Best Practices
  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              Yes          Yes
     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
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
BA Risk Assessment Questionnaire
Trends in Healthcare IT


        Informatics   Collaboration




         Mobile           EHR
        Computing         HIE

                                      25
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
                                            26

compTIA 2011 Survey
EMR and EHR systems




                      27
Health Information Exchange (HIE)




                                    28
Cloud-based services
                               Public Cloud
                                   EHR Applications
    Assessment and                 Private-label e-mail
    Agreement with your
    Cloud Service
    Providers
                               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                     29

computers.
Informatics




              30
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.


                                                        31
Reported Breaches involving BAs




                                                                           32
https://docs.google.com/spreadsheet/ccc?key=0ArhiA7aQWV1XdEFfNlNPTkxJbWx
PbFJvY1d1ajJCOHc
Recent Resolution Agreement
with HHS




                              33
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 risk assessment questionnaire
    (due diligence) is recommended

   Periodic review of your top tier business associates and
    training requirements
                                                               34
Additional Resources


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




                                                      35
Next Steps
   Business Associate Package
       BA Risk Assessment Questionnaire
       Sample Policies and Procedures
       4-hour Training/Consulting
      ehr20.com/services
   Next Live Webinars
       HIPAA/HITECH Security Assessment(5/2/2012)
       OCR/HHS HIPAA/HITECH Audit Preparation(5/9/2012)
        Sign-up at ehr20.com/webinars
   Career Development
        Send your resume to info@ehr20.com

                                                           36
Questions?
E-mail: info@ehr20.com
  Call: 802-448-2255

                         37
Thank you!!


              38

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Business Associate Assurance: What Covered Entities Need to Know

  • 1. Business Associate Assurance: What covered entities need to know
  • 2. Webinar Objective Understand the risks associated with business associates and implement the steps required to mitigate the risks to secure Protected Health Information(PHI). E-mail: info@ehr20.com 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(Training, Webinar & Workshops)  Consulting Services  Toolkit(Tools, Best Practices & Checklist) Goal: To make compliance an enjoyable and painless experience, while building capability and confidence.
  • 4. Glossary 1. PHI: Protected Health Information 2. HHS: Health and Human Services 3. OCR: Office for Civil Rights 4. CIA: Confidentiality, Integrity and Availability 5. HIE: Health Information Exchange 6. HITECH: Health Information Technology for Economic and Clinical Health Act 4
  • 5. The American Recovery and Reinvestment Act of 2009 and HITECH 5
  • 6. 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) 6
  • 7. BA Applicability and Penalties 7
  • 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 Sub-contractors that Access PHI
  • 11. 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. 11
  • 12. 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. 12
  • 13. Examples of No Business Associate Relationship  Physician Services  Nursing Services  Laboratory Services  Radiology Services  Physical Therapy  Occupational Therapy  Bank Services  Courier Services 13
  • 14. Responsibilities, Obligations and Duties of BA  Must comply with HIPAA  May not use or disclose PHI  Minimum necessary use  Breach Notification to CE and HHS  Direct civil and criminal liability 14
  • 15. Business Associate Scope Covered Entity BA HHS/OCR • BA Contract • HIPAA Privacy and • Breach Notification Security Rule • Minimum Necessary • Breach Notification Sub- contractors 15
  • 16. HIPAA Titles - Overview 16
  • 18. 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) 18
  • 19. PHI Health Information Individually Identifiable Health Information PHI 19
  • 20. 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 20 identify the individual
  • 21. Criteria for Business Associates ‐ Corporate size ‐ Volume of data accessed ‐ Number of facilities serviced ‐ Type of services provided ‐ Complexity of services provided ‐ Location ‐ Previous data breaches, complaints or incidents involving BA
  • 22. BA Engagement Best Practices 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 Yes Yes 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
  • 23. 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
  • 24. BA Risk Assessment Questionnaire
  • 25. Trends in Healthcare IT Informatics Collaboration Mobile EHR Computing HIE 25
  • 26. 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 26 compTIA 2011 Survey
  • 27. EMR and EHR systems 27
  • 29. Cloud-based services  Public Cloud  EHR Applications Assessment and  Private-label e-mail Agreement with your Cloud Service Providers  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 29 computers.
  • 31. 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. 31
  • 32. Reported Breaches involving BAs 32 https://docs.google.com/spreadsheet/ccc?key=0ArhiA7aQWV1XdEFfNlNPTkxJbWx PbFJvY1d1ajJCOHc
  • 34. 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 risk assessment questionnaire (due diligence) is recommended  Periodic review of your top tier business associates and training requirements 34
  • 35. Additional Resources  HHS FAQ - http://www.hhs.gov/ocr/privacy/hipaa/faq/busine ss_associates/index.html 35
  • 36. Next Steps  Business Associate Package  BA Risk Assessment Questionnaire  Sample Policies and Procedures  4-hour Training/Consulting ehr20.com/services  Next Live Webinars  HIPAA/HITECH Security Assessment(5/2/2012)  OCR/HHS HIPAA/HITECH Audit Preparation(5/9/2012) Sign-up at ehr20.com/webinars  Career Development Send your resume to info@ehr20.com 36
  • 37. Questions? E-mail: info@ehr20.com Call: 802-448-2255 37